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Regulation

Woodcock, Marks to recuse themselves from FDA reviews of COVID-19 products

FDA center directors Janet Woodcock and Peter Marks will not participate in reviews of COVID-19 products after taking on leadership roles in Operation Warp Speed, FDA Commissioner Stephen Hahn announced in an email to agency...

Fourth-line GIST showdown ends in an FDA win for Deciphera, a rejection for Blueprint

FDA approved Qinlock repretinib from Deciphera as fourth-line treatment for advanced gastrointestinal stromal tumors (GIST), marking the first approved therapy for the indication. Also on Friday, competitor Blueprint said FDA issued a complete response letter...

Refusal-to-file letter for BMS-bluebird cell therapy further muddies chances of Celgene payout

Partners BMS and bluebird are insistent that FDA’s refusal-to-file letter for their BCMA-targeting cell therapy is merely the result of a documentation issue that isn’t representative of any larger problem. But the resulting delay, which...

FDA guidance steers COVID-19 drug developers to controlled, sub-grouped trials

A pair of new FDA guidance documents covering COVID-19 drug development provides much needed clarity for the hundreds of drugmakers that have embarked on clinical and preclinical development programs for the novel coronavirus over the...

$8B Loxo deal yields first drug with approval of Lilly’s targeted lung cancer therapy

FDA’s approval of Retevmo selpercatinib from Eli Lilly is the second approval for a genetically defined subset of non-small cell lung cancer patients this week. The selective RET inhibitor is the first product of the...

CRISPR comes of age years ahead of schedule with first diagnostic authorization

FDA’s authorization of a CRISPR-based diagnostic for COVID-19 from Sherlock Biosciences is another step in the right direction for COVID-19 diagnostics, but it’s a much bigger win for the CRISPR technology. It represents the first...

FDA approval of Novartis’ capmatinib heralds arrival of new targeted lung cancer therapies

FDA’s approval of the c-MET inhibitor Tabrecta capmatinib from Novartis is the first for a series of targeted non-small cell lung cancer therapies expected to reach the market this year. It’s also the first approval...

Extended review of Bristol’s CAR T leaves little daylight for CVR from Celgene deal

The latest delay in the regulatory timeline for BMS’s CAR T therapy liso-cel means that any further snags would jeopardize a potential payout worth up to $6.8 billion to Celgene’s shareholders that was associated with...

As first subcutaneous anti-CD38 mAb, Darzalex Faspro secures J&J’s lead in MM, shaves hours off infusion time

FDA’s approval of a subcutaneous form of Darzalex secures J&J’s leading position in the anti-CD38 market just two months after a new entrant threatened to cut into its market share. It’s also a game changer...

CHMP backs new therapy for 1L AML, triple combos for asthma

EMA’s CHMP this month recommended four new medicines for approval, including a new front-line therapy for AML and triple combination therapies for asthma. The agency recommended approval for Daurismo glasdegib from Pfizer Inc. (NYSE:PFE) to...

China's proposed annual NRDL revisions could increase pricing pressure

China's proposed guidelines regarding the annual revision of its National Drug Reimbursement List could increase pricing pressure for all included drugs. Draft opinions released by China’s National Healthcare Security Administration (NHSA) Wednesday proposed extending price...

Zejula’s label expansion reaches an untapped ovarian cancer population

The label expansion for GlaxoSmithKline’s Zejula niraparib will allow the company to tap into a broad ovarian cancer patient population that hasn’t been touched by other PARP inhibitors. It also sends another signal to drugmakers...

人人为我,我为人人: 协调全球监管,打赢新冠大流行这场硬仗

Publisher's note: the English language version of this article may be found here .  新冠疫情激起了全球医药产业的广泛响应, 许多公司正将其专精与技术投入其中, 开发疫苗和疗法。 然而, 在不同国家或地区的监管上, 我们还没有看到全球总协同。 相反, 许多监管上的决策只局限于不同的国家层面, 让全产业的努力显得支离破碎...

FDA’s options for staying on track with PDUFA timelines during COVID-19

The COVID-19 pandemic is severely limiting FDA’s ability to conduct in-person pre-approval site inspections, putting the agency’s ability to meet its regulatory timelines at risk. To avoid delays, companies need to prepare to provide all...

All for one, one for all: An urgent call to harmonize global drug regulation against COVID-19

The COVID-19 pandemic has spurred enormous activity in the drug industry around the world with many companies pooling their expertise and technologies to develop vaccines and treatments. However, we have no visible global coordination of...