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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The government shutdown threw a wrench into several biotech company’s plans for initial public offerings (IPOs). Although the government is only guaranteed to stay open until February 15, several biotechs are working to get their IPOs launched in that window. Here’s a look.
The U.S. Food and Drug Administration approved the first treatment for acquired thrombotic thrombocytopenic purpura (aTTP). Sanofi’s Cablivi was given the greenlight and will become a cornerstone of the company’s new rare blood disorders franchise.
After Health and Human Services Secretary Alex Azar, a former executive with Eli Lilly, unveiled a pricing reform that would allow pharma companies to end the rebate system and pass those savings directly to consumers, leaders from across the pharma industry are offering early support for the proposal.
Across the globe, pharma companies are making an impact. Last week BioSpace launched the first of a weekly roundup of international biotech and pharma news. Here’s the latest edition.
Takeda Pharmaceutical released data from its Phase IIIb/IV clinical trial for Adynovate. On the same day, jurors in a Delaware federal court ordered Takeda’s Baxalta unit to pay $155.19 million to Bayer AG for infringing a patent for Adynovate.
During the president’s annual address to Congress and the nation, Trump said that as a result of his administration’s efforts to lower the costs of prescription drugs, “in 2018 drug prices experienced their single largest decline in 46 years.”
Investors are not happy after Austin, Texas-based Pain Therapeutics announced that it was no closer to seeing its drug candidate Remoxy ER, an abuse-deterrent, extended-release gel formulation of oxycodone, approved by the U.S. Food and Drug Administration.
Genentech, a Roche company, is flexing its litigation muscle this week. The South San Francisco-based company has filed 18 lawsuits over the past few weeks to block competitors from selling a generic version of a treatment for idiopathic pulmonary fibrosis, a fatal lung-scarring disease.
Catalyst won approval in 2018 for the LEMS treatment and set the price of the drug at $375,000 for the rare disease.
Last week HHS floated a plan that would allow companies to pass rebates of 26 to 30 percent of a drug’s list price directly to patients in order to be reflected in what consumers pay at the pharmacy counter.