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Results of a Merck/Moderna collaboration are the first evidence of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial, according to the companies. Read More
An FDA inspection of Consolidated Chemical’s St. Louis, Mo., drug manufacturing facility from July 25 to Aug. 2 resulted in a Form 483 citing water leaks, lack of water testing, poor building condition and other lapses. Read More
Two potentially first-in-class small molecule oral agents induced complete remission in nearly 30 percent of patients with genetically induced leukemias generally associated with very poor prognoses, according to reports from the American Society of Hematology (ASH) Annual Meeting in New Orleans. Read More
In the biggest pharmaceutical purchase announced this year, Amgen has inked a $28 billion deal with Horizon Therapeutics, gaining access to one blockbuster eye drug and two others that are future revenue-drivers. Read More
For the Moderna option, children between six months and five years old can receive a single bivalent booster dose two months after completing the primary series. Read More
Manufacturers of parenteral nutrition (PN) products should determine the amount of aluminum in small-volume parenterals (SVP) as well as large-volume parenterals (LVP) to ensure PN products do not exceed the recommended daily limit, according to a new FDA draft guidance that clarifies key factors in determining the aluminum content in SVPs. Read More