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BioWorld - Wednesday, May 27, 2026
Home » Topics » U.S., BioWorld

U.S., BioWorld
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U.S. flag and White House podium

White House budget proposal for FY 2022 long on ambition, short on details

April 12, 2021
By Mark McCarty
The Biden administration has released an exceedingly brief budget framework for fiscal year 2022 that includes $6.5 billion for an advanced research program at the NIH, which mimics a similar program at the Department of Defense (DoD). Beyond that, there is a clear indication that the CDC would see an uptick in monies, but the proposal offers no numbers for the FDA budget, making this one of the skinnier budget proposals to come out of the White House in recent memory.
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Cavazzoni no longer acting

April 12, 2021
By Mari Serebrov
The “acting” has been dropped from Patrizia Cavazzoni’s title as director of the U.S. FDA’s Center for Drug Evaluation and Research (CDER).
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MACPAC tackles 'accelerated' prices

April 12, 2021
By Mari Serebrov
If the U.S. Congress is receptive to recommendations approved by the Medicaid and CHIP Payment and Access Commission (MACPAC) April 9, the FDA's accelerated approval path for innovative new drugs could lose a bit of its appeal. And sponsors using that path may speed the pace of seeking full approval.
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Biopharma research illustration

Bayh-Dole: What’s at risk when the government goes marchin’ in

April 8, 2021
By Mari Serebrov
In the debate over the interpretation of the U.S. government’s patent march-in rights under the Bayh-Dole Act, those arguing for march-in as a price control cite the billions of tax dollars being invested in scientific research at universities that may lead to marketable inventions.
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Patent law book and gavel

Proposed NIST rule escalates debate over Bayh-Dole march-in

April 6, 2021
By Mari Serebrov
Nearly 16,500 groups and individuals put in their two cents on a proposed National Institute of Standards and Technology (NIST) rule clarifying that the U.S. government, under the Bayh-Dole Act, can’t march in on patents derived from federally funded research just because it doesn’t consider the price of the resulting product “reasonable.”
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Patent gears

U.S. GAO gives a reality check on march-in rights

April 1, 2021
By Mari Serebrov
U.S. lawmakers, advocacy groups and state officials who urged the Department of Health and Human Services (HHS) to march in on patents covering Gilead Sciences Inc.’s COVID-19 drug, Veklury (remdesivir), likely were disappointed, and perhaps surprised, by the Government Accountability Office’s (GAO) conclusion this week that, despite a $161.5 million taxpayer investment in the antiviral’s development, there are no government patents to march in on.
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U.S. flag and money

Biden plans a give-and-take for biopharma, med tech

March 31, 2021
By Mari Serebrov
The Made in America Tax Plan President Joe Biden is proposing to pay for his $2 trillion U.S. American Jobs Plan could change the way multinational drug and device companies do business, as well as curb M&As that take advantage of global tax benefits.
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Abecma product image

Bluebird, BMS win FDA nod for first BCMA-targeting CAR T therapy

March 29, 2021
By Jennifer Boggs
The first BCMA-targeted CAR T therapy, idecabtagene vicleucel, cleared FDA approval for use in adults with multiple myeloma (MM) who have received four or more prior lines of therapy. Developed by partners Bluebird Bio Inc. and Bristol Myers Squibb Co., the drug, branded Abecma, is also the first CAR T drug indicated for MM. It is designed for use as a one-time infusion, with a recommended dose range of 300 to 460 x 106 CAR-positive T cells. The personalized therapy will be produced at BMS’ cellular manufacturing facility in Summit, N.J. Bluebird developed the lentiviral vector used in Abecma.
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Proposed REMS not enough to mitigate tanezumab risk

March 25, 2021
By Mari Serebrov
If the March 25 vote from a joint FDA advisory committee meeting is anything to go by, the long and bumpy development road for Pfizer Inc.’s tanezumab, a nonopioid pain drug, may have just gotten longer and bumpier. In what was nearly a unanimous vote, the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee said the sponsor’s proposed risk evaluation and mitigation strategy (REMS) was not adequate to ensure the benefits of tanezumab in alleviating osteoarthritis pain outweigh its risks, which include further joint deterioration.
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Box of Astrazeneca COVID-19 vaccine vials

Astrazeneca will publish findings from U.S. COVID-19 vaccine trial after DSMB criticism

March 23, 2021
By Nuala Moran
LONDON – Astrazeneca plc promised to publish the primary analysis of the phase III U.S. trial of its COVID-19 vaccine by the morning of March 25, after chastisement from the data safety monitoring board (DSMB) for using “outdated” information in the interim results published on March 22.
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