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Three Democratic representatives from the House Committee on Oversight and Reform sent a letter to the Treasury Department and the Department of Justice (DOJ) Monday, expressing their alarm at certain companies claiming tax benefits from their opioid settlement expenses. Read More
Nektar Therapeutics’ experimental immunotherapy bempegaldesleukin paired with Bristol Myers Squibb’s (BMS) blockbuster checkpoint inhibitor, Opdivo (nivolumab), did not shrink tumors, slow the growth of tumors or prolong survival rates for metastatic melanoma patients in a phase 3 trial in which the combo was compared to Opdivo alone. Read More
Agropharma Laboratories of Salinas, Puerto Rico, has received a three-observation Form 483 citing issues with laboratory controls, cleanliness of the facility and quality control. Read More
An FDA investigator observed that Belport, a drugmaker in Camarillo, Calif., doing business as Gingi-Pak, didn’t conduct microbiological testing of the water used to manufacture its drug products, among other quality lapses noted during a Nov. 8 to 12, 2021, inspection of its facility. Read More
Despite the fact that many states have lifted their mask mandates and the last surge of a COVID-19 variant of concern peaked several weeks ago, we are nowhere near public health officials announcing the end of the public health emergency, according to epidemiologists who track COVID-19. Read More
AbbVie’s Qulipta (atogepant), already approved for prevention of episodic migraine, has released new phase 3 data that also support its preventive effect for chronic migraine. Read More
Armed with positive phase 3 data, Venatorx Pharmaceuticals will ask regulators to approve its investigational combination antibiotic, cefepime-taniborbactam, as a treatment for complicated urinary tract infections (cUTI) in adults. Read More
“The evidence shows antibiotics are not needed by most children and young people with middle ear infections,” said Paul Chrisp, director of NICE’s Center for Guidelines. Read More