Genentech filed a lawsuit aiming to stop Pfizer’s proposed Herceptin biosimilar from reaching the market — asking the court to compensate for losses in sales should the copy launch before…

The European Medicines Agency adopted a guideline for sponsors developing new products for autism spectrum disorder, providing recommendations on diagnostic criteria, target populations and clinical trial design. Source: Drug Industry…

The FDA finalized guidance for manufacturers looking to produce generic versions of opioid painkillers with abuse-deterrent labeling, as a part of the agency’s push to lower overall exposure to opioids…

The FDA cited a Chinese medical instrument company for problems in the manufacturing of drugs included in its production. Source: Drug Industry Daily

New York’s attorney general indicted a pharmacy owner, pharmacist and three pharmacies for defrauding Medicaid of $3 million in reimbursements for drugs that were never dispensed. Source: Drug Industry Daily

The European Medicines Agency adopted the fifth revision of its substantive guideline covering all stages of oncology drug development, expanding upon the previous version’s section on safety data. Source: Drug…

The European Union landed on Amsterdam as the new home for the European Medicines Agency headquarters, following three rounds of voting and a tiebreaker against Milan. The agency hopes to…

A worker at an Idaho compounding pharmacy used “a worn plastic store club card” to scoop a powdered drug into empty gelatin capsules, in violation of federal regulations, the FDA…

A newly unsealed lawsuit filed this summer alleged Eli Lilly ran an illegal kickback operation with two healthcare marketing firms. Source: Drug Industry Daily

A federal judge refused to dismiss a false advertising lawsuit filed by Allergan against drug compounder Imprimis Pharmaceuticals concerning its dry-eye drug Klarity, meant to compete with Allergan’s Restasis. Source:…