Trodelvy Hits Key Secondary Endpoint in Breast Cancer Trial
Once again, Gilead Sciences is touting a Trodelvy (sacituzumab govitecan-hziy) win in patients with HR+/HER2- metastatic breast cancer. Source: Drug Industry Daily
Novartis Calls Third Strike for Ilaris in Lung Cancer
Novartis has a third strike-out in a series of trials pitting its anti-inflammatory drug Ilaris (canakinumab) against nonmetastatic non-small cell lung cancer (NSCLC). Source: Drug Industry Daily
Enhertu Sees More Success With Another Phase 3 Trial Win in Breast Cancer
Partners Daiichi Sankyo and AstraZeneca said a phase 3 trial of Enhertu (trastuzumab deruxtecan) to treat HER2-positive metastatic breast cancer met its primary and secondary endpoints, with the expected blockbuster…
Illinois Tool Works Given a Form 483 for Old and New Issues
The FDA handed Illinois Tool Works’ drug manufacturing facility in Olathe, Kan., a six-observation Form 483 citing several repeated quality lapses following an inspection from March 28 to April 1.…
Brainstorm Counting on New Subanalysis for ALS Treatment
Brainstorm Cell Therapeutics is counting on a corrected subanalysis of a phase 3 trial to change the FDA’s mind about NurOwn, an unusual investigational treatment for amyotrophic lateral sclerosis (ALS).…
House Passes Landmark Bill Allowing U.S. to Negotiate Drug Prices for Medicare
After years of trying to pass legislation that would allow the U.S. government to negotiate with drugmakers on prescription drug prices for the Medicare program, the Democrat-controlled U.S. House of…
Monkeypox Vaccine Data Don’t Support FDA Administration Recommendations, Maker Says
Bavarian Nordic is chiding the FDA after the agency recommended intradermal (ID) administration of Jynneos, the company’s monkeypox vaccine, in its Aug. 11 Emergency Use Authorization (EUA). Source: Drug Industry…
Risk Information in Promotional Tweets Better than Links, FDA Study Shows
A new FDA study of character-space-limited (CSL) communications to promote prescription drugs showed that patients understood a drug’s risk better when the risk was included in an initial tweet rather…
135 Million More Emergent COVID-19 Vaccine Doses Must be Trashed, Say Lawmakers
New evidence shows that an additional 135 million COVID-19 vaccine doses manufactured at the troubled Emergent BioSolutions’ Bayview, Md., facility will need to be destroyed following the discovery of quality…
Catalent to Acquire CDMO Metrics Contract Services for $475 Million
Catalent announced that it will shell out $475 million to acquire Metrics Contract Services, a specialty contract development and manufacturing organization (CDMO) with a 333,000 square-foot facility in Greenville. Source:…
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