The FDA issued a warning letter to API manufacturer Megafine Pharma, citing data integrity violations and GMP issues. Source: Drug Industry Daily

Morton Grove Pharmaceuticals, a subsidiary of Wockhardt, received a warning letter from the FDA listing GMP compliance issues at its Illinois facility, including insufficient investigations into product instability. Source: Drug…

Two senior Democratic congressmen met with President Donald Trump and discussed a bill granting Medicare the ability to negotiate drug prices, which they plan to introduce in the House within…

The FDA released updated guidelines for its Controlled Substances Staff and outlined their role and responsibilities in the review process. Source: Drug Industry Daily

Australia’s Therapeutic Goods Administration increased first-time inspections of drug manufacturing facilities by 16 percent in the second half of 2016, compared to the same period a year earlier, according to…

South Korea has temporarily banned several drugs produced by Novartis and fined the company nearly $175,000 over kickbacks. Source: Drug Industry Daily

President Trump said he is working on “a new system” that will lower drug prices for patients and boost competition in the industry. Source: Drug Industry Daily

CDER plans to start using a new informatics platform for new drug approvals in October, following the processes already in place for generic drug reviews, says CDER Director Janet Woodcock.…

The FDA has asked Scynexis to hold new clinical studies of an intravenous formulation of its antifungal treatment, SCY-078, until the agency can review available pre-clinical and clinical data. Source:…

A UK patent court invalidated two of AbbVie’s Humira patents — clearing a major barrier for drugmakers seeking EU approvals for biosimilar versions of the blockbuster arthritis treatment. Source: Drug…