Archive for December 2022

Centrient Pharmaceuticals’ active pharmaceutical ingredient (API) facility in Punjab, India, received a warning letter from the FDA for multiple deficiencies including lax records, test validations and inadequate contaminant controls. Source: Drug Industry Daily

The FDA says a single, well-controlled trial may be used to support a drug candidate for treatment of pulmonary tuberculosis (TB) if additional confirmatory evidence is available, in a revised draft guidance released yesterday. Source: Drug Industry Daily

The Biden Administration will seek a change in the coverage of generic medicines in plans offered through the Affordable Care Act (ACA) marketplace, according to a notice issued by HHS. Source: Drug Industry Daily

As Congress continues to look for new ways to lower the cost of insulin, states are taking matters into their own hands. Source: Drug Industry Daily

Cytokinetics’ omecamtiv mecarbil received an 8-3 thumbs-down from the FDA’s Cardiovascular and Renal Drugs Advisory Committee, with the majority agreeing that the risks of the myosin activator outweigh its benefits for treating patients with heart failure and reduced ejection fraction. Source: Drug Industry Daily

The landmark Inflation Reduction Act (IRA) passed in August means good news for seniors who need insulin, but diabetics under age 65 are still waiting for relief as legislators, regulators and industry all work toward lowering the price of the life-sustaining drug. Source: Drug Industry Daily

Japan’s Takeda is acquiring Nimbus Therapeutics subsidiary Nimbus Lakshmi and its tyrosine kinase 2 (TYK2) inhibitor NDI-034858 in a deal worth up to $6 billion. Source: Drug Industry Daily

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. Source: Drug Industry Daily

An “untitled” letter from the FDA requires the same level of response as a warning letter, says one former FDA compliance director. Source: Drug Industry Daily

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. Source: Drug Industry Daily