Archive for December 2022

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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large-volume parenterals (LVP) to ensure PN products do not exceed the recommended daily limit, according to a new FDA draft guidance that clarifies key factors in determining the aluminum content in SVPs. Source: Drug Industry Daily

The FDA issued a 10-observation Form 483 to Aurobindo’s Telangana, India, plant after a November visit, outlining several violations of current good manufacturing practices (cGMP). Source: Drug Industry Daily

Four years into a multidistrict class action lawsuit, a federal court judge has dismissed 1,189 of the 2,000 lawsuits charging that Merck’s Zostavax shingles vaccine caused either the disease or shingles-related injuries. Source: Drug Industry Daily

FDA Commissioner Robert Califf predicts the agency’s largest area of expansion over the next five years will be in the regulatory apparatus for reviewing cell, regenerative and gene therapies. Source: Drug Industry Daily

The FDA plans to prioritize its enforcement and regulatory actions against specific homeopathic drug categories that pose a significant risk to public health, the agency said in a final guidance. Source: Drug Industry Daily

The FDA rapped independent testing lab Valisure in an untitled letter for violating the Drug Supply Chain Security Act (DSCSA) and for “methodological deficiencies” in its testing protocols, disputing the company’s claims that its pharmacy business was not subject to FDA regulation. Source: Drug Industry Daily

The FDA has added a Sun Pharmaceutical facility in Gujarat, India, to an import alert following an agency inspection, but is exempting 14 products to avoid potential shortages. Source: Drug Industry Daily

The FDA has issued two proposed rules on investigational new drug applications (IND) that would require more detailed IND reports and exemptions for clinical trials for drug uses of a food, dietary supplement or cosmetic product. Source: Drug Industry Daily