pharma news

Pharma News for AstraZeneca, Regeneron, Tenaya, Daiichi, C4X Discovery
C4X Discovery and AstraZeneca Signs Deal; FDA Rejects Spectrum’s Poziotinib; Orphan Drug Designation to Tenaya’s Gene Therapy; EC Approves Regeneron’s Libtayo; Response Letter to Poziotinib for Metastatic NSCLC Harboring HER2 Exon 20 Mutations; Japan Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer

C4X Discovery Holdings and AstraZeneca Signs Exclusive USD 402 Million Global License C4X Discovery Holdings has signed an exclusive global license with AstraZeneca worth up to USD 402 million for the development and commercialization of the NRF2 Activator program. The agreement will allow AstraZeneca to develop...

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Pharma News Updates Merck, Regeneron, Provention, Ardelyx, AbbVie
FDA Approves Teplizumab to Delay the Onset of Type 1 Diabetes; FDA Backs Ardelyx’s CKD Therapy Xphozah; Merck to Acquire Imago BioSciences; Accelerated Approval to ImmunoGen’s ELAHERE; Regeneron and CytomX Announces Research Collaboration; FDA Grants Priority Review to Epcoritamab R/R LBCL

Merck to Acquire Imago BioSciences, Inc. for USD 1.35 Billion While its rumored acquisition of Seagen has yet to materialize, Merck & Co has continued to bolster its pipeline with smaller transactions, the most recent of which was a USD 1.35 billion agreement to acquire Imago BioSciences and its bomedemstat ...

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Pharma News for Genentech, Sanofi, Merck
Genentech’s gantenerumab Fails in Phase III Trial; CHMP Recommends’ Dupixent; FDA Clears Imfinzi and Imjudo with chemotherapy; NICE Recommends Ipsen’s Cabometyx (cabozantinib); NICE Backs KEYTRUDA; NRG Announces £16 Million Series A Funding; FDA Backs AstraZeneca’s PT027

Genentech’s gantenerumab Fails in Phase III Trial for Alzheimer’s Disease In yet another setback for an amyloid-targeting drug, Roche's Genentech division has reported disappointing top-line results from its highly anticipated phase III trial of gantenerumab in early Alzheimer's disease. The failure is entirely ...

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Pharma News for Amgen, AstraZeneca, Sanofi, Anavex, Sensorion, GSK
Amgen’s Olpasiran Candidate; GSK’s Novel Antibiotic for Urinary Tract Infections; AstraZeneca and Sanofi’s Beyfortus Approval; FDA Orphan Designation to Anavex’s Anavex2-73; FDA Rare Pediatric Disease Designation to Sensorion’s OTOF-GT; GSK’s Blenrep Fails in Phase III Trial in R/R Multiple Myeloma

Amgen Reports Promising Mid-stage Results for its Olpasiran Candidate  Amgen has reported encouraging mid-stage results for its olpasiran candidate for lowering lipoprotein(a) - a risk factor for atherosclerotic cardiovascular disease - and now plans to move forward with a phase III program as soon as possi...

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Pharma News for Actinium, Santhera, Gilead, Seres, BMS, Boehringer
Actinium Announces SIERRA Trial Results; Santhera Seeks FDA Review for Vamorolone; Seres Announces BLA Submission for SER-109; BMS Announces Results of COMMANDS Trial; Boehringer’s PDE4B Moves Late-stage Clinical Testing; FDA Rejects Gilead’s Hepcludex; Approval to J&J’s BCMAxCD3 Bispecific Antibody for Multiple Myeloma; Syncona to Acquire AGTC

Actinium Announces Positive Top-line Results from Pivotal Phase III SIERRA Trial of Iomab-B Actinium Pharma is on track to submit its targeted radiotherapy for AML patients requiring a bone marrow transplant in the United States, boosted by top-line data from a pivotal trial. The SIERRA trial of Iomab-B, an anti...

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Pharma News Updates for Sumitomo, AstraZeneca, and AbbVie
Sumitomo to Purchase Myovant; AstraZeneca’s Tremelimumab Plus Imfinzi Approved in the US; AbbVie Acquires DJS Antibodies; Roche and Hookipa Pharma Signs USD 25 Million Deal; FDA Accepts BMS’s New Drug Application for CAMZYOS; Jazz and Zymeworks Sign Exclusive Licencing Agreement

FDA Accepts Bristol Myers Squibb’s Supplemental New Drug Application for CAMZYOS Bristol Myers Squibb declared that the U.S. FDA had accepted its supplemental new drug application for CAMZYOS for an expanded indication to reduce the need for septal reduction therapy. CAMYZOS is currently FDA-approved for treatin...

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Pharma News and Updates for Takeda, Gilead, and Odyssey
CHMP Reviews Takeda’s Qdenga; FDA Sets Date for Gilead’ Trodelvy Review; Odyssey’s Announces $ 168 Million Series B Financing; Tavros and Vividion Signs Agreement; Pharming Submits Leniolisib for Approval in the EU; FDA Fast Track Designation to Mereo’s Alvelestat

CHMP Gives Positive Opinion on Takeda’s Qdenga  The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given its approval to Takeda GmbH’s Qdenga, a live, attenuated dengue tetravalent vaccine (TAK-003). It is the first time the CHMP has reviewed a medicinal product ...

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Pharma News Merck, AstraZeneca, and GSK
Merck’s Sotatercept Trial Result; PARP Rivals Closing in on AstraZeneca and Merck’s Lynparza; FDA Clears GSK’s Boostrix for Pertussis; Fast Track Designation to Nanoscope Therapeutics’s MCO-010; FDA Awards Fast Track Designation to Eftilagimod Alpha Plus Pembrolizumab; Solid Biosciences to Acquire AavantiBio

Merck’s Sotatercept Clears Phase III Trial Merck’s USD 11.5 billion acquisition of Acceleron last year was based on the promise of pulmonary arterial hypertension (PAH) candidate sotatercept, which has recently met the mark in a much-anticipated phase III trial. The STELLAR trial found that adding the activin re...

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Pharma News for Sangamo, Santen, and Eli Lilly
Daiichi Sankyo’s Ezharmia; Pfizer & Sangamo Hemophilia A Gene Therapy Trial; Approval for Fennec’s Pedmark; FDA Approves UBE and Santen’s OMLONTI; EC Approves AstraZeneca’s Tezspire; FDA Approves Selpercatinib; FDA Grants Accelerated Approval to Eli Lilly’s Retevmo; GSK & Spero Announce Exclusive License Agreement

Daiichi Sankyo Receives the First Approval for its Blood Cancer Drug Ezharmia Daiichi Sankyo has received the first global approval for Ezharmia, a first-in-class dual EZH1 and EZH2 inhibitor for the treatment of patients with relapsed or refractory adult T-cell leukemia/lymphoma (ATL). The Japanese Ministry of ...

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Pharma News and Updates for Akero Chiesi Pfizer
AstraZeneca’s Danicopan Trial; CHMP Recommends Sanofi/AstraZeneca’s nirsevimab; Akero’s NASH Drug Trial; FDA Grants Orphan Drug Status to SY-5609; BMS’s Opdivo Trial Results; Pfizer to File for FDA Approval for Meningitis Vaccine; EMA Orphan Drug Designation to CAN-2409; FDA Starts Priority Review of Chiesi ‘s velmanase alfa

AstraZeneca’s Danicopan Shows Positive Results in Phase III Trial Danicopan, an oral Factor D inhibitor developed by AstraZeneca, was expected to fail a phase II trial in rare kidney disease in 2020, but a new readout could revive the drug. Danicopan (ALXN2040) has demonstrated efficacy as an adjunct treatment f...

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