Regulation

Competence & continuity at CDER; plus BIO 3.0, AACR and 2Q preview: a BioCentury podcast

On the latest BioCentury This Week podcast, BioCentury editors discuss what Patrizia Cavazzoni’s appointment as permanent director of FDA’s Center for Drug Evaluation and Research means for the biopharma...

April 5 Quick Takes: FDA extends review of Rinvoq in atopic dermatitis; plus Acadia, Supernus

AbbVie Inc. (NYSE:ABBV) said FDA extended by three months its review for an sNDA for Rinvoq upadacitinib to treat moderate to severe atopic dermatitis following the agency’s request for an updated assessment of the oral...

March 31 Quick Takes: Basket of EU approvals includes MS, SMA drugs; plus Amarin, AbbVie, Cara-Vifor

The European Commission approved Kesimpta ofatumumab from Novartis AG (NYSE:NVS; SIX:NOVN) to treat relapsing forms of multiple sclerosis. The subcutaneously administered drug was originally developed by Genmab A/S (CSE:GMAB; NASDAQ:GMAB). Evrysdi risdiplam, an oral small molecule...

FTC challenge to Illumina’s Grail acquisition focused on potential harms from its supplier role

The FTC’s 4-0 vote to challenge Illumina’s pending $7.1 billion Grail acquisition aligns with acting agency Chair Rebecca Kelly Slaughter’s vow to expand scrutiny of biotech M&A beyond the traditional scope of product overlap. Though at least...

Abernethy and the obvious at FDA; plus CEPI and EpimAb: a BioCentury podcast

Amy Abernethy set out to tackle “the blooming obvious” issues faced by FDA when she joined the agency two years ago. In the latest BioCentury This Week podcast, BioCentury’s editors discuss the key takeaways from...

March 26 Quick Takes: ADCs from Astellas-Seagen, Gilead under EMA review; plus Pfizer-Lilly, BrainStorm and Ilya

EMA to review Padcev for urothelial cancerAstellas Pharma Inc. (Tokyo:4503) and Seagen Inc. (NASDAQ:SGEN) said EMA accepted an MAA for Padcev enfortumab vedotin, an antibody-drug conjugate (ADC) targeting PRR4, to treat locally advanced or metastatic urothelial...

FDA approval solidifies bluebird’s anti-BCMA CAR T as ‘cornerstone’ of BMS’s multiple myeloma portfolio

FDA’s approval late Friday of Abecma idecabtagene vicleucel marks the second CAR T cell therapy BMS will bring to market as it continues to fill out its cancer portfolio ahead of revenue losses from...

CHMP backs GSK’s lupus drug for kidney complication, J&J’s oral MS therapy

GSK’s Benlysta and J&J’s Ponvory are two of the latest therapies to win support from EMA’s CHMP, which did not issue any negative recommendations in March. The agency recommended a label extension for Benlysta belimumab to treat active lupus...

March 24 Quick Takes: A first for Twist, Biotia and a refusal-to-file letter for Novo; plus Novartis’ radioligand, Zealand, four Japan approvals and more

Twist Bioscience Corp. (NASDAQ:TWST) said it and partner Biotia Inc. received emergency use authorization from FDA for the first hybridization capture-based next-generation sequencing SARS-CoV-2 assay. The SARS-CoV-2 NGS Assay can sequence and surveil the evolution of virus...

AEs similar across COVID-19 vaccines in Europe: Data Byte

At least 20 European countries have temporarily suspended the use of AstraZeneca’s COVID-19 vaccine due to concerns around thromboembolic events, but the rates of the side effects show little difference from the other two COVID-19...

Tivozanib, at last, is Aveo’s first approved drug in the U.S.

After nine years and more than $200 million raised since Aveo first submitted tivozanib to FDA in 2012, the drug has been approved by the agency for renal cell carcinoma, giving the company its first...

March 5 COVID Quick Takes: Lilly mAbs clear EU hurdle; plus Adaptive authorization, Takeda pushes vaccine ahead in Japan, Aerpio therapy out of I-SPY

EMA’s CHMP recommended use of bamlanivimab from AbCellera Biologics Inc. (NASDAQ:ABCL) and Eli Lilly and Co. (NYSE:LLY), alone and together with Lilly’s etesevimab. The committee’s opinion backs use of bamlanivimab and the combo for confirmed COVID-19 in...

Novavax preps for Q2 COVID vaccine EUA submission; plus Fibrogen, Inovio, J&J, Aslan, Merck, Oncopeptides and Athenex

Novavax Inc. (NASDAQ:NVAX) said in its 4Q20 earnings report that it is discussing COVID-19 vaccine NVX-CoV2373 with FDA and may submit a request for emergency use authorization of candidate next quarter. The biotech announced on...

Nod for Roche’s oral SMA drug among CHMP’s latest opinions: Data Byte

February’s recommendations by EMA’s CHMP included a nod in favor of Roche’s Evrysdi risdiplam, setting the drug up to become the first oral spinal muscular atrophy therapy in Europe.  CHMP recommended, under its accelerated assessment...

Feb. 18 Quick Takes: Label expansion for Entresto; plus Amgen, Sesen, BeiGene, Cortexyme and more

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA approved Entresto sacubitril/valsartan to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with chronic heart failure. The approved population includes heart failure patients with...