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.
LONDON – The World Health Organization (WHO) is to set up a channel for confidential reporting of illegal, unregistered, unethical or unsafe human genome editing research, as part of a new governance framework it is proposing to develop.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Bluebird, Humanigen, Innovent, Lysogene.
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.
NICE has said “no” to regular NHS funding for a rare disease gene therapy from Orchard Therapeutics Ltd. in draft guidance – although experience from Novartis AG’s pricey Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy shows this could change. That’s because this week NICE published final guidance that recommends funding for Zolgensma, thought to be the world’s most expensive drug, after an initial rejection late last year.
Officials at Sigilon Therapeutics Inc. declined to comment beyond a press release on the FDA’s clinical hold for the phase I/II study with encapsulated cell therapy SIG-001 for severe or moderately severe hemophilia A. Shares of Cambridge, Mass.-based Sigilon (NASDAQ:SGTX) closed at $6.90 on July 9, down $2.34, or 25% after Wall Street learned of the regulatory move, which came because one of three patients treated has developed inhibitors to factor VIII (FVIII).
As rumblings continued about possible skulduggery between Biogen Inc. and the FDA related to Aduhelm (aducanumab), an already precedent-setting case took yet another turn: Acting FDA Commissioner Janet Woodcock asked acting U.S. Inspector General Christi Grimm’s office to conduct an independent review of goings-on that led to approval of the amyloid-beta-targeting drug in Alzheimer’s disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, ASC, Astrazeneca, Beigene, Biogen, Enveric, Triact.
Following a priority review, the FDA approved Bayer AG’s Kerendia (finerenone) for chronic kidney disease (CKD) associated with type 2 diabetes (T2D). A non-steroidal mineralocorticoid receptor antagonist, Kerendia targets a key driver in CKD and has proven positive as well with regard to cardiovascular outcomes – risked especially by patients with loss of kidney function.
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.
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