Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Issuance of U.S. Patent No. 10,335,391 Further Strengthens Aclaris’ RHOFADE Patent Portfolio
SonoCloud ultrasound device for glioblastoma patients will be tested for first time at US clinical sites
The judge ruled that the U.S. Department of Health and Human Services did not have the authority to compel companies to disclose the list prices without Congressional approval.
Primary endpoint of event free survival (EFS) rate at 180 days of 90.9 percent reported for rivo‑cel in BP-004 European registrational trial
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
Da Volterra, a clinical-stage biopharmaceutical company developing new therapeutics to protect the intestinal microbiota, announced the completion of patient recruitment for its Phase 2 trial ‘SHIELD’ evaluating DAV132 in patients receiving antibiotics.
The executive order will demand that drugs purchased by the federal government will not cost more than the lowest price paid by other nations.
Hutchison China MediTech Limited will be announcing its interim results for the six months ended June 30, 2019 on Tuesday, July 30, 2019 at 7:00 am British Summer Time (BST) (2:00 pm Hong Kong Time (HKT); 2:00 am Eastern Daylight Time (EDT)).
Shares of Karyopharm Therapeutics have skyrocketed more than 36% after the U.S. Food and Drug Administration approved the Newton, Mass.-based company’s treatment for multiple myeloma.
As fireworks illuminate the night skies across the United States this weekend in celebration of Independence Day, BioSpace takes a look at some of the highlights of the pharma industry from the first half of 2019 and earlier that provides millions of patients with the independence of health.