Archive


Category: BMS

  • PharmaShots Weekly Snapshots (November 15 – 19, 2021)

    Jazz’ Sunosi (solriamfetol) Receives NICE Recommendation for the Treatment of Excessive Daytime Sleepiness Caused by Narcolepsy Published: Nov 19, 2021 | Tags: Jazz, Sunosi, solriamfetol, NICE, Recommendation, Excessive Daytime Sleepiness, Narcolepsy Antengene’s Selinexor (ATG-010) Receives NMPA’s IND Approval for P-I/II SWATCH Study to Treat Non-Hodgkin Lymphoma Published: Nov 19, 2021 | Tags: Antengene, Selinexor, ATG-010, […]

  • Janssen and BMS Present Results of Milvexian in P-II AXIOMATIC-TKR Study for the Treatment of TKR Surgery at AHA 2021, Published in NEJM

    Shots: The P-II AXIOMATIC-TKR study evaluates the efficacy and safety of milvexian (qd/bid) vs enoxaparin (SC) in 1242 patients with elective TKR surgery The trial met both of its pre-specified proof-of-principle requirements i.e., milvexian (bid) showed significant efficacy, reduction in the risk of postoperative VTE in a dose-dependent manner without increasing the risk of bleeding […]

  • PharmaShots Weekly Snapshots (November 08 – 12, 2021)

    Eisai Presents Results of Lecanemab in P-IIb Study 201 Study for the Treatment of Alzheimer’s Disease at CTAD 2021 Published: Nov 12, 2021 | Tags: Eisai, Lecanemab, P-IIb, Study 201 Study, Alzheimer’s Disease, CTAD 2021 Novo Nordisk’s Wegovy (semaglutide) Receives CHMP’s Recommendation for Approval to Treat Obesity Published: Nov 12, 2021 | Tags: Novo Nordisk, […]

  • BMS Collaborates with Inspirna to Evaluate Yervoy (ipilimumab) + RGX-104 (abequolixron) for the Treatment of Metastatic Endometrial Cancer

    Shots: The companies collaborated to evaluate Inspirna’s RGX-104 + BMS’ Yervoy in P-Ib/II expansion study for patients with metastatic endometrial cancer whose genomes holds E2 or E4 APOE genetic biomarker & who have progressed on prior checkpoint inhibitor therapy Inspirna will sponsor the study & will lead the study costs. RGX-104 is currently being evaluated […]

  • BMS’ Catherine Owen on pharma commercialisation: the pharmaphorum podcast

    Episode 42 of the pharmaphorum podcast heard from Catherine Owen, who’s senior vice president of major markets at Bristol Myers Squibb, about the future of pharma commercialisation and communications. As part of that we looked at how she approaches the 19 markets she oversees and the challenges that can present. And Catherine suggests some areas […]

  • BMS’ Deucravacitinib Fails to Meet its Primary and Secondary Endpoints in P-II LATTICE-UC Study for the Treatment of Moderate to Severe Ulcerative Colitis

    Shots: The P-II LATTICE-UC study evaluates the safety and efficacy of deucravacitinib (PO) vs PBO in patients with mod. to sev. UC The trial did not meet the 1EPs of clinical remission @12wks. & 2EPs of clinical response as assessed by modified Mayo score, endoscopic response & histological improvement @12wks. The safety profile was consistent […]

  • PharmaShots Weekly Snapshots (September 27 – October 01, 2021)

    BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma Published: Oct 1, 2021 | Tags: BMS, EMA, MAA, Relatlimab, Nivolumab, Metastatic Melanoma Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19 Published: Oct 1, 2021 | Tags: Merck, […]

  • Deep Dive: Communications and Commercialisation

    The COVID-19 pandemic kickstarted a period of profound change in how the pharmaceutical industry approaches both communications and commercialisation. In some cases it was an accelerant for existing plans, but it has also caused some new shifts in the landscape, shifts that have yet to be completed. This issue assesses European pharma’s approach to strategic […]

  • PharmaShots’ Key Highlights of Third Quarter 2021

    The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B, […]

  • BMS Reports Five-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -214 for the Treatment of Advanced or Metastatic Renal Cell Carcinoma

    Shots: The P-III CheckMate -214 trial evaluates Opdivo (3mg/kg) + Yervoy (1mg/kg, q3w for 4 doses) vs sunitinib in 1096 patients with previously untreated advanced/mRCC Results: @median follow-up of 67.7mos., combination showed superior OS in intermediate, poor risk patients & randomized or ITT population; m-OS (47.0 vs 26.6mos.) & (55.7 vs 38.4mos.); ORR (42% vs […]

  • ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurrent ESCC in Japan

    Shots: The application is based on P-III CheckMate -648 study evaluating Opdivo (3mg/kg, q2w, IV) + Yervoy (1mg/kg, q6w up to 24mos.) or Opdivo + CT vs CT alone in patients with unresectable advanced or recurrent ESCC The results demonstrated an improvement in OS at pre-specified interim analysis in patients with tumor cell PD-L1 expression […]

  • BMS Reports Three-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -743 Trial for 1L Treatment of Unresectable Malignant Pleural Mesothelioma

    Shots: The P-III CheckMate -743 trial evaluates Opdivo (3mg/kg, q2w) + Yervoy (1mg/kg, q6w) vs CT in 605 patients with previously untreated unresectable MPM. The results will be presented at ESMO 2021 The result showed an improvement in OS with a reduction in risk of death, patients were alive (23% vs 15%) @3yrs., improvement in […]

  • PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

    Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer […]

  • PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

    Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer […]

  • PharmaShots Weekly Snapshots (August 23 – 27, 2021)

    Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency Published: Aug 27, 2021 | Tags: Ascendis, Skytrofa, lonapegsomatropin-tcgd, US, FDA, Approval, Pediatric Growth Hormone Deficiency Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021 Published: Aug 27, 2021 | Tags: […]

  • PharmaShots Weekly Snapshots (August 16 – 20, 2021)

    Janssen Presents Results of Rybrevant (amivantamab-vmjw) in P-I CHRYSALIS Study for Advanced NSCLC with METex14 Mutations at WCLC Published: Aug 20, 2021 | Tags: Astellas, FibroGen, Evrenzo, Roxadustat, EC, Approval, Symptomatic Anemia, Chronic Kidney Disease Astellas and FibroGen’s Evrenzo (roxadustat) Receive EC’s Approval for Symptomatic Anemia Associated with Chronic Kidney Disease Published: Aug 20, 2021 […]

  • Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue

    Immunology deals with physiological functioning of the immune system in states of both health and disease as well as malfunctions of the immune system in immunological disorders With the new advancement in immune sector, global pharmaceuticals continue to grow in the field despite the disruption during the COVID-19. As in 2019, Abbvie again secured the […]

  • Have a chat to help others through loneliness

    Looking back over the past 18 months, the Joni Mitchell lyric ‘you don’t know what you’ve got til it’s gone’ comes to mind. It’s only now, having been isolated, that we can appreciate how much small moments of contact with family and friends can mean. Bristol Myers Squibb’s Janice Creasy discusses how  and help reduce feelings […]

  • PharmaShots Weekly Snapshots (July 26 – 30, 2021)

    Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, Evrysdi, risdiplam, FIREFISH Study, Type 1 SMA, NEJM BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III SEQUOIA Trial for the Treatment of Chronic Lymphocytic Leukemia Published: July 30, 2021 | […]

  • PharmaShots’ Key Highlights of Second Quarter 2021

    The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team […]

  • PharmaShots Weekly Snapshots (May 31 – June 4, 2021)

    Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Published: June 4, 2021 | Tags: Tonix Pharmaceuticals, TNX-102 SL, P-III, RELIEF Study, Fibromyalgia, ASCP 2021 Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis Published: June 4, 2021 | Tags: […]

  • BMS’ Abecma (idecabtagene vicleucel) Receives the Health Canada’s Approval as the First Anti-BCMA CAR T Cell Therapy for Relapsed and Refractory Multiple Myeloma

    Shots: The conditional approval is based on the results of the P-II KarMMa study involves assessing Abecma in 122 patients with RRMM prior treated with 3L+ therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 Ab and who are refractory to their last treatment Results: @median follow-up of 13.3 mos., ORR (74%); CR […]

  • PharmaShots Weekly Snapshots (May 24 – 28, 2021)

    Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug Designation,  Amyotrophic Lateral Sclerosis The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes Published: May 28, 2021 | Tags: US, FDA, EMDAC, Provention Bio, Teplizumab, Delaying Diabetes uniQure […]

  • ONO and BMS’ Opdivo + Yervoy Receive Approval for 1L Treatment for Unresectable Advanced or Recurrent Malignant Pleural Mesothelioma

    Shots: The approval is based on P-III CheckMate -743 study assessing Opdivo + Yervoy vs SOC Pt. based CT in patients with previously untreated unresectable malignant pleural mesothelioma The combination regimen has demonstrated significant extension of OS vs CT. The safety profile of combination treatment was consistent with those previously reported in the studies for […]

  • New Cell & Gene Therapy Collective seeks to boost UK adoption

    The UK has been a global leader in introducing cell and gene therapies that can potentially transform the lives of patients with debilitating diseases – but there are still many barriers to wider adoption. These challenges often arise because these therapies go through the same value assessment processes as less complex medicines, and the infrastructure […]

  • BMS Receive the CHMP’s Positive Opinion Recommending Approval of Opdivo (nivolumab) + Yervoy (ipilimumab) for dMMR or MSI-H mCRC After Prior Chemotherapy

    Shots: The opinion is based on P-II CheckMate -142 study assessing Opdivo + Yervoy in patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer whose disease had progressed during or after prior treatment with CT If approved, Opdivo in combination with Yervoy will be the first dual immunotherapy approved in the EU in […]

  • PharmaShots Weekly Snapshots (May 17 – 21, 2021)

    BeiGene Reports Results of Tislelizumab + CT in P-III RATIONALE 309 Study as 1L Treatment for Recurrent or Metastatic Nasopharyngeal Cancer Published: May 21, 2021 | Tags: BeiGene, Tislelizumab, CT, P-III, RATIONALE 309 Study, Recurrent, Metastatic Nasopharyngeal Cancer Aurinia to Present Results of Lupkynis (voclosporin) in AURORA 2 Continuation Study for Lupus Nephritis at EULAR […]

  • BMS Extends its 2019 Collaboration with Exscientia for AI Driven Drug Discovery

    Shots: Exscientia to receive ~$50M as up front, ~$125M as milestones and additional clinical, regulatory, and commercial milestones of over $1.2B along with royalties on net sales of any marketed therapies resulting from the collaboration The expanded collaboration has the potential to add to the BMS drug pipeline whilst enhancing Exscientia’s portfolio of shared assets. […]

  • PharmaShots Weekly Snapshots (May 03 – 07, 2021)

    AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer Published: May 7, 2021 | Tags: AstraZeneca, Imfinzi, durvalumab, Tremelimumab, P-III, POSEIDON Study, Stage IV Non-Small Cell Lung Cancer Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + […]

  • BMS Signs a Research Collaboration with DarwinHealth to Discover Novel Cancer Target Initiative

    Shots: DarwinHealth will receive an upfront and eligible to receive as a commercial milestone, as part of the NCTI collaboration The focus of the collaboration is to identify NCTs across tumor subtypes for different cancer types by using quantitative systems biology-based algorithms, databases, and technologies and leads to the development of drugs with multi-subtype indications […]

  • PharmaShots Weekly Snapshots (Apr 19 – 23, 2021)

    BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, Receive, EC, CHMP, Positive Opinion, MPM, AML Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan Published: Apr 23, 2021 | Tags: Gilead, Reports, NDA, Submission, […]

  • PharmaShots Weekly Snapshots (Apr 12 – 16, 2021)

    ThermoFisher to Acquire PPD for ~$17.4B Published: Apr 16, 2021 | Tags: ThermoFisher, Acquire, PPD, ~$17.4B Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal Muscular Atrophy in Adults and Children Published: Apr 16, 2021 | Tags: Roche, Evrysdi (risdiplam), Receives, Health Canada, Approval, Spinal Muscular Atrophy, Adults, Children GSK Discontinues the P-II Trials of […]

  • PharmaShots Weekly Snapshots (Apr 05 – 09, 2021)

    Evotec and Exscientia Initiate Human Clinical Trials of their Novel Immuno-Oncology Drug Published: Apr 9, 2021 | Tags: Evotec and Exscientia, Initiate, Human Clinical Trials, Novel, Immuno-Oncology Drug PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab Published: Apr 9, 2021 | Tags: PlantForm, Signs, Research, Development Agreement, Bio-Manguinhos/Fiocruz, Develop, Biosimilar Pembrolizumab […]

  • BMS and PsiOxus Therapeutics Expand their 2016 Immuno-Oncology Collaboration

    Shots: In the P-I SPICE study, the companies will evaluate the clinical combination of BMS’ Opdivo with PsiOxus’ NG-641 and optimize the combination IV dosing regimen in late-stage cancer patients to treat a range of tumor types PsiOxus will be responsible to conduct P-I study with patient recruitment expected to initiate in Q3’21 NG-641 is […]

  • PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021)

    Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19 Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19 Acceleron Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM Published: Apr 2, 2021 | Tags: Acceleron, Presents, Results, Sotatercept, P-II PULSAR […]

  • BMS and bluebird bio’s Abecma (idecabtagene vicleucel) Receive the US FDA’s Approval as the First Anti-BCMA CAR T Cell Therapy for R/R Multiple Myeloma

    Shots: The approval is based on the P-II  KarMMa trial that involves assessing Abecma in 127 patients with r/r MM prior treated with 3L+ therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 Ab Results: ORR (72%); sCR (28%); mDoR (11mos.); responses were rapid and durable, with a median time to response of […]

  • PharmaShots Weekly Snapshots (Mar 22 – 26, 2021)

    Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Published: Mar 26, 2021 | Tags: Pfizer and BioNTech, Initiate, COVID-19 Vaccine Trial, Children, Under 12 Tetra Bio-Pharma Initiates Additional Studies of ARDS-003 in Neuroinflammation and Antiviral Diseases Published: Mar 26, 2021 | Tags: Tetra Bio-Pharma, Initiates, Additional Studies, ARDS-003,  Neuroinflammation, Antiviral Diseases Immunai […]

  • BMS Report Results of Relatlimab + Opdivo (nivolumab) in P-II/III RELATIVITY-047 Study in Patients with Previously Untreated Metastatic or Unresectable Melanoma

    Shots: The P-II/III RELATIVITY-047 (CA224-047) study involves assessing the FD combination of relatlimab (160 mg) + Opdivo (480mg) vs Opdivo (480mg, IV, q4w) alone in 714 patients in a ratio (1:1) with previously untreated metastatic or unresectable melanoma The study met its 1EPs of the PFS while the follow-up for 2EPs of OS and ORR […]

  • PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

    Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, […]

  • PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

    Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, […]

  • PharmaShots Weekly Snapshots (Mar 01 – 05, 2021)

    Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly and Incyte, Report, Results, Olumiant (baricitinib), P-III, BRAVE-AA2, Study, Severe, Alopecia Areata Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Published: Mar 5, 2021 | Tags: […]

  • BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive CHMP’s Positive Opinion as 1L Treatment for Advanced Renal Cell Carcinoma

    Shots: The CHMP recommendation is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC The P-III result showed improvements in PFS, OS and ORR with consistent efficacy benefits observed across key subgroups of patients and was well tolerated, with a low […]

  • PharmaShots Weekly Snapshots (Feb 22- 26, 2021)

    Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Published: Feb 26, 2021 | Tags: Regeneron, Reports, IDMC, Clearance, Efficacy, REGEN-COV (Casirivimab + Imdevimab), P-III, COVID-19, Outpatient, Outcomes, Trial Daiichi Sankyo Collaborates with LYSA-LYSARC-CALYM for Valemetostat in Patients with R/R B-Cell Lymphoma Published: Feb 26, 2021 | […]

  • PharmaShots Weekly Snapshots (Feb 15- 19, 2021)

    RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204  Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204 Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer Published: Feb 19, 2021 | Tags: Astellas, Seagen, Reports, Submission, […]

  • The Paradox of Rare: Chalking out Challenges in the Rare Disease Market

    How is a Rare disease defined? Well, it depends on the geography in question, since there is no universal definition, even so, the definition revolves around the point of prevalence or incidence of rare disease. However, despite the changing attributes in the definition, there is one common ground every country faces‒challenges in mapping the patient […]

  • PharmaShots Weekly Snapshots (Feb 08 – 12, 2021)

    Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings Published: Feb 12, 2020 | Tags: Visby, POC, COVID-19, Test, Receives, US, FDA, EUA, Use, CLIA, Waived, Settings Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies Published: Feb 12, 2020 | Tags: Takeda, Collaborates, Ensoma, Accelerate, Next-Generation, Vivo Gene […]

  • Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value

    The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common reasons for deal termination. Sanofi and Hanmi’s agreement in 2015 ranked first under which Hanmi regained WW rights to its protein/peptide discovery technology, lapscovery. The second position goes to the […]

  • BMS Report Results of Opdivo (nivolumab) + Cabometyx (cabozantinib) in P-III CheckMate -9ER Trial for 1L Treatment of Advanced Renal Cell Carcinoma

    Shots: The P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC Results: @median follow-up of two years (23.5 mos.); median PFS (17.0 vs 8.3mos.), ORR (54.8% vs. 28.4%); Disease control rate (88.2% vs. 69.9%); CR (9.3% vs 4.3%); OS (34% reduction in risk […]

  • PharmaShots Weekly Snapshot (Feb 01-05, 2021)

    Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, Ulcerative Colitis Enzene Receives Marketing Authorization for Teriparatide (biosimilar) in India Published: Feb 5, 2020 | Tags: Enzene, Receives, Marketing Authorization, Teriparatide (biosimilar), India Johnson & Johnson Reports EUA Submission […]

  • Top 20 Life Sciences Deals of 2020 by Total Deal Value

    Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research partnerships in 2020 Artios partnered with Merck with an option to license up to 8 oncology programs proving to be the highest valued deal of 2020 with a total deal […]

  • PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

    Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment Published: Jan 15, 2020 | Tags: Philips, Collaborates, Merck KGaA, […]

  • PharmaShots’ Key Highlights of Fourth Quarter 2020

    The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated […]

  • PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

    Merck Collaborates with Siemens for the Digitalization of Production Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test PostEra Collaborates […]

  • Schrödinger Signs a $2.7B Agreement with BMS to Develop and Commercialize Therapies in Multiple Disease Areas

    Shots: Schrödinger to receive $55M upfront and is eligible to receive $2.7B as preclinical, development, regulatory & commercial milestones along with royalties on sales of each product commercialized by BMS Schrödinger to grant BMS exclusive WW rights to develop & commercialize the development candidates emerges from the collaboration The collaboration will merge Schrödinger’s computational platform […]

  • 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, […]

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

    Shots: The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of […]

  • Top 20 Immunology Companies Based 2019 Immunology Segment Revenue

    Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed, the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or […]

  • Insights+: The US FDA New Drug Approvals in September 2020

    The US FDA has approved 6 NDAs in Sept 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 85 novel products so far in 2020, including 6 in Sept 2020. Additionally, last year […]

  • BMS to Acquire MyoKardia for ~$13.1B

    Shots: BMS to acquire all the outstanding shares of MyoKardia’s common stock for $225.00/ share in cash, making a total deal value of ~$13.1B. The transaction is expected to be close in Q4’20 The acquisition will foster BMS’ CV portfolio with the addition of MyoKardia’s mavacamten. BMS expects to explore mavacamten in additional indications, including […]

  • PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)

    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, […]

  • BMS to Acquire Forbius for its AVID200 to Expand its Footprints in Oncology and Fibrosis

    Shots: Forbius will receive up front and milestones while BMS will acquire Forbius’s TGF-beta program, including the lead investigational asset, AVID200. The transaction is expected to be closed in Q4’20 Prior to closing, Forbius’ non-TGF-beta assets will be transferred to a newly formed private company, which will be retained by Forbius’ existing shareholders AVID200 is […]

  • PharmaShots Weekly Snapshot (Aug 17 -21 2020)

    1. BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia Published: Aug 20, 2020 | Tags:  BioMarin, Reports, NDA, Submission, US, FDA, Vosoritide, Children, Achondroplasia 2. Junshi and Impact to Establish Joint Venture for Senaparib (IMP4297) in China Published: Aug 20, 2020 | Tags:  Junshi, Impact, Establish, Joint Venture, […]

  • BMS Signs an Exclusive Worldwide License Agreement with Dragonfly Therapeutics for DF6002

    Shots: Dragonfly to receive $475M as up front and is eligible to receive development, regulatory and commercial milestones in addition to 24% royalties on global sales of the therapy. BMS to get exclusive WW license to Dragonfly’s IL-12 investigational immunotherapy program, including its extended half-life cytokine DF6002 BMS will be responsible for the development & […]

  • Top 20 Prescription Drugs Based on 2019 Revenue

    The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they […]