Merck’s Oral Pill for HIV Shows Efficacy in Two Trials
Merck’s investigational once-daily combination pill for HIV has shown positive results in two late-stage trials. Source: Drug Industry Daily
Novartis’ Canakinumab Just Can’t Get the Magic Back
For the second time, Novartis’ workhorse anti-inflammatory, Ilaris (canakinumab), has failed to prove its mettle as an anti-cancer agent. Source: Drug Industry Daily
AstraZeneca Continues Its Hit Parade With Yet Another Imfinzi Win
AstraZeneca has scored another win with Imfinzi (durvalumab), showing that the checkpoint inhibitor in combination with standard chemotherapy improved both overall and progression-free survival for patients with advanced biliary tract…
Report: 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…
EMA’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…
Senate 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…
FDA’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…
OND 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…
U.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…
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