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Regulation

Borio, Dolsten say FDA’s COVID-19 vaccine guidance hits mark

FDA has laid the groundwork for robust, randomized, placebo-controlled trials of vaccines for COVID-19, but it will be up to groups such as NIH and Operation Warp Speed to encourage coordination among developers to harmonize...

June 30 Quick Takes: Another first for Ultragenyx; plus approvals for Genentech’s Phesgo, Keytruda, Bavencio and Ultomiris

Ultragenyx’s Dojolvi wins FDA approval for rare disease FDA approved Dojolvi triheptanoin (UX007) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat long-chain fatty acid oxidation disorders, making it the first drug approved for the indication. The...

Data Bytes: Drug approvals in Japan

On Monday, Japan’s Ministry of Health, Labour and Welfare announced at least nine drug approvals, five of which are products from Novartis AG (NYSE:NVS; SIX:NOVN). Two of the approvals are for HIF-PH inhibitors to treat...

Intercept: Surrogate endpoint not enough for FDA to approve NASH therapy

Intercept believes FDA’s “evolving” thinking on efficacy endpoints for NASH therapies led to the complete response letter for Ocaliva that destroyed about two-fifths of the company’s market value on Monday. The company said FDA declined...

Boxed warning on Zogenix’s Dravet syndrome therapy could hamper market prospects

FDA’s approval of a resubmitted NDA for Fintepla to treat seizures associated with Dravet syndrome sets Zogenix up to compete with GW’s Epidiolex in the rare epilepsy market, but the drug’s prospects may be hampered...

Data Bytes: CHMP’s June opinions

A recommendation by EMA’s CHMP suggests remdesivir from Gilead Sciences Inc. (NASDAQ:GILD) could soon gain a speedy conditional approval to treat COVID-19. The committee announced the decision this week along with a basket of other...

With deep experience at the EC and WHO, Cooke primed to lead EMA amid pandemic

When Emer Cooke takes the reigns of EMA at year-end, she’ll be faced with navigating the agency through year two of the pandemic and the first full year of a post-Brexit relationship with the U.K....

Myovant eyes third NDA for relugolix after endometriosis readout

An NDA submission for an endometriosis therapy could come early next year from Myovant, whose shares gained $2.49 (14%) to $19.90 Tuesday after the company posted positive data for relugolix in a second Phase III...

FDA pilot project aims to provide symptom data to cancer patients

FDA Tuesday launched a pilot version of Project Patient Voice, a website that will give patients and physicians information that isn’t on labels about patient-reported symptoms for cancer drugs. Project Patient Voice will present sponsor-provided...

FDA guidance aims to help sponsors salvage trials disrupted by COVID-19

As COVID-19 safety concerns and social distancing measures continue to disrupt clinical trials around the U.S., FDA has released guidance to help investigators adapt the design and analysis of affected studies. By the end of...

International regulators concerned by poor COVID-19 trials, advocate master protocols

Regulators around the world are concerned that small, underpowered and discontinued trials of COVID-19 therapies are crowding out studies that could provide definitive results, according to a readout provided by EMA from a June 12...

Asserting its independence, FDA revokes chloroquine authorizations

FDA took more than six weeks to rescind the EUA for hydroxychloroquine and chloroquine after the agency first raised concerns over the safety of the malaria drugs to treat COVID-19. The move reverses a decision...

Approval of Biocon, Mylan insulin product could herald cheaper insulin in U.S.

After traveling a winding path that included patent disputes and complete response letters, Semglee insulin glargine from Biocon and Mylan has at last gained FDA’s approval to treat diabetes. Biocon Ltd. (NSE:BIOCON; BSE:532523) and Mylan...

FDA planning to work with sponsors to salvage trials damaged by COVID-19

COVID-19 has disrupted clinical trials around the world, causing sponsors to wrap up studies sooner than anticipated, modify protocols to allow for remote collection of data, and in some cases contemplate methods to compensate for...

EUA for Illumina COVID-19 NGS test opens path to high-volume screening for workplaces, schools

The first FDA-authorized next-generation sequencing test for COVID-19 could strike the right balance of volume, sensitivity and speed needed for routine screening to help reopen society. Illumina Inc. (NASDAQ:ILMN) announced Tuesday it received FDA Emergency...