Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.
Apotex Corp. agreed to pay $26 million to the state of Texas to resolve claims that it had reported inflated drug prices to the Texas Medicaid program.
The COVID-19 pandemic brought in-person inspections of device manufacturing sites to a near halt, but that has left the agency with a significant backlog in these inspections. The FDA’s Associate Commissioner for Regulatory Affairs Judith McMeekin said recently that the FDA is intent on prodding Congress to provide the Office of Regulatory Affairs (ORA) with more monies, particularly given the meager increases in funding for oversight of the med-tech industry in the past few years.
10x Genomics Inc. launched its latest platform for single-cell analysis, the Chromium X Series, to cost-effectively "enable massively large-scale experiments," according to the company.
Hoping to get Germany to drop its opposition to a proposed World Trade Organization (WTO) waiver of intellectual property (IP) rights, several U.S. lawmakers have asked to meet with German Chancellor Angela Merkel when she’s in Washington for a July 15 summit with President Joe Biden.
The M&As that are the current business model of the drug and device world are in for increased scrutiny under the executive order U.S. President Joe Biden signed July 9. Answering the administration’s call for a whole-of-government-approach to increasing competition in the U.S., the Department of Justice “will closely examine its antitrust guidelines and policy statements to better educate the public on its enforcement priorities, and it will heighten its efforts to prevent mergers that would result in excessive consolidations of purchasing power,” U.S. Attorney General Merrick Garland said.
While U.S. lawmakers continue their debate on reducing spending for prescription drugs, government payers are exploring innovative reimbursement ideas to cover gene and cell therapies that could cost millions of dollars for a cure or a durable effect against rare diseases.
With 15 more U.S. states signing on, a bankruptcy settlement appears to be in sight for privately owned Purdue Pharma LP. It also has U.S. lawmakers calling for reforms to the country’s bankruptcy laws.
U.S. Rep. Carolyn Maloney (D-N.Y.) came out swinging against the biopharma industry’s innovation talking point July 8 when she released a House Oversight Committee staff report on U.S. drug prices and the games drug manufacturers play to delay competition.
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