Drugs

BioNTech Agrees to Buy Priority Voucher for $205 Million

BioNTech says it has entered into an agreement to acquire for $205 million an FDA Priority Review Voucher that was awarded to Scholar Rock. The voucher grants an FDA priority review for a single application, which reduces the target FDA review timeline and could lead to expedited approval.

BioNTech says it intends to use the voucher to “support a future filing of an asset in its late-stage oncology pipeline.” The company did not identify the oncology candidate for which it intends to use the voucher. One possibility is pumitamig (BNT327), a PD-L1/VEGF-A bispecific antibody being developed with Bristol Myers Squibb. The drug's substantial commercial potential could make an accelerated FDA review particularly valuable. Another possibility is trastuzumab pamirtecan (BNT323), for which BioNTech and DualityBio have been discussing a potential BLA submission.

Senate HELP Committee Plans 11/18 Vote on Overton FDA Nomination

The Senate Health, Education, Labor and Pensions (HELP) Committee has announced an 11/18 vote on President Trump's nomination of Heidi Overton as FDA commissioner, setting up a potentially contentious confirmation effort before Democrats take control of the Senate in January. The White House is reportedly preparing an

Confirm Overton Now: Kathleen Jaeger

Among the many issues facing Congress before the end of the year, it should confirm Heidi Overton as FDA commissioner, according to healthcare strategy and consulting firm Medsecurean founder and CEO Kathleen Jaeger, who previously was CEO of the Generic Pharmaceutical Association (now the Association for Accessible Medicines). Writing in

FDA Probe Leads to Arrest of Canadian Drug Importation Executive

A senior executive of Canadian prescription drug supplier CANARX has been arrested on federal charges involving an alleged scheme to illegally import prescription drugs into the U.S., according to CNBC. John Thomas Howard, the company's treasurer and a director, was arrested Sunday on charges including smuggling, conspiracy,

BioNTech Agrees to Buy Priority Voucher for $205 Million

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Senate HELP Committee Plans 11/18 Vote on Overton FDA Nomination

Confirm Overton Now: Kathleen Jaeger

FDA Probe Leads to Arrest of Canadian Drug Importation Executive

Makary Confirms Allegations of Industry Pressure on FDA