Archive for March 2021
NICE Issues Another No to Merck’s Keytruda for Advanced Bladder Cancer
The UK’s National Institute for Health and Care Excellence (NICE) has decided it will not fund Keytruda (pembrolizumab), Merck’s second-line advanced bladder cancer drug. Source: Drug Industry Daily
Read MoreU.S. Will Send 4 Million AstraZeneca Vaccine Doses to Canada and Mexico
In a marked change in policy, the U.S. will send an estimated 4 million doses of AstraZeneca (AZ)/Oxford University’s COVID-19 vaccine to Canada and Mexico, according to a White House press briefing yesterday. Source: Drug Industry Daily
Read MoreOND Managed a Slew of EUAs, a Reorg, PDUFA Goals and Regular Business During Pandemic, Says Annual Report
Despite the unprecedented disruption and shift in priorities that COVID-19 brought to FDA’s Office of New Drugs (OND) in 2020, the office approved 53 novel drugs, published 31 new guidances and wrapped up the reorganization it had been working on since 2019, said Peter Stein, OND’s director, in the office’s annual report. Source: Drug Industry…
Read MoreFDA’s Peter Marks Testifies About Updating Vaccines to Address COVID-19 Variants
Top U.S. health officials, including an FDA regulator testified on Capitol Hill this week that real-world evidence from people vaccinated against COVID-19 and data from ongoing trials will be used to decide how vaccines should be updated to handle variant strains. Source: Drug Industry Daily
Read MoreSenate Confirms Xavier Becerra as HHS Secretary
The Senate confirmed Xavier Becerra as HHS secretary yesterday in a narrow 50-49 vote, with just one Republican siding with Democrats to support his confirmation and the closest vote so far for any of President Biden’s Cabinet nominations. Source: Drug Industry Daily
Read MoreEMA’s Blood Clot Investigation Finds AstraZeneca’s COVID-19 Vaccine Still Safe and Effective
The European Medicines Agency (EMA) has concluded its evaluation of a small number of blood-clot cases in patients vaccinated with AstraZeneca’s (AZ) COVID-19 vaccine, finding the two-shot inoculation is still safe and effective, though it could be associated with low levels of blood platelets in very rare instances. Source: Drug Industry Daily
Read MoreReport: CDER is Meeting User Fee Goals but Struggling With Biosimilar Application Targets
The FDA approved 17 original abbreviated new drug applications (ANDAs) in the third quarter of fiscal 2020, 14 in the fourth quarter and 18 in the first quarter of fiscal 2021. It’s seen a downward trend in manufacturing supplements for new drug applications (NDAs), biologics license applications (BLAs) and ANDAs, approving 314 in the third…
Read MoreTGA Issues Guidance on Clinical Decision Support Software
Beginning Feb. 25, the way that software-based medical devices are regulated in Australia will change, and clinical decision support software (CDSS) that meets the definition of a medical device must be included in the Australian Register of Therapeutic Goods. Source: The GMP Letter
Read MoreNew MDR Notified Body Designated in Finland
SGS FIMKO Oy, a Helsinki-based subsidiary of the certification giant SGS, became the 18th notified body to be designated to provide product certifications under the European Medical Device Regulation (MDR). Source: The GMP Letter
Read MoreEC Details How Legacy Devices Will Be Managed in Eudamed
The European Commission released new guidance explaining how Legacy Devices will be identified in the Eudamed database and how their unique device identifiers will be generated and assigned. Source: The GMP Letter
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