pharma news
Aug 23, 2022
EMA to review Cidara Therapeutics’ Rezafungin; EU Approves Gilead Sciences’ Sunlenca; FDA Approves Axsome’s Auvelity; EU Marketing Authorisation to Oncopeptides’s Pepaxti; Merck Signs $ 3.5 B Deal with Orna; FDA to review AstraZeneca and Merck’s Lynparza; FDA Approval to Bluebird’s Zynteglo; FDA Decision Date for GSK’s Momelotinib
EU Regulator Starts its Review of Cidara Therapeutics’ Candidiasis Therapy Rezafungin The EU regulator has begun its review of Cidara Therapeutics’ once-weekly antifungal rezafungin, with a decision expected next year as a new option for serious, invasive candida infections. The application is based on the ReSTO...
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Aug 16, 2022
Novartis’ Canakinumab for NSCLC; Novartis’s Zolgensma Updates; Trodelvy Prospects in New Breast Cancer Use; Novartis Secures European Approval For Pluvicto; Bristol-Myers Squibb’s Abecma Phase III Trials; Trastuzumab Approved for Deruxtecan for HER2-Mutant NSCLC
Novartis’ Canakinumab Fails in Phase III Trials for NSCLC Canakinumab's prospects as an anticancer therapy were already dwindling when a third phase III trial in non-small cell lung cancer (NSCLC) failed to reach its objectives. The most recent setback came from the CANOPY-A study, which included patients with N...
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Aug 02, 2022
Bristol-Myers Squibb’s Opdivo & Yervoy Combo Trial; Sarepta’s Gene Therapy SRP-9001 for DMD; Ionis’s End-Stage Renal Disease Drugs; FDA Approves Arcutis’s Zoryve Cream; Gilead’s Biktarvy for HIV and Hepatitis B; FDA to Review Biogen’s ALS Therapy Tofersen
Bristol-Myers Squibb’s Opdivo and Yervoy Combo Fails in Phase III Trial Bristol-Myers Squibb has reported that their Opdivo and Yervoy checkpoint inhibitor combo failed a phase III trial as adjuvant (post-surgery) therapy for renal cell carcinoma (RCC), the most frequent type of kidney cancer. The CheckMate -914...
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Jul 12, 2022
Novo Nordisk’s Concizumab for Hemophilia; AbbVie Ends its Alliance with Alector; ADC Therapeutics and Sobi Enters in Exclusive Licensing Deal; BMS’ Opdivo Gets NHS Use; Merck to Acquire Seagen; FDA Priority Review to Roche’s Lunsumio; AstraZeneca to Acquire TeneoTwo; FDA Orphan Drug Designation to PBI-200
Novo Nordisk Reports Phase III Results of Concizumab Drug for Hemophilia A or B Novo Nordisk has announced Phase III results for their concizumab drug for hemophilia A or B, demonstrating efficacy in preventing bleeding events and paving the way for regulatory filings later this year. Concizumab, an anti-tissue ...
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May 31, 2022
Bristol-Myers Squibb’s Opdivo Approval; Mirati’s KRAS-inhibitor Adagrasib; J&J and Legend Biotech’s CAR-T Carvykti Approval; Roche’s Glofitamab; Arena Pharma’s Etrasimod Phase 3 Trials; FDA Approves Dermavant’s Vtama; FDA Approves Novartis’ Cell Therapy; NICE Approves Merck’s Keytruda
Bristol-Myers Squibb’s Opdivo Gets FDA Approval for Esophageal Cancer The FDA has approved two combination drug regimens based on Bristol-Myers Squibb’s PD-1 inhibitor Opdivo for previously untreated advanced Esophageal Cancer, encroaching on the territory belonging to Merck & Co’s rival Keytruda. The latest...
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May 17, 2022
BMS Sells NY Biologics Plant; FDA Approves Mitsubishi Tanabe’s Radicava, Love Pharma Acquires MicroDoz; Sandoz Launches Generic of Roche’s Esbriet; Pfizer to Acquire Biohaven Pharma; eureKARE’s Cell and Gene Therapy CDMO; Atamyo’s LGMD Gene Therapies; FDA approves Eli Lilly’s Type 2 Diabetes Treatment
Love Pharma Completes the Acquisition of MicroDoz Therapy LOVE Pharma Co. has announced the completion of its acquisition of MicroDoz Theraphy Inc. ("MicroDoz"). Love Pharma holds exclusive manufacturing, marketing, packaging, selling, and distribution licenses in Europe, the United Kingdom, and North America. U...
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Apr 19, 2022
GSK Acquires Sierra Oncology; BriaCell’s Targeted Breast Cancer Immunotherapy; Merck’s Tepmetko; Gilead’s Magrolimab for MDS and AML; Eli Lilly’s Retevmo; Merck’s Pneumococcal Vaccine; FDA Approves Bevacizumab Biosimilar; Halozyme to Acquire Antares Pharma
GSK Acquires Sierra Oncology for USD 1.9 Billion GlaxoSmithKline has agreed to buy Sierra Oncology and its lead drug assets, momelotinib, for anemia caused by the blood malignancy myelofibrosis. GSK is paying USD 55 per share in cash for Sierra, a 39% premium to the company's closing share price yesterday, valui...
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Apr 05, 2022
Precigen’s PRGN-3006; Yescarta Approved as a First CAR T-cell Therapy for R/R LBCL; Biogen & Ionis’ BIIB078; Nobelpharma’s HYFTOR (sirolimus topical gel) 0.2%; Cerevance Parkinson’s Drug; Sanofi & Regeneron’s Dupixent; Clovis’s Rubraca for Ovarian Cancer; Immunocore Eye Cancer Cell Therapy Approval
FDA Approves Yescarta as a First CAR T-cell Therapy for Initial Treatment of R/R Large B-cell Lymphoma Until now, existing CAR-T therapies have been reserved for patients with blood cancer who have tried multiple treatments. The FDA has approved Yescarta, a CD19-directed CAR-T therapy developed by Gilead Science...
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Mar 31, 2022
Ypsomed-CamDiab’s Collaboration; Vela Diagnostics’s NGS-Based Pan-Cancer Panels; Fresenius’s SMOFlipid Lipid Injectable Emulsion; Sientra Gained Regulatory Nod to Market Breast Implants; Synchron’s Endovascular BCI Stentrode Device; HLT’s TAVR Clinical Studies
Ypsomed Collaborated with CamDiab for Smartphone-based Automated Insulin Delivery On March 22, 2022, Ypsomed, a leading manufacturer of injection and infusion systems for self-medication partnered with CamDiab Ltd, developer of CamAPS FX, an app for the management of glucose levels via insulin pumps using an ada...
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Mar 22, 2022
Bristol Myers’ Opdivo combo Opdualag for Melanoma; Biogen’s Aduhelm; Marinus’ Ztalmy for CDKL-5 Deficiency Disorder; Merck’s Keytruda + Lynparza; Vitaris’s Breyna; Moderna’s Second COVID-19 Booster Shot; Takeda’s Exkivity; BMS’s First LAG-3 Checkpoint Inhibitor
NHS Grants Fast Track Access to Takeda’s Exkivity Takeda has secured UK approval for its lung cancer therapy Exkivity, with an NHS access deal that could see it prescribed to patients within the next few weeks. The Medicines and Healthcare products Regulatory Agency has granted conditional marketing authorisa...
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