Given the negative response to a proposed amendment allowing the price of NHS-dispensed drugs to be listed on labeling, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has decided not to go forward with the policy, it announced Nov. 11.
Kaléo Inc. agreed to pay $12.7 million to end whistleblower allegations that the Richmond, Va.-based company caused the submission of false claims for Evzio (naloxone hydrochloride), an injectable drug used to reverse opioid overdoses.
Shares of Alkermes plc slipped 15% Nov. 9 on news that longtime partner Janssen Pharmaceutica NV plans to partially terminate two license agreements related to know-how royalties on U.S. sales of paliperidone products using Alkermes’ nanoparticulate technology. While the move is expected to result in only a modest near-term impact on the Dublin-based firm’s bottom line, it took both company management and investors by surprise.
Lawfully selling prescription opioid drugs is not a public nuisance, the Oklahoma Supreme Court said in overturning a $465 million judgment against Johnson & Johnson (J&J).
As part of its pharmacovigilance program for Alzheimer’s drug Aduhelm (aducanumab), Biogen Inc. is evaluating a handful of reports published in the FDA Adverse Event Reporting System Public Dashboard, including the Aug. 18 death of a 75-year-old woman with Alzheimer’s and other co-morbidities.
In the Biohaven Pharmaceutical Holding Co. Ltd. and Pfizer Inc. collaboration to commercialize Nurtec ODT (rimegepant) outside the U.S., Biohaven will receive tiered double-digit royalties on ex-U.S. net sales as well as milestone payments of up to $1.24 billion. The target: more than 1 billion migraine sufferers worldwide with lots of clinical competition.
Just a day after the world's first approval of Merck & Co. Inc.'s oral antiviral for COVID-19 positioned it to offer a new way to keep Britons at high risk of severe disease out of the hospital, Pfizer Inc. is stopping a phase II/III trial of its oral antiviral, Paxlovid, early for "overwhelming efficacy" in a similar group. Interim results showed that combining the drug, also known as PF-07321332, with ritonavir reduced the risk of hospitalization or death for adults with mild to moderate COVID-19 but at high risk of severe disease by 89% vs. placebo.
A closely watched oral antiviral for the treatment of mild to moderate COVID-19 will soon be available in Britain after a conditional authorization by the U.K. Medicines and Healthcare products Regulatory Agency. Developed by Ridgeback Biotherapeutics Inc. and Merck & Co. Inc., the drug will be marketed as Lagevrio (molnupiravir) and made available via a national study this winter, the government said.
It looks like direct Medicare drug price negotiations are back in the U.S. fiscal 2022 budget bill.
Nearly a week after President Joe Biden dropped drug pricing reforms from his Build Back Better budget framework, congressional Democrats came together on a scaled-back version of the pricing provisions originally included in H.R. 3.
With the U.S. biosimilar pathway clearly developed, industry and the FDA are turning their attention to interchangeables in the third iteration of the biosimilar user fee agreement (BsUFA).
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