A Chicago jury has ruled that Endo Pharmaceuticals didn’t violate antitrust laws by paying Impax $112 million to delay the release of a generic that would compete against Opana ER,…
AstraZeneca is buying TBio subsidiary TeneoTwo, which will shore up its hematology pipeline with TeneoTwo’s candidate for relapsed and refractory B-cell non-Hodgkin lymphoma. Source: Drug Industry Daily
Faced with a barrage of pleas from both clinicians and patients, the FDA will hold a second expert panel hearing on Amylyx’s AMX0035, a drug intended to treat amyotrophic lateral…
Three big drug U.S. distributors accused of fueling the opioid crisis in West Virginia’s Cabell County and the city of Huntington were let off on Monday as a U.S. District…
To help clear up confusion about the Drug Supply Chain Security Act (DSCSA) enhanced drug distribution security requirements that will go into effect on Nov. 27, 2023, the FDA has…
FDA approval alone does not ensure “the optimal administration” of novel treatments like immunotherapy for traditionally underserved populations, according to the authors of a study published in JAMA Network Open.…
The FDA issued I3 Pharmaceuticals a Form 483 for multiple quality deficiencies observed during an inspection of its Warminster, Pa., facility from Feb. 7 to Feb. 22. Source: Drug Industry…
The pharmaceutical industry spends more on lobbying than any other industry, having shelled out $314 million across about 1,600 lobbyists in 2021, spending almost three times the amount of the…
In a move that may bode ill for the entire class of phosphatidylinositol 3-kinase (PI3K) inhibitors, the FDA has issued a warning against Secura Bio’s Copiktra (duvelisib), citing a 9…
Pfizer is jockeying for full FDA approval of its oral antiviral COVID-19 treatment, Paxlovid, which would allow the company to sell the drug commercially. Source: Drug Industry Daily