FDA
Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite assurances of swift reviews under the FDA’s new Commissioner’s National Priority Voucher program.
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After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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As its acquisition by Takeda Pharmaceutical edges closer and closer, Shire reported a solid second-quarter.
Only a matter of days after Roche filed its second-quarter financial report, it’s had plenty of news to report.
The U.S. Food and Drug Administration (FDA) approved New York-based Progenics Pharmaceuticals’ New Drug Application (NDA) for Azedra for adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. It is the first and only therapy approved for these indications.
The U.S. Food and Drug Administration (FDA) approved Indivior’s Perseris for schizophrenia.
Bristol-Myers Squibb reported a strong second quarter, with total revenues of $5.7 billion, up 11 percent from the same quarter in 2017, when it reported $5.144 billion. Sales were driven by Eliquis (apixaban) and Opdivo (nivolumab).
Shares of AbbVie are up slightly this morning after the company announced that it finally received regulatory approval for its endometriosis drug elagolix. The approval marks the first new approved oral treatment for endometriosis-associated pain in more than 10 years.
GlaxoSmithKline continues to make headway in the development of two-drug regimens to benefit HIV patients – even those who have high levels of the virus.
Shares of Eli Lilly jumped in premarket trading after the company reported total revenue of $6.35 billion for the second quarter, a 9 percent increase in revenue over the same period last year.
Shares of Agios Pharmaceuticals jumped this morning after the company said the FDA approved its oral leukemia treatment Tibsovo (ivosidenib). It’s the second approval for the company in less than a year.
The U.S. Food and Drug Administration is looking to address supply chain threats by potentially importing foreign drugs under a narrow scope.