Policy
A renewal of the FDA’s pediatric rare disease voucher program is couched within a massive $1.2 trillion spending bill the House is set to vote on later this week.
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Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
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.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 11, 2020.
Eli Lilly is moving quickly to get a newly-approved precision oncology treatment, Retevmo, for certain lung and thyroid cancers into the hands of patients.
The new at-home saliva self-collection assay allows for broader screening than the standard and uncomfortable method using nose and throat swabs at a healthcare facility or testing location that requires a physical interaction with a healthcare professional.
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here’s a look at what’s on the schedule for the next two weeks.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 8, 2020.
To date, 10 plasma companies globally have joined the CoVIg-19 Plasma Alliance, founded to accelerate development of a plasma-derived hyperimmune globulin therapy against COVID-19.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 7, 2020.
Developed by Novartis, the drug, Tabrecta, is designed for a type of NSCLC that has spread to other parts of the body and cannot be removed by surgery.
The CD19-directed chimeric antigen receptor (CAR) T cell therapy is a treatment for adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies.
The drug can potentially reduce the risk of cardiovascular death and hospitalization for heart failure.