| | | |   | Hi, it’s Meghana! Hope to see you at the STAT Summit this week — I’ll be there Wednesday. Today, we see worrisome trends in the vaccine approval process from India’s Covivax, see one addiction drug maker acquire another, and more. | | | The questionable approval process for India’s Covid-19 vaccine Bharat Biotech was backed by the Indian government to develop a homegrown Covid-19 vaccine. But a STAT review of documents shows that regulators endorsed the vaccine, called Covaxin, despite questionable trial protocols and discrepancies in the trial participants. For instance, the Phase 3 protocol was approved while Phase 2 was still underway — and a final vaccine candidate was selected without Phase 2 data. Now, public health experts are expressing concern that the Bharat Biotech vaccine may have been hastily approved. “My issue is that the confidence of the public and medical community in the regulator takes a beating when the regulator and the (expert committee) seem to accept ‘inadequate information’ to base their decisions on — or lack the clarity in their minutes to explain why this was rational,” one public health expert in India told STAT. “They appear to be under duress and this is a very worrying scenario.” Read more. | Stoke Therapeutics epilepsy drug worked, but not quite enough Although the higher dose of an epilepsy drug from Stoke Therapeutics did reduce the frequency of seizures, the efficacy still wasn’t strong enough to provide a meaningful benefit for children with a rare form of the disease. Three monthly injections of the drug, STK-001, led to a 55% reduction in convulsive seizures with Dravet Syndrome, a rare genetic epilepsy. But the trial was small — just six patients — and most of the efficacy was seen in two of the youngest patients. Stoke plans to enroll and treat more patients, and will offer updated study results next year. Still, the company’s stock dropped 18% on the news. “We are encouraged by the data from our ongoing studies of STK-001, which continue to demonstrate favorable safety findings and reductions in seizure frequency among a highly refractory group of patients,” Stoke Chief Medical Officer Barry Ticho said in a statement. Read more. | CGT report: Are you ready for commercial success in a fast-paced future of cell and gene therapies? There are more than 500 products in the cell and gene pipeline. However, these therapies will face a steeper climb to commercialization compared with traditional biopharmaceutical products. Download the report for patient and market access insights on leveraging CRISPR technology to treat blood disorders, regulatory and policy changes to watch for, an interview on AstraZeneca’s innovative cell therapy pipeline for chronic diseases, and trends shaping the commercialization of novel cell and gene therapies. Access the full report now. | FDA documents don’t seem to favor Ardelyx drug FDA briefing documents show that tenapanor, a chronic kidney disease drug from Ardelyx, may not have so bright a future. An advisory committee will meet Wednesday to evaluate the company’s New Drug Application. But the FDA has already written that the “magnitude of treatment effect” was lower with the Ardelyx drug than with already-approved drugs controlling serum phosphorus in dialysis patients with chronic kidney disease. As BioSpace points out, this is the second time tenapanor has been evaluated by the FDA. Even though it hit its Phase 3 endpoints, it was rejected by regulators — saying that the decrease in serum phosphorus was still “small and of unclear clinical significance.” | Maker of Narcan bought by maker of Suboxone Opiant, the maker of addiction drug Narcan, is being acquired by Indivior — the maker of addiction drug Suboxone — for $145 million. Although there has been some stagnancy in the addiction market, the Wall Street Journal writes, recent U.S. policy will push billions of dollars into addiction treatment. “It’s a bipartisan issue across Washington,” Indivior’s CEO told the Journal. “We see some momentum building, additional funding from the administration as well as legislation that serves to normalize this disease.” Indivior has a market cap of some $2.7 billion, while Opiant is much smaller, worth about $49 million. But Opiant has several addiction drugs under development, including a vaccine for heroin addiction, an implant for opioid addiction, and an overdose-reversing nasal spray containing nalmefene. In late-stage trials, the latter worked better than naloxone-based medicines like Narcan to treat fentanyl overdose. | More reads - Roche’s experimental Alzheimer’s treatment fails to slow cognitive decline across two clinical trials, STAT
- Moderna data suggest new Covid booster is more effective against Omicron variants, STAT
- A fake tweet sparked panic at Eli Lilly and may have cost Twitter millions, Washington Post
| Thanks for reading! Until tomorrow,  | | | |
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