BioCentury | Feb 29, 2020
Regulation

Lilly’s Emgality fails to win CHMP support for cluster headaches

EMA’s CHMP rebuffed Lilly’s bid to treat cluster headaches with Emgality in its February roundup, which included a positive opinion on Shionogi’s antibiotic. The agency issued a negative opinion to Eli Lilly and Co. (NYSE:LLY)...
BioCentury | Feb 26, 2020
Product Development

Regulatory Roundup: FDA reviewing GSK, Takeda applications for earlier lines of cancer treatment; plus Novartis, Halozyme-Genentech, MacroGenics, CSL, Lilly

FDA is reviewing four earlier or additional indications for a slate of cancer drugs, plus a first-time application for MacroGenics’ anti-HER2 mAb. The agency also approved the first quadrivalent flu vaccine and a CV application...
BioCentury | Feb 19, 2020
Regulation

Regulatory Roundup: Priority Review for Xpovio, Tecentriq in new indications; plus CRLs delay Keytruda dosing update

FDA granted Priority Review to supplemental applications for Karyopharm's Xpovio and Roche's Tecentriq, setting June deadlines for decisions that could expand each drug's label. The agency will consider granting accelerated approval to Xpovio selinexor to...
BC Extra | Jan 16, 2020
Company News

Jan. 15 Company Quick Takes: Japan Tobacco gets rights to Dermavant therapy; plus Clovis, BMS, Recordati, BeiGene, Insilico-Pfizer, Novartis

Japan Tobacco gets Japanese rights to Dermavant’s dermatology therapy  Japan Tobacco Inc. (TOKYO:2914) licensed from Dermavant Sciences exclusive rights to develop and commercialize tapinarof in Japan for dermatology indications including psoriasis and atopic dermatitis. The...
BC Extra | Jan 13, 2020
Company News

Jan. 13 Company Quick Takes: AZ ends fish oil trial; plus Lynparza, Lilly-NextCure, Innovent, Amgen-Qiagen-Guardant, Axsome-Pfizer

AstraZeneca ends CV outcomes trial of Epanova  AstraZeneca plc (LSE:AZN; NYSE:AZN) discontinued the Phase III STRENGTH trial after an IDMC determined it is unlikely to show that Epanova improved cardiovascular outcomes in patients with mixed...
BC Extra | Jan 7, 2020
Company News

Jan. 6 Company Quick Takes: China approvals for AZ, Sanofi and Gene+; plus Apollomics-GlycoMimetics, Pfizer-Merck KGaA and more

Trio of approvals from China’s NMPA   China’s National Medical Products Administration approved NDAs for Lokelma sodium zirconium cyclosilicate from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat hyperkalemia and anti-PCSK9 mAb Praluent alirocumab from Sanofi (Euronext:SAN;...
BioCentury | Jan 1, 2020
Regulation

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...
BC Extra | Dec 5, 2019
Company News

Dec. 4 Company Quick Takes: Allakos on the block?; plus Aurinia, Tecentriq, Gatehouse-AZ, Novartis-Amazon, Merck KGaA-Ping An and ICT

Allakos shares jump on report of potential sale Allakos Inc. (NASDAQ:ALLK) declined to comment on a Bloomberg report citing unnamed sources that the company has hired a financial adviser to explore strategic options, including a...
BC Innovations | Oct 3, 2019
Targets & Mechanisms

Blocking the MAPK pathway for Trk inhibitor resistant cancers

Targeting the MAPK pathway could be a key to overcoming a new mechanism of tissue-agnostic therapy resistance identified by a Memorial Sloan Kettering Cancer Center team. FDA has approved two inhibitors of TrkA, TrkB and...
BioCentury | Sep 14, 2019
Product Development

Success in lung cancer niches will hinge on access to next-gen sequencing

New targeted lung cancer therapies against RET, KRAS and c-MET are all outperforming standard of care in the clinic, including checkpoint inhibitors. But whether these therapies see uptake will likely depend more on whether next-generation...
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