The U.S. FDA wants feedback on its latest idea to reduce the number of unused prescription opioids shelved in American homes: requiring prepaid mail-back envelopes to be dispensed with the painkillers.
Privately held Orasis Pharmaceuticals Ltd. is a step closer to challenging Abbvie Inc.’s Vuity (pilocarpine hydrochloride) ophthalmic solution for treating presbyopia, a version of farsightedness. Orasis plans to submit an NDA to the U.S. FDA in the second half of the year based on phase III results from two studies showing CSF-1 hit its primary and secondary endpoints.
Sponsors developing PI3K inhibitors to treat hematologic malignancies in the U.S. may have to up their game if they want to get FDA approval. The Oncologic Drugs Advisory Committee voted 16-0, with one abstention, that future approvals of the drugs should be supported by randomized data. Given the FDA’s briefing document ahead of the April 21 meeting and its presentations to the committee, the agency is likely to follow that recommendation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, JW, Keymed, Teva.
After several delays due to COVID-19, Canada is on track to implement, within a few months, its first major changes to its Patented Medicines Regulations in more than 30 years. One change coming July 1 is a new basket of comparator countries that will be used to determine whether a drug’s Canadian price is excessive.
Shares in Medincell SA dropped 29.1% Apr. 20 on news that the U.S. FDA slapped a complete response letter (CRL) on an NDA for an extended release, long-acting formulation of risperidone, which it is co-developing with Teva Pharmaceuticals Industries Ltd. as a maintenance treatment for schizophrenia.
The U.S. COVID-19 vaccine program is at risk of “booster fatigue,” which will undermine public confidence in the vaccines, several members of the CDC’s Advisory Committee on Immunization Practices (ACIP) said April 20 as they met to discuss the future of the vaccines. Rather than relying on boosters, “we need to use our expertise to advocate for something that’s better,” something that resolves the ill effects of COVID-19, whether it’s mild or severe, said Lynn Bahta, an immunization program clinical consultant for the Minnesota Department of Health.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adicet, Astrazeneca, Axsome, Aytu, Daiichi Sankyo, Hansa, Innovative Cellular, Merck, Navidea, Novavax, NTC, Ribomic, Serum Institute, Takeda..
With renewed focus on the U.S. Cancer Moonshot, the price of oncology drugs is more than a satellite issue, especially as new drugs launch with ever-increasing prices and other cancer drugs continue to see price hikes.
Deciding not to roll the dice this time, Johnson & Johnson (J&J) and its U.S.-based Janssen Pharmaceutical Cos. removed themselves April 18 from an ongoing opioid trial in West Virginia by agreeing to a $99 million settlement with the state.
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