A former FDA inspector accused the agency of downplaying safety problems at a Merck plant tapped to manufacture Johnson & Johnson’s COVID-19 vaccine. The whistleblower alleged that a 2018 inspection uncovered evidence that employees in the facility in Durham, N.C.engaged in a host of unsanitary practices. A letter to President Biden from the U.S. Office […]
Merck
Merck spinoff Organon to acquire Alydia Health for up to $240M
Merck (NYSE: MRK) announced today that it entered into an agreement for its spinoff Organon to acquire Alydia Health for up to $240 million. Alydia Health develops treatments focusing on preventing maternal morbidity and mortality caused by postpartum hemorrhage (PPH) or abnormal postpartum uterine bleeding, according to a news release. The company develops the Jada […]
Report: Biden to buy 100M additional doses of J&J COVID-19 vaccine
President Joe Biden is reportedly set to announce plans to purchase an additional 100 million doses of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine. An NBC News report said that Biden is set to announce the purchase of the single-dose vaccines on Wednesday, according to two officials from his administration. Get the full story at our sister site, Drug Discovery […]
Merck moving to Phase 2 study of drug-eluting implant to prevent HIV infection
Merck (NYSE:MRK) today announced positive results from a Phase 1 study of its subdermal drug-eluting implant for preventing HIV-1 infection. The investigational implant has the potential for extended administration of islatravir for pre-exposure prophylaxis (PrEP) of HIV-1 infection, according to a news release. Get the full story at our sister site, Drug Delivery Business News.
Report: Biden to announce partnership for Merck to make J&J’s COVID-19 vaccine
President Joe Biden is reportedly set to announce a partnership in which Merck (NYSE:MRK) will make Johnson & Johnson’s (NYSE:JNJ) recently approved COVID-19 vaccine. The Washington Post reported that the agreement between the two competitors will boost the supply of the single-dose vaccine from J&J’s Janssen subsidiary, which received FDA emergency use authorization last week. Get the full story at […]
Drug companies agree not to release COVID-19 vaccine until it’s ready
Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine. The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” […]
The most innovative pharmaceutical agents of 2020
The Galien Foundation recently announced nominees for most innovative pharmaceutical agents for its 14th Annual Prix Galien USA Awards. The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical, pharmaceutical drugs and medical technology products that are designed to improve the human condition. “As we celebrate 50 years of the Prix Galien process, […]
MedTech 100 roundup: Another rebound as markets continue to fluctuate
Medtech stocks rebounded from a significant dip earlier in June last week, continuing to highlight the topsy-turvy nature of the markets during the COVID-19 pandemic. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 85.00 points at the end of last week (June 19). That total represents […]
Merck acquires Themis to speed COVID-19 vaccine development
Merck (NYSE:MRK) announced today that it completed the acquisition of vaccine and immune-modulation therapy developer Themis for an undisclosed amount. In connection with the acquisition, the U.S. Federal Trade Commission granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, while Merck gained merger control from the Austrian Federal Competition Authority, […]
Merck eyes tiny patches as a vaccine delivery method
Merck has exercised its option to use Vaxxas‘ High Density Microarray Patch (HD-MAP) platform as a delivery platform for a vaccine candidate, the companies announced today. The companies did not disclose what the vaccine candidate is supposed to treat. But Merck this month announced two COVID-19 vaccine development efforts: a collaboration with IAVI and plans […]
RefleXion, Merck team up on late-stage cancer study
RefleXion announced today that it entered into a clinical collaboration with Merck to evaluate Merck’s (NYSE:MRK) Keytruda anti-PD-1 therapy in clinical trials. Hayward, Calif.-based therapeutic oncology company RefleXion is joining forces with Merck to evaluate Keytruda’s safety and efficacy in combination with RefleXion’s biology-guided radiotherapy (BgRT) in multiple late-stage cancers, including non-small cell lung cancer, in […]