While it’s called the FDA Modernization Act (FDAMA) 3.0, the short bipartisan bill introduced in the U.S. Senate Sept. 15 is basically a message to the FDA: “The move away from animal testing in FDAMA 2.0 wasn’t a congressional suggestion. It’s a mandate, so get it done.”
With an eye on shutting down national security threats and securing American innovation, the U.S. House overwhelmingly passed the Biosecure Act Sept. 9 with a vote of 306-81. The next stop on the bill’s path to enactment is a Senate vote and, if it gets that, then on to the president’s desk.
Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.
Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.
While the Biden administration continues applauding the savings it claims will be delivered by the first round of Medicare negotiations, many U.S. patients and their families are worried about the cost of the biopharma price-setting program – a cost they measure not in dollars and cents, but in worsening illness and lives that may be lost to a downturn in innovation and an upturn in barriers to access.
Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.
Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.
With inter partes reviews (IPR) once feared as patent killers, the mere fact that an IPR petition challenging a drug or device patent had been filed with the U.S. Patent and Trademark Office was enough to send a company’s stock tumbling. That initial fear has “kind of ebbed and flowed” over the past 12 years as the patent reviews established by the America Invents Act have come of age, Aziz Burgy, a partner and patent litigator at Axinn, Veltrop & Harkrider LLP, told BioWorld.
With time running out on the 118th U.S. Congress, a group of lawmakers is urging the leadership of the House Energy and Commerce Committee to consider a bipartisan path forward on strengthening the 340B drug discount program.
Noting that the median list price of new drugs that entered the U.S. market last year hit $300,000, senior officials of the three biggest pharmacy benefit managers (PBMs) in the country once again denied responsibility for those prices as they testified before the House Oversight Committee July 23 in the third hearing the committee has held on PBM practices.
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