Moderna’s COVID-19 vaccine is third approved in UK

The UK has approved the Moderna coronavirus vaccine, hard on the heels of its go-ahead in Europe, although supplies are not expected to arrive for several weeks.

Moderna’s mRNA-1273 is the third COVID-19 vaccine to be approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA) and is the second mRNA vaccine after Pfizer/BioNTech’s Comirnaty, which got the nod in December.

The UK government has ordered 17 million doses of the new vaccine, but none will be available before March, when Moderna is able to bring new production capacity online.

That means for now, the country’s immunisation programme will continue to rely on Comirnaty and the AstraZeneca/University of Oxford shot approved just before the New Year.

Around 1.5 million people in the UK have received at least one dose of either Pfizer/BioNTech or AZ vaccines, and that includes around a quarter of the over-80s age bracket who are particularly vulnerable to COVID-19.

The government’s target is to vaccinate 15 million people – around 22% of the total population – by the middle of next month.

The UK is facing a marked escalation in cases however, with the attest daily figures showing 68,000 new cases and 1,325 coronavirus-related deaths, and with a more transmissible strain of SARS-CoV-2 threatening to overwhelm the NHS.

The latest vaccine approval was welcomed by NHS Confederation chief executive Danny Mortimer, but he also stressed that “it does not mean the COVID-19 crisis today is over, especially as a major incident is declared in London, hospitalisations for coronavirus continue to rocket, and as many as one in 50 people are now infected.”

He went on: “It will…be weeks and months until the NHS feels the benefit of the vaccination programme.”

Moderna’s shot claimed conditional EU approval earlier this week, and the first supplies will start to arrive in Europe next week, according to Moderna. The European Commission has ordered 160 million doses, but Brexit means the UK will not benefit from the EU’s allocation and rollout plans.

Meanwhile, mRNA-1273 was also granted emergency use authorisation by the FDA on 18 December, with the US scheduled to receive 20 million doses by the end of 2020. Moderna has also said it aims to make 100 and 125 million more doses available in the first quarter of 2021, of which 85 to 100 million have been claimed by the US

The approval is based on trials showing mRNA-1273 had 94% efficacy in preventing disease, including in the elderly, roughly the same as the Pfizer/BioNTech shot and a little better than the 70% protection rate seen with AZ’s candidate.

The Oxfam charity welcomed that the UK now has more than enough vaccine on order to protect the entire population during 2021, but called for vaccine developers to share the science and technology behind them worldwide so less well-off countries don’t miss out.

“Nine in 10 people in the poorest countries are set to miss out on a vaccine unless the UK government and companies like Moderna urgently shift position,” said Oxfam’s health policy manager Anna Marriott.

“A failure to act is not just wrong but self-defeating and short-sighted – as long as the virus is allowed to spread in other parts of the world, public health and economic recovery in the UK will continue to be under threat,” she added.

The post Moderna’s COVID-19 vaccine is third approved in UK appeared first on .

UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine

The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules.

With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to bring the virus under control.

The UK is in a national lockdown that could last into March, with more than 62,000 new cases and 1,000 coronavirus-related deaths recorded yesterday as a more transmissible strain threatens to overwhelm the country’s health service.

As things stand, the two rival mRNA-based vaccines from Pfizer/BioNTech and Moderna are now approved for use in the EU.

Meanwhile in the UK, the Pfizer/BioNTech and AstraZeneca shots have been quickly approved.

The UK government has an order for just 7 million shots of the Moderna vaccine covering just half a percent of the population, while the European Commission has secured 160 million doses, enough to cover around 18% of the population.

US-based Moderna said that first deliveries of the vaccine in Europe will begin next week.

Moderna’s vaccine is arguably the most effective approved so far at around 95%, while AstraZeneca’s rival that has been swiftly approved in the UK ahead of Europe works in around 62% of cases when given its recommend dose.

The Pfizer/BioNTech seems to be of comparable efficiency to the Moderna shot, and is being rolled out across the UK along with the AZ vaccine.

There is evidence to suggest the AZ vaccine’s efficacy could be improved to 90% by giving a half-dose to start with, but UK regulators have not been given sufficient evidence to approve this formulation.

After a rolling review began of Moderna’s vaccine late last year, the European Commission has issued a conditional marketing authorisation the day after it was backed by regulators from the CHMP scientific committee.

Moderna has said it is in talks with the UK regulator over approval, where European Commission decisions on medicines no longer automatically apply because of Brexit.

Under Brexit transition arrangements the Medicines and Healthcare products Regulatory Authority (MHRA) will continue to adopt decisions by the European Commission on medicines.

In usual circumstances companies are required to submit an identical filing request to the MHRA after a CHMP positive opinion

The UK regulator would then follow the decision of the European Commission, which nearly always rubber-stamps the CHMP’s decision within a few weeks.

But on this occasion the process has not been possible because of the accelerated timelines for vaccine approval because of the pandemic.

Questioned by pharmaphorum, the MHRA was unable to comment on arrangements for the Moderna vaccine at the time of writing.

However Moderna said separately that it is in talks with the MHRA to get the vaccine approved.

 

 

 

The post UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine appeared first on .

Insights+: COVID-19 Healthcare News Monthly Updates – December 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. Life sciences companies are putting all of their efforts into finding a treatment or developing a vaccine for this disease. PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where we have covered news updates regarding collaborations, clinical trials, funding, and regulatory guidelines related to the COVID-19 from Jan to date.

01. NeuroRx and Relief Conclude Enrollment in their Phase 2b/3 Trial of RLF-100 for Critical COVID-19 with Respiratory Failure

Dec 29, 2020 | Clinical Trial

02. Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Dec 29, 2020 | Regulatory

03. Introducing COMIRNATY, the EU Brand Name for Pfizer & BioNTech’s COVID-19 Vaccine, Developed by Brand Institute

Dec 28, 2020 | Regulatory

04. INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine

Dec 24, 2020 | Collaboration

05. Aurobindo Pharma and COVAXX Sign an Exclusive Agreement to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

Dec 24, 2020 | Collaboration

06. Providence Therapeutics COVID-19 Vaccine Receives Health Canada Authorization to Begin Clinical Trials

Dec 23, 2020 | Regulatory

07. Serum Institute Of India And Dynavax Announce First Participants Dosed In The Phase 1/2 Clinical Trial For A COVID-19 Vaccine

Dec 23, 2020 | Clinical Trial

08. Infor and MphRx Announce Global Solution to Help Healthcare Organizations Manage COVID-19 Vaccine Inoculation with Real-World Clinical Data

Dec 22, 2020 | Clinical Trial

09. eTrueNorth Enabling Patient Recruitment in Clinical Trial to Accelerate the Use of Wearable Diagnostics for Early Identification and Containment of COVID-19

Dec 22, 2020 | Clinical Trial

10. RedHill’s Phase 2/3 COVID-19 Study of Opaganib Passes Second DSMB with Unanimous Recommendation to Continue

Dec 22, 2020 | Clinical Trial

11. RDIF, The Gamaleya National Center, AstraZeneca and R-Pharm sign an Agreement to Cooperate on COVID-19 Vaccine Development

Dec 21, 2020 | Collaboration

12. Principle LTC’s Tower Nursing & Rehabilitation Center Joins with Eli Lilly and Company on Phase 3 Drug Trial for COVID-19 Prevention

Dec 21, 2020 | Clinical Trial

13. Positive Results Show that C21 can Become an Important Complement to COVID-19 Vaccines

Dec 21, 2020 | Clinical Trial

14. ImmuneMed’s hzVSF-v13, COVID-19 Clinical Trials Accelerate Development of the Treatment

Dec 20, 2020 | Clinical Trial

15. Data from ACTT-2 Trial of Baricitinib in Hospitalized COVID-19 Patients Supportive of the U. S. FDA EUA Published in New England Journal of Medicine

Dec 19, 2020 | Clinical Trial

16. Lilly to Begin Pragmatic Study of Neutralizing Antibody Bamlanivimab (LY-CoV555) for COVID-19 in New Mexico

Dec 18, 2020 | Clinical Trial

17. Stroke and Altered Mental State Increase Risk of Death for COVID-19 Patients

Dec 18, 2020 | Clinical Trial

18. Beckman Coulter Launches One of the First High-Quality, High-Throughput COVID-19 Antigen Test Ideal for Mass Testing in the U.S.

Dec 18, 2020 | Regulatory

19. Research on Preventative Nasal Spray, Which Protects Against COVID-19 and Common Cold, Published in Leading Peer-Reviewed Academic Journals

Dec 17, 2020 | Clinical Trial

20. New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Dec 17, 2020 | Clinical Trial

21. Circuit Clinical And The Center for Integrated Global Biomedical Sciences At The University at Buffalo Join Efforts In Regional And Global COVID-19 Clinical Research

Dec 17, 2020 | Collaboration

22. Pathology Lab and Health Information Exchange Partner with iSpecimen to Bring COVID-19 Specimens to Researchers

Dec 17, 2020 | Collaboration

23. Ampion Demonstrates Safety In COVID-19 Patients And Initiates Global Clinical Trial For Intravenous Ampion

Dec 17, 2020 | Clinical Trial

24. Pressure BioSciences PCT Platform at Forefront in Generating Pivotal Findings by Diverse COVID-19 Research Teams in USA, China, and Europe

Dec 17, 2020 | Regulatory

25. BAT progresses COVID-19 candidate vaccine into Phase I human clinical trials

Dec 16, 2020 | Clinical Trial

26. International, Federal, State and Local Agencies Choose Salesforce to Help Manage their COVID-19 Vaccine Efforts

Dec 16, 2020 | Regulatory

27. Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

Dec 15, 2020 | Regulatory

28. RedHill’s Phase 2/3 COVID-19 Candidate Opaganib Reduces ARDS-Related Blood Clotting in Preclinical Model

Dec 15, 2020 | Clinical Trial

29. Muscular Dystrophy Association Releases FAQs for the Neuromuscular Disease Community for Access to the COVID-19 Vaccines

Dec 15, 2020 | Regulatory

30. Medela Announces New Data Demonstrating that Thopaz+ Digital Chest Drain Improves Safety and Helps Prevent Cross-Contamination During the COVID-19 Pandemic and Beyond

Dec 15, 2020 | Clinical Trial

31. Binx Health Receives EUA Authorizing At-Home COVID-19 Sample Collection by Universities and Employers

Dec 15, 2020 | Regulatory

32. Harbour BioMed and Utrecht University Announce License Agreement with AbbVie and Initiation of COVID-19 Antibody Clinical Trials

Dec 14, 2020 | Collaboration

33. Anixa Biosciences Covid-19 Therapy Demonstrates Comparable Potency to Remdesivir in Pre-Clinical Testing

Dec 14, 2020 | Clinical Trial

34. Emmes Announces its Contribution to Second Remdesivir Clinical Trial for COVID-19

Dec 14, 2020 | Clinical Trial

35. HLS Therapeutics Reports Efficacy and Safety Results from Pilot Study Treating COVID-19 Infected Outpatients with Vascepa (Icosapent Ethyl)

Dec 14, 2020 | Clinical Trial

36. Pharmacy Organizations Welcome FDA Authorization of COVID Vaccine: “We Stand Ready to Serve”

Dec 11, 2020 | Regulatory

37. Kintor Proxalutamide’s COVID-19 Clinical Trial Shows Significant Reduction in Hospitalization and Ventilation Rates

Dec 11, 2020 | Clinical Trial

38. Data from ACTT-2 Trial of Baricitinib in Hospitalized COVID-19 Patients Supportive of the EUA Published in New England Journal of Medicine

Dec 11, 2020 | Clinical Trial

39. ADEXUSDx COVID-19 Antibody Test Filed for Point of Care Emergency Use Authorization

Dec 10, 2020 | Regulatory

40. INOVIO and Advaccine Announce First Dosing of Subject in Phase 2 Clinical Trial for COVID-19 DNA Vaccine Candidate INO-4800 in China

Dec 10, 2020 | Clinical Trial

41. The Himalaya Drug Company shares results of a clinical study that evaluated the role of herbal immunomodulators as an adjuvant treatment in the management of COVID-19

Dec 10, 2020 | Clinical Trial

42. Pharming Announces Enrolment of First Patient in US Clinical Trial for the Treatment of COVID-19 with RUCONEST

Dec 10, 2020 | Clinical Trial

43. Cyxone Receives Regulatory Approval to Initiate a Clinical Phase 2 Study with Rabeximod in Covid-19 patients

Dec 08, 2020 | Regulatory

44. NorthShore Joins Fight Against COVID-19 with Convalescent Plasma Trials for Close Contact Exposed and Newly Diagnosed Patients

Dec 08, 2020 | Clinical Trial

45. Vicore Pharma Reports Positive Top Line Data from the ATTRACT Clinical Study in Patients with COVID-19

Dec 08, 2020 | Clinical Trial

46. Eurofins U.S. Clinical Diagnostic Laboratories Partner with Insurance Providers to Cover FDA-Authorized At-Home COVID-19 Test

Dec 07, 2020 | Collaboration

47. INOVIO Doses First Subject in Phase 2 Segment of its INNOVATE Phase 2/3 Clinical Trial for INO-4800, its DNA Medicine to Prevent COVID-19

Dec 07, 2020 | Clinical Trial

48. NeuroRx and Relief Therapeutics Meet 165 Patient Enrollment Target in Phase 2b/3 Trial of RLF-100 for Critical COVID-19 with Respiratory Failure

Dec 07, 2020 | Clinical Trial

49. Hematologists Play Vital Role in Advancing COVID-19 Research, Potential Treatments

Dec 05, 2020 | Clinical Trial

50. New CRISPR-Based Test for COVID-19 Uses a Smartphone Camera

Dec 04, 2020 | Regulatory

51. Lilly and UnitedHealth Group Partner on Pragmatic Study of Neutralizing Antibody Bamlanivimab (LY-CoV555) for COVID-19

Dec 04, 2020 | Collaboration

52. Senhwa Announces the First Patient Enrolled in an Investigator Initiated Trial Of Silmitasertib as a Treatment for COVID-19

Dec 03, 2020 | Clinical Trial

53. Ixlayer and CIC Health Partner to Make COVID-19 Tests More Accessible to School Districts and Universities

Dec 03, 2020 | Collaboration

54. Drawbridge Health Partners with University of Cambridge Researchers for Use of OneDraw Blood Collection Device in COVID-19 and Other Clinical Studies

Dec 03, 2020 | Collaboration

55. Made-in-Canada COVID Testing Now Available: LuminUltra Receives Health Canada Authorization for Rapid, Portable COVID-19 qPCR Testing Solutions

Dec 03, 2020 | Regulatory

56. INOVIO Expands Global Manufacturing Consortium For Its COVID-19 Vaccine Candidate INO-4800 With Addition of Kaneka Eurogentec S.A.

Dec 03, 2020 | Regulatory

57. Octapharma USA Presents Results of Investigational Use of Octagam 10% for Severe COVID-19 Patients at ASH Annual Meeting

Dec 02, 2020 | Clinical Trial

58. Ampio’s Phase I Study For Inhaled Ampion Advances To Completing Enrollment Of COVID-19 Patients With Respiratory Distress

Dec 02, 2020 | Clinical Trial

59. European Based Rapid PCR-COVID19 Home-Test Company Selfdiagnostics is toSubmit Request for Authorisation

Dec 02, 2020 | Regulatory

60. Celularity Announces Positive DMC Safety Review and Continuation of its Phase I/II CYNK-001-COVID-19 (CYNKCOVID) Study

Dec 01, 2020 | Clinical Trial

61. World’s Leading Life Science Companies Now Enrolling COMMUNITY, A Global, Platform Trial For Hospitalized Patients With COVID-19

Nov 30, 2020 | Clinical Trial

62. Harvard’s Wyss Institute Licenses its eRapid Technology to The iQ Group Global to Accelerate the Development of COVID-19 Diagnostics

Nov 30, 2020 | Regulatory

63. LuminUltra Expands Testing Capacity Including Range of COVID-19 Offerings with Acquisition of Source Molecular Corporation

Nov 30, 2020 | Collaboration

64. Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

Nov 30, 2020 | Clinical Trial

Related Post:-  Insights+: COVID-19 Healthcare News Monthly Updates – November 2020

The post Insights+: COVID-19 Healthcare News Monthly Updates – December 2020 first appeared on PharmaShots.

PharmaShots’ Most Read News of 2020

“Lockdown’ declared Collins Dictionary word of the year. The year 2020, well known as COVID-19 year has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements, and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2020.

1. Bayer Signs an Exclusive Option to License Agreement with Dare Biosciences to Commercialize Ovaprene in the US

  • Dare to receive up front, $20M as option exercise fee, $310M as commercial milestones, royalties on sales of the product along with access to Bayer’s clinical and market capabilities and remain responsible for development & regulatory activities of Ovaprene
  • Bayer to get exclusive right to commercialize Ovaprene in the US, once approved by the FDA. Dare is expected to file IDE for the therapy in H1’20 and the initiation of its clinical study in H2’20 following FDA’s review and clearance of the IDE
  • Ovaprene is an investigational hormone-free monthly vaginal contraceptive, currently in development for the prevention of pregnancy and if approved, will be the first monthly non-hormonal contraceptive therapy

2. Theramex to Acquire Commercial Rights of MSD’s Zoely to Expand its Footprints

  • Theramax acquires commercialization rights of Zoely, allowing it to commercialize the therapy in 50+ countries globally. Earlier, Theramax has right to commercialize Zoely in eleven countries in the EU while MSD retains rights in the US and Canada
  • The acquisition of further rights of Zoely expands Theramex global footprints by providing innovative therapies to maintain the healthcare of women
  • Zoely is a combined oral contraceptive therapy consisting of two steroid hormones: 17-beta estradiol and nomegestrol acetate

3. Gilead Signs an Exclusive License Agreement with Rockefeller University for its Portfolio of HIV Abs

  • Rockfeller to receive up front, milestones plus royalties on sales and will retain rights to perform non-clinical and early-stage clinical research on the portfolio of HIV Abs. Gilead to get exclusive rights to develop and commercialize Rockefeller’s full portfolio of HIV bNAbs
  • The focus of the agreement is to enhance Gilead’s HIV pipeline and will advance academic programs into potential future products
  • 3BNC117 and 10-1074 are clinical-stage products with the ability to be used as HIV long-acting therapies for treatment and prevention

4. Fujifilm’s CAD EYE Receives CE Mark to Support the Detection of Colonic Polyp Utilizing AI in the EU

  • Fujifilm’s CAD EYE receives CE mark, backing the real-time detection of colonic polyps during colonoscopy utilizing AI, will be available with software EW10-EC01 and the compatible expansion unit EX-1 in combination with the ELUXEO 7000 system
  • CAD EYE utilizes FUJIFILM’s REiLi AI technology and can perform complex segmentation of 2D/3D images, spot lesions & is compatible with various imaging modalities. It automatically engages with white light or LCI mode to improve the accuracy of lesion detection
  • CAD EYE is customized detection support used with the ELUXEO system, aimed to improve lesion detection in the colon at the expert level and is expected to be available with EX-1 in Mar’2020

5. GSK Reports the Acceptance of EMA’s MAA for Zejula (niraparib) as 1L Maintenance Treatment for Platinum-Responsive Advanced Ovarian Cancer

  • The EMA has accepted Type II Variation (T2V) for Zejula as maintenance therapy in a 1L setting for women with advanced platinum-responsive advanced OC, regardless of biomarker status. The validation indicates the acceptance of MAA and the initiation of CHMP’s formal review process
  • The submission is based on P-III PRIMA study assessing Zejula vs PBO in women in a ratio (2:1) as 1L therapy for stage III/ IV platinum-responsive advanced OC. The study demonstrated clinical outcomes of Zejula
  • Zejula (PO, qd) is a PARP inhibitor, indicated as a monothx. for the maintenance treatment of patients with platinum‑sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based CT

6. Esperion’s Nexlizet (bempedoic acid and ezetimibe) Tablet Receives the US FDA’s Approval as LDL-Cholesterol Lowering Medicine

  • The approval is based on P-III trial Fixed Combination Drug Product LDL-C Lowering program, involves assessing of Nexlizet vs PBO when added on to maximally tolerated statins
  • The study resulted in well-tolerated data and lowered LDL-C by 38%, when added on to maximally tolerated statins. Also, the results are published in The European Journal of Preventative Cardiology
  • Nexlizet is an oral qd, non-statin LDL-cholesterol lowering medicine approved by the US FDA on Feb 21, 2020 and will be available in Jul 2020. Nexletol (bempedoic acid) is a novel ATP Citrate Lyase inhibitor involves lowering of LDL-C by cholesterol biosynthesis and up-regulating the LDL receptors, will be available from Mar 30, 2020

7. AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III CASPIAN Study as 1L Treatment for Extensive-Stage Small Cell Lung Cancer

  • The P-III CASPIAN study involves assessing of Imfinzi + SOC (etoposide and carboplatin/ cisplatin CT) or Imfinzi + Tremelimumab vs CT as monothx. as a 1L treatment for 805 patients with ES-SCLC in 200+ centers across 23 countries
  • The first arm (Imfinzi + SOC) has met its 1EPs of OS in Jun’2019 while the second arm (Imfinzi + tremelimumab) did not meet its 1EPs of OS. The safety profile of each therapy is consistent with the known safety profiles
  • Imfinzi (durvalumab) is mAb targeting PD-L1, acts by blocking the interaction of PD-L1 with PD-1 & CD80 and is currently under review in combination with etoposide and carboplatin/cisplatin as 1L treatment for ES-SCLC in the US, EU and Japan with its anticipated PDUFA date in 2021

8. Novo Nordisk’s Fiasp (insulin aspart injection) Receives Health Canada’s Approval for Children with Diabetes

  • Health Canada has expanded the approval of Fiasp (10mL vials) to include use in insulin infusion pumps for the improvement of glycemic control in pediatric patients aged ≥2yrs with diabetes (T1D/T2D both)
  • The approval is based on data from 7 clinical studies that verified the safety & efficacy of Fiasp in children. The label change for use in insulin infusion pumps is based on Health Canada’s review of data from 5 clinical studies which demonstrated the efficacy of Fiasp used in insulin infusion pumps in adults with diabetes
  • Fiasp is the first and only fast-acting mealtime insulin injection, administered at the beginning of a meal or within 20 minutes after starting a meal and has received FDA’s approval as an IV infusion or SC MDI in adults with diabetes

9. Merck KGaA’s ERBITUX (cetuximab) Receives NMPA’s Approval as a 1L treatment for Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck

  • The approval is based on P-III CHANGE II study assessing extreme regimen (ERBITUX + cisplatin + 5-FU, followed by ERBITUX as maintenance therapy) vs Pt. based CT (cisplatin + 5-FU) in 243 patients aged ≥18 yrs. with R/M SCCHN, prior not treated with any systemic therapy in China
  • The P-III CHANGE II study results: improvement in PFS (5.5 vs 4.2mos.); OS (10.2 vs 8.4mos.), ORR (50% vs 27%) with no new safety findings
  • ERBITUX is an IgG1 mAb targeting the EGFR and is an approved therapy in 100+ countries for RAS wild-type m-CRC and for HNSCC

10. Bausch Health to Initiate Clinical Study Evaluating Virazole (Ribavirin for Inhalation Solution, USP) in Patients with COVID-19 in Canada

  • The clinical study will evaluate the safety and efficacy of Virazole + SOC in hospitalized patients aged ≥18yrs. with respiratory distress due to COVID-19
  • The clinical study has been approved by Health Canada and is expected to initiate within the next few weeks. The company is working with multiple health authorities including the US FDA regarding additional studies to assess Virazole as a treatment for COVID-19 infection
  • Virazole (ribavirin for inhalation solution, USP) aerosol is indicated only for lower respiratory tract infection due to RSV. The Bausch Foundation is working with health authorities in Italy to make Virazole for inhalation available free of charge in compassionate use in hospitals

11. Amgen Signs a Partnership with Adaptive Biotechnologies to Develop Abs for COVID-19

  • Adaptive to expand its platform for selection of B cell receptors of recovered patients from COVID-19. Amgen will utilize its Ab engineering and drug development capabilities to select and develop Abs designed to bind and neutralize SARS-CoV-2. Additionally, Amgen ‘s subsidiary DeCODE Genetics located in Iceland, will provide genetic information from patients infected with COVID-19
  • The focus of the collaboration is to combine expertise to discover and develop fully human neutralizing Abs for SARS-CoV-2 virus to treat COVID-19 where Adaptive’s immunological medicine platform will help in identification of virus neutralizing Abs
  • Additionally, the Abs can be used to treat patients with COVID-19 and can be administered to patients with who are at increased risk of exposure to SARS-CoV-2

12. BioNTech and Pfizer Complete Dosing of BNT162 in First Cohort of P-I/II Study in Germany

  • The companies reported that the first cohort of BioNTech’s P-I/II clinical trial has dosed 12 participants with BNT162 in Germany since dosing began on Apr 23, 2020. Following the regulatory approvals, both the companies plan to initiate the clinical study for BNT162 in the US
  • The dose-escalation portion of the P-I/II study will include ~200 healthy participants aged 18-55yrs. and will target a dose range of 1-100 µg, focusing on determining the optimal dose for further studies and to evaluate the safety and immunogenicity of the vaccine
  • The study will evaluate the effects of repeated vaccination following a prime injection for 3 vaccine candidates that contain uRNA or modRNA. The fourth vaccine candidate contains saRNA will be evaluated following a single dose of vaccine. Additionally, BioNTech is collaborating with Fosun Pharma to develop BNT162 in China, where the companies expect to conduct clinical studies

13. Fresenius Kabi Signs an Agreement with Medec to Commercialize IDACIO (adalimumab, biosimilar) in Germany

  • Fresenius Kabi and Medec collaborated to offer IDACIO as an additional therapy option for rheumatologists and dermatologists to treat rheumatic illnesses. From Jun 01, 2020, Medec’s will market the biosimilar therapy
  • Last year, Fresenius Kabi launched IDACIO in the EU for arthritis and psoriasis. The collaboration offers patients and doctors new benefits and synergies in therapy offerings as well as consulting
  • Medac provides methotrexate (metex PEN, metex FS) as the parenteral treatment of patients with chronic inflammatory diseases, the affected patients are treated with a combination of methotrexate and adalimumab

14. Neurocrine Biosciences Exercises its Option with Idorsia for ACT-709478

  • Idorsia to receive $45M upfront in cash, $365M for development & regulatory milestone, one-time sales threshold and royalties on sales. Additionally, will receive $7M in funding to discover, identify and develop additional novel T-type calcium channel blockers
  • Neurocrine exercises its option to license rights for ACT-709478 (post IND acceptance from the US FDA on Apr 30, 2020) for rare pediatric epilepsy. In 2019, Neurocrine and Idorsia signed a preclinical research collaboraion for ACT-709478 to treat rare pediatric epilepsy
  • ACT-709478 is an selective, orally-active and brain penetrating T-type calcium channel blocker also received the US FDA’s Rare Pediatric Disease designation for rare pediatric epilepsy with completion of P-I in 2019 and expected P-II initiation in in H2’20

15. Moderna Signs a Ten-Year Worldwide Agreement with Lonza to Manufacture mRNA-1273 Against COVID-19

  • The companies intend to establish manufacturing suites at Lonza’s facilities in the US and Switzerland to manufacture mRNA-1273 at both sites. The collaboration will deploy Lonza’s global expertise in technology transfer and manufacturing while the technology transfer expected to begin in Jun’2020
  • The focus of the collaboration is to enable the manufacturing of mRNA-1273 up to 1B doses/year and anticipates the manufacturing of the first batches of mRNA-1273 at Lonza US site in Jul’2020, assuming the currently expected dose of 50µg
  • Manufacturing operations at Lonza US site is covered by Moderna’s agreement with BARDA under which BARDA will support late-stage clinical development programs of mRNA-1273. On Apr 27, 2020, Moderna has submitted IND to the US FDA for P-II studies with its expected initiation in Q2’20

16. Roche’s Enspryng (satralizumab) Receives MHLW’s Approval for Neuromyelitis Optica Spectrum Disorder in Japan

  • The approval is based on two P-III SAkuraStar & SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx & as an add-on therapy to baseline IST vs PBO in 95 & 83 patients aged 20-70 & 13-73yrs. in a ratio (2:1) & (1:1) administered at week 0,2 & 4 in patients with NMOSD respectively
  • In overall population: reduction in the risk of relapse (62% & 55%); In the pre-specified subgroup of AQP4-IgG seropositive patients: reduction in the risk of relapse (79% & 74%) respectively
  • Enspryng is a mAb targeting IL-6 and is under PR in Canada for NMOSD patients who are AQP4-IgG seropositive. In Oct’2019, the FDA & EMA has accepted the MAA for the therapy with expected CHMP & FDA’s decision in 2020

17. Cipla Launches Cipremi (remdesivir lyophilized powder for injection 100 mg) to Treat Patients with Severe COVID-19

  • The US FDA has issued a EUA to Gilead for emergency use of remdesivir to treat hospitalized COVID-19 patients. In May, Gilead has extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s Remedisvir called CIPREMI
  • Cipla has received DCGI’s approval for restricted emergency use in India as part of the accelerated approval process. Cipla will provide training on the use of the drug, informed patient consent documents, conduct post-marketing surveillance as well as to conduct a P-IV clinical trial on Indian patients
  • As per ACTT-1 study, 1063 patients were treated with Remdesivir vs PBO over 60 centers across the US, EU and Asia demonstrated faster time to clinical recovery in hospitalized patients with the mortality rate as (7.1% vs 11.9%)

18. Sorrento Submits EUA to the US FDA for its COVI-TRACK Test to Detect COVID-19

  • Sorrento has reported that its EUA is under review at the US FDA for its COVI-TRACK in vitro diagnostic test kit for the detection of IgG and IgM Abs in sera of patients exposed to the SARS-CoV-2 virus
  • Following the issuance of an EUA, the COVI-TRACK test will be available for distribution to clinical testing sites nationwide. The assay develops three clear lines that confirm the assay validity and the qualitative detection & differentiation of IgM and IgG Abs to the COVID-19
  • Sorrento has secured manufacturing capacity to ramp up the production of up to 5M test kits/ month with the availability of results in ≤8mins. The assay showed specificity > 97% and diagnostic sensitivity of > 94% in an analytical validation

19. Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside the Japan

  •  Fujifilm to receive upfront, license fee along with royalties on sales of the therapy. Dr. Reddy’s and GRA to get the exclusive right to develop & commercialize Avigan globally (Ex- Japan). Additionally, Dr. Reddy’s would have exclusive rights for the therapy in India
  • Fujifilm will provide pre/ clinical data of Avigan to Dr. Reddy’s and GRA for utilizing it in clinical studies targeting COVID-19. Moreover, Dr. Reddy’s will get right to use Avigan’s patents of formulation and manufacturing method and will establish a setup for developing drug-like Avigan and utilizes the GRA’s global sales network to supply the manufactured drugs
  • Fujifilm is currently conducting a clinical study on Avigan targeting COVID-19 patients in the US and Japan and is collaborating with multiple companies to increase the drug’s production

20. ViiV Healthcare’s Rukobia (fostemsavir) Receives the US FDA’s Approval for HIV in Patients with Limited Treatment Options

  • The approval is based on P-III BRIGHTE study assessing Rukobia (600mg, ER) + OBT in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort
  • In the randomized cohort, 60% adults achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count @96wks., HIV-1 RNA <40 copies/mL @24 & 96wks. (53% & 60%); changes in CD4+ cell count (90 & 205 cells/mm3) respectively
  • In the nonrandomized cohort, 37% achieved HIV-1 RNA <40 copies/mL @24 & 96wks.; HIV-1 RNA <200 copies/mL (42% & 39%); mean changes in CD4+ cell count (41 & 119 cells/mm3) respectively. Fostemsavir is a first-in-class HIV-1 attachment inhibitor, currently under EMA’s review with additional submissions to regulatory authorities anticipated in 2020 & 2021

21. Zydus Launches Cheapest Version of Remdesivir at $37.41 per Vial in India

  • The company has launched Remdec at a price of $37.41 (Rs. 2800) for a 100mg lyophilized injection. The generic version is the most economical Remdesivir brand in India
  • In Jun’2020, Zydus signed a non-exclusive agreement with Gilead to manufacture and commercialize Remdesivir for severe COVID-19 in India. The API of the therapy has been developed and manufactured at the group’s API manufacturing facilities in Gujarat
  • The drug will be made available across India via Zydus’ strong distribution chain reaching out to government and private hospitals treating COVID patient

22. Johnson & Johnson to Acquire Momenta Pharmaceuticals for $6.5B

  • J&J acquires Momenta in all-cash transaction at a price of $52.50/ share, making a total deal value as $6.5B. The transaction is expected to be closed in H2’20
  • The acquisition allows J&J to expand its portfolio for autoimmune diseases with the addition of Momenta’s Nipocalimab (M281) to its pipeline. In addition to nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets
  • Janssen plans to retain Momenta’s presence in Cambridge, Massachusetts which will increase J&J footprint and capabilities in the key innovation hub. Nipocalimab provides an opportunity for Janssen to deliver transformative treatments in autoantibody-driven autoimmune diseases

23.  Novartis’ Beovu (brolucizumab) Receives EMA’s Approval for its Safety Label Update to Treat Wet Age-Related Macular Degeneration

  • The EU label update includes additional categorization of retinal vasculitis and/or retinal vascular occlusion, usually in the intraocular inflammation. The approval follows Novartis completion of safety review and initiation of an update to the Beovu prescribing information globally
  • The label update is applicable to all 27 EU member states as well as UK, Iceland, Norway, and Liechtenstein. Beovu is now approved for wet AMD treatment in 40+ countries including in the US, EU, UK, Japan, Canada, and Australia
  • Beovu (brolucizumab) is the clinically advanced humanized single-chain Ab fragment (scFv) that enhances tissue penetration, rapid clearance from the systemic circulation, and drug delivery characteristics. Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause, potential risk factors, and mitigation of AEs

24. Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

  • The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission
  • The therapy has shown a reduction in cellular damage and lung edema in preclinical studies and may provide similar benefits in patients with severe SARS-CoV-2 infection. BI 764198 was well tolerated in P-I study in healthy adults
  • BI 764198 is potent & selective inhibitor of TRPC6, focusing to reduce the need for ventilator support and to improve patient recovery rate

25. Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the treatment of Unresectable Hepatocellular Carcinoma

  • The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or sorafenib (400 mg, bid) in unresectable HCC patients who had not received prior systemic therapy which included analyses of a cohort of Chinese patients (n=194) from the same study
  • Results: Tecentriq in combination with Avastin reduced the risk of OS by 56% (among Chinese patients) and 42% (global results) & the PFS risk by 40% (among Chinese patients) and 41% (global results) as compared with sorafenib
  • IMbrave150 is the 1st P-III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Additionally. in May 2020, the US FDA approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy

26. Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s Keytruda (pembrolizumab) in Patients with Various Cancers

  • Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors
  • In preclinical studies, THOR-707 demonstrated the ability to induce the expansion of CD8+T-cells resulting in anti-tumor effects both as a single agent as well as in combination with an anti-PD1 mAb
  • THOR-707 is currently being evaluated by Sanofi in an ongoing P-I dose escalation and expansion trial assessing THOR-707 and determining its recommended P-II dose alone and in combination with anti-PD-1 and anti-EGFR antibodies

27. AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

  • Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to co-commercialize novel TATs in the US while AstraZeneca will lead commercialization in the ROW with equal profit & loss sharing globally
  • The collaboration leverages Fusion’s TAT platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of Abs and cancer therapies, including DDRis
  • Additionally, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion’s FPI-1434) and AstraZeneca’s therapies for the treatment of multiple cancers. Both companies will retain full rights to their respective assets

28. Lucira’s All-In-One Test Kit Receives the US FDA’s EUA as the First COVID-19 Test for Self-Testing at Home

  • The Lucira’s COVID-19 all-in-one test kit test has been authorized for home use with self-collected nasal swab samples in individuals aged≥ 14yrs. who are suspected of COVID-19 by their HCPs
  • It is also authorized for use in POC settings for all ages, but samples must be collected by an HCP when the test is used at the POC to test individuals <14yrs. The test is currently authorized for prescription use only
  • Lucira plans to amend its EUA or file a new EUA so people who think they’re infected with COVID-19 can communicate with a medical professional online through a website to arrange a prescription and overnight delivery of the test kit by Q2’21

29. UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

  • The acquisition will bolster UCB’s pipeline program, capabilities, and platforms in the gene therapy space. The Handl Therapeutics will continue to be based in Leuven, Belgium while working closely with UCB’s international research teams
  • In addition, the UCB collaborated with Lacerta to focus on CNS diseases, under which Lacera will lead research, preclinical activities, and the early manufacturing process development, while UCB will complete IND-enabling studies, manufacturing, and clinical development
  • The collaboration will allow UCB to access Lacerta’s expertise in AAV-based CNS targeted gene therapies, fortifying UCB’s ability to produce effective treatments for neurodegenerative diseases

30. Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

  • Janssen acquires rights to Hemera’s HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy
  • The acquisition will boost Janssen’s eye disease portfolio & strengthens its gene therapy capabilities
  • HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping to prevent further damage to the retina and preserve vision. The P-I study of the therapy for patients with geographic atrophy is completed while the P-I study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate the long-term safety

Related Post: PharmaShots’ Most Read News of 2019

The post PharmaShots’ Most Read News of 2020 first appeared on PharmaShots.

PharmaShots Weekly Snapshots (Dec 21-23, 2020)

Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer

Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s Approval, HER2-positive Breast Cancer, Phesgo, receives, Roche, Treatment

AMO Pharma Initiates P-II REACH-CDM study of AMO-02 (tideglusib) to treat Congenital Myotonic Dystrophy

Published: Dec 22, 2020 | Tags: AMO Pharma, AMO-02, Initiation, REACH-CDM, Treatment of Congenital Myotonic Dystrophy

Ocular Therapeutix Reports sNDA Submission of Dextenza (dexamethasone ophthalmic insert) to the US FDA for Ocular Itching

Published: Dec 22, 2020 | Tags: (dexamethasone ophthalmic insert), Dextenza, Ocular Itching, Ocular Therapeutix, reports, sNDA Submission, Us FDA

Janssen Initiates Rolling Submission of BLA to US FDA of Autoleucel (cilta-cel) to Treat Multiple Myeloma

Published: Dec 21, 2020 | Tags: Autoleucel (cilta-cel), BLA, Initiates, Janssen, Multiple Myeloma, Rolling, Submission, Us FDA

Voyager Therapeutics Provides Update on NBIB-1817(VY-AADC) Program to Treat Parkinson Disease

Published: Dec 22, 2020 | Tags: (VY-AADC), NBIB-1817, Parkinson Disease, Provides, Update, Voyager Therapeutics

Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment of Multiple Myeloma

Published: Dec 22, 2020 | Tags: (daratumumab), DARZALEX, Health Canada Approval, Janssen, Multiple Myeloma, receives, Treatment

AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma

Published: Dec 22, 2020 | Tags: Asthma, AstraZeneca, Corticosteroid, Dependent, Oral, P-III, patients, reports, results, Severe, SOURCE, Tezepelumab, Trial

Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19

Published: Dec 21, 2020 | Tags: (BNT162b2), BioNTech, Comirnaty, Conditional Marketing Authorization, COVID-19, EC, Pfizer, receives

Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS

Published: Dec 21, 2020 | Tags: (peginterferon beta-1a), Biogen, European Commission, Marketing Authorization, Plegridy, receives, Relapsing-Remitting MS

Servier to Acquire Agios’ Oncology Business for ~$2B

Published: Dec 21, 2020 | Tags: $2B, Agios, Agreement, business, Its, Oncology, Royalties, Sell, Servier, Signs

Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema

Published: Dec 21, 2020 | Tags: Diabetic, Edema, Faricimab, Global, Macular, P-III, reports, results, Roche, Studies, Two

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Published: Dec 21, 2020 | Tags: (osimertinib), approval, AstraZeneca, Early-Stage, EGFR-mutated Lung Cancer, receives, Tagrisso, US FDA’s

Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19

Published: Dec 18, 2020 | Tags: Against, COVID-19, EUA, Moderna, mRNA-1273, receives, US, Us FDA

Ultragenyx Signs a License Agreement with Mereo for Setrusumab in Osteogenesis Imperfecta

Published: Dec 17, 2020 | Tags: Agreement, Imperfecta, Mereo BioPharma, Osteogenesis, Setrusumab, Signs, Ultragenyx

ViiV Healthcare’s First Long-Acting Injectable Receive EC’s Approval for the Treatment of HIV

Published: Dec 21, 2020 | Tags: EC Marketing Authorization, Edurant Receives, HIV-1 Infection, Rekambys, ViiV Healthcare, Vocabria (cabotegravir)

Philips to Acquire BioTelemetry for ~$2.8B

Published: Dec 18, 2020 | Tags: Acquires, BioTelemetry, Philips

Merck Signs a ~$1B Pact with Janux to Develop Cancer Therapies Using T Cell Engager Technology

Published: Dec 18, 2020 | Tags: Agreement, Candidates, Develop, Drug, Engager, Immuno, Janux Therapeutics, Merck, Novel, Oncology, Signs, T Cell, technology, Using

GSK Signs a License Agreement with Sosei Heptares Targeting Immune Disorders of the Digestive System

Published: Dec 21, 2020 | Tags: Digestive System, Global License Agreement, GPR35, GSK, Immune Disorders, Signs, Sosei Heptares

Related News: PharmaShots Weekly Snapshots (Dec 14-18, 2020)

The post PharmaShots Weekly Snapshots (Dec 21-23, 2020) first appeared on PharmaShots.

Moderna and BioNTech – who are they?

Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. Just who are these companies and who is behind them, asks Richard Staines.

A year ago, the names Moderna and BioNTech were known mainly to those who followed biotech and pharma dealings.

But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge.

Compared with many of the established names in pharma these companies are young upstarts but they have managed to achieve what other big names in the industry have failed to do and harness the power of mRNA to make medicine.

Their technology is based on synthetic messenger RNA – short for ribose nucleic acid – which is a short transcript of a longer DNA code.

As it’s just a messenger molecule, it does not affect the body’s own genetic code when it is injected as a vaccine – but what it does do is instruct cells to code for copies of a certain protein.

In this case that is the “spike” protein seen on the surface of the coronavirus that it uses to invade host cells.

The body produces antibodies against the protein, which neutralise the virus in the event of an infection.

It’s a revolutionary approach that allowed the vaccine to be made within a few days of the SARS-CoV-2 genetic code becoming available – what’s taken months are the rigorous clinical trials that proved the vaccines were safe and effective.

There has been considerable anxiety over whether using such an untried technology would be the best approach against COVID-19.

What the companies have now proved is that the technology can be used to make safe and effective vaccines in record time.

The companies are based on opposite sides of the Atlantic – Moderna was founded in Massachusetts in 2010 under the name ModeRNA Therapeutics by a team of investors two years after BioNTech began operating from a small lab in Mainz, Germany.

But both drew on the mRNA technology developed by Katalin Kariko from the University of Pennsylvania and her collaborator Drew Weissman, an immunologist from Boston University.

Together the pair had managed to find a way to get the human body to accept strands of mRNA without an immune reaction, by tinkering with the chemical make-up of the molecule.

It was a landmark discovery that meant a technology once derided as being a pipe dream could have applications in the real world as a medicinal therapy.

Moderna’s founders were led by Derrick Rossi, a post doctorate fellow from Stanford University who championed the technology to a team from Flagship Ventures, a Massachusetts firm founded and run by Noubar Afeyan.

CEO Stephane Bancel was hired the following year from France’s bioMerieux and Moderna went on to raise more than $2.6 billion in a series of private funding rounds, while fiercely guarding any details about the technology it was developing.

This changed in 2018 when Moderna went public with what was at that time the largest IPO in biotech history.

The launch raised $500m from investors using what is arguably the slickest stock market ticker out there – MRNA.

Its portfolio of products was broad – including a drug being developed with AstraZeneca for cardiovascular diseases, a cancer immunotherapy and a potential Zika vaccine.

“I was intrigued by the personalities of the founders. They are very good doctors, scientists and entrepreneurs. Whatever they were beginning they did it with the end in mind.”

While Moderna blazed its investment trail and tried to find ways to make sure its mRNA vaccines did not produce dangerous immune reactions, a small biotech called BioNTech had licensed in the technology from Kariko and Weissman.

Run by husband-and-wife team Ugur Sahin and his wife Ozlem Tureci, BioNTech wanted to use the technology to create individualised cancer therapies.

Matthias Kromayer, a general partner at the German investment fund MIG that helped found BioNTech in 2008, said he first met the pair 15 years ago and was immediately intrigued.

He told pharmaphorum: “They are very good doctors, scientists and entrepreneurs. Whatever they were beginning they did it with the end in mind.”

The company began to strike several deals with big pharma companies to develop cancer drugs and in 2013 hired Kariko, who had spent years working on mRNA at Penn, to oversee the mRNA work as senior vice president.

Fast-forward to the beginning of 2020 and the companies realised that they would have to quickly change their research priorities to vaccine development as the coronavirus pandemic began to emerge in China.

Kromayer said the risks and opportunities to take on the coronavirus vaccine challenge were huge for BioNTech, which only went public on the Nasdaq at the end of 2019.

He said: “It was a risk – if (the vaccine) had failed it would have shed negative light on mRNA tech. But it was a once in a lifetime opportunity.”

But according to Kromayer the BioNTech team were confident that mRNA was the solution to the coronavirus problem, as mRNA sequences can be generated in such a short amount of time.

“You can manufacture mRNA vaccine overnight and still it is stable,” said Kromayer.

The rest is history – Pfizer stepped in and licensed the technology, choosing the most promising of four potential mRNA vaccines from BioNTech.

Both Moderna and Pfizer’s shots aced the quickly convened clinical trials and became the first vaccines to make it to market less than a year after the pandemic began.

Thanks to the innovation there are hopes that peoples’ lives may return to normal as 2021 progresses but according to Kromayer this is just the tip of the iceberg for mRNA therapeutics.

The founders of both Moderna and BioNTech realised early on that this is far more than just a vaccine and could be used to tackle diseases that have proved impossible to tackle with the previous generations of medical technology.

Rossi, who left Moderna in 2014 had initially thought it could be used to reprogramme cells to act like stem cells but realised its potential after a bruising encounter with Robert Langer, the legendary MIT scientist and entrepreneur.

According to Kromayer potential uses include pre-emptive vaccines for diseases such as Parkinson’s as well as to create personalised cancer therapies.

Kromayer concluded: “The message is that mRNA based medicines are not just here to serve as vaccines it is much, much, more. This will revolutionise medicine over the next 10-15 years in areas we do not even imagine.”

The post Moderna and BioNTech – who are they? appeared first on .

Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19

Shots:

  • The US FDA has authorized EUA of mRNA-1273 vaccine against COVID-19 in individuals ≥18yrs. The delivery to the US govt. will begin imminently while Moderna will continue to gather additional data and plans to file BLA for full licensure in 2021
  • Allocation and distribution will be prioritized according to populations identified by the CDC’s ACIP. The Company expects to have b/w 100-125M doses available globally in the Q1’21, with 85-100M of those available in the US
  • The US govt. ordered total 200M doses to date & retains an option to purchase up to an additional 300M doses, ~20M doses will be delivered by the end of Dec 2020

Click here ­to­ read full press release/ article | Ref: Moderna | Image: CTech

The post Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19 first appeared on PharmaShots.

Moderna’s COVID-19 vaccine is second for US after FDA green light

As expected, the FDA has moved swiftly ahead with emergency approval of Moderna’s COVID-19 vaccine after a positive assessment at its vaccines advisory committee.

The authorisation means that around six million more vaccine doses can now be rolled out in the US coronavirus immunisation programme, adding to the almost three million doses of Pfizer/BioNTech’s already-approved shot which started to be administered a few days ago.

The emergency use authorisation (EUA) for mRNA-1273 came the day after the FDA’s advisory panel voted 20-0 with one abstention that the benefits of the vaccine outweighed the risks for people aged 18 and over.

Moderna said delivery of supplies of mRNA-1273 will begin immediately, and reiterated its intention to provide 20 million doses to the US government out of its total order of more than 200 million before the end of this month.

The biotech now expects to have between 100 and 125 million doses available in the first quarter of 2021, of which 85 to 100 million have been claimed by the US.

On Friday meanwhile, the European Commission said it had exercised an option for an additional 80 million doses of Moderna’s product, taking its total order to 160 million doses. The UK has ordered seven million doses, Japan 50 million and South Korea 20 million.

The new supplies come as a quarter of a million new cases are being recorded each day in the US, the highest national rate in the world, with daily deaths averaging around 2,500 in the last couple of weeks.

Some US states re already saying they are unable to get access to promised supplies of Pfizer and BioNTech’s BNT-162b, as federal officials suggested manufacturing issues were at risk of holding up supplies of the shot – although that has been disputed by Pfizer. The US government’s objective is to have 100 million people vaccinated by April.

“It has been less than a year since the world first learned of SARS-CoV-2 and the terrible disease it can cause,” said Francis Collins, director of the US National Institutes of Health (NIH) which carried out clinical trials of mRNA-1273 and also contributed a technology used to stabilise the jab.

“To have not one but two safe and highly effective COVID-19 vaccines ready for deployment to the American public is truly a remarkable scientific achievement, and a significant step toward ending the pandemic that has caused so much suffering,” he added.

Moderna’s vaccine should be easier to distribute than the Pfizer/BioNTech shot as it requires temperatures of around -20 C for shipping – similar to a normal freezer – rather than -70 C.

The company has also updated its handling guide for the distribution for mRNA-1273 to include local transport under controlled conditions in a liquid state at 2-8 C, noting that “this important update eases the logistical burden of transporting the vaccine to more remote locations and ensures that the barriers to being vaccinated are lowered.”

The post Moderna’s COVID-19 vaccine is second for US after FDA green light appeared first on .

FDA gives nod to Moderna vaccine for Covid-19

The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.

PharmaShots Weekly Snapshots (Dec 14-18, 2020)

Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada

Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz

Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases

Published: Dec 17, 2020 | Tags: Adult, Amgen, approval, Biosimilar, CLL, GPA, MPA, NHL, patients, receives, RIABNI, Rituxan, Rituximab, rituximab-arrx, Us FDA

NOWDiagnostics Receives CE Mark for its ADEXUSDx COVID-19 Antibody Fingerstick Test

Published: Dec 17, 2020 | Tags: ADEXUSDx COVID-19, Antibody Fingerstick Test, COVID-19, Launches, NOWDiagnostics

GSK’s Benlysta (belimumab) Receives the US FDA’s Approval as the First Therapy for Active Lupus Nephritis (LN)

Published: Dec 17, 2020 | Tags: (belimumab), Active, Benlysta, GSK, Lupus Nephritis (LN), Recieves, US, US FDA’s Approval

GSK Signs an Exclusive License Agreement with Surface Oncology to Develop and Commercialize SRF813

Published: Dec 17, 2020 | Tags: Commercialize, Develop, Exclusive License Agreement, GSK, Signs, SRF813, Surface Oncology

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Published: Dec 17, 2020 | Tags: Advisory, Against, Committee, COVID-19, EUA, Moderna, receives, Supporting, US, Us FDA, vaccine, Vote

Novartis to Acquire Cadent Therapeutics for ~$770M

Published: Dec 17, 2020 | Tags: $770M, Acquire, Cadent, Novartis, therapeutics

Kite’s Tecartus (KTE-X19) Receives EC’s Conditional Marketing Authorization for R/R Mantle Cell Lymphoma

Published: Dec 16, 2020 | Tags: (KTE-X19), EC’s Conditional Marketing Authorization, Europe, Kite, receives, Relapsed or Refractory Mantle Cell Lymphoma, Tecartus, ZUMA-2 Study

Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation

Published: Dec 16, 2020 | Tags: Advanced, Amgen, KRAS G12C, Metastatic, Mutation, NDA, NSCLC, reports, Sotorasib, Submission, Us FDA

Novartis’s Zolgensma Receives Health Canada Approval as the One-Time Gene Therapy for Pediatric Patients with SMA

Published: Dec 16, 2020 | Tags: approval, Health Canada, Novartis, One-Time Gene Therapy, receives, Spinal Muscular Atrophy (SMA), Zolgensma

Novo Nordisk to Initiate a P-lll Study of Semaglutide to Treat Alzheimer Disease

Published: Dec 16, 2020 | Tags:  Alzheimer Disease, Novo Nordisk, P-lll Development, Semaglutide, Start

Novartis’s Entresto Receives the US FDA’s Advisory Committee Recommendation to Treat Patients with HFpEF

Published: Dec 15, 2020 | Tags: Advisory, Committee, Entresto, HFpEF, Novartis, patients, Positive, receives, Recommendation, Treat, USFDA

Abbott’s COVID-19 IgG Quantitative Antibody Blood Test Receives CE Mark

Published: Dec 15, 2020 | Tags: Abbott, antibody, Blood, CE Mark, COVID-19, IgG, Quantitative, receives, Test

Ellume’s COVID-19 Home Test Receives the US FDA’s EUA as First Over-the-Counter Diagnostic Test

Published: Dec 15, 2020 | Tags: Antigen, COVID-19, Ellume, EUA, receives, Test, Us FDA

Bone Health’s OsteoBoost Vibration Belt Receives the US FDA’s Breakthrough Device Designation for Osteoporosis

Published: Dec 15, 2020 | Tags: Belt, Bone Health Technologies, Breakthrough, Designation, Device, OsteoBoost, receives, USFDA, Vibration

Takeda Reports the US FDA’s Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis

Published: Dec 15, 2020 | Tags: (budesonide oral suspension), Eosinophilic Esophagitis (EoE), NDA, reports, TAK-721, Takeda, US FDA’s Acceptance

Athenex’s Klisyri (tirbanibulin) Receives the US FDA’s Approval for Actinic Keratosis on the Face or Scalp

Published: Dec 15, 2020 | Tags: (tirbanibulin), Actinic Keratosis, Athenex’s, Face, Klisyri, receives, Scalp, US FDA’s Approval

Gilead Amends Agreement with Galapagos for Development and Commercialization of Jyseleca (filgotinib)

Published: Dec 15, 2020 | Tags: Agreement, Commercialization, Development, Filgotinib, Galapagos, Gilead, Jyseleca, Signs

Lilly to Acquire Prevail Therapeutics for ~$1.04B

Published: Dec 15, 2020 | Tags: ~$1.04B, Acquire, Lilly, Prevail Therapeutics

EMA’s CHMP Recommends Four-Week Dosing Option for AstraZeneca’s Imfinzi to Treat Unresectable NSCLC

Published: Dec 15, 2020 | Tags: approval, AstraZeneca, CHMP, EU, Imfinzi, NSCLC, Recommended, Unresectable

CureVac Commences P-llb/lll Trial of CVnCoV for COVID-19

Published: Dec 14, 2020 | Tags: Commences, COVID-19, CureVac, CVnCoV, P-llb/lll Trial

Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer

Published: Dec 15, 2020 | Tags: Advanced, breast, Cancer, Cobas, Launch, Metastatic, Mutation, patients, PIK3CA, Roche, Test

Samsung Bioepis Initiates P-Ill Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Dec 14, 2020 | Tags: (Denosumab), Initiates, P-Ill Study, Prolia, Proposed Biosimilar, Samsung Bioepis, SB16

Genentech Signs a Worldwide License Agreement with Relay Therapeutics to Develop and Commercialize RLY-1971

Published: Dec 14, 2020 | Tags: Agreement, Commercialization, Develop, Genentech, Relay Therapeutics, RLY-1971, Signs, Worldwide License

Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis

Published: Dec 14, 2020 | Tags: approval, Genentech, Multiple Sclerosis, ocrelizumab, Ocrevus, Primary, Progressive, receives, Relapsing, Us FDA

Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for Approval to Treat HER2 Positive Metastatic Breast Cancer

Published: Dec 11, 2020 | Tags: approval, AstraZeneca, breast, Cancer, CHMP, Daiichi Sankyo, Deruxtecan, EU, HER2, Metastatic, Positive, Recommended, trastuzumab

Novartis’ Ruxolitinib Fails to Meet its Primary Endpoint in P-lll RUXCOVID Study for COVID-19

Published: Dec 14, 2020 | Tags: COVID-19, Novartis, P-lll, reports, results, RUXCOVID Study, ruxolitinib

AstraZeneca’s Trixeo Aerosphere Receives EU’s Approval for the Maintenance Treatment of COPD

Published: Dec 14, 2020 | Tags: AstraZeneca’s, China, EU’s Approval, Japan, moderate to severe chronic obstructive pulmonary disease (COPD), receives, Trixeo Aerosphere, US

Alvotech and Fuji Pharma Extends Agreement for the Commercialization of Four Biosimilars in Japan

Published: Dec 10, 2020 | Tags: Agreement, Alvotech, Biosimilar, Commercialization, Extends, Four, Fuji Pharma, Japan, Medicines

Pfizer and BioNTech’s BNT162b2 Receives the US FDA’s EUA to Prevent COVID-19

Date: Dec 11, 2020 | Tags: BioNTech, BLA, BNT162b2, COVID-19, EUA, files, Pfizer, Prevent, receives, Us FDA

AstraZeneca to Acquire Alexion for $39B

Published: Dec 12, 2020 | Tags: $39B, Acquires, Alexion, AstraZeneca

Related News: PharmaShots Weekly Snapshots (Dec 7-11, 2020)

The post PharmaShots Weekly Snapshots (Dec 14-18, 2020) first appeared on PharmaShots.

FDA aims for fast approval of Moderna’s COVID-19 shot after panel vote

The FDA is looking to quickly approve Moderna’s COVID-19 vaccine after it was unanimously backed by a panel of experts.

Yesterday’s advisory panel meeting voted 20-0 in favour of approving Moderna’s vaccine and although the vote is non-binding, you could probably bet your house on the FDA backing the shot as it rarely goes against the advice of its experts after such strong backing.

The vaccine was also given a glowing review by FDA staffers in a briefing document posted ahead of the meeting and looks set to become the second COVID-19 vaccine to hit the US market after Pfizer/BioNTech’s rival was approved last week.

Pfizer’s vaccine was approved within a day of a positive vote from the Vaccines and Related Biological Products Advisory Committee.

Roll-out of the Pfizer vaccine has already begun and FDA commissioner Stephen Hahn said the agency will work “rapidly” towards issuing an Emergency Use Authorization for Moderna’s shot.

The US has agreed to buy 200 million doses and there are six million doses ready move to ship as soon as the vaccine is officially approved.

Yesterday’s panel vote heard that the vaccine worked in 94% of cases, based on clinical data gathered so far, and is safe.

It is also slightly easier to move around – although it is an mRNA-based shot like Pfizer the storage temperature is around -20C, considerably less demanding than temperatures of around -75C required to maintain the integrity of its already-approved rival.

Moderna’s vaccine is also given in two shots, with the injections four weeks apart compared with the three-week interval required for Pfizer’s.

The UK has also pre-ordered seven million doses of the Moderna vaccine, which is also being reviewed by the country’s regulator the Medicines and Healthcare products Regulatory Agency (MHRA).

Canada also plans to get two million doses by March, part of a total 56 million doses ordered from Moderna.

The European Union has also announced a contract to buy 80 million doses and an option to buy 80 million more once the vaccine is formally approved.

The post FDA aims for fast approval of Moderna’s COVID-19 shot after panel vote appeared first on .

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Shots:

  • The VRBPAC voted 20-0, with one abstention that the benefits of the Moderna’s vaccine outweighed its risks for use in people aged ≥18yrs
  • The recommendation is based on data analysis from the pivotal P-III clinical study that demonstrated 94.1% efficacy
  • The US FDA’s committees provide non-binding recommendations. The FDA will take the VRBPAC’s recommendation into consideration in making a final decision on approval

Click here ­to­ read full press release/ article | Ref: Moderna | Image: Pharmaphorum

The post Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19 first appeared on PharmaShots.

Precision measurement in 2021: Why accuracy is key to the vaccine ‘cold chain’ and disrupting the spread of Covid-19

By creating new networks for 24/7 temperature monitoring, alerts and reporting, the challenges of deploying transportation at ultra-low temperatures can be overcome. This also illustrates the crucial role that precision measurement will have to play.

FDA backs Moderna COVID-19 shot ahead of emergency use vote

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%.

The document has been published just after the US started the rollout of Pfizer and BioNTech’s vaccine after it got an emergency green light last week, and ahead of an expert panel due to consider Moderna’s shot on Thursday.

If the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) agrees with the agency’s assessment it could be available before the end of the week, accelerating the pandemic immunisation programme.

Like Pfizer/BioNTech’s BNT-162b, Moderna’s mRNA-1273 is based on messenger RNA coding for the SARS-CoV-2 spike protein, and will be administered in a two-dose regimen given a few weeks apart.

The FDA says no specific safety concerns with mRNA-1273 have been seen in the 30,400-patient COVE trial that underpins the EUA application, with minor effects like fever, headache and fatigue common but manageable, a serious side effects rare.

The overall 94.5% efficacy rating two weeks after the second dose is in line with interim data from the trial, although the FDA notes that it seems to be less effective in older people.

For the 18 to 64 age group efficacy comes in at 96%, but drops to 86% in the over-65s – both values are  way above the threshold that should be needed to support emergency use during the pandemic.

The shot also worked equally well in white, black and Hispanic subjects, men and women, and those with conditions like obesity and diabetes that increase the risk of severe COVID-19.

Importantly, there was also some preliminary data pointing to a reduction in asymptomatic SARS-CoV-2 infections – something that hasn’t yet been demonstrated with other vaccines – as well as prevention of severe disease.

All told, 38 trial participants in the placebo arm of the trial tested positive for asymptomatic COVID-19 at the time of their second dose, well above the 14 positives in the mRNA-1273 arm.

If the VRBPAC votes in favour of mRNA-1273 shipments are expected to begin within 24 hours, and Moderna has said it expects to be able to provide up to 6 million doses in the initial rollout, adding to around 3 million doses of the Pfizer/BioNTech jab.

The first doses of BNT-162b are being used to treat healthcare workers and elderly people in care homes, and it will be many months before vaccinations are available for all America’s 330 million population. Both vaccines will be provided free of charge to recipients.

The federal government has already signed supply agreements with Moderna and Pfizer/BioNTech for 300 million doses in 2021, enough to dose 150 million people. mRNA-1273 requires less intensive refrigeration that BNT-162b, so could be more suitable for distribution to more remote areas of the US.

There is also hope that vaccines from Johnson & Johnson and AstraZeneca could also be available in the first quarter of 2021.

The post FDA backs Moderna COVID-19 shot ahead of emergency use vote appeared first on .

Pfizer/BioNTech COVID-19 vaccinations start across the US

Hospitals in the US have started vaccinating their front-line staff against COVID-19, as deaths in the country crossed the 300,000 threshold with more than 200,000 new cases reported yesterday.

Shipments of Pfizer/BioNTech’s mRNA vaccine BNT-162b are being shipped to hundreds of hospitals and other distribution facilities across the US, with the first three million doses earmarked for  healthcare workers and elderly.

Just three days after the FDA granted Emergency Use Authorisation for the shot, the first dose administered outside a clinical trial was given yesterday to intensive care nurse Sandra Lindsay at the Long Island Jewish Medical Center in Queens, New York.

It’s likely to be months before all eligible healthcare workers for the first wave receive vaccinations. Hopeful eyes are already turning to the Moderna’s mRNA-1273 vaccine, which is scheduled to be reviewed by FDA advisors on Thursday, to help boost available supplies.

The first nursing home residents aren’t expected to start receiving their doses until next week, according to Army General Gustave Perna, chief operating officer for Operation Warp Speed, the US vaccination task force.

The immunisation programme comes as hospitals around the country say they are already struggling to cope with the influx of COVID-19. The US has the highest death toll from the disease worldwide, ahead of Brazil, India and Mexico, and there are fears of a further spike as the holiday season gathers pace.

The US government is predicting that 20 million Americans will have received at least one of the two doses of the vaccines by the end of the year, with another 30 million set to be immunised during January and another 50 million by the end of March.

President Trump took a break from his relentless tweeting about alleged election fraud to briefly acknowledge the milestone on the path to recovery from the pandemic.

Canada also gave the first doses of BNT-162b to healthcare workers yesterday, a week after the UK started the ball rolling on its own vaccination programme – the first to get started in the world.

Because BNT-162b is made from RNA, it has strict temperature requirements and has to be stored at -70 C in dry ice to prevent it from breaking down, although it can be kept at regular refrigeration temperatures temporarily – around three days – after being defrosted for administration.

That will pose a logistical challenge for all countries, requiring a massive and carefully controlled shipping operation as doses come off the production line at Pfizer’s facility in Michigan.

Around 5 million doses of Moderna’s vaccine could be ready to ship straightaway if the FDA gives a green light, possibly as soon as Friday, with distributor McKesson handling that roll-out. Moderna’s shot is a little easier to handle as it only needs to be kept at -20 C.

Meanwhile, Operation Warp Speed’s chief executive Dr Moncef Slauoi also suggested yesterday that Johnson & Johnson could get approval for its shot in late January or early in February, while AstraZeneca may be in a position to seek FDA approval as early as February.

The post Pfizer/BioNTech COVID-19 vaccinations start across the US appeared first on .

PharmaShots Weekly Snapshots (Dec 7-11, 2020)

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing

Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, Support, Suspected, Test, Testing, Volume

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, Sign

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020

Published: Dec 10, 2020 | Tags: (atezolizumab), ESMO Virtual Congress 2020, IMvigor010 Study, Muscle-Invasive Urothelial Cancer (MIUC), P-III, reports, results, Roche, Tecentriq

Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

Published: Dec 9, 2020 | Tags: (BIIB037) US FDA, aducanumab, Alzheimer Disease, Biogen, J-NDA Submission, reports

Gilead to Acquire MYR for ~$1.4B

Published: Dec 10, 2020 | Tags: ~$1.4B, Acquire, Gilead Sciences, MYR GmbH

Boehringer Ingelheim to Acquires NBE-Therapeutics ~ $1.5B

Published: Dec 10, 2020 | Tags: Acquires, Boehringer Ingelheim, NBE-Therapeutics

Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

Published: Dec 9, 2020 | Tags: (BNT162b2), BioNTech, COVID-19, Health Canada Authorization, Interim Order, patients, Pfizer, receives

Google Launches Health Research App Focusing on Respiratory Illnesses

Published: Dec 9, 2020 | Tags: App, COVID-19, Flu, Google, Launches, Virtual Medical Research

Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

Published: Dec 9, 2020 | Tags: HR+/HER2- Metastatic Breast Cancer, Kisqali, MONALEESA-7 Trial, Novartis, P-III, reports, results

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Published: Dec 9, 2020 | Tags: Collaborates, COVID-19, Moderna, Roche, SARS-CoV-2 Ab Test, Vaccine Trials

Lilly Reports Results of Tirzepatide in P-lll SURPASS-1 Monotherapy Trial for Type-2 Diabetes

Published: Dec 9, 2020 | Tags: Lilly, Monotherapy Trial, P-lll, reports, results, SURPASS-1, Tirzepatide, Type-2 diabetes

Boehringer Ingelheim to Acquires Labor Dr. Merk & Kollegen for Boosting its Next Generation Cancer Immunology Program

Published: Dec 9, 2020 | Tags: Acquires, Boehringer, Cancer Immunology Program, Kollegen, Labor Dr. Merk, Next Generation, Strength

Elsevier Acquires Shadow Health

Published: Dec 9, 2020 | Tags: Acquires, Elsevier, Extensive Portfolio, Shadow Health

Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020

Published: Dec 8, 2020 | Tags: 62, Across, ALL, Annual, antibody, ASH, Bispecific, Blood, cancers, Data, From, Meeting, Portfolio, Presents, Range, Roche, Virtual

Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation

Published: Dec 8, 2020 | Tags: Advanced or Metastatic Non-Small Cell Lung Cancer, Amgen, Breakthrough Therapy Designation, KRAS G12C, Mutation, receives, Sotorasib, US FDA’s

Medtronic Launches Carpediem as the First Pediatric and Neonatal Acute Dialysis Machine in the US

Published: Dec 8, 2020 | Tags: Acute, Carpediem, Dialysis, First, Launch, Machine, Medtronic, neonatal, Only, Pediatric, System, US

AstraZeneca Reports Results of AZD1222 in Interim Analysis of P-lll Program for COVID-19

Published: Dec 8, 2020 | Tags: AstraZenca, AZD1222, Clinical Trials, COVID-19, Four, Interim Analysis, P-lll, reports, results

Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial

Published: Dec 8, 2020 | Tags: (ABL001), ASCEMBL Study, Asciminib, Chronic, Chronic Myeloid Leukemia, Novartis, P-lll, Philadelphia Chromosome, reports, results

RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

Published: Dec 8, 2020 | Tags: Artificial Intelligence, Multi-Year Collaboration, Novartis, Ophthalmology, Provide, RetinAI, Signs, Solutions

Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2

Published: Dec 7, 2020 | Tags: Agreement, Astellas, Commercialization, Development, KaliVir Immunotherapeutics, Novel, Oncolytic, Signs, VET2-L2, Virus

Qiagen Launches QuantiFERON SARS-CoV-2 RUO Solution for COVID-19

Published: Dec 7, 2020 | Tags: COVID-19, Launches, Qiagen, QuantiFERON, SARS-CoV-2 RUO, Solution

Bayer Signs an Exclusive Worldwide License Agreement with Atara for Mesothelin-Targeted CAR T-cell Therapies to Treat Solid Tumors

Published: Dec 6, 2020 | Tags: Agreement, Atara, Bayer, Exclusive, License, Mesothelin-Targeted CAR T-cell Therapies, Signs, Solid Tumors, Worldwide

Nektar Therapeutics Presents Preclinical Data of NKTR-255 in P-Ib/II Study at ASH 2020

Published: Dec 7, 2020 | Tags: 2020, 62nd, Annual, ASH, Meeting, Nektar Therapeutics, NKTR-255, P-Ib/II, preclinical, Presents, results, study

AbbVie Reports Results of Imbruvica (ibrutinib) in Two P-III Studies as 1L Treatment for Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, AbbVie, CLL, ILLUMINATE Study, Imbruvica, Integrated Analysis, Long-Term, P-lll, reports, RESONATE-2

Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma

Published: Dec 7, 2020 | Tags: (polatuzumab vedotin), (R/R) Diffuse Large B-Cell Lymphoma, Bendamustine, GO29365 Study, MabThera / Rituxan (rituximab), P-lb/ll, Polivy, reports, Result, Roche

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

Published: Dec 7, 2020 | Tags: 62nd, Annual, ASH, Haemophilia A, HAVEN, Hemlibra, I-IV, Meeting, P-III, People, Presents, results, Roche, Studies, Virtual

AstraZeneca Reports Long-Term Efficacy and Tolerability of Calquence (acalabrutinib) in P-ll ACE-LY-004 Study for MCL

Published: Dec 7, 2020 | Tags: (acalabrutinib) in P-ll ACE-LY-004 Study for Relapsed or Refractory Mantle Cell Lymphoma, AstraZenca, Calquence, Long-Term Efficacy, reports, Tolerability

Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia

Published: Dec 5, 2020 | Tags: Based, CLL14, combination, MURANO, P-III, People, R/R CLL, reports, results, Roche, Studies, Venclexta, Venclyxto

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin Lymphoma

Published: Dec 5, 2020 | Tags: Adult, iNHL, Kite, P-II, patients, Refractory, Relapsed, reports, results, study, Yescarta, ZUMA-5

Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment for High-Risk Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, High-Risk Chronic Lymphocytic Leukaemia, ILLUMINATE Study, Imbruvica, Janssen, P-lll, reports, RESONATE-2, results

Related Post: PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

The post PharmaShots Weekly Snapshots (Dec 7-11, 2020) first appeared on PharmaShots.

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Shots:

  • Roche allied with Moderna to utilize the Elecsys anti-SARS-CoV-2 S Ab test in mRNA-1273 study. The collaboration will facilitate the quantitative measurement of SARS-CoV-2 Abs and help to establish a correlation b/w vaccine-induced protection and levels of anti-RBD Abs
  • The alliance follows US FDA’s EUA for the Elecsys anti-SARS-CoV-2 S Ab test. Moderna’s vaccine is in late-stage trials with 30,000+ participants, showed the efficacy of 94% in preventing COVID-19, and is designed to trigger an Ab response to proteins found on the coronavirus spike’s receptor-binding domain
  • Elecsys Anti-SARS-CoV-2 is an immunoassay for the qualitative, in vitro detection of Abs (including IgG) to SARS-CoV-2

Click here to­ read full press release/ article | Ref: Roche | Image: The Conversation

The post Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials first appeared on PharmaShots.

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Shots:

  • Roche allied with Moderna to utilize the Elecsys anti-SARS-CoV-2 S Ab test in mRNA-1273 study. The collaboration will facilitate the quantitative measurement of SARS-CoV-2 Abs and help to establish a correlation b/w vaccine-induced protection and levels of anti-RBD Abs
  • The alliance follows US FDA’s EUA for the Elecsys anti-SARS-CoV-2 S Ab test. Moderna’s vaccine is in late-stage trials with 30,000+ participants, showed the efficacy of 94% in preventing COVID-19, and is designed to trigger an Ab response to proteins found on the coronavirus spike’s receptor-binding domain
  • Elecsys Anti-SARS-CoV-2 is an immunoassay for the qualitative, in vitro detection of Abs (including IgG) to SARS-CoV-2

Click here to­ read full press release/ article | Ref: Roche | Image: The Conversation

The post Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M

Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat

Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC

Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, Jazz Pharma, P-III, patients, PharmaMar, results, SCLC, study, Zepzelca

reMYND Commences P-l Study of RES19-T for Alzheimer’s Disease

Published: Dec 3, 2020 | Tags: Alzheimer, Commencement, First-in-Human, P-l, reMYND, RES19-T, Treatment, Trial

Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes

Published: Dec 2, 2020 | Tags: Abbott, Adults, approval, canada, Children, Diabetes, FreeStyle Libre 2, health, receives

Exactech Acquires Muvr and its Digital Health Tech for Orthopedic Practices

Published: Dec 2, 2020 | Tags: Acquires, Exactech, Muvr Labs, Orthopedic

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Published: Dec 3, 2020 | Tags: Janssen, Reports, BLA Submission, Amivantamab, US FDA, Metastatic NSCLC, EGFR Exon 20 Insertion Mutations

Merck KGaA Collaborates with Artios Pharma for DNA Damage Cancer Therapies

Published: Dec 3, 2020 | Tags: Agreement, Artios Pharma, Damage, DNA, Merck KGaA, Novel, Oncology, Response, Signs, Targets

Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

Published: Dec 2, 2020 | Tags: Acquires, Age Related Macular Degeneration, Biosciences, Gene, Hemera, Janssen, Late, Novel, Pioneering, Rights, Solutions, Stage, therapy, Treatment

AstraZeneca to Unveil its Robust Pipeline of Breast Cancer at SABCS

Published: Dec 3, 2020 | Tags: AstraZenca, DESTINY-Breast01, Enhertu, HER2 -Positive Metastatic Breast Cancer, HR, P-l, P-ll, reports, results, SERD AZD9833, SERENA-1 Study

AbbVie Collaborates with Frontier Medicines to Develop Novel Therapies and E3 Degraders Against Difficult-to-Drug Targets

Published: Dec 2, 2020 | Tags: AbbVie, Agreement, Develop, Discover, E3 Degraders, Frontier Medicines, Novel Therapies, Sign

Roche’s Elecsys Anti-SARS-CoV-2 S Receives the US FDA’s EUA to Detect Ab Against SARS-CoV-2 Spike Protein

Published: Dec 2, 2020 | Tags: (Anti-SARS-CoV-2 S), COVID-19, Elecsys, EUA, Receive, Roche’s, US FDA’s

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Published: Dec 2, 2020 | Tags: Against, BioNTech, BNT162b2, COVID-19 COVID-19, EUA, MHRA, Pfizer, receives, Regulatory, UK

Roche’s Gavreto (pralsetinib) Receives the US FDA’s Approval for Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers

Published: Dec 2, 2020 | Tags: (pralsetinib), Advanced or Metastatic RET-Mutant, Gavreto, receives, RET Fusion-Positive Thyroid Cancers, Roche’s, US FDA’s Approval

AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~$350M

Published: Dec 1, 2020 | Tags: $350M, Acquire, Agreement, AstraZeneca, CRESTOR, European, Grünenthal, Rights, rosuvastatin, Signs

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform

Published: Dec 1, 2020 | Tags: Casirivimab, Collaborates, COVID-19 Antibody Cocktail, Delivery, Gene Therapy Platform, Imdevimab, Investigate, Penn, Regeneron

Boston Scientific to Divest BTG’s Specialty Pharma Business for ~$800M

Published: Dec 1, 2020 | Tags: Agreement, Boston, BTG, business, International, Pharmaceuticals, Scientific, Sell, Signs, Specialty, Stark

BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19

Published: Dec 1, 2020 | Tags: application, BioNTech, BNT162b2, CMA, Covid-19 Vaccine, EMA, Pfizer, Submitted

Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

Published: Dec 1, 2020 | Tags: Adults, approval, Genentech Xolair, Nasal Polyps, Novartis, omalizumab, receives, US FDA

Eisai Sign a Research Agreement with Wren Therapeutics to Discover Potential Treatment for Synucleinopathies

Published: Nov 30, 2020 | Tags: Discover, Eisai, Novel Small Molecule, Research Agreement, Sign, Synucleinopathies, Wren Therapeutics

 AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol

Published: Nov 30, 2020 | Tags: Antisense, AstraZeneca, Initiates, ION449, Ionis, LDL-C, Lower, Medicine, P-IIb, PCSK9, reports, study, Targeting

Kaia Health Allied with Chiesi Group to Commercialize COPD App in Europe

Published: Nov 30, 2020 | Tags: Agreement, Chiesi Group, Europe, Kaia Health, Sign

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study

Published: Dec 1, 2020 | Tags: Amgen, COMMUNITY, COVID-19, enrolled, First, Patient, patients, reports, Takeda, Trial, UCB

Sanofi’s Dupixent (dupilumab) Receives EC’s Approval for Children with Severe Atopic Dermatitis

Published: Nov 30, 2020 | Tags: (dupilumab), Atopic Dermatitis, Dupixent, European Commission Approval, receives, Sanofi’s

Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

Published: Nov 30, 2020 | Tags: 100%, 94.1%, COVID-19, Effective, EUA, Filing, Moderna, mRNA, Severe, Shows, Today, Us FDA, vaccine

AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure

Published: Nov 30, 2020 | Tags: approval, AstraZeneca, Chronic Heart Failure, dapagliflozin, Forxiga, Japan, MHLW, receives, Treatment

AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum

Published: Nov 27, 2020 | Tags: (adalimumab), AbbVie, Additional, Eisai, Humira, Indication, MHLW Approval, Pyoderma Gangrenosum, receives

Shionogi and Nagasaki University Collaborate with the Kitasato Institute for Antimalarial Drugs

Published: Nov 25, 2020 | Tags: Agreement, Antimalarial, drugs, Kitasato Institute, Nagasaki, Shionogi, Signs, University

Shionogi Receives MHLW’s Approval for Xofluza’s sNDA to Treat Post-Exposure Prophylaxis of Influenza Virus Infection

Published: Nov 27, 2020 | Tags: (baloxavir marboxil), approval, Infection, Influenza Virus, MHLW, Post-Exposure Prophylaxis, receives, Shionogi, sNDA, Treat, Xofluza

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

Published: Nov 29, 2020 | Tags: 2M, Additional, Against, Agreement, Amends, COVID-19, doses, Government, Moderna, mRNA, mRNA-1273, UK, vaccine

Dr. Reddy’s to Divest Select Anti-Allergy brands to Dr. Reddy’s in Russia and Other CIS Countries

Published: Nov 28, 2020 | Tags:  Acquire, Dr. Reddy, Glenmark, Kazakhstan, Russia, Ukraine, Uzbekistan

Related Post: PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

The post PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020) first appeared on PharmaShots.

Pfizer cut vaccine production targets because of raw material shortage – reports

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports.

The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.

That’s enough to inoculate 25 million people as the dosing schedule involves two shots three weeks apart.

A Pfizer spokesperson told Reuters that the “scale-up of the raw material supply chain took longer than expected”.

Results from Pfizer’s clinical trial also took longer than expected to materialise and caused further delays, the spokesperson added.

Modifications to Pfizer’s production lines are complete and finished doses are being made at a rapid pace.

The Wall Street Journal reported the news first, quoting an unnamed source directly involved in the development that some early batches of raw materials had failed to meet standards, causing production delays.

The first shipments of the vaccine are reportedly in the UK following approval by the country’s medicines regulator.

Pfizer has asked the FDA for an emergency authorisation of the vaccine in the US and the US government expects to the first tranche to include about 6.4 million doses.

In a separate announcement, rival vaccine firm Moderna said it expected to have between 100 and 125 million doses available globally in the first quarter of 2021.

Of those 85-100 million will be available in the US and 15-25 million will be available outside the US.

The company said it is still on course to manufacture between 500 million and up to a billion doses of the vaccine globally in 2021.

Moderna’s vaccine is also under review by regulators including the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The UK has secured 7 million doses of Moderna’s vaccine after upping its order by 2 million earlier this week.

This could mean the UK could have access to up to 357 million doses of vaccines from seven different developers if they are all approved by regulators.

There are now more than 50 vaccines in clinical development and more than a dozen in late-stage trials, according to a regularly updated document from the World Health Organization.

The post Pfizer cut vaccine production targets because of raw material shortage – reports appeared first on .

The known unknowns of COVID-19 vaccines

News that COVID-19 vaccines are up to 95 per cent effective has scientists cautiously optimistic. But questions remain.

“There’s a long list of things we don’t know,” says Maria Sundaram, a postdoctoral fellow at the Centre for Vaccine Preventable Diseases at the University of Toronto. Health Canada is currently reviewing early findings from Moderna, Pfizer/BioNTech and, more recently, the University of Oxford/AstraZeneca. All three show promise, but not have shared their full data, instead issuing a series of press releases.

The biggest unknowns are whether these results will hold up once full study findings are published and if a similar level of protection can be expected for other COVID-19 vaccines coming down the pipeline. The results could also change once these vaccines are rolled out on a population scale. We know that these vaccines work in clinical trials but we won’t know if their effectiveness will be the same in real-world scenarios.

“There’s no way that we can see that without a vaccine being licenced,” said Sundaram.

Although the trials included a diverse group of participants, including older adults and those from racial-ethnic minorities, it’s hard to know whether these findings will be generalizable to a broad range of people once the vaccines become available, experts say. For example, there is no information about how well this vaccine works in children. All three trials reported early results only in adults over the age of 18.

In addition, we don’t know if the vaccines prevent asymptomatic transmission.

“That’s something that is often an issue when designing vaccines for respiratory viruses that are administered intramuscularly,” according to Alyson Kelvin, a virologist with the Canadian Centre for Vaccinology at Dalhousie University who has recently been seconded to work on COVID-19 vaccines. “When we give a vaccine in your arm, it’s often hard to get mucosal immunity in the upper respiratory tract,” like your nose, which is needed to stop transmission. A key for effective policy, she says, will be knowing whether someone who is vaccinated is still able to transmit the virus.

Also unknown is how well the vaccines will work in people who have already had COVID-19. All three studies excluded people with prior COVID-19 infection, although Pfizer/BioNTech and Oxford/AstraZeneca plan to look at this in a separate analysis.

As with all new vaccines, the length of protection has yet to be determined, since all three trials only began enrolling participants this summer. The companies have not disclosed how long participants were observed or whether any violated the study rules, which could change the initial efficacy estimates.

“Right now, we only have the interim data,” said Kelvin. We won’t know their long-term safety profile or whether they might cause rare side effects until after the vaccines are deployed to the public, although no safety issues have been identified to date.

“They seem to have a really positive safety profile. I haven’t seen anything that I am initially concerned with,” says Kelvin.

Protection could also be lower if people don’t adhere to the vaccine schedule. All three vaccines require two doses spaced at least three or four weeks apart.

“I think one really important question is: are people going to come back in for a second dose?” asks Sundaram. She says this might be an issue particularly if the first dose causes adverse reactions like a headache or fever.

Vaccine side effects may make people more hesitant to get vaccinated in the first place. In a StatsCan survey conducted before the recent vaccine announcements, about one in seven Canadians said they were unlikely to get a COVID-19 vaccine, citing a lack of confidence in safety and concerns about its side effects.

What about other COVID-19 vaccines in development?

All three vaccines reporting early results use newer technologies that deliver genetic material from the SARS-CoV-2 virus – either alone through what’s call messenger RNA (or mRNA, used by Pfizer/BioNTech and Moderna) or contained inside another virus or “vector” that can’t replicate on its own (Oxford/AstraZeneca). They then hijack the body’s own cells to make copies of the viral spike protein, the crown-like molecule protruding from the surface of the SARS-CoV-2 virus.

These types of vaccines have never been licenced before for use in humans.

Nine other COVID-19 vaccines are currently in late-stage trials, including four that rely on more conventional vaccine models using an inactivated (or killed) virus. These vaccines may elicit a more robust immune response that targets other viral components, not just the spike protein. They also may be better tolerated than some of the mRNA or viral vector vaccines based on earlier trial results.

Four are non-replicating viral vectors like the Oxford/AstraZeneca vaccine. These types of vaccines could have lower vaccine efficacy if people have pre-existing immunity to the vector. (Oxford/AstraZeneca tries to get around this by using a chimpanzee adenovirus, rather than a human one, as their vector.)

Others, like Novavax’s protein subunit vaccine, may be better able to generate a protective antibody response in the upper respiratory tract, which is important for blocking transmission, says Kelvin, whose lab is also developing a COVID-19 subunit vaccine.

Because they use different ways to trick the body’s immune system to produce antibodies, scientists can’t say whether these vaccines will be able to replicate the 90 to 95 per cent efficacy seen in the early trials.

“I don’t know what to expect. I’ll be honest with you,” states Sundaram. “I think it’s hard to use the results from these (three) studies to extrapolate to the other ones, especially for the other vaccine types.”

The number of doses, vaccination schedules and route of administration could also affect vaccine efficacy – along with patient factors such as age, underlying conditions and pre-existing immunity and viral factors such as genetic mutation. Experts say the latter is of less concern since SARS-CoV-2 doesn’t mutate as much as other RNA viruses, like influenza.

Looking ahead

While much remains unknown about these vaccines, these early results exceed the expectations of most scientists and bode well for other COVID-19 vaccines in development. Recently, Health Canada announced it would license a COVID-19 vaccine if it met a threshold of at least 50-per-cent efficacy.

The true impact of these new COVID-19 vaccines on curbing the pandemic will depend both on their efficacy but also their uptake on a population scale.

Given potential delays in vaccine manufacturing and rollout, a COVID-19 vaccine will likely not be enough to end the pandemic. But it will be another tool in our public health toolbox, alongside physical distancing, contact tracing and community supports, says Sundaram.

“As always, there’s more work to be done and further questions to be asked in Phase 4 studies,” says Sundaram. “But this is exactly the sort of direction that we would have hoped things would go. So, I’m very happy about that.”

The post The known unknowns of COVID-19 vaccines appeared first on Healthy Debate.

Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

Shots:

  • The P-III COVE study demonstrated 94.1% efficacy against COVID-19 and 100% efficacy against severe COVID-19. The vaccine was well tolerated with no serious safety concerns identified to date
  • Moderna plans to submit an EUA to the FDA & an application for CMA with the EMA and to progress with the rolling reviews, which have already been initiated with international regulatory agencies
  • The FDA has told Company to expect VRBPAC meeting for mRNA-1273 on Dec 17, 2020. The Company will submit data from the P-III COVE study to a peer-reviewed publication

Click here ­to­ read full press release/ article | Ref: Moderna | Image: Fox Business

The post Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study first appeared on PharmaShots.

Moderna seeks COVID vaccine okay as data backs 94% efficacy

Moderna has said it will file for US, European and UK emergency approval of its coronavirus vaccine straight away, after reporting updated phase 3 results for the shot.

The primary analysis from the 30,000-subject COVE trial of mRNA-1273 – based on 196 confirmed cases of COVID-19 – has come in at 94% efficacy, with 185 cases in the placebo arm and just 11 among those given the vaccine after two months of follow-up.

The efficacy rate is almost identical to an earlier readout after 95 confirmed cases of COVID-19 in COVE, which is being run by the US National Institute of Allergy and Infectious Diseases (NIAID), and the safety profile also looks clean, according to Moderna.

It also appears to prevent volunteers from getting very sick from the virus, as all 30 cases of severe COVID-19, and single coronavirus-related death, were in the placebo arm.

The FDA and EMA will now look at the results and see if the mRNA-based vaccine can be given a green light for widespread use, and according to Moderna the data will be discussed at a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on 17 December.

Pfizer and BioNTech’s mRNA-based shot BNT162b was the first coronavirus vaccine to be submitted for emergency approval in the US on 20 November, but at the time of writing hadn’t yet been given a green light.

AstraZeneca and the University of Oxford’s adenoviral shot AZD1222 meanwhile has also been submitted for approval in Europe under the rolling review procedure, as well as in the UK. The company expects to file for approval in the US after the readout of a US trial in 40,000 patients that hasn’t yet generated results.

While AZD1222’s efficacy hasn’t matched the mRNA vaccines in trials so far, it will be cheaper and easier to distribute as it can be kept at standard refrigeration temperatures.

As it stands, the Pfizer/BioNTech shot has to be kept at -70 degrees Celsius – although the partners are testing stability at warmer temperatures – and Moderna has data suggesting its vaccine is stable for a month in standard refrigeration once taken out of a freezer.

AZD122 is expected to cost around $4 per dose, compared to approximately $20 for BNT162b and $32-plus for mRNA-1273.

Russia’s adenoviral shot Sputnik V meanwhile has a claimed efficacy of 92%, will cost less than $10 a dose, and can also be stored at standard fridge temperatures.

Moderna said that it will also seek prequalification and emergency use listing from the World Health Organization (WHO), which provide a route to market for vaccines, drugs and other healthcare products that meet pressing public health needs, particularly in low- and middle-income countries.

As with the other vaccine data readouts, there are still a lot of unanswered questions, including whether the shots can cut viral transmission rates – including asymptomatic transmission – how long protection may last, the impact on hospitalisation rates, and long-term safety.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death,” commented Moderna’s chief executive Stéphane Bancel.

The US biotech has reiterated its expectation of having 20 million doses of mRNA-1273 available by the end of the year, which is earmarked to supply the US, which has ordered 100 million doses. 50 million doses are also due to head to Japan, and 20 million to Canada, while the UK has just raised its order to 7 million.

Shares of Moderna were up more than 16% on the Nasdaq as the markets opened in the US.

The post Moderna seeks COVID vaccine okay as data backs 94% efficacy appeared first on .

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

Shots:

  • Moderna amended its current supply agreement with the UK govt. for an additional 2M doses of mRNA-1273 against COVID-19. The UK govt. has now secured 7M doses of mRNA-1273
  • The agreement reflects Moderna’s commitment to making its vaccine available in multiple countries. Moderna ramp up its global manufacturing to be able to deliver ~500M doses/yr & possibly ~1B doses/yr, beginning in 2021
  • The company is working with its strategic manufacturing partners, Lonza of Switzerland and ROVI of Spain, for manufacturing and fill-finish outside the US. Additionally, Moderna reported that the vaccine showed 94.5% efficacy

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Stat

The post Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine first appeared on PharmaShots.

Concerns emerge after AZ’s lucky vaccine trial ‘mistake’

AstraZeneca may have tried a positive spin on the trial mistake that led to the accidental discovery of the low dose COVID-19 vaccine regime with the highest efficacy– but the revelation has drawn a mixed response from commentators.

The company’s share price has tumbled since the announcement of the trial results from AZD-1222 at the beginning of the week, reflecting an overall loss of confidence in the company’s handling of the trial.

This was also reflected in numerous press reports that called into question the strength of the findings, particularly in the smaller group of patients who were given the lower dose.

As pointed out by the New York Times, there were fewer than 2,800 volunteers who got the more effective dose, which was accidentally given at half strength followed by a full strength dose 28 days later.

There were more than 23,000 participants in the data from the UK and Brazil, and the numbers used to calculate efficacy are lower than those used by rivals such as Moderna and Pfizer/BioNtech to calculate efficacy.

Pfizer tested its vaccine on more than 43,000 people and Moderna based its findings on more than 30,000 patients.

And then there’s the question of the deviation from the trial protocol that AZ’s research chief Mene Pangalos admitted to earlier this week.

After realising several thousand volunteers had accidentally received the wrong dose, Oxford University academics running the trial decided to press on regardless with the weaker dosing regime, breaking with the predetermined design.

As pointed out by Canada’s CBC, the change was okayed by regulators but nevertheless the stronger effect could still be a statistical quirk.

There was another confounding factor in that none of the people in the low-dose group were more than 55 years old.

Younger people would tend to produce a stronger immune response than older people, which could account for the differing results.

The decision to pool results and give a composite figure from the two dose strengths is another factor that is causing concern.

Moncef Slaoui, who leads the US COVID-19 vaccine programme Operation Warp Speed has told reports that his team are trying to determine what immune response the vaccine produced.

A separate study being conducted in the US may be modified to include the half-dose followed by a full strength booster, said Slaoui, who used to be GlaxoSmithKline’s vaccines chief.

Many reports point out that AZ’s shot has an advantage in that it can be stored in fridges instead of at the ultra-cool temperatures required by those from Moderna and Pfizer.

But trial results from these mRNA-based rivals seem to be much cleaner and could pave the way to faster decisions from regulators, which could be due in the next few days.

The post Concerns emerge after AZ’s lucky vaccine trial ‘mistake’ appeared first on .

PharmaShots Weekly Snapshot (Nov 16-20, 2020)

Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19

Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli Lilly, Emergency Use Authorization, FDA’s, Incyte, receives, Remdesivir

Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS

Published: Nov 20,2020 | Tags: Agreement, ARDS, Commercialize, Develop, Manufacture, Mesoblast, Novartis, Remestemcel-L, Signs, Treatment

Alvotech Reports the US FDA and EMA’s Acceptance of AVT02 Proposed Biosimilar to Humira (adalimumab)

Published: Nov 20,2020 | Tags: (adalimumab), Alvotech, AVT-301 Study, AVT-GL-101, AVT02, Chronic Plaque Psoriasis, EMA, Humira, Proposed Biosimilar, Regulatory Applications, Submits, Us FDA

Lilly Signs Agreement with Ypsomed to Advance an Automated Insulin Delivery System for People with Diabetes

Published: Nov 20, 2020 | Tags: Lilly, Signs, Agreement, Ypsomed, Advance, Automated Insulin Delivery System, People, Diabetes

Pfizer And LianBio Collaborate to Expand the Development of Novel Therapeutics in Greater China

Published: Nov 20, 2020 | Tags: Pfizer, LianBio, Collaborate, Expand, Development, Novel Therapeutics, Greater China

AstraZenca’s Imfinzi (durvalumab) Receives the US FDA’s Approval for Less-Frequent Fixed-Dose Use

Published: Nov 20,2020 | Tags: AstraZenca, CASPIAN Study, durvalumab, Imfinzi, P-lll, PACIFIC, US FDA’s

Chiesi’s Bronchitol (mannitol) Inhalation Powder Receives the US FDA’s Approval for Cystic Fibrosis

Published: Nov 19, 2020 | Tags: approval, Bronchitol, Chiesi, Cystic Fibrosis, Inhalation, Mannitol, Powder, Pulmonary, receives, US FDA

Lucira’s All-In-One Test Kit Receives the US FDA’s EUA as the First COVID-19 Test for Self-Testing at Home

Published: Nov 19, 2020 | Tags: Authorization, COVID-19, First, Home, Lucira, Lucira Health, Molecular, Prescription, receives, Test, Us FDA

Bayer to Fund Five New Startup Companies as Part of G4A Digital Health Partnerships Program

Published: Nov 19, 2020 | Tags: Bayer, Collaborate, Developed, G4A Digital Health, Healthcare Solutions, Integrated

ViiV’s PROgress Study Demonstrates Inclusion of PROs into Clinical Practice Can Improve HIV Care

Published: Nov 19, 2020 | Tags: Progress, reports, results, study, ViiV Healthcare

Pear Therapeutics Launches Somryst Insomnia App Via an End-to-End Virtual Care Experience

Published: Nov 19, 2020 | Tags: Chronic Insomnia, Launches, Pear Therapeutics, Somryst

Pfizer and BioNTech’s BNT162b2 Demonstrates 95% Efficacy in Preventing COVID-19

Published: Nov 19, 2020 | Tags: 95%, BioNTech, BNT162b2, COVID-19, Demonstrates, Efficacy, Pfizer, Preventing

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza

Published: Nov 19, 2020 | Tags: EC’s, Influenza, Marketing Authorization, patients, quadrivalent recombinant influenza vaccine, receives, Sanofi, Supemtek

Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders

Published: Nov 18,2020 | Tags: Acceptance, Biogen, Biosimilar, FDA Filing, Lucentis, ranibizumab, Retinal Vascular Disorders, Samsung Bioepis, SB11

BioMarin Pharmaceutical Signs an Agreement with Deep Genomics on Advancing Programs Identified Using Artificial Intelligence

Published: Nov 18, 2020 | Tags: Advancing, Agreement, Artificial Intelligence, BioMarin Pharmaceutical, Deep Genomics, Identified, Programs, Signs, Using

Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2

Published: Nov 18, 2020 | Tags: 4, COVID-19, Delivery, Deployment, Immunization, Pfizer, Pilot, Program, states, Updates, US,

Sanofi’s Avalglucosidase alfa Receives US FDA’s Priority Review as Enzyme Replacement Therapy for Pompe Disease

Published: Nov 18, 2020 | Tags: Avalglucosidase-alfa, BLA, Enzyme Replacement Therapy, Pompe disease, Priority Review, receives, Sanofi, US, FDA

ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention

Published: Nov 18,2020 | Tags: Breakthrough, Cabotegravir, Designation, HIV, receives, therapy, Us FDA, ViiV Healthcare

Bayer’s Finerenone Demonstrates Positive Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes

Published: Nov 18,2020 | Tags: BAY 94-8862, Bayer, Cardiovascular Disease, Chronic Kidney Disease, FIDELIO-DKD Study, Finerenone, Inflammatory, Type 2 Diabetes

QBiotics’ Stelfonta (tigilanol tiglate) Receives the US FDA’s Approval as the First Treatment for Non-Metastatic MCT in Dogs

Published: Nov 17, 2020 | Tags: (tigilanol tiglate injection), Non-Metastatic Mast Cell Tumors, QBiotics Group, receives, Stelfonta, US FDA’s Approval

Johnson & Johnson Initiates Second Global P-III Study of its COVID-19 Vaccine

Published: Nov 17, 2020 | Tags: COVID-19, ENSEMBLE, ENSEMBLE-2 Study, Initiates, Johnson & Johnson, P-lll

Roche Signs a License Agreement with Lead Pharma to Develop Oral Therapies for Immune-Mediated Diseases

Published: Nov 17,2020 | Tags: Develop, Immune Mediated Diseases, Lead Pharma, License Agreement, Research Collaboration, Roche, Signs, Small Oral Molecules

Zymeworks and ALX Oncology Collaborate to Evaluate Zanidatamab + ALX148 for Advanced HER2‑Expressing Breast Cancer

Published: Nov 17,2020 | Tags: Advanced, ALX Oncology, ALX148, Breast Cancer, Collaborate, Evaluate, HER2‑Expressing, Zanidatamab, Zymeworks

Moderna’s mRNA-1273 Demonstrates 94.5% Efficacy in Preventing Symptomatic COVID-19

Published: Nov 17, 2020 | Tags: COVE Study, COVID-19, Interim Analysis, Moderna, mRNA-1273, P-lll, reports, results

Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19

Published: Nov 17,2020 | Tags: Against, Bharat Biotech, Covaxin, COVID-19, Initiates, P-III, study

Microsoft Collaborates with Twist and Illumina to Advance Data Storage in DNA

Published: Nov 16, 2020 | Tags: advance, Collaborates, Data Storage, DNA, Illumina, Microsoft, Twist

J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development

Published: Nov 16, 2020 | Tags: Agreement, Candidate, Covid-19 Vaccine, Development, Expand, J&J, U.S. Department of Health & Human Services

Eisai’s Fycompa (perampanel) Receives EC’s Approval for Expanded Indication in Pediatric Patients with POS and PGTCS

Published: Nov 16, 2020 | Tags: Eisai’s, EU’s Approval, Fycompa, perampanel, PGTCS, POS, receives

Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to Treat Influenza

Published: Nov 16, 2020 | Tags: baloxavir marboxil, EU’s Approval, Influenza, receives, Roche, Xofluza

Eli Lilly Signs a License Agreement with Seed Therapeutics for Protein Degradation-Based Therapies

Published: Nov 16, 2020 | Tags: Eli Lilly, License Agreement, Protein Degradation-Based Therapies, Seed Therapeutics, Signs

Henlius Report the NMPA’s Acceptance of HLX15 (biosimilar, Daratumumab) to Treat Multiple Myeloma

Published: Nov 16, 2020 | Tags: (biosimilar, Acceptance, daratumumab, Henlius, HLX15, Multiple Myeloma, NMPA, Report, Treat

Related Post: PharmaShots Weekly Snapshots (Nov 09-13, 2020)

The post PharmaShots Weekly Snapshot (Nov 16-20, 2020) first appeared on PharmaShots.

Moderna’s mRNA-1273 Demonstrates 94.5% Efficacy in Preventing Symptomatic COVID-19

Shots:

  • The P-lll COVE study involves the assessing of mRNA-1273 (100 µg dose level) in 30,000 patients with COVID-19 in the ratio of (1:1) aged > 18 yrs. in the US
  • The study met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5% in the first interim analysis of the P-III COVE study. The first interim analysis included 95 participants with confirmed cases of COVID-19
  • Moderna plans to submit a EUA with US FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of >2mos.

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Stat

The post Moderna’s mRNA-1273 Demonstrates 94.5% Efficacy in Preventing Symptomatic COVID-19 first appeared on PharmaShots.

UK eyes access deal as Moderna’s COVID-19 shot hits the mark

Moderna is the third group in a week to report encouraging phase 3 data with a coronavirus vaccine, saying today that its mRNA-1273 shot had an efficacy of 94.5% in the 30,000-patient COVE study.

The results set up an emergency use authorisation (EUA) filing in the US “within weeks” according to the company, and the UK government has also said it is now in active negotiations with the biotech to try to claim a share of the supply if approved.

The interim analysis from COVE comes after 95 confirmed cases of COVID-19 among the vaccine and placebo groups in the study, which was carried out by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) in the US.

That’s the same number of cases that prompted the readout of data from a trial of Pfizer/BioNTech’s BNT162b2 a week ago – another mRNA-based vaccine with a 90% efficacy rate – and rather more than the 20 cases used to give a 92% efficacy measure for Russia’s adenovirus-based Sputnik V candidate.

Pfizer chief executive Albert Bourla was among the first to congratulate Moderna on the encouraging data, tweeting:

In COVE, 90 cases of COVID-19 were seen in the control arm, compared to five in the mRNA-1273 group. There were also 11 cases of severe COVID-19 out of the 95 total, all of which occurred in the placebo group.

Moderna and the NIAID have also pointed to spectrum of COVID-19 cases in the study, saying that 15 of the 95 were people aged over 65, while 20 were from diverse communities including Hispanic/Latino, black/African American, and Asian American.

A UK government spokesperson said that “advanced discussions” are ongoing with Moderna to ensure UK access to the vaccine, suggesting that doses would become available in spring 2021 in the UK “at the earliest.”

There will be a queue for early access, however. Moderna said towards the end of last month that it had received $1.1 billion in deposits for mRNA-1273, with 100 million doses destined for the US, 50 million heading to Japan, and 20 million to Canada.

Moderna has previously said it expects to produce and ship around 20 million doses of mRNA-1273 to the US this year – a reduction on earlier estimates. It says it could be able to make 500 million to a billion doses next year.

As with the other two vaccine data readouts there are still a lot of unanswered questions with COVE, including whether it can cut viral transmission rates – including asymptomatic transmission – and how long its protection may last.

As more cases of COVID-19 occur in the ongoing study, Moderna notes that the point estimate for vaccine efficacy could change. Nevertheless, there’s little doubt that having three separate vaccines claiming 90%-plus efficacy is a massive boost to hopes of widespread immunisation in 2021.

“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” said Moderna CEO Stéphane Bancel.

“We look forward to the next milestones of submitting for an EUA in the US, and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study,” he added.

The post UK eyes access deal as Moderna’s COVID-19 shot hits the mark appeared first on .

PharmaShots Weekly Snapshots (Nov 09-13, 2020)

Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US

Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US

GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine

Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine

BD Acquires the Medical Business Assets of CUBEX

Published: Nov 13, 2020 | Tags: BD, Acquires, Medical Business, Assets, CUBEX

Health2Sync Divulges Benefits of Integrating Fitbit Wearable Devices into Diabetes Care in Taiwan

Published: Nov 13,2020 | Tags: Health2Sync, Divulges, Benefits, Integrating, Fitbit, Wearable Devices, Diabetes, Care, Taiwan

UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

 Published: Nov 13,2020 | Tags: UCB, Acquires, Handl Therapeutics, Augment, Gene Therapy,  Portfolio

Medtronic Launches InPen Integrated with CGM Data for People with Diabetes on MDI

Published: Nov 13,2020 | Tags: CGM Data, Diabetes, InPen, Integrated, Launches, MDI, Medtronic

Qiagen Collaborate with TScan to Develop T Cell-Based COVID-19 Test

Published: Nov 12,2020 | Tags: COVID-19, Exclusive, License Agreement, Option, Qiagen, Research, Signs, TScan Therapeutics

AstraZenca’s Calquence (acalabrutinib) Fails to Meet its Primary Endpoint in P-II Studies for COVID-19

Published: Nov 12,2020 | Tags: acalabrutinib, AstraZenca, CALAVI, Calquence, COVID-19, P-ll Study, Report, Respiratory Complications, results

Pfizer and BioNTech to Supply EU with up to 200M Doses of BNT162B2 Against COVID-19

Published: Nov 12,2020 | Tags: Agreement, BioNTech, BNT162b2, EU, European Commission, m-RNA Vaccine, Pfizer, Signs, Supply

Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Published: Nov 12,2020 | Tags: Abrocitinib, JADE REGIMEN Study, moderate to severe Atopic Dermatitis (AD), P-lll, Pfizer, Positive, Report, results

Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC

Published: Nov 12,2020 | Tags: HNSCC, Interim, Moderna, mRNA-4157, P-l study, pembrolizumab, Report, results, SITC 2020

J&J Resumes all Clinical Trial of its COVID-19 Vaccine in the EU

Published: Nov 12,2020 | Tags: Clinical Trial, COVID-19, EU, J&J, Resumes, vaccine

CureVac Publishes Results of CVnCoV in Interim P-l Study for COVID-19

Published: Nov 11,2020 | Tags: COVID-19, CureVac, CVnCoV, Interim, P-l study, reports, results

Prestige Signs an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

Published: Nov 11,2020 | Tags: Agreement, Biosimilar, Commercialize, Israel, Prestige, Signs, Teva, trastuzumab, Tuznue

NightWare Receives the US FDA’s Approval for the First Medical Device to Stop NightMAres Related to PTSD

Published: Nov 11,2020 | Tags: Designed, Marketing, New Device, Nightmare Disorder, Permit, PTSD, Reduce, Sleep, US FDA

Samsung Bioepis Initiates P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Nov 11,2020 | Tags: (Denosumab), Initiates, P-I study, Prolia, Proposed Biosimilar, Samsung Bioepis, SB16

Abbott Launches IonicRF Generator for Patients with Chronic Pain in the US

Published: Nov 11,2020 | Tags: Abbott, Chronic, Generator, IonicRF, Launch, Pain, patients, US, Use

Henlius Reports First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)

Published: Nov 11,2020 | Tags: Henlius, Reports, First, Patient Dosing, P-l Study, HLX14, denosumab, biosimilar

Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373 to Treat COVID-19

Published: Nov 10, 2020 | Tags: COVID-19, Fast Track Designation, Novavax, NVX-CoV2373, receives, Treat, US FDA

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

Published: Nov 10,2020 | Tags: Amgen, Asthma, AstraZeneca, NAVIGATOR, P-III, patients, Positive, reports, results, Severe, Tezepelumab, Trial, Uncontrolled

Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19

Published: Nov 10,2020 | Tags: Bamlanivimab, COVID-19, Diagnosed, EUA, Lilly, LY-CoV555, receives, recently, Treatment, Us FDA

Pfizer and BioNTech’s BNT16`2b2 Demonstrates 90% Efficacy in Preventing COVID-19

Published: Nov 10,2020 | Tags: Against, BioNTech, BNT162b2, Clinical, Pfizer, reports, study

AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia

Published: Nov 10,2020 | Tags: (acalabrutinib), AstraZeneca’s, Calquence, Chronic Lymphocytic Leukaemia (CLL), EU’s Approval, receives

Bayer Reports Regulatory Submission of Finerenone (BAY 94-8862) to the US and EU for CKD and T2D

Published: Nov 10,2020 | Tags: (BAY 94-8862), Bayer, EMA, Finerenone, Regulatory Applications, Submits, Treat Chronic Kidney Disease (CKD), Type 2 Diabetes (T2D), Us FDA

Alvotech and Cipla Collaborate to Ensure Access to Biosimilars in South Africa

Published: Nov 9,2020 | Tags: Access, Alvotech, Biosimilars, Cipla, Ensure, Exclusive Partnership, Expand, South Africa

Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS

Published: Nov 9,2020 | Tags: (canakinumab), CAN-COVID Trial, Covid-19, Pneumonia, Cytokine Release Syndrome (CRS), Ilaris, Novartis, P-lll, Report, results

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma

Published: Nov 9,2020 | Tags: 2020, 218, Advanced, Renal, Cell, Carcinoma, Eisai, Everolimus, IKCS, lenvatinib, Lenvima, P-II, Presents, results, study

Celltrion Reports Results of CT-P59 in P-I Study for COVID-19

Published: Nov 9, 2020 | Tags: 2020, Celltrion, Clinical, Conference, CT-P59, Fall, Korean Society of Infectious Diseases, P-I, Presents, results, Trial

The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

Published: Nov 9, 2020 | Tags: aducanumab, Advisory, Biogen, Committee, EMERGE, ENGAGE, Meeting, P-III, reports, study, Updates, Us FDA

Merck and Transcenta Collaborate to Implement Continuous Manufacturing for Protein Therapeutics

Published: Nov 9, 2020 | Tags: Collaborate, Continuous Manufacturing, Implement, Merck, Protein Therapeutics, Transcenta

Related Post: PharmaShots Weekly Snapshot (Nov 02-06, 2020)

The post PharmaShots Weekly Snapshots (Nov 09-13, 2020) first appeared on PharmaShots.

Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC

Shots:

  • The expansion cohort of P-l study involves assessing of mRNA-4157 + Keytruda (pembrolizumab) vs Keytruda monothx. in 10 patients with HPV (-) HNSCC and 17 patients with MSS-CRC, presented at the SITC 2020.
  • Results: in the HPV(-) HNSCC group, ORR (50% vs 14.6%) with 2 patients achieving CR & 3 patients achieving PR; mPFS (9.8 vs 2.0 mos.); DCR (90%); median duration of response has not been reached. No responses were observed in the MSS-CRC group of patients
  • The company continues to recruit in HPV(-) HNSCC cohort and has decided to expand the size of the current cohort based on the interim data reported

Click here­ to­ read full press release/ article | Ref: Businesswire | Image: Stat

The post Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC first appeared on PharmaShots.

UK could get COVID-19 vaccines early next year, ahead of European countries

COVID-19 vaccines could be approved and available early next year in the UK ahead of European countries, after its national regulator began its own rolling reviews of shots from AstraZeneca and Moderna.

AstraZeneca has confirmed that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has begun a fast-track rolling review of its AZD1222, the COVID-19 vaccine it developed in conjunction with Oxford University.

This followed last week’s news that the MHRA has begun a parallel rolling review of a rival from Moderna.

The rolling review allows for a real-time assessment of the clinical data from clinical trials, accelerating a process that normally takes around a year to complete using the centralised European regulatory system.

Using the MHRA could allow the UK to make regulatory decisions on COVID-19 vaccines ahead of the European system, where medicines and vaccines are first reviewed by the CHMP scientific committee before being passed on to the European Commission.

But a source close to process told pharmaphorum that it is “eminently possible” that the MHRA could reach its conclusions ahead of its European counterparts as the country reaches the end of the Brexit transition period.

A spokesperson for the MHRA said that from 1st January, it will have new powers to approve medicines, including vaccines including “greater flexibility to do this faster, while maintaining the highest standards of safety, quality and effectiveness.”

The spokesperson said: “The MHRA will evaluate the data rigorously on the quality, safety and effectiveness of COVID-19 vaccines to reach a scientifically robust independent opinion if an earlier authorisation is necessary before the EMA (European Medicines Agency) authorises a product.”

“Patient safety is our top priority. The independent Commission on Human Medicines will advise the UK government on the safety, quality and effectiveness of any potential vaccine. No vaccine will be deployed in the UK unless stringent standards have been met through a comprehensive clinical trial programme”

Representatives of the MHRA used to sit on the CHMP but no longer participate as a result of Brexit, leaving the UK to make its own decisions on medicines regulation should it choose to do so.

According to the source, COVID-19 vaccines could be available in early January depending on the length of time it takes for trial data to be published and shared with regulators.

COVID vaccines are being developed at warp speed, with the development and review process that normally takes up to a decade to complete compressed into less than a year after research began at the end of January.

The MHRA’s approach to the AZ and Moderna vaccines also paves the way for similar fast reviews to rivals from the likes of Pfizer/BioNTech and Novavax, which the UK government also has on order and are reaching the end of the clinical trial process.

The news comes as the country prepares for another national lockdown, which will disrupt business and limit people’s freedoms for at least another month.

A vaccine is seen as a potential way out of the cycle of lockdowns that have already caused severe hardship across the UK, which is one of the countries worst hit by COVID-19.

An AstraZeneca spokesperson told pharmaphorum: “Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the communities where the clinical trials are being conducted. It is then up to the regulatory bodies to review and make approval decisions based on this data, as quickly as possible.

“The EMA announced in October that its CHMP had started a ‘rolling review’ of data for AZD1222, the first COVID-19 vaccine to be evaluated under these arrangements. We confirm the MHRA’s rolling review of our potential COVID-19 vaccine.”

 

The post UK could get COVID-19 vaccines early next year, ahead of European countries appeared first on .

Moderna banks $1.1bn in COVID-19 vaccine deposits, signs Japan supply deal

Moderna is still preparing for the launch of its COVID-19 vaccine mRNA-1273 – assuming phase 3 trials go to plan – but has already received $1.1 billion in deposits for the shot.

The figure was revealed by CEO Stéphane Bancel in Moderna’s third-quarter results call on which he also highlighted a new agreement to supply 50 million doses of mRNA-1273 to Japan in the first half of next year with the help of Takeda.

The Japanese deal adds to a 100 million-dose agreement with the US governments agreed in August, worth some $1.5 billion, as well as a 20 million order from Canada and others including a recent agreement with Qatar.

Bancel reiterated Moderna’s expectation of an initial data readout from the pivotal COVE trial of mRNA-1273 in early November, with the critical two-month safety follow-up on half the 30,000 enrolled subjects later towards the end of that month.

That is the basis for filing for emergency use authorisation (EUA) of the vaccine in the US, according to criteria set out by the FDA. In the meantime, rolling reviews are also underway in the UK and Canada and planned in the EU.

The $1.1 billion cash injection has been booked as deferred revenue by Moderna, and helped the company generate positive cash flow for the first time in its 10-year history.

The vaccine also sets up 2021 to be the “most important inflection year in Moderna’s history”, according to Bancel – not least because it has emerged as the test bed for the biotech’s entire drug development platform.

“We intend to reinvest the returns from the sales of the vaccine into our pipeline development and hope to bring more medicines to the market,” he said. “I believe that the long-term strategic implication are large.”

Moderna’s chief medical officer Tal Zaks said on the call that clinical results with mRNA-1273 to date indicate the shot is generally safe and well-tolerated – with flu-like symptoms and injection site reactions the most common side effect reported with the two-dose regimen.

He also stressed that neutralising antibodies rise quickly after a second dose, and are seen consistently in patients regardless of age – a positive result because the immune system tends to weaken with age and older people are those most at risk of dying from the coronavirus.

Last month, Moderna said it was slowing enrolment in COVE to make sure that older patients, younger people with chronic diseases, and subjects of African American, Hispanic/Latin and Asian descent were included in the trial population.

Hitting the data readout timeline depends on 53 cases of COVID-19 being diagnosed for the interim analysis, and with rates of infection climbing around the world that should be easier to achieve. Further analysis of the data will also be triggered COVID-19 cases reach 106 and then 151, the final threshold.

Moderna said it expects to produce around 20 million doses of mRNA-1273 ready to ship in the US this year, which is a reduction on earlier estimates. It says it could be able to make 500 million to a billion doses next year.

The biotech has retained full control of its vaccine rather than partnering with a larger company, and has agreed to supply it to the US at a cost of $25 per dose.

The post Moderna banks $1.1bn in COVID-19 vaccine deposits, signs Japan supply deal appeared first on .

Moderna nears COVID-19 vaccine finish line as it wraps up study enrolment

Moderna is close to completing its phase 3 trial of COVID-19 vaccine candidate mRNA-1273 after completing recruitment of the 30,000 subjects in the trial.

It’s also revealed that more than 25,000 of them have already received the second dose of the shot in the COVE study, putting it in contention to be the first coronavirus vaccine company to be ready to file for emergency use authorisation in the US.

As with all COVID-19 vaccines, Moderna will need two months of safety data following the final vaccine dose before it will be able to file for an EUA, but the milestone puts it just behind Pfizer and BioNTech in the race to that objective with a possible filing date in early December.

Shares in the company climbed nearly 5% after the announcement continuing an upwards trend that means the stock is now trading at almost four times its value at the start of the year.

The latest milestone follows a rolling reviews of mRNA-1273 in Canada, which allow the country’s regulator to start reviewing data as it becomes available, and Moderna is now gearing up to file via  similar mechanism in Europe.

Moderna shared demographic data from the study at an FDA committee meeting today which showed that it included some of the groups most at risk from COVID-19.

That includes 7,000 people aged over 65 and more than 5,000 younger people with chronic diseases that make them more likely to get severe symptoms like diabetes and obesity, while around a third of subjects of African American, Hispanic/Latin and Asian descent.

Last month, Moderna said it was slowing enrolment in COVE to “ensure the representation of…communities of colour, ” and on that measure it seems to have an advantage over Pfizer/BioNTech’s BNT162b2 vaccine, which completed phase 3 recruitment in mid-September but has only 25% ethnic minorities.

Studies have suggested that that black and minority ethic people are at higher risk of dying from COVID-19 than the rest of the population.

The study – funded with the help of $955 million of US government money – is comparing two 100 µg doses of mRNA-1273 given by intramuscular injection 28 days apart to a matched placebo, and the primary endpoint is the prevention of symptomatic COVID-19 disease 14 days after the second administration.

Like Pfizer/BioNTech and other coronavirus vaccine developers, Moderna has committed to ensuring that it has full safety and efficacy data available before filing for an EUA.

If COVE is positive and mRNA-1273 gets approved, Moderna has said it is on track to deliver up to 500 million doses per year, and possibly up to a billion doses per year beginning in 2021, thanks to a manufacturing collaboration with Lonza.

Initially supplies will be much more limited of course, and the US has already placed orders for 100 million doses of mRNA-123 in a $1.5 billion deal agreed in August.

The post Moderna nears COVID-19 vaccine finish line as it wraps up study enrolment appeared first on .

Pfizer to wait until after election to file COVID-19 vaccine in US

Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it waits for important safety data to become available.

The vaccine is being developed by Pfizer and development partner BioNTech and will wait until late November to make its application with the FDA.

In a letter published on its website Pfizer may have the data to say whether the vaccine is effective this month, based on the findings of the ongoing 40,000 person clinical trial.

But CEO Alfred Bourla cautioned that the safety data will only be ready in the third week of November.

There have already been two safety scares in COVID-19 vaccine trials – Johnson & Johnson earlier this week put its phase 3 trial on hold because of an undisclosed illness in a patient.

A US trial of AstraZeneca’s shot is also on hold after a similar incident, although studies in other parts of the world have restarted.

As vaccines will be given to healthy individuals, regulators have far less tolerance for adverse events.

There are further concerns that political interference during the election build-up could undermine the credibility of a mass vaccination programme.

Bourla said: “So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US. soon after the safety milestone is achieved in the third week of November.”

Despite the concerns of scientists president Donald Trump has said that there would be a vaccine available before the election on 3rd November and is hoping that approval could be the “October Surprise” that could boost his popularity ahead of the vote.

Rival Moderna has said it could apply for an Emergency Use Authorization for its rival vaccine as soon as November.

The European Medicines Agency has already started a rolling review of the Pfizer/BioNTech and AstraZeneca vaccines.

The post Pfizer to wait until after election to file COVID-19 vaccine in US appeared first on .

PharmaShots Weekly Snapshot (Oct 12-16, 2020)

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease

Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec

Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis

Published: Oct 15, 2020 | Tags: Clinical, Trial, Galapagos, GLPG1972/S201086, Knee Osteoarthritis, Patients, P-II, Report, results, ROCCELLA, Servier

Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19

Published: Oct 15, 2020 | Tags: advance, Against, Clinical, Study, COVID-19, MRT5500, Sanofi, Translate, Bio

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

Published: Oct 15, 2020 | Tags: Chugai, Drug, First, Japan, MHLW, NDA, Oral, Report, Risdiplam, Spinal Muscular Atrophy

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

Published: Oct 15, 2020 | Tags: Adult, approval, KEYTRUDA, Merck, patients, pembrolizumab, receives, Relapsed Refractory cHL, US, FDA

Eli Lily to Acquire Disarm Therapeutics for ~$1.36B

Published: Oct 15, 2020 | Tags: ~$1.36B, Acquire, Disarm, Therapeutics, Eli Lily

Eli Lilly Pauses Enrollment in ACTIV-3 Clinical Trial Due to Safety Concerns

Published: Oct 14, 2020 | Tags: ACTIV-3, Clinical, Decision, Due, Eli Lilly, Enrollment, NIAID, Pause, Trial

Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil

Published: Oct 14, 2020 | Tags: Abivertinib Maleate, ANVISA, approval, COVID-19, Mild, P-II, patients, Proceed, receives, Severe, Sorrento, STI-5656, Trial

Bayer Report Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

Published: Oct 14, 2020 | Tags: 1EP, Aliqopa, Bayer, copanlisib, Meets, patients, reports, results, Rituximab

Takeda Collaborates with Accenture and AWS to Transform into a Cloud-Based Company

Published: Oct 13, 2020 | Tags: Accenture, AWS, Cloud-Based Company, Collaborates, Takeda, Transform

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

Published: Oct 15, 2020 | Tags: approval, atoltivimab, Ebolavirus, First, Inmazeb, maftivimab, odesivimab, receives, Regeneron, Treatment, US, FDA

Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B

Published: Oct 14, 2020 | Tags: ~$1.8B, AVV, Gene, Therapy, Develop, Dyno, License, Agreement, Roche, Signs

Boehringer Ingelheim Presents Results of Gilotrif (afatinib) for NSCLC at IASLC NACLC 2020

Published: Oct 14, 2020 | Tags: 2020, Boehringer Ingelheim, Gilotrif, IASLC, NACLC, Report, Result

Moderna Initiates Rolling Submission to Health Canada for mRNA-1273 Against COVID-19  

Published: Oct 14, 2020 | Tags: COVID-19, Health Canada, Moderna, mRNA Vaccine, mRNA-1273, Rolling Submission

Prestige’s PBP1510 Receives EMA’s Positive Opinion on Orphan Designation for Pancreatic Cancer

Published: Oct 14, 2020 | Tags: Designation, EMA, Opinion, Orphan, Pancreatic cancer, PBP1510, Positive, Prestige, receives

Celltrion Launch P-III Post-Exposure Prophylaxis Clinical Trial of CT-P59 for COVID-19

Published: Oct 14, 2020 | Tags: Anti, Candidate, Celltrion, Clinical Trial, COVID-19, CT-P59, Launch, mAb, P-III, Treatment

Linnaeus Reports First Patients Dosing with LNS8801 + Keytruda (pembrolizumab) in P-I/II Study for Advanced Cancer

Published: Oct 14,2020 | Tags: Advanced Cancer, First Patients Dosing, KEYTRUDA, Linnaeus, LNS8801, pembrolizumab, reports

J&J Pauses Dosing in COVID-19 Vaccine Studies Due to Unexplained Illness

Published: Oct 14, 2020 | Tags: COVID-19, Dosing, J&J, Pauses, Unexplained Illness, Vaccine, Studies

Roche to Launch Elecsys SARS-CoV-2 Antigen Test for Suspected COVID-19 Patients

Published: Oct 13, 2020 | Tags: Antigen, COVID-19, Laboratory, Launch, patients, Roche, SARS-CoV-2, Suspected, Test

Sanofi Reports Results of Dupixent (dupilumab) in P-III LIBERTY ASTHMA VOYAGE Study in Children with Asthma

Published: Oct 13, 2020 | Tags: Asthma, attacks, Biologic, Children, children’s, Demonstrate, dupilumab, Dupixent, Function, Improvement, Lung, P-III Trial, Reduced, reports, results, Sanofi, Severe

Gilead and Galapagos Report Results of Filgotinib in P-llb/lll SELECTION Study for Ulcerative Colitis

Published: Oct 13, 2020 | Tags: Filgotinib, Galapagos, Gilead, P-2B/3, reports, results, SELECTION Study, Ulcerative Colitis (UC)

Lilly Reports Results of Mirikizumab in P-ll SERENITY Study for Crohn’s Disease

Published: Oct 13, 2020 | Tags: Crohn Disease, Improvement and Reduction of Intestinal Inflammation, Lilly, Mirikizumab, P-ll, reports, results, SERENITY Study

Takeda Reports Results of Entyvio (vedolizumab) in Interim Analysis from VISIBLE OLE Study for Moderately to Severely Active Ulcerative Colitis

Published: Oct 13, 2020 | Tags: Active, During, Entyvio, Long-Term, Maintenance, Moderately, reports, results, Severely, Takeda, therapy, Vedolizumab

Abbott’s AdviseDx SARS-CoV-2 IgM Test Receives the US FDA’s EUA for COVID-19

Published: Oct 13, 2020 | Tags: Abbott, antibody, Authorization, Blood, Test, COVID-19, Emergency, IgM, New, receives, Test, U.S.FDA, Use

Innovent and Lilly’s Halpryza (biosimilar, rituximab) Receive NMPA’s Approval in China

Published: Oct 12, 2020 | Tags: Autoimmune Disease, Halpryza, Innovent, Lilly, NMPA Granted Marketing Approval, Rituximab

Janssen Reports Five-Year Data of Stelara (ustekinumab) in P-lll LTE Study for Severe Crohn’s Disease

Published: Oct 12, 2020 | Tags: Five-Year, Janssen Pharmaceutical, LTE Study, P-lll, Report, results, Severe Crohn’s Disease, Stelara, ustekinumab

AstraZeneca Advances its AZD7442 in Two P-III Clinical Studies for COVID-19

Published: Oct 12,2020 | Tags: Acting, antibody, AstraZeneca, AZD7442, COVID-19, Long, P-III, Test, Treatment, Trials

Janssen Reports Results of Tremfya (guselkumab) in Interim Analysis of P-II GALAXI 1 Study for Moderately to Severely Active Crohn’s Disease

Published: Oct 12,2020 | Tags: Active Crohn’s Disease, guselkumab, Interim, Janssen, P-II, patients, reports, Result, study, Tremfya

Pfizer’s Ibrance (palbociclib) Fails to Meet its Primary Endpoint in P-lll PENELOPE-B Study for Early Breast Cancer

Published: Oct 12,2020 | Tags: Breast Cancer, German Breast Group, Ibrance, P-lll, Palbociclib, PENELOPE-B Study, Pfizer Inc., Report, results

Innovent and Lilly’s Halpryza (biosimilar, rituximab) Receive NMPA’s Approval in China

Published: Oct 10,2020 | Tags: Autoimmune Disease, Halpryza, Innovent, Lilly, NMPA, Granted, Marketing Approval, Rituximab

Related Post: PharmaShots Weekly Snapshot (Oct 5-9, 2020)

The post PharmaShots Weekly Snapshot (Oct 12-16, 2020) first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)

  1. Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout

Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE Study, Important Clinical Improvement, P-II, patients, reports, results, SEL-212, Selecta Biosciences, Sobi

2. Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults

Published: Oct 1, 2020 | Tags: COVID-19, Moderna, mRNA-1273, P-l study

3. Alnylam Reports Results of Lumasiran in P-III ILLUMINATE-B Study for Primary Hyperoxaluria Type 1 in Children Under the Age of Six

Published: Oct 1, 2020 | Tags:  Alnylam, ILLUMINATE-B, Lumasiran, P-III study, Primary Hyperoxaluria Type 1, reports, results

4. Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension

Published: Oct 1, 2020 | Tags: Janssen, NDA, Pulmonary Arterial Hypertension, reports, selexipag, Submission, Treat, UPTRAVI, USFDA

5. Henlius Signs an Exclusive License Agreement with Accord for HLX02 (biosimilar, trastuzumab) in the US and Canada

Published: Oct 1, 2020 | Tags: Accord Healthcare Inc., Develop and Commercialize, Exclusive License Agreement, Henlius, HLX02

6.  Sanofi Launches Tetraxim (DTaP-IPV) for Preschoolers in India

Published: Oct 1, 2020 | Tags: (DTaP-IPV), India, Launches, Preschoolers, Sanofi, Tetraxim

7. Abbott’s FreeStyle Libre 3 System Receives CE Mark in Europe

Published: Sept 30, 2020 | Tags: Abbott, CE Mark, Europe, FreeStyle Libre 3 System, receives

8. Medtronic to Acquire Avenu Medical

Published: Sept 30, 2020 | Tags: Acquire, Avenu Medical, Ellipsys Vascular Access system, endovascular solutions, Medtronic

9. BMS’s Reblozyl (luspatercept) Receives Health Canada Approval for Beta Thalassemia

Published: Sept 30, 2020 | Tags: Beta Thalassemia, BMS, Health Canada Approval, Luspatercept, Reblozyl

10. Junshi Reports Results of Dual Regimen in P-III Jupiter-02 Study as 1L Therapy for Nasopharyngeal Carcinoma

Published: Sept 30, 2020 | Tags: 1L Therapy, Dual Regimen, Junshi Biosciences, Jupiter-02 Study, Nasopharyngeal Carcinoma (NPC), P-lll

11. Galapagos Reports First Patients Dosing with GLPG3970 (Toledo Compound) for Psoriasis

Published: Sept 30, 2020 | Tags: First Patients Dosing, Galapagos, GLPG3970, LADYBUG study, ll CALOSOMA study, P-l/ll, Psoriasis, SEA TURTLE study

12. Regeneron’s REGN-COV2 Demonstrate Reduction in Viral Load and Improve Symptoms in Non-Hospitalized Patients with COVID-19

Published: Sept 30, 2020 | Tags: COVID-19, Demonstrate, Improve Symptoms, Non-Hospitalized, patients, Reduction, Regeneron, REGN-COV2, Viral Load

13. Boston Scientific Launches ACURATE neo2 Aortic Valve System in Europe

Published: Sept 29, 2020 | Tags: ACURATE neo2 Aortic Valve System, Boston Scientific Corporation, Europe, Launches

14. Inovio Reports FDA’s Partial Clinical Hold on P-II/III Trial of INO-4800 Against COVID-19

Published: Sept 29, 2020 | Tags: COVID-19, FDA’s, INO-4800, Inovio, P-ll/lll Study

15. CSL Behring’s Haegarda (C1 Esterase Inhibitor) Receives the US FDA’s Approval for Pediatric Patients with Hereditary Angioedema

Published: Sept 29, 2020 | Tags: CSL behring, HAE, Haegarda, Hereditary Angioedema, Pediatric Patients, US FDA’s Approval

16. Pfizer’s Xeljanz (tofacitinib) Receives the US FDA’s Approval for Active Polyarticular Course Juvenile Idiopathic Arthritis

Published: Sept 29, 2020 | Tags: Active Polyarticular Course Juvenile Idiopathic Arthritis, approval, FDA, receives, tofacitinib, US, XELJANZ

17. AbbVie’s Elezanumab (ABT-555) Receives the US FDA’s Orphan Drug and Fast Track Designation for Spinal Cord Injury

Published: Sept 29, 2020 | Tags: AbbVie, Elezanumab, FDA, FT, ODD, Spinal Cord Injury, US

18. Sarepta Reports Two-Year Follow Up Results of SRP-9001 for Duchenne Muscular Dystrophy

Published: Sept 29, 2020 | Tags: Duchenne Muscular Dystrophy, reports, results, Sarepta, SRP-9001, Two-Year Follow Up

19. Innovent Report Results of Dual Regimen in P-III ORIENT-32 Study as 1L Therapy for Advanced HCC

Published: Sept 28, 2020 | Tags: 1L Therapy, Byvasda, Hepatocellular Carcinoma (HCC), Innovent Biologics, Tyvyt

20. Pfizer Initiates Clinical Study of Eighth Candidate Emerges Under the Collaboration with Sosei Heptares

Published: Sept 28, 2020 | Tags: Candidate, Clinical Study, Collaboration, Emerges, Initiates, Pfizer, Sosei Heptares, Under

21. Roche Reports Two-Year Data for Evrysdi (risdiplam) in Infants with Type 1 SMA

Published: Sept 28, 2020 | Tags: (risdiplam), Data, Evrysdi, Infants, reports, Roche, Two-Year, Type 1 SMA

22. GSK’s Nucala (mepolizumab) Receives the US FDA’s Approval as the First Treatment for Hypereosinophilic Syndrome

Published: Sept 28, 2020 | Tags: (mepolizumab), approval, FDA, GSK, Hypereosinophilic Syndrome, Nucala, receives, US

23. Chugai’s Tecentriq (atezolizumab) and Avastin (bevacizumab) Receive MHLW’s Approval as 1L Treatment for Unresectable Hepatocellular Carcinoma

Published: Sept 28, 2020 | Tags: (atezolizumab), (bevacizumab), 1L, approval, Avastin, Chugai, MHLW, Receive, Tecentriq, Treatment, Unresectable Hepatocellular Carcinoma

24. Gilead’s Jyseleca (filgotinib) Receives the MHLW’s Approval for Rheumatoid Arthritis in Japan

Published: Sept 28, 2020 | Tags: Filgotinib, Gilead, JAK1 Inhibitor, Jyseleca, MHLW Approval, Rheumatoid Arthritis, Structural Joint Damage

The post PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020) first appeared on PharmaShots.

Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults

Shots:

  • Moderna reported the publication of the second interim analysis of the open-label P-I study of mRNA-1273 in the NEJM. The study evaluated a 2dose vaccination schedule of mRNA-1273 given 28 days apart in 40 adults across two dose levels (25/100µg) in two age cohorts (56-70/ 71+) and reports results @Day 57 (1mos. following the second dose)
  • mRNA-1273 induced consistently high levels of pseudovirus neutralization Ab titers in all participants, elicited Th1-biased CD4 T cell responses across all age group, neutralizing Ab titers and T cell responses is consistent with reported in younger adults, both the doses were well tolerated
  • Results were consistent using 3 live virus assays. Additionally, the US government has agreed to purchase 100M doses of mRNA-1273, with an option to purchase an additional 400M dose

Click here ­to­ read full press release/ article | Ref: Moderna | Image: Stat

The post Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults first appeared on PharmaShots.

Moderna’s Covid-19 vaccine shows antibody, T-cell responses a month after second dose in interim Phase I data

The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.

Moderna’s COVID vaccine works in older people, according to new data

Moderna has said that its coronavirus vaccine stimulated an immune response in older people in phase 1 trials, suggesting that the jab is effective in the age groups most susceptible to COVID-19.

An analysis of the latest data from a phase 1 trial showed that in 20 older adults given the vaccine – ten between the ages of 56 and 70 and ten aged 71 and older – the vaccine produced neutralising antibodies and T-cells in comparable levels to those aged 18 to 55-years-old.

These antibody levels were also higher than those typically seen in people recovering from the virus, the company said.

There were also no serious adverse events reported. Some patients reported fatigue, chills, headaches and pain at the injection site, though the majority of symptoms resolved within two days. 

Each participant received two 100 microgram doses of the vaccine 28 days apart – the same dose used in the vaccine’s ongoing phase 3 trials.

Moderna said the results show that the vaccine works as well in older adults as it does in people aged 18 to 55-years-old.

Death rates from COVID-19 are much higher in older people, but often people in these age groups show smaller immune responses from vaccines than younger adults.

The company’s shares rose about 6% on the news.

Health officials had previously expressed concerns that Moderna’s phase 1 study was small and that results may differ for other populations, including older people. This analysis may allay those concerns.

The company has also noted that 18% of the participants enrolled in its phase 3 study are Black, Latino, Native American or Alaska Native – groups that are often underrepresented in clinical studies but have been hard-hit by COVID-19.

Moderna has received funding from the US government to expand its late-stage trial. The US has also bought 100 million doses of the mRNA vaccine for more than $1.5 billion – a deal that sparked controversy when the consumer advocacy group Public Citizen said that taxpayers were “paying twice” for the jab.

The post Moderna’s COVID vaccine works in older people, according to new data appeared first on .

Is COVID the Rx for the Pharmaceutical Industry’s Reputation?

Darlene Dobry, Pharmaceutical Marketing

Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals

As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, the Pharma industry appears to be the shining hope to help us return to a new normal. Could the industry’s response to this global public health crisis be the Rx for its tarnished reputation?

The Pharma industry has long been at the center of a firestorm, cited consistently as one of the most disliked and distrusted industries in the Gallup poll. It’s not surprising given the media coverage of CEO and company financial disclosures, patent trials, illegal activities, and questionable practices, legal settlements, price gouging, product recalls, and, most recently, its role in the devastating opioid epidemic. While the public’s high distrust and disdain are directed at “greedy” Pharma, prescription drug spending accounts for between 10-12% of total US healthcare costs, and now, in our time of greatest need, we turn to this industry to help us confront COVID-19. This pandemic has brought the committed, community-focused side of Pharma to the forefront, with its rapid and relentless pursuit to deliver the best science to solve this crisis.

Pharmaceuticals Collaborating for COVID’s Rx

There are brilliant and talented people in dozens of companies, both established manufacturers and small start-ups, working tirelessly to find a solution. Early efforts developed and produced testing assays to help the healthcare community identify and confirm the virus. The expanded focus now pursues proven treatments and vaccines. We see unexpected partnerships and creativity abound in the race to find answers that will address the crippling impact on public health and disrupt the economy and supply chains. Thomas Cueni, who leads the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in Geneva, notes, “the industry, which is traditionally fiercely competitive, has come together.”

For example, rivals like Sanofi and GSK are working to bring their innovative technologies together for a vaccine, with Astra-Zeneca and Oxford University signing a global development and distribution agreement for a CO-19 vaccine, Takeda and CoVIg-19 Alliance investing in plasma therapies, Regeneron and Sanofi conducting clinical trials for their jointly marketed Rheumatoid Arthritis drug Kevzara, and Pfizer and BioNTech are collaborating on an mRNA vaccine. There is an impressive number of ongoing trials to evaluate existing drugs for other diseases, including Gilead’s Remdesivir which now has FDA authorization for emergency use, and Gilead Sciences is applying for full authorization in the U.S., specialty biotech companies like Moderna and Novavax have also entered the race and are fast-tracked for their vaccine candidates.

Pharma’s Investments & Innovations during COVID-19

Beyond drug treatment and vaccine development, the industry has also brought new ingenuity and investment to fight COVID-19 and support the healthcare system; Johnson & Johnson is pledging $300M over ten years to help front-line workers, Astra-Zeneca donating 9M face masks to protect healthcare workers around the world, companies deploying their 3D printing capabilities to manufacture PPE and equipment, and Consumer Product companies producing hand sanitizers.

This industry, its brilliant researchers, and dedicated employees are unwavering in their mission to be a part of the solution by investing in unknowns despite the risk, diverting focus from other commercially available/development assets, and pioneering scientific innovation to confront COVID-19. With the sheer number of companies in this race, we stand the best chance of finding solutions and having the scale to keep up with the alarming projections of cases. It also helps to foster competition and encourage fair pricing. Despite Pharma‘s commitment to the cause, there continue to be critics who attribute Pharma’s efforts to capitalizing on a crisis and solely focused on profit. For those who feel Pharma should not make a profit from the deep investment, at this moment, it’s difficult to put a price on overcoming this enemy.

Pharma Marcom & PR during COVID

With the knowledge that consumers look to brands and companies that demonstrate social responsibility, philanthropic and community support, other industry leaders and I agree that there is an opportunity for Pharma to begin to evolve from some of the negative perceptions and elevate recognition of its essential role in moving us from “StayatHome” to “StayHealthy.” We are beginning to see public opinion improve throughout this pandemic, according to a recent Harris poll. From a marketing and public relations standpoint, I’m hopeful the Pharmaceutical Research and Manufacturers of America (PhRMA) will take this moment to elevate public awareness and highlight the level of corporate commitment and investment behind the scenes of this pandemic.

This is not self-serving. This is about scientific innovation, leadership during crisis, corporate responsibility, and saving lives. The industry should continue to demonstrate its thought leadership during this time through scientific publications and serving as an expert voice. As consumers increasingly search for information about the virus, vaccines, and treatment, Pharma needs to ensure the public has access to credible, scientifically-grounded content across media channels. Given the sequelae from this pandemic, there is also a tremendous need to address mental health and wellbeing. With the significant investment and access to mental health solutions and services, Pharma can also answer this call.

Pharma Marketing & Healthcare Marketing | COVID & Beyond

As advertising and communication experts, now is the time to step up and be even truer and more innovative pharmaceutical marketing agency partners. While our pharma, medical and healthcare clients are redirecting their efforts toward COVID-19, our own industry must be even more proactive and creative. Let’s bring pharmaceuticals strategically inventive marketing communication ideas and messaging programs to keep their brands and marketing more relevant during the COVID pandemic. Let’s help pharmas more effectively reach their increasingly “remote” customers and patients. Let’s drive better search rankings by developing more useful and authoritative content to educate online-engaged healthcare audiences. Let’s explore corporate campaigns and grass-roots programs to draw medical and pharmaceutical enterprises closer to their patient communities and genuinely bolster reputations. As experts in social media, let’s help Pharma be consistently compliant and proactively trustworthy participants in conversations concerning diseases & conditions. Let’s elevate the pharma industry’s core values currently on display through successfully inventive creativity and discerning innovation. As partners, let’s work tirelessly to create and focus insightful spotlights on the heroic efforts of our client-partners — healthcare and medical innovators dedicated to making “life-changing” differences within today’s life-changing public health crisis.

COVID and Healthcare Marketing — related articles: [Podcast] Hospital Crisis Management and Healthcare PR in the Age of COVID-19 | 5 Ways You Can Use Social Media and Digital Marketing to Help the Public During the COVID-19 Pandemic | Healthcare Marketing: Pause, Pivot, or Push for Success?

 

The post Is COVID the Rx for the Pharmaceutical Industry’s Reputation? appeared first on Healthcare Success.

Anger at US deal for Moderna’s ‘taxpayer-funded’ COVID-19 vaccine

The US government has signed another big coronavirus vaccine supply deal, snapping up 100 million doses of Moderna’s mRNA jab for a little over $1.5 billion –around $15 per dose or $30 per course.

That’s a steep discount on the $32 to $37 price per dose in its earlier smaller deals, revealing that purchasing power will be a big factor as supplies of COVID-19 vaccines become available – and also that countries with deep pockets will be at the front of the queue.

Nevertheless, consumer advocacy group Public Citizen has slammed the amount Moderna is charging the US for the mRNA-1273 vaccine, saying that as taxpayer money had funded 100% of the work done to bring it to market the US is “paying twice” for the shot.

“When the president bragged on the campaign trail about his deal-making prowess, this isn’t what people had in mind,” said the organisation.

“It is absurd that Trump and [Health and Human Services Secretary Alex Azar] are touting $30 per course as a good deal for the American people, in light of the consistent and ongoing support from the US government towards mRNA-1273 research, development and manufacturing.”

The $1.525 billion order includes $300 million in incentive payments for swift delivery, in other words if the vaccine is approved for marketing or gets an emergency-use green light on or before 31 January next year.

It takes the total amount allocated to the vaccine by the US government to $2.48 billion, including $955 million previously awarded to Moderna to fund clinical development and manufacturing of mRNA-1273.

The shot is in a phase 3 trial called COVE which started last month with the help of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Moderna has previously said it is on track to deliver up to 500 million doses per year, and possibly up to a billion doses per year beginning in 2021, thanks to a manufacturing collaboration with Lonza.

The company also has a large-scale fill and finish contract with Catalent’s biologics facility in Indiana, following $1.3 billion in funding from investors in a public equity offering in May.

Shares in Moderna spiked up around 5% on the announcement, but fell back just as quickly to end the day only fractionally up.

Analysts said the US deal could lead to others being signed quickly as other countries try to snap up available stocks, once again raising fears of “vaccine nationalism” that will leave lower-income countries at the back of the queue when it comes to access.

The US government previously signed deals – all for 100 million doses – of a vaccine from Pfizer/BioNTech at a cost of $39 per course, $21 per dose for a Sanofi/GlaxoSmithKline shot, and $10 per dose for a Johnson & Johnson candidate.

It also has deals in place to supply vaccines from Novavax and AstraZeneca/University of Oxford for 100 million doses at $16 and 300 million doses at $4, respectively.

“The Trump Administration is increasing the likelihood that the US will have at least one safe, effective vaccine by 2021,” said Azar in a statement.

The post Anger at US deal for Moderna’s ‘taxpayer-funded’ COVID-19 vaccine appeared first on .

Moderna secures more than $1.5B federal government deal to provide Covid-19 vaccine

The agreement, which includes 100 million doses of mRNA-1273 and an option to acquire 400 million more, brings the total amount of money the biotech company has received from the federal government for its vaccine efforts to nearly $2.5 billion.

Moderna Prices its COVID-19 Vaccine at $32-$37 per Dose for Smaller Volume Agreements

Shots:

  • For smaller volume agreements, the company has priced its COVID-19 vaccine ranging from $32-$37/ dose, higher than the price of Pfizer’s vaccine candidate
  • The company is in talks with several countries for supply agreements of its vaccine, adding that it had already received about $400M for supply. The P-III study of mRNA-1273 is being conducted in collaboration with NIH and BARDA with an anticipated completion of enrollment in Sept’2020
  • Moderna has received $1B from the US government under a plan to ramp up vaccine development. The company’s vaccine candidate is one of the few that have already advanced to the final stage of testing

Click here ­to­ read full press release/ article | Ref: Reuters | Image: PharmaShots




PharmaShots Weekly Snapshot (Jul 27- 31, 2020)

 1.  Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease 

Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease

2.  Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium

Published: Jul 30, 2020 | Tags: Johnson & Johnson, Initiates, P-I/IIa, Study,  Ad26,  US, Belgium

 3. Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer

Published: Jul 31, 2020 | Tags: Roche, Receives, US, FDA, Approval, VENTANA HER2 Dual ISH Test, CDx, Identify, Breast Cancer

4. Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

Published: Jul 31, 2020 | Tags: Takeda, Pevonedistat, Receives, US, FDA, Breakthrough Therapy Designation, Patients, Higher-Risk Myelodysplastic Syndromes, HR-MDS

5. Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Published: Jul 31, 2020 | Tags: Roche, Tecentriq, Cotellic, Zelboraf, Receives, US, FDA, Approval, Patients, Advanced, Melanoma

6. Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets

Published: Jul 30, 2020 | Tags: Sangamo, Signs, Worldwide, License Agreement, Novartis, Develop, Genomic Therapies, Three, Neurodevelopmental Targets

7.  Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes

Published: Jul 30, 2020 | Tags: Eli Lilly, Reports, Results, Jardiance, empagliflozin, P-III, EMPEROR Trial, Heart Failure, Patients, Reduced Ejection Fraction, with and without, Diabetes

8.  AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

Published: Jul 29, 2020 | Tags: AstraZeneca, Tagrisso, Osimertinib, Receives, US, FDA, BT, Designation, Adjuvant Treatment, Patients, Stage IB-IIIA EGFR-Mutated, Lung Cancer

9. Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

Published: Jul 30, 2020 | Tags: Glenmark, Report, Results, FabiFlu, favipiravir, P-III, Clinical Study, Patients, Mild, Moderate, COVID-19

10. UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

Published: Jul 29, 2020 | Tags: UCB Canada, Brivlera, brivaracetam, Receives, Health Canada, Approval, Treat, Partial-Onset Seizures, Pediatric, Epilepsy Patients

11. BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness

Published: Jul 23, 2020 | Tags: BARDA, Signs, Multi-Year Agreement, Regeneron, REGN-EB3, National Preparedness

13.  Baxter and Ayogo Expand their Partnership to Advance Digital Health Solution for Home Dialysis

Published: Jul 29, 2020 | Tags: Baxter, Ayogo, Expand, Partnership, Advance, Digital, Health Solution, Home Dialysis

14.  Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

Published: Jul 29, 2020 | Tags: Merck, MK-6482, Receives, US, FDA, Breakthrough Therapy Designation, Treat, Patients, Von Hippel-Lindau Disease- Associated, Renal Cell Carcinoma

15AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis

Published: Jul 28, 2020 | Tags: AbbVie, Reports, Results, Rinvoq, upadacitinib, P-III, AD Up, Study, Patients, Atopic Dermatitis

16.   Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Published: Jul 29, 2020 | Tags: Roche, Actemra/RoActemra, tocilizumab, Fails, Meet, Primary Endpoint, P-III, COVACTA Study, Patients, COVID-19, Associated Pneumonia

17.  Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Published: Jul 28, 2020 | Tags: Sanofi, GSK, Sign, Agreement, UK, Government, Supply, ~60M, Doses, COVID-19, Vaccine

18.  Eli Lilly’s P-tau217 Blood Test Demonstrate High Accuracy in Diagnosis of Alzheimer’s Disease

Published: Jul 29, 2020 | Tags: Eli Lilly, P-tau217, Blood Test, Demonstrate, High Accuracy, Diagnosis, Alzheimer’s Disease

19.  Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease

Published: Jul 28, 2020 | Tags: Roche, UCB, Collaborate, Develop, UCB0107,  Alzheimer’s Disease

20.  Zebra Medical Receives the US FDA’s Approval for its HealthMammo Mammography Tool

Published: Jul 27, 2020 | Tags: Zebra Medical, Receives, US, FDA, Approval, HealthMammo, Mammography Tool, Oncology, Breast Cancer

21.   AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

Published: Jul 27, 2020 | Tags: AstraZeneca, Reports, Results, Farxiga, P-III, DAPA-CKD, Study, Patients, Chronic Kidney Disease

22.  Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

Published: Jul 28, 2020 | Tags: Eli Lilly, Amends, 2013, Agreement, Chi-Med, Commercialize, Elunate, Fruquintinib, China

23. AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19

Published: Jul 27, 2020 | Tags: AstraZeneca, Signs, Agreement, Emergent BioSolutions, Expand, Manufacturing, AZD1222, COVID-19

24.  Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Published: Jul 28, 2020 | Tags: Pfizer, BioNTech, Initiate, P-II/III, Global Study, Lead, mRNA, Vaccine, Candidate, Against, COVID-19

25.  Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India

Published: Jul 26, 2020 | Tags:  Three, Pharma, Companies, Launch, Favipiravir, COVID-19, India

26. Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

Published: Jul 27, 2020 | Tags: Kite, Tecartus, brexucabtagene autoleucel, Receives, US, FDA, Approval, First, Cell-Based, Gene Therapy, Relapsed, Refractory, MCL

27.   Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Published: Jul 26, 2020 | Tags: Centus Biotherapeutics, Equidacent, (bevacizumab, biosimilar, Receives, CHMP, Positive Opinion, Treatment, Multiple Cancer Indications

28.   AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Published: Jul 27, 2020 | Tags: AstraZeneca, Signs, Agreement, Daichii Sankyo, Develop, Commercialize, DS-1062, Worth, Up to, $6B, Global, Oncology,

29. Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer

Published: Jul 27, 2020 | Tags: Sorrento, Acquire, SmartPharm, Develop, Pipeline, Gene-Encoded, Therapeutic Antibodies, Targeting, COVID-19, Cancer, Oncology, Global




Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. Life sciences companies are putting all of their efforts into finding a treatment or developing a vaccine for this disease. PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where we have covered news updates regarding collaborations, clinical trials, funding, and regulatory guidelines related to the COVID-19 from Jan to date.

75. Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Jul 30, 2020 | Clinical Trial

74. Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Jul 29, 2020 | Collaboration

73. UK’s Recovery Continues to Test Roche’s Tocilizumab in COVID-19

Jul 29, 2020 | Clinical Trial

72. Roche’s Actemra/RoActemra Fails in COVID-19 Trial

Jul 29, 2020 | Clinical Trial

71. Green Cross’ GC5131A Receives the Regulatory Approval for P-II Trial for COVID-19

Jul 29, 2020 | Regulatory

70. Relief’s RLF-100 (aviptadil) Receives the US FDA’s Expanded Access Protocol to Treat Respiratory Failure in COVID-19

Jul 29, 2020 | Regulatory

69. AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19  

Jul 28, 2020 | Regulatory

68. Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Jul 28, 2020 | Clinical Trial

67. Gilead’s Veklury (Remdesivir) Health Canada’s Marketing Authorization with Conditions (NOC/c) to Treat COVID-19 

Jul 28, 2020 | Regulatory

66. Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India  

Jul 27, 2020 | Launch

65. Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer  

Jul 27, 2020 | Collaboration

64. AI Therapeutics Reports Initiation of P-II Trial of LAM-002A (apilimod dimesylate) for COVID-19 Patients

Jul 27, 2020 | Clinical Trial

63. Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)  

July 24, 2020 | Clinical Trial

62. Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Jul 27, 2020 | Clinical Trial

61. The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19  

Jul 27, 2020 | Launch

60. Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India  

Jul 27, 2020 | Launch

59. Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Jul 27, 2020 | Clinical Trial

58. AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Jul 27, 2020 | Clinical Trial

57. Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19  

Jul 20, 2020 | Diagnostic

56. Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Jul 20, 2020 | Clinical Trial

55. Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India  

Jul 16, 2020 | Clinical Trial

54. Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19

Jul 16, 2020 | Launch

53. AstraZeneca and the University of Oxford to Share Positive News on its COVID-19 Vaccine Imminently

Jul 15, 2020 | Collaboration

52. 3M Collaborates with MIT to Develop Paper-Based Diagnostic Test for COVID-19

Jul 13, 2020 | Collaboration

51. Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July, 2020

Jul 13, 2020 | Clinical Trial

50. The International Fencing Federation (FIE) Reports the Global COVID-19 Support Plan

July 13, 2020 | Launch

49. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms  

Jul 12, 2020 | Regulatory

48. The Zimbabwe Government to Launch US $10M COVID-19 Relief Package

Jul 11, 2020 | Launch

47. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms

Jul 10, 2020 | Regulatory

46. AstraZeneca Collaborates with ProteinQure to Design Novel Peptide Therapeutics

Jul 10, 2020 | Collaboration

45. Cipla Launches Cipremi at $53.34 per Vial in India

Jul 10, 2020 | Launch

44. The Health Ministry of Kyrgyzstan Reports Supply of Avifavir an Antiviral Drug form Russia

Jul 09, 2020 | Regulatory

43. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Clinical Trial

42. Angion Commences P-II Study of ANG-3777 in Patients with Acute Lung Injury Associated with COVID-19 Pneumonia in Brazil

Jul 08, 2020 | Clinical Trial

41. The European Commission Signs an Agreement with Roche and Merck to Supply their COVID-19 Therapies in EU

Jul 09, 2020 | Collaboration

40. GSK and Medicago to Initiate P-I Trial of Plant-Based COVID-19 Vaccine in July 2020

Jul 08, 2020 | Clinical Trial

39. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Collaboration  

38. Innovation Pharmaceuticals Reports Results Brilacidin in COVID-19 Clinical Trial

 Jul 07, 2020 | Clinical Trial

37. Reven Reports Publication of Two COVID-19 Articles for RJX Platform

Jul 07, 2020 | Regulatory

36. Emergent Signs a Five-Year Manufacturing Services Agreement with Janssen for Ad26.COV2-S to Treat COVID-19  

Jul 07, 2020 | Collaboration   

35. Constant Therapeutics’ TXA127 will be Evaluated in P-II Trial for COVID-19 Patients

Jul 07, 2020 | Clinical Trial

34. Sinovac’s P-III COVID-19 Trial Receives the Brazilian Regulator Approval  

Jul 07, 2020 | Regulatory

33. Nasus Pharma Reports Results of TaffiX as a Intranasal Antiviral Protection Against SARS-CoV-2

Jul 07, 2020 | Clinical Trial

32. Mylan Receives EUA Approval for its Remdesivir to Treat COVID-19  

Jul 07, 2020 | Regulatory

31. Diffusion Pharmaceuticals Reports IND Submission for P-Ib/IIb COVID-19 Clinical Program with TSC to the US FDA

Jul 07, 2020 | Clinical Trial

30. Novavax to Receive $1.6B Funds from the US

Jul 07, 2020 | Grants

29. Aboundbio Signs an Agreement with SaudiVax for COVID-19

Jul 07, 2020 | Collaboration

28. Hepion Pharmaceuticals Reports Preclinical Results of CRV431 for Treating COVID-19

Jul 07, 2020 | Clinical Trial

27. Therapeutic Solution Reports Submission of Publication of Preclinical Data on StemVac for Supporting COVID-19 Indication

 Jul 07, 2020 | Clinical Trial

26. Regeneron with its Partner NIAID Report the Initiation of P-III Trial to Evaluate REGN-COV2 for Treatment and Prevention of COVID-19  

Jul 06, 2020 | Clinical Trial

25. Mylan’s Remdesivir Lyophilized Powder for Injection Receives the DCGI Accelerated Approval for Restricted Emergency Use in COVID-19 Patients in India    

Jul 06, 2020 | Regulatory

24. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

23. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Trial for Patients with COVID-19 in the US

Jul 03, 2020 | Clinical Trial

22. Moderna Reports the Enrollment of P-II Trial for its mRNA-1273 to Treat COVID-19  

Jul 03, 2020 | Clinical Trial

21. Sorrento Selects T-VIVA-19 as a Targeted Protein Vaccine Candidate Against COVID-19

Jul 02, 2020 | Clinical Trial

20. Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside Japan

Jul 02, 2020 | Collaboration

19. Pfizer and BioNTech Report Results of BNT162b1 mRNA-Based Vaccine in P-I/II Study Against COVID-19

Jul 02, 2020 | Clinical Trial

18. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

17. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Study for Patients with COVID-19 in the US

Jul 02, 2020 | Clinical Trial

16.  Phase II Study of MRx-4DP0004 in Patients Hospitalized with COVID-19 Open for Enrolment

Jul 02, 2020 | Clinical Trial

15.  Regulatory Authorities Step Up Cooperation in Connection with COVID-19

Jul 02, 2020 | Regulatory

14. Austria Donates €2M to CEPI to Support COVID-19 Vaccine Programmes

Jul 02, 2020 | Grant

13. Liminal BioSciences Joins CoVIg Plasma Alliance to Develop New COVID-19 Therapy

Jul 02, 2020 | Collaboration

12. Biophytis Receives FDA IND Clearance for COVA, a P-II/III Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

Jul 02, 2020 | Clinical Trial

11.  EUSA Receives the US FDA Approval of P-III Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

Jul 02, 2020 | Clinical Trial

10.  Moderna Faces Delay in its COVID-19 Vaccine Trial

Jul 02, 2020 | Clinical Trial

9. Anivive Initiates Two Pre-Clinical Studies of GC376 for the Treatment of COVID-19

Jul 02, 2020 | Clinical Trial

8. MediciNova Announces Opening of IND for MN-166 (ibudilast) for Prevention of Acute Respiratory Distress Syndrome in Patients with COVID-19

Jul 01, 2020 | Clinical Trial

7. GoldenBiotech’s Antroquinonol Receives FDA Approval on COVID-19 P-II Trial in the US

Jul 01, 2020 | Regulatory

6. New Study Highlights Senhwa Biosciences Silmitasertib as Potential Treatment for COVID-19

Jul 01, 2020 | Clinical Trial

5. International Regulators Provide Guiding Principles for COVID-19 Clinical Trials

Jul 01, 2020 | Regulatory

4.  FibroGenesis Identifies Mechanism Responsible for Blocking COVID19-Like Lung Inflammation

Jul 01, 2020 | Clinical Trial

3. Inimmune Awarded $2M SBIR to Advance Vaccine Technologies

Jul 01, 2020 | Grant

2. UNION Receives Danish Medicines Agency’s Approval to Initiate Clinical Study With Niclosamide for Treatment of COVID-19

Jul 01, 2020 | Clinical Trial

1. FAMHP Facilitates and Supports the Development of COVID-19 Treatments and Vaccines

Jul 01, 2020 | Regulatory

Related Post : Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – June 2020




Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial

The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named COVE.

Moderna gets further $472m as expanded phase 3 COVID-19 trial begins

A US government agency is to give a further $472 million to biotech Moderna, after it announced plans to expand a phase 3 trial for its potential COVID-19 jab.

The latest funding from the Biomedical Advanced Research and Development Authority follows a tranche worth $483 million, awarded to kick-start development of Moderna’s mRNA-based vaccine codenamed mRNA-1273 in April.

Moderna has decided to expand the number of participants in a phase 3 trial after discussions with the FDA and with the Trump administration’s Operation Warp Speed.

The total number of patients involved in the phase 3 trial will be 30,000, and total funding awarded is around $955 million.

The phase 3 COVE study is expected to begin today and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

After a review by the FDA, the trial will involve a 100 microgram dose and the endpoint will be prevention of symptomatic COVID-19 disease.

Key secondary endpoints include prevention of severe COVID-19 disease – defined as the need for hospitalisation – and prevention of infection by SARS-CoV-2.

Moderna says it is on track to deliver up to 500 million doses per year, and possibly up to a billion doses per year beginning in 2021 thanks to its manufacturing collaboration with Lonza.

The company also has a large-scale fill and finish contract with Catalent’s biologics facility in Indiana, following $1.3 billion in funding from investors in a public equity offering in May.

Moderna’s vaccine is based on cutting-edge but unproven technology, which uses a strand of mRNA to instruct the patient’s body to make copies of the “Spike” protein found on the surface of the SARS-CoV-2 coronavirus that causes COVID-19.

It’s hoped that this will prime the immune system to swing into action and neutralise the virus should patients become infected.

According to a regularly updated document from the World Health Organization, there are now 25 potential COVID-19 vaccines in clinical development.

A candidate developed by China’s Sinovac is at the top of the list, although Moderna’s drug may move up in the WHO’s reckoning following the latest development.

Feature image courtesy of Rocky Mountain Laboratories/NIH

The post Moderna gets further $472m as expanded phase 3 COVID-19 trial begins appeared first on .

PharmaShots Weekly Snapshot (Jul 20- 24, 2020)

 1.  Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis 

Published: Jul 24, 2020 | Tags: Gilead, Galapagos, Jyseleca, filgotinib, Receive, CHMP, Positive Opinion,  Moderate, Severe, Rheumatoid Arthritis

2.  Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs

Published: Jul 24, 2020 | Tags: Synaffix, Expands, Existing Collaboration, ADC, Explore, Two Additional Programs

 3. Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)

Published: Jul 23, 2020 | Tags: Zydus, Initiate, Clinical Study, Desidustat, Patients, Chemotherapy Induced Anemia, CIA

4. AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

Published: Jul 24, 2020 | Tags: AstraZeneca, Breztri Aerosphere, Receives, US, FDA, Approval, Maintenance Treatment, COPD

5. Abbott’s IOS-Compatible App Receives the US FDA’s Approval for Patients with Neurological Disorder

Published: Jul 17, 2020 | Tags: Abbott, IOS-Compatible App, Receives, US, FDA, Approval, Patients, Neurological Disorder

6. BioMarin Reports the Submission of MAA to EMA for Vosoritide to Treat Children with Achondroplasia

Published: Jul 23, 2020 | Tags: BioMarin, Reports, Submission, MAA, EMA, Vosoritide, Treat, Children, Achondroplasia

7.  Ovid Therapeutics and University of Connecticut Collaborate to Accelerate the Development of OV101 (gaboxadol) for Angelman Syndrome

Published: Jul 22, 2020 | Tags: Ovid Therapeutics, University of Connecticut, Collaborate, Accelerate, Development, OV101, gaboxadol, Angelman Syndrome

8.  Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

Published: Jul 22, 2020 | Tags: Genentech, Reports, Results, Port Delivery System, Ranibizumab, P-III, Archway Study, Neovascular Age-Related Macular Degeneration

9. Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Published: Jul 22, 2020 | Tags: Glenmark, Report, Results, FabiFlu, favipiravir, P-III, Clinical Study, Patients, Mild, Moderate, COVID-19

10. Daiichi Sankyo Signs a Research Agreement Gustave Roussy for DS-1062 and Patritumab Deruxtecan to Treat Lung and Breast Cancer

Published: Jul 23, 2020 | Tags: Daiichi Sankyo, Signs, Research Agreement, Gustave Roussy, DS-1062, Patritumab Deruxtecan, Treat, Lung, Breast Cancer

11. Chugai and Biofourmis Collaborate to Develop Solutions for Digitally Measuring Endometriosis Pain

Published: Jul 23, 2020 | Tags: Chugai, Biofourmis, Collaborate, Develop, Solutions, Digitally Measuring, Endometriosis Pain

13.  AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis

Published: Jul 22, 2020 | Tags: AbbVie, Reports, Results, Rinvoq, upadacitinib, Monotherapy, P-III, Measure Up 2, Study, Atopic Dermatitis

14.  Evotec Collaborates with Quantro Therapeutics to Discover and Develop Novel Therapies for Cancer and Other Diseases

Published: Jul 22, 2020 | Tags: Evotec, Collaborates, Quantro Therapeutics, Discover, Develop, Novel, Therapies, Cancer, Other Diseases

15Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

Published: Jul 20, 2020 | Tags: Boston Scientific, Receives, US, FDA, Approval, Next-Generation, WATCHMAN FLX, Left Atrial, Appendage Closure Device

16.   Gilead to Acquire Tizona’s Stakes for $300M

Published: Jul 22, 2020 | Tags: Gilead, Acquire, Tizona, Stake, $300M, AbbVie, TTX-080, TTX-03

17.  Biocon Collaborates with Voluntis on Digital Therapeutics for Insulins

Published: Jul 21, 2020 | Tags: Biocon, Collaborates, Voluntis, Digital Therapeutics, Insulins

18.  Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

Published: Jul 22, 2020 | Tags: Paige, Receives, US, FDA, 510(k), Clearance, FullFocus Viewer, Use, Digital Pathology

19.  The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19

Published: Jul 21, 2020 | Tags: The UK, Government, Launch, AbC-19, Lateral Flow, Free Finger-Prick Test, COVID-19

20.  Roche Collaborates with Jnana Therapeutics to Discover Novel Therapies to Treat Immune-Mediated and Neurological Diseases

Published: Jul 21, 2020 | Tags: Roche, Collaborates, Jnana Therapeutics, Discover, Novel Therapies, Treat, Immune-Mediated, Neurological Diseases

21.   Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India

Published: Jul 20, 2020 | Tags: Mylan, Launches, Remdesivir, Under, Brand Name, Desrem, COVID-19, India

22.  Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Published: Jul 21, 2020 | Tags: Pfizer, BioNTech, Elicits, Strong, T-cell, Response, P-I/II, Study, Against, COVID-19, Germany

23. AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Published: Jul 20, 2020 | Tags: AstraZeneca, Oxford University, AZD1222, Delivers, Strong, Immune Response, P-II/III, COV001, Study, Against, COVID-19  

24.  Royalty Pharma Acquires PTC’s Royalty Interest in Risdiplam for $650M

Published: Jul 19, 2020 | Tags: Royalty Pharma, Acquires, PTC, Royalty Interest, Risdiplam,  $650M

25.  Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19

Published: Jul 19, 2020 | Tags:  Quest Diagnostic, Receives, US, FDA, First, EUA, Sample Pooling, COVID-19

26. Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis

Published: Jul 19, 2020 | Tags: Roche, Signs, RWD, Collaboration, PicnicHealth, Create, Personalized Treatment, Patients, Multiple Sclerosis

27.   Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Published: Jul 19, 2020 | Tags: Celltrion, Initiates, P-I, Study, COVID-19, Antibody Treatment, South Korea

28.   GSK to Acquire 10% stake in CureVac for $163M

Published: Jul 20, 2020 | Tags: GSK, Acquire, 10%, Stake, CureVac, $163M




Controversy as pharma execs predict profits from COVID-19 vaccines

Concerns have emerged about access to some potential COVID-19 vaccines after pharma executives from three companies said they expect to make profits from their products in evidence to a US Congressional panel.

Moderna, Merck & Co, and Pfizer said they expect to profit from coronavirus vaccines if they are approved, although AstraZeneca and Johnson & Johnson said they will price their respective vaccines only to cover costs if they are approved.

The hearing was discussing the efforts to develop a safe, effective, and accessible vaccine against COVID-19.

US-based Moderna is in mid-stage clinical development, making it one of the front-runners in the race to develop a vaccine against the SARS-CoV2 virus that causes COVID-19.

Along with AstraZeneca, Moderna has received funding from the US government to help develop its vaccine, although Pfizer has not.

The funding would make any profits controversial, something that lawmakers addressed in their conversations with the pharma representatives, who attended the hearing via a video link.

Merck & Co’s vaccine has yet to enter the clinic, but the company’s considerable financial clout and the accelerated development timelines for COVID-19 vaccines mean this could change very quickly.

Julie Gerberding, chief patient officer for US-based Merck told the House of Representatives subcommittee on oversight and investigations: “We will not be selling our vaccine at cost, although it is premature for us as we’re a long way from understanding the cost-basis.”

Reuters reported that Gerberding and a representative from Moderna did not comment on the price they have in mind for their vaccines at the hearing.

Representing Pfizer, chief business officer John Young said that the company intends to make a profit from its vaccine, developed in partnership with Germany’s BioNTech, if it gets approved.

Young said: “We recognize that these are extraordinary times and our price will reflect that.”

Pfizer and BioNTech have reported promising early results from their vaccine and are preparing for late-stage trials, scheduled to begin in the coming weeks.

Jan Schakowsky, Democrat representative from Illinois who sits on the committee, was clearly unimpressed by some of the responses, particularly from Pfizer.

There are now 24 potential vaccines in clinical development, with the World Health Organization listing several phase 3 products developed in China as the most advanced.

AstraZeneca is close behind, and is hoping to have its vaccine ready by the end of the year after favourable early data from a phase 1 clinical trial announced earlier this week.

Feature image courtesy of Rocky Mountain Laboratories/NIH

The post Controversy as pharma execs predict profits from COVID-19 vaccines appeared first on .

Moderna’s $37B market cap is too high, despite COVID-19 vaccine; analyst

JP Morgan has downgraded its valuation of Moderna, saying its $37 billion market cap is way too high even if its COVID-19 vaccine mRNA-1273 succeeds in clinical trials.

Moderna’s share price has rocketed 385% this year, driven by the development of mRNA-1273, but the analysts think there are too many unknowns surrounding the coronavirus pandemic and the prospects for a vaccine to justify its valuation.

They have downgraded the stock from overweight to neutral, stressing however that the move “is not a call on any sort of diminished expectations around the company or mRNA-1273.”

More important are questions such as how long the pandemic will last, what price vaccine makers will be able to charge, and how many effective vaccines will become available, says JP Morgan.

Just yesterday, there were positive preliminary trial results with two other coronavirus vaccines – from Oxford University/AstraZeneca and CanSino Biologics – and at last count there were 24 candidates in clinical development.

mRNA-1273 – one of five vaccines in the clinical pipeline based on RNA – is also one of the furthest ahead in development, having already started phase 3 testing.

Earlier this month, Moderna reported initial clinical results from a US National Institutes of Health (NIH) study showing that two doses of the shot was able to stimulate neutralising antibodies against SARS-CoV-2, the virus that causes COVID-19.

“We remain bullish on Moderna’s long-term outlook, disruptive platform (in the vaccine space and otherwise), and chances of being one of the first companies to bring a COVID-19 vaccine to market,” write the JP Morgan analysts in a research note.

More positive data readouts could drive the company’s share price and market cap still higher, but “we’re simply unable to continue to fundamentally justify it,” they add.

They also think success with the COVID-19 candidate will read through to the rest of Moderna’s pipeline, which includes other vaccine candidates as well as RNA-based drugs for cancer immunotherapy and other diseases.

At the moment JP Morgan ascribes a value of $25 billion for Moderna’s mRNA platform, which is substantially above any other companies it covers.

They place a value for mRNA-1273 of $16 per Moderna share – trading at more than $82 today – with a 60% chance of success for the programme and peak sales estimates of $4.2 billion to 6.4 billion, depending on the duration of the pandemic.

The top end of those estimates apply if SARS-CoV-2 becomes endemic or the pandemic lasts through 2025 with people requiring annual shots for protection.

The lower end of the model – which JP Morgan give a 10% probability to – is that the pandemic lasts through 2022.

The post Moderna’s $37B market cap is too high, despite COVID-19 vaccine; analyst appeared first on .

PharmaShots Weekly Snapshot (Jul 13- 17, 2020)

 1.  Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis

Published: Jul 17, 2020 | Tags: Eli Lilly, Reports, Results, Mirikizumab, P-III, OASIS-2, Study, Treat, Moderate, Severe, Plaque Psoriasis

2.  Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced / Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid Tumors

Published: Jul 16, 2020 | Tags: Oncorus, Initiates, P-I, ONCR-177, Patients, Advanced, Refractory, Cutaneous, Subcutaneous, Metastatic, Nodal Solid Tumors

 3. Thermo Fisher Scientific Amends its Agreement to Acquire QIAGEN

Published: Jul 16, 2020 | Tags: Thermo Fisher Scientific, Amends, Agreement, Acquire, QIAGEN

4.  Kiniksa’s Rilonacept Receives the US FDA’s Orphan Drug Designation to Treat Pericarditis

Published: Jul 16, 2020 | Tags: Kiniksa, Rilonacept, Receives, US, FDA, Orphan Drug Designation, Treat, Pericarditis

5. Merck KGaA Takes an Early Option in its Existing Immuno-Oncology Collaboration with F-star

Published: Jul 17, 2020 | Tags: Merck KGaA, Takes, Early Option, Existing, Immuno-Oncology, Collaboration, F-star

6. Kronos Bio to Acquire Gilead’s SYK Inhibitor Portfolio

Published: Jul 17, 2020 | Tags: Kronos Bio, Acquire, Gilead, SYK Inhibitor, Portfolio, Entospletinib, Lanraplenib

7.  Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF

Published: Jul 16, 2020 | Tags: Merck, Bayer, Receive, US, FDA, Priority Review, Vericiguat, Reduce, Risk, CV Death, Patients, Symptomatic Chronic Heart Failure, HFrEF

8.  MSD Collaborates with Novocure to Evaluate Tumor Treating Fields Together with Keytruda (pembrolizumab) in Non-Small Cell Lung Cancer

Published: Jul 15, 2020 | Tags: MSD, Collaborates, Novocure, Evaluate, Tumor Treating Fields, Together, Keytruda, pembrolizumab, Non-Small Cell Lung Cancer

9. Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India

Published: Jul 15, 2020 | Tags: Zydus, Initiates, Adaptive, P-I/II, Clinical Study, Evaluating, ZyCoV-D, Against, COVID-19, India

10.  NCCN Collaborates with Pfizer to Explore Adoption of Biosimilars in Oncology

Published: Jul 16, 2020 | Tags: NCCN, Collaborates, Pfizer, Explore, Adoption, Biosimilars, Oncology

11.  AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack

Published: Jul 16, 2020 | Tags: AstraZeneca, Report, Results, Brilinta, ticagrelor, P-III, THALES Study, Patients, Acute Ischemic Stroke, Transient Ischemic Attack

12.  Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19

Published: Jul 16, 2020 | Tags: Novartis, Launches, Zero Profit, Portfolio, Symptomatic Treatment, COVID-19

13.  Medtronic to Acquire Medicrea to Boost its Spine Offerings

Published: Jul 15, 2020 | Tags: Medtronic, Acquire, Medicrea, Boost, Spine Offerings

14.   AstraZeneca and the University of Oxford to Share Positive News on its COVID-19 Vaccine Imminently

Published: Jul 15, 2020 | Tags: AstraZeneca, University of Oxford, Share, Positive News, COVID-19 Vaccine, Imminently

15.   GSK’s Belantamab Mafodotin Receives the US FDA Advisory Committee’s Recommendation to Treat Relapsed/Refractory Multiple Myeloma

Published: Jul 14, 2020 | Tags: GSK, Belantamab Mafodotin, Receives, US, FDA, Advisory Committee, Recommendation, Treat, Relapsed/Refractory, Multiple Myeloma

16.  3M Collaborates with MIT to Develop Paper-Based Diagnostic Test for COVID-19

Published: Jul 14, 2020 | Tags: 3M, Collaborates, MIT, Develop, Paper-Based, Diagnostic Test, COVID-19

17.  Samsung Biologics Signs Multi-Product Development and Manufacturing Agreement with ImmuneOncia

Published: Jul 15, 2020 | Tags: Samsung Biologics, Signs, Multi-Product, Development, Manufacturing, Agreement, ImmuneOncia

18.  Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July, 2020

Published: Jul 14, 2020 | Tags: Moderna, Anticipate, Initiate, Late-stage, COVID-19, Vaccine, Trial, 27 July, 2020

19.   Sanofi and MD Anderson Sign a Five-Year Pact to Expedite Oncology Research and Development

Published: Jul 14, 2020 | Tags: Sanofi, MD Anderson, Sign, Five-Year, Pact, Expedite, Oncology, Research, Development

20.  Merck Signs an Exclusive Agreement with Dewpoint Therapeutics to Develop Curative Treatment for HIV

Published: Jul 13, 2020 | Tags: Merck, Signs, Exclusive Agreement, Dewpoint Therapeutics, Develop, Curative Treatment, HIV

21.  Roche’s Mosunetuzumab Receives the US FDA’s Breakthrough Therapy Designation to Treat Relapsed or Refractory Follicular Lymphoma

Published: Jul 14, 2020 | Tags: Roche, Mosunetuzumab, Receives, US, FDA, Breakthrough Therapy Designation, Treat, Relapsed, Refractory, Follicular Lymphoma

22.  Roche Expands its Collaboration with Immunomedics to Evaluate Tecentriq Based Combination Therapy in Urothelial and Non-Small Cell Lung Cancers

Published: Jul 13, 2020 | Tags: Roche, Expands, Collaboration, Immunomedics, Evaluate, Tecentriq, Based, Combination Therapy, Urothelial, Non-Small Cell Lung Cancers

23.  Roche Signs a ~$1B Agreement with Blueprint Medicines for its Precision Therapy to Treat Patients with RET-Altered Cancer Indications

Published: Jul 14, 2020 | Tags:  Roche, Signs, ~$1B, Agreement, Blueprint Medicines, Precision Therapy, Patients, RET-Altered, Cancer Indications

24. Paige Secures Funding from Goldman Sachs to Continue Innovation in Digital Pathology

Published: Jul 13, 2020 | Tags: Paige, Secures, Funding, Goldman Sachs, Continue, Innovation, Digital Pathology

25.   Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms

Published: Jul 10, 2020 | Tags: Gilead, Veklury, remdesivir, Receives, the TGA, Approval, Treat, Adults, Adolescent, Severe, COVID-19 Symptoms

26.   Pfizer with its Partner BioNTech Receives the US FDA’s Fast Track Designation for Two mRNA Based Therapies to Treat COVID-19

Published: Jul 13, 2020 | Tags: Pfizer, Partner, BioNTech,, Receives, the US FDA, Fast Track Designation, Two, mRNA, Based, Therapies, Treat, COVID-19

25. Samsung Biologics Expands its Development Partnership with STCube for STM418

Published: Jul 13, 2020 | Tags: Samsung Biologics, Expands, Development, Partnership, STCube, STM418

26.   Roche’s Reports Results of Tecentriq in P-III IMagyn050 Study for Women with 1L Newly Diagnosed Advanced Stage Ovarian Cancer

Published: Jul 13, 2020 | Tags: Roche, Reports, Results, Tecentriq, P-III, IMagyn050 Study, Women, 1L, Newly, Diagnosed, Advanced, Stage, Ovarian Cancer

27.  Biocon’s ALZUMAb (Itolizumab) Receives the DCGI’s Approval for Emergency Use to Treat Patients with Moderate to Severe COVID-19

Published: Jun 11, 2020 | Tags: Biocon, ALZUMAb, Itolizumab, Receives, the DCGI, Approval, Emergency, Use, Treat, Patients, Moderate, Severe, COVID-19




FDA guidance eases some Covid-19 vaccine concerns, but others remain

Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.

Moderna publishes Phase 1 Covid-19 vaccine data showing robust immune responses

Evaluation of durability is still under evaluation, but the responses to mRNA-1273 show neutralizing antibody titers multiple times higher than those of recovered patients. Additionally, T-cell responses suggest potentially lower risk of enhanced respiratory disease.