Policy
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
FEATURED STORIES
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
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.
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Texas-based Pain Therapeutics is urging the FDA to reconsider the Complete Response Letter it issued in August for the company’s opioid-treatment, Remoxy. Representatives from Pain Therapeutics will meet with the FDA on Jan. 31. 2019 to discuss the request, the company announced late Monday.
On Friday, the FDA approved Merck’s Keytruda, an anti-PD-1 therapy, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with the chemotherapy drug sorafenib.
Clinical data for a fish-oil-based drug from Amarin Corporation PLC confirmed the drug’s ability to reduce the relative risk reduction of adverse cardiovascular events by 25 percent, including a 20 percent reduction in cardiovascular death.
Move part of effort to increase awareness and educate about preventive measures
The U.S. Environmental Protection Agency (EPA) has settled with two California companies for failing to provide required notifications for the handling of toxic chemicals.
The Food and Drug Administration is taking care of a few approvals and committee meetings ahead of the Thanksgiving holiday week. They include drugs for COPD, a pain drug, and a sublingual film formulation of a well-known drug for erectile dysfunction. Here’s a look.
Scott Gottlieb, commissioner of the Food and Drug Administration (FDA), provided an update on the agency’s Expanded Access program.
Al Qassimi, Khorfakkan, Saqr, Shaam, Fujairah, Dibba, Kuwait, Obaidullah and Kalba hospitals covered under the program