The U.S. FDA on January 21 expanded the health regulator’s approval for the use of Gilead Sciences’ antiviral drug remdesivir to treat non-hospitalized patients 12 years and older for the treatment of mild-to-moderate COVID-19 disease with high risk of hospitalization.
Rick Pazdur, director of the U.S. Food and Drug Administration’s Oncology Center of Excellence and longtime defender of the agency’s accelerated approval program, acknowledged that some changes are likely needed to the process to ensure timely receipt of confirmatory trial data.
Alzheimer’s patient groups, disappointed by Medicare’s plan to sharply limit coverage of new drugs for the brain-wasting disease, are planning publicity and lobbying campaigns to protest a proposal they say could delay their use for 10 years.
Nearly 30 generic drugmakers in Asia, Africa and the Middle East will make cheap versions of Merck & Co’s COVID-19 pill, under a landmark U.N.-backed deal to give poorer nations wider access to a drug seen as a weapon in fighting the pandemic.
Pfizer released data from several studies showing that nirmatrelvir, the active main protease inhibitor of the company’s antiviral combination therapy Paxlovid (nirmatrelvir/ritonavir), is effective against the Omicron variant of SARS-CoV-2. Additionally, a study conducted by 23andMe and published in Nature Genetics identified a genetic risk factor tied to the loss of smell from COVID-19.
AstraZeneca reported what the company called “unprecedented survival,” in the HIMALAYA Phase III trial using a single priming dose of tremelimumab added to the anti-PD-L1 checkpoint inhibitor Imfinzi (durvalumab) compared to Bayer’s Nexavar (sorafenib) as a first-line treatment for unresectable hepatocellular carcinoma (HCC) patients who had not received previous systemic therapy and as a result, were not eligible for localized treatment.
Gilead Sciences Inc. said an unauthorized network of drug distributors and suppliers sold pharmacies more than $250 million of counterfeit versions of the company’s HIV treatments over the last two years, endangering patients.
The U.S. Food and Drug Administration approved drugs from AbbVie Inc. and Pfizer Inc. for treating the skin disease eczema, the companies said on Jan. 14.
Gilead Sciences Inc. on Jan. 14 notified the U.S. health regulator of the company’s decision to voluntarily withdraw the use of the drug Zydelig for two types of cancer – follicular lymphoma and small lymphocytic leukemia.
A U.S. judge on January 14 barred Martin Shkreli from the pharmaceutical industry for life and ordered him to pay $64.6 million after he famously raised the price of the drug Daraprim and fought to block generic competitors.