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.

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

Shots:

  • The US FDA has granted FT designation to NVX-CoV2373 which is currently in late-phase clinical development. Novavax expects to initiate pivotal P-III study in the US & Mexico by the end of Nov’2020
  • The company’s ongoing P-lll trial in the UK to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 is expected to be fully enrolled by the end of Nov. Depending on the overall COVID-19 attack rate, interim data in the UK trial is expected in Q1’21
  • NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant

Click here ­to­ read full press release/ article | Ref: Novavax | Image: Newsroom Keck Medicine of USC

The post Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373 to Treat COVID-19 first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Nov 02-06, 2020)

AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Published: Nov 6, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US FDA, Approval, Acute, High,Risk, Transient, Ischaemic, Stroke

Novo Nordisk to Acquire Emisphere Technologies for $1.8B

Published: Nov 6, 2020 | Tags: Novo Nordisk, Acquire, Emisphere Technologies, $1.8B

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

Published: Nov 5, 2020 | Tags: AstraZeneca’s, Forxiga, (dapagliflozin), Receives, EU, Approval, Heart Failure

AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer

Published: Nov 5, 2020 | Tags: AstraZeneca, MSD, Lynparza, Olaparib, Receives, EU, Approved, HRD, Positive, Advanced, Ovarian, Cancer

Merck KGaA Collaborates with Iktos to Deploy AI in New Drug Design

Published: Nov 5, 2020 | Tags: Iktos, Signs, Agreement, Merck, KGaA, AI, New, Drug, Design

Formycon Reports BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

Published: Nov 5, 2020 | Tags: Formycon, Reports, BLA, Resubmission, Strategy, Lucentis, Biosimilar, FYB201

Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis

Published: Nov 5, 2020 | Tags: Cosentyx, Novartis, P-IIIb, patients, Psoriatic Arthritis, reports, results, secukinumab, study, ULTIMATE

Merck to Acquire VelosBio for $2.75B

Published: Nov 5, 2020 | Tags: $2.75B, Acquire, Merck, Oncology Pipeline, VelosBio

Innovent and Lilly Report Results of Tyvyt (sintilimab) in Seven Clinical Studies to be Presented at the ESMO ASIA Congress 2020

Published: Nov 5, 2020 | Tags: 2020, 7, Asia, Clinical, Congress, ESMO, Injection, Innovent, Lilly, Presents, results, Sintilimab, Studies, Tyvyt

Coloplast Acquires Nine Continents Medical

Published: Nov 4, 2020 | Tags: Coloplast, Acquires, Nine Continents Medical

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Published: Nov 4, 2020 | Tags: Novavax, Collaborates, Commonwealth, Australia, Supply, 40M, Doses, NVX-coV2373, COVID-19

BioInvent Presents New Clinical and Preclinical Data of BI-1206 at ASH Annual Meeting

Published: Nov 5, 2020 | Tags: ASH Annual Meeting, BI-1206, BioInvent, Follicular Lymphoma Mantle Cell Lymphoma, Marginal Zone Lymphoma, P-l/lla Study, reports, results

Jounce Stops Enrollment in P-II EMERGE Study Evaluating Vopratelimab for Lung Cancer

Published: Nov 4,2020 | Tags: Jounce Therapeutics, P-II EMERGE trial, Program, reports, Update, Vopratelimab

Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

Published: Nov 4, 2020 | Tags: Acceptance, Achondroplasia Regulatory, BioMarin, Children, FDA, NDA, reports, US, Vosoritide

CEPI to Invest ~$328M in Clover’s COVID-19 Vaccine Candidate

Published: Nov 3, 2020 | Tags: CEPI, Clover Biopharmaceuticals, Covid-19 Vaccine, Expand, Fund, Partnership

Abbott to Launch its Cardiac Mapping Platform in Europe and Australia

Published: Nov 2,2020 | Tags: Abbott, approval, CE Mark, EnSite X EP System, receives, TGA

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis

Published: Nov 4,2020 | Tags: BMS, BMS-986165, Deucravacitinib, Moderate, P-III, patients, Plaque, POETYK PSO-1, Positive, Psoriasis, reports, results, Severe, study

Boston Scientific’s Ranger DCB Receives the US FDA’s Approval for Peripheral Artery Disease in the SFA and PPA 

Published: Nov 4,2020 | Tags: approval, Boston Scientific, DCB, patients, Peripheral Artery Disease, PPA, Range, receives, SFA, Treatment, Us FDA

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Published: Nov 3,2020 | Tags: Advanced, breast, Cancer, HR+/HER2, Kisqali, MONALEESA-7, Novartis, P-III, reports, results, ribociclib, study, Women

Tetra Therapeutics Reports Positive Results of BPN14770 in P-II Study for Fragile X Syndrome

Published: Nov 3, 2020 | Tags: BPN14770, FXS, P-II, patients, Positive, reports, results, study, Tetra Therapeutics

Roche’s Tecentriq (atezolizumab) + Avastin (bevacizumab) Receive the EC’s Approval for Unresectable Hepatocellular Carcinoma

Published: Nov 3, 2020 | Tags: (atezolizumab), (bevacizumab), Aavastin, EU Approval Unresectable Hepatocellular Carcinoma (HCC), receives, Roche’s, Tecentriq

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Published: Nov 3, 2020 | Tags: 2020, ACR, Celltrion Healthcare, Convergence, CT-P17, P-III, Positive, Presents, RA, results, study, Treatment

Janssen Reports sNDA Submission of Paliperidone Palmitate 6-Month (PP6M) to the US FDA for Schizophrenia

Published: Nov 3, 2020 | Tags: (PP6M), Invega Sustenna, Invega Trinza, Janssen, NDA submission, reports, Us FDA

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

Published: Nov 3, 2020 | Tags: AstraZeneca, Cancer, Collaborate, Combination Therapies, Commercialize, Develop, Fusion, Next-Generation Radiopharmaceuticals

Novartis Reports Results of Aimovig (erenumab) in P-lV Study for Episodic and Chronic Migraine

Published: Nov 2, 2020 | Tags: Aimovig, Episodic and Chronic Migraine (HER-MES), erenumab, Novartis, P-lV Study, positive results, Report

Sun Pharma Reports Five Year Results of Ilumya (tildrakizumab-asmn) in P-III Studies for Moderate-to-Severe Plaque Psoriasis

Published: Nov 2, 2020 | Tags: 5-year, Ilumya, Moderate, P-III, patients, reports, results, reSURFACE 1, reSURFACE 2, Severe, Studies, Sun Pharma, tildrakizumab-asmn

 Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva

Published: Nov 2, 2020 | Tags: Fibrodysplasia Ossificans Progressiva, Garetosmab, LUMINA-1 Trial, P-ll, patients, Regeneron, REGN2477, Report, results

UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis

Published: Nov 2, 2020 | Tags: BE SURE, Bimekizumab, Moderate, P-III, patients, Psoriasis, reports, results, Severe, study, UCB

Sanofi to Acquire Kiadis for ~$358M

Published: Nov 2, 2020 | Tags: $358.76M, Acquire, Kiadis, Offers, Sanofi

Medtronic Expands ENT Portfolio with the Acquisition of Ai Biomed and the Approval of NIM Vital Nerve Monitoring System

Published: Nov 2, 2020 | Tags: Acquires, Ai Biomed Corp., ENT Portfolio, Medtronic’s, NIM Vital, Parathyroid Detection System, receives, US FDA’s Approval

Related Post: PharmaShots Weekly Snapshot (Oct 26 – 30, 2020)

The post PharmaShots Weekly Snapshot (Nov 02-06, 2020) first appeared on PharmaShots.

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Shots:

  • Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community
  • The delivery will start as early as H1’21, following the completion of P-III study and the TGA’s approval of the vaccine. The vaccine regimen is expected to require two doses per individual, administered 21 days apart.
  • NVX-CoV2373 is evaluated in P-ll trial in the UK and 2 ongoing P-ll studies that began in Aug’2020, a P-llb trial in SA, and a P-l/ll continuation in the US and Australia. Additionally, Novavax has multiple agreements for the supply of NVX-CoV2373 directly to the US, UK, Canada, and through partnerships, supply to Japan, South Korea, and India

Click here to­ read the full press release/ article | Ref: GlobeNewswire | Image: MediCircle

The post Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19 first appeared on PharmaShots.

UK government signs contract for COVID-19 challenge trial

The UK government has signed a contract to develop a controversial COVID-19 human challenge trial, where participants will be deliberately infected in a controlled environment with coronavirus to test whether a vaccine is effective.

Contract research organisation (CRO) hVIVO, a subsidiary of Open Orphan, has signed the contract with the UK government to develop the trial model.

This will involve manufacture of the challenge virus and the first-in-human characterisation study for the virus.

The characterisation study, which is expected to be completed in May 2021, still needs ethical and regulatory approval.

It is designed to assess the minimum dose of the virus required, before moving on to the next stage when a vaccine will be administered.

The study will be sponsored by Imperial College London and conducted by hVIVO at The Royal Free Hospital’s specialist research unit in London, under the scrutiny of highly trained scientists and medics.

hVIVO will also be expanding its clinical operations in London to conduct the trial.

It’s not clear which vaccine will be involved in the study – there are several in the last stages of clinical development and the UK government has orders for candidates from AstraZeneca, Pfizer/BioNTech, Novavax, Valneva, Sanofi/GSK and Johnson & Johnson.

No financial details of the contract with hVIVO were disclosed.

Challenge trials are controversial because of the risks involved with infecting patients with a potentially lethal virus, although with the SARS-CoV-2 coronavirus these could be managed as most people develop mild symptoms and those at high risk of a serious infection are relatively easy to identify.

hVIVO is already known for its challenge studies in other infectious diseases, which are conducted a 24-bedroom quarantine clinic with onsite virology, providing individually isolated rooms and connected to a specialist laboratory facility.

Open Orphan, which comprises of two commercial CRO services business hVIVO and Venn Life Sciences, has been working on several coronavirus challenge study models and expects to be busy over the next few months helping several pharma and biotech companies test their vaccines.

Anyone interested in being contacted and provided with details about future COVID-19 human challenge study research may leave their contact details at www.UKCovidChallenge.com.

The World Health Organization has been keeping tabs on the development of vaccines since the start of the pandemic and says there are now 44 in clinical development.

The three most advanced are being developed in China where the pandemic is thought to have originated, followed by a candidate from Oxford University and AstraZeneca in the UK.

Feature image courtesy of Rocky Mountain Laboratories/NIH

The post UK government signs contract for COVID-19 challenge trial 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?

 

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PharmaShots Weekly Snapshot (Aug 10 – 14, 2020)

1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children

Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, FDA, Approval, SMA, Adults, Children

2.  The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

Published: Aug 07, 2020 | Tags: Guardant Health, Guardant360 CDx, Receives, US, FDA, Approval, First, Liquid Biopsy, NGS, Assay, Identify, EGFR, Mutations, Non-Small Cell Lung Cancer

 3. Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Published: Aug 10, 2020 | Tags: Roche, Report, Mixed Results, Etrolizumab, P-III, Studies, Patients, Moderately, Severely, Active, Ulcerative Colitis

4. Boehringer Ingelheim Acquires GST to Boost its Stem Cell Capabilities in Animal Health

Published: Aug 10, 2020 | Tags: Boehringer Ingelheim, Acquires, GST, Boost, Stem Cell Capabilities, Animal Health

5. Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Published: Aug 11, 2020 | Tags: Gilead, Reports, NDA, Submission, US, FDA, Veklury, Remdesivir, Treat, COVID-19

6. Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic HER2-Overexpressing Breast Cancer in Brazil

Published: Aug 11, 2020 | Tags: Samsung Bioepis, Launches, Ontruzant, trastuzumab, biosimilar, Early, Metastatic, HER2-Overexpressing, Breast Cancer, Brazil

7. Olympus to Acquire Arc Medical Design for Expanding its Product Portfolio

Published: Aug 10, 2020 | Tags: Olympus, Acquire, Arc Medical Design, Expand, Portfolio

8.  Bayer to Acquire KaNDy Therapeutics for Augmenting its Women’s Healthcare Portfolio

Published: Aug 11, 2020 | Tags: Bayer, Acquire, KaNDy Therapeutics, Augment, Women’s Healthcare, Portfolio

9.  Ligand to Acquire Pfenex for $516M

Published: Aug 11, 2020 | Tags: Ligand, Acquire, Pfenex, $516M

10. Medtronic to Acquire Companion Medical for Adding Smart Insulin Pen to its Diabetes Unit

Published: Aug 11, 2020 | Tags: Medtronic, Acquire, Companion Medical, Smart Insulin Pen, Diabetes Unit

11. BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer

Published: Aug 11, 2020 | Tags: BMS, Opdivo, nivolumab, Yervoy, ipilimumab, CT, Receive, Health Canada, Approval, Metastatic, Non-Small Cell Lung Cancer

12. Sarepta Therapeutics Collaborates with University of Florida to Accelerate the Development of Therapies for Rare Genetic Diseases

Published: Aug 12, 2020 | Tags: Sarepta Therapeutics, Collaborates, University of Florida, Accelerate, Development, Therapies, Rare Genetic Diseases

13.  Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

Published: Aug 12, 2020 | Tags: Innovent, Eli Lilly, Report, sNDA, Acceptance, Tyvyt, sintilimab, Combination Regimen, 1L Therapy, in Squamous, Non-Small Cell Lung Cancer, China

14. Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor

Published: Aug 12, 2020 | Tags: Roche, Collaborates, Celleron Therapeutics, Emactuzumab, Patients with Tenosynovial Giant Cell Tumor

15. Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Published: Aug 13, 2020 | Tags: Regeneron, Reports, US, FDA, Acceptance, Evinacumab, BLA, Priority Review, Treatment, Patients, HoFH

16Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Published: Aug 13, 2020 | Tags: Roche, Reports, US, FDA, Acceptance, sBLA,  Xolair, (omalizumab), Prefilled Syringe, Self-Administration, Across, All, Indications

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

Published: Aug 13, 2020 | Tags:  Zydus, Launches, Remdac, (remdesivir), $37.41, Vial, India

18.   Novo Nordisk Resumes P-III Study of Concizumab for Patients with Hemophilia A and B

Published: Aug 13, 2020 | Tags: Novo Nordisk, Resumes, P-III, Study, Concizumab, Patients, Hemophilia A and B

19.  Alphabet’s Verily Establishes CLIA-Certified Lab Focusing on COVID-19 Testing

Published: Aug 11, 2020 | Tags: Alphabet, Verily, Establishes, CLIA-Certified, Lab, Focusing, COVID-19, Testing

20.   Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors

Published: Aug 13, 2020 | Tags: Strata Oncology, Collaborates, Mirati Therapeutics, Broaden, Enrollment, Clinical Trial, MRTX849, Patients,  Advanced Solid Tumors

21.  AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Published: Aug 13, 2020 | Tags:  AstraZeneca, Initiate, Production, COVID-19, Vaccine, Early, 2021

22. EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine

Published: Aug 13, 2020 | Tags: Johnson & Johnson, EC, Supply, 200M, Doses, COVID-19, Vaccine

23.  SK bioscience Collaborate with Novavax to Supply Antigen for COVID-19 Vaccine

Published: Aug 14, 2020 | Tags: Novavax, SK bioscience, Collaborate, NVX-CoV2373, Treat, COVID-19

24. Novavax Collaborates with UK Government to Supply 60M Doses of NVX-CoV2373 to Combat COVID-19

Published: Aug 14, 2020 | Tags: Novavax, Collaborates, UK Government, Supply, 60M, Doses,  NVX-CoV2373, Combat, COVID-19

25. Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

Published: Aug 13, 2020 | Tags: Solasia, Signs, License Agreement, Isofol, Develop, Commercialize, Arfolitixorin, mCRC, Japan

Related Post: PharmaShots Weekly Snapshot (Aug 03- 07, 2020)

Novavax Collaborates with UK Government to Supply 60M Doses of NVX-CoV2373 to Combat COVID-19

Shots:

  • Novavax will supply ~60M doses of its COVID-19 vaccine to the UK government for P-III study evaluating the efficacy of NVX-CoV2373 in ~9,000 adults aged 18-85yrs. in the UK. The trial is expected to initiate in Q3’20
  • Novavax will expand its collaboration with FUJIFILM Diosynth, which will manufacture the antigen component of NVX-CoV2373 from its Billingham, Stockton-on-Tees site in the UK, in addition to its sites in NC and Texas in the US
  • The FUJIFILM Diosynth site in the UK is expected to produce up to 180M doses annually, which boosts the global supply of NVX-CoV2373 for additional markets. NVX‑CoV2373 elicited robust Ab responses superior to seen in human convalescent sera in P-I/II clinical study while P-II study is expected to begin in Aug’2020

Click here to­ read full press release/ article | Ref: Novavax | Image: Reuters

SK bioscience Collaborate with Novavax to Supply Antigen for COVID-19 Vaccine

Shots:

  • SK bioscience signs a development and supply agreement for Novavax’ NVX-CoV2373 to supply it globally including the COVAX facility. SK bioscience will manufacture the vaccine antigen component for use in the final drug product
  • SK bioscience will utilize its cell culture and recombinant protein capability, will initiate the production of the NVX-CoV2373 antigen at its facility in Andong L-house, South Korea, expected to begin in Aug’2020
  • Additionally, the companies have signed a letter of intent with the Republic of Korea’s Ministry of Health and Welfare for equitable access to NVX-CoV2373 in global market and to make it available in South Korea

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Novavax

UK signs coronavirus vaccine deals with J&J and Novavax

The UK is to buy millions more doses of potential coronavirus vaccines from Johnson & Johnson and Novavax, with the latter expanding its manufacturing operation in the country.

Johnson & Johnson’s Janssen pharmaceuticals unit will supply an initial 30 million doses on a not-for-profit basis for emergency use in the pandemic, with an option for an additional 22 million doses.

Novavax said separately that the UK is buying a further 60 million doses of its vaccine candidate, NVX-CoV2373 for a phase 3 clinical trial.

Both the UK and the US have six COVID-19 vaccine deals between them as governments from across the world race to strike deals with drugmakers for vaccines.

Reuters reported that J&J is also working with the UK government on a phase 3 trial testing a two-dose regimen of its vaccine candidate, running in parallel to a phase 3 trial of its single-dose vaccine.

Novavax is based in the US but is collaborating with Fujifilm Diosynth Biotechnologies on a manufacturing operation in Stockton-on-Tees in the UK in addition to sites in North Carolina and Texas in the US.

The UK site is expected to produce up to 180 million doses annually, which further boosts the global supply of NVX-CoV2373 for other markets.

Novavax is planning a phase 3 trial in the coming weeks after encouraging results from an early study showing the vaccine produced higher levels of neutralising antibodies than in recovered patients.

The phase 3 trial could provide enough data to support approval before the end of the year, the company has said.

According to the World Health Organization there are now 29 potential vaccines in clinical trials, none of which have yet been proven to work.

The most advanced is from the University of Oxford and AstraZeneca – and the UK has already ordered 100 million doses of this should it prove effective in ongoing phase 3 trials.

The UK government has also ordered 90 million doses of two other COVID-19 vaccines from BioNTech/Pfizer and Valneva.

 

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Novavax says COVID-19 vaccine could be approved by year-end

Novavax’s COVID-19 vaccine produced higher levels of neutralising antibodies than produced by recovered patients in an early trial, paving the way for a phase 3 trial and potential approval by year-end.

The US biotech is gearing up to produce two billion doses of the vaccine in 2021 following the results from its vaccine candidate, codenamed NVX-CoV2373.

Maryland-based Novavax said that adding its adjuvant, which aims to boost the body’s immune response, did enhance the vaccine’s effectiveness.

Novavax has received funding from Operation Warp Speed, the Trump administration’s scheme to accelerate development of vaccines and treatments in the effort against the coronavirus pandemic.

Early last month Novavax said it received $1.6 billion in funding from the scheme, which will fund the scale-up of manufacturing and a phase 3 trial involving around 30,000 people.

This trial could produce enough data to support approval before the end of the year, a company spokesperson told Reuters.

Results came from the phase 1 portion of a phase 1/2 clinical trial testing two doses of the vaccine (5 and 25 micrograms).

Novavax said the vaccine produced neutralising antibodies after two doses in a cohort of 131  healthy adults aged between 18 and 59 years.

The company added that the vaccine was well-tolerated and reactions were generally mild – tenderness and pain were the most frequent local symptoms after the first dose.

Systemic events such as headache, fatigue and muscle pain were less frequently reported, the company said, and duration of these events was less than two days.

The vaccine is based on an antigen derived from the Spike protein found on the surface of the SARS-CoV-2 coronavirus, which is the most commonly used target for the other vaccines in development against COVID-19.

It works by causing the body to produce antibodies that can bind to the Spike protein and neutralise the virus, preventing it from taking hold in the body.

There are 26 potential vaccine candidates in clinical trials, according to the World Health Organization’s reckoning, with the most advanced being from the University of Oxford and AstraZeneca.

This is in phase 3 development and a “challenge trial” where healthy patients are inoculated and infected with the virus could be up and running by the end of the year.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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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.