The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
AbbVie and Allergan have each received a second request for additional information from the US Federal Trade Commission (FTC) in connection with AbbVie’s pending $63-billion acquisition of Allergan, which was announced earlier this year (June...
A roundup of developments and latest news from Canada (Health Canada), Germany (Merz and Oncotec), India (Lupin) and the US (Darmerica).
Canada
Health Canada Requests Companies Stop Ranitidine Distribution for NDMA Assessment
Health Canada, the...
The US Food and Drug Administration (FDA) has released a suite of guidances to continue to encourage innovative approaches to the development of digital health tools and to advance the agency’s approach to overseeing these technologies along with...
Novo Nordisk gets FDA approval for an oral form of semaglutide, a drug to treat Type II diabetes, and Biogen and Eisai have late-stage setback for Alzheimer’s drug.
Novo Nordisk Receives FDA Approval for Oral Form of Diabetes Drug
The FDA has...
GlaxoSmithKline (GSK) is investing $120 million to expand its manufacturing facility in Upper Merion, Pennsylvania to support the delivery of the company’s pipeline for cancer medicines and other specialty diseases.
GSK says the new...
The US House of Representatives Speaker Nancy Pelosi (D-Calif.) has introduced a proposed drug pricing plan (H.R.3, The Lower Drug Costs Now Act) to address the cost of prescription drugs. The proposed legislation would establish a fair price...
Boehringer Ingelheim (BI) and Inflammasome Therapeutics, a developer of therapies for degenerative diseases, have entered into a co-development and license agreement to develop up to three therapies for patients with retinal diseases. The pact...
Sandoz, the generics arm of Novartis, and Torrent Pharmaceuticals, an Ahmedabad, India-based pharmaceutical company, have made voluntary recalls of certain products, respectively ranitidine and losartan, for containing certain nitrosamine...
US Senator Amy Klobuchar (D-MN), Ranking Member of the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, and eight other senators, have sent a letter to US Federal Trade Commission (FTC) Chairman Joseph Simons...
Sanofi and Novo Nordisk are partnering in separate deals for insulin delivery. Sanofi and Abbott are partnering to integrate glucose sensing and insulin-delivery technologies. Novo Nordisk and Medtronic are collaborating to integrate insulin-dosing...
The US Food and Drug Administration (FDA) has issued a final guidance, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act, to outline the issues that the agency will consider in...
H. Lundbeck, a Valby, Denmark-based pharmaceutical company, has agreed to acquire Alder Biopharmaceuticals, a Bothell, Washington-based clinical-stage biopharmaceutical company developing therapeutic antibodies for treating migraines, in a deal...
As part of its investigation of nitrosamine impurities in certain active pharmaceutical ingredients (APIs), the European Medicines Agency’s (EMA) Executive Director Guido Rasi has asked the EMA’s Committee for Medicinal Products for Human Use...
The US Food and Drug Administration (FDA) reports that it has found that some medicines with the active pharmaceutical ingredient (API), ranitidine, contain a nitrosamine impurity, N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as...
Purdue Pharma has reached an agreement of more than $10 billion for settling opioid litigation. The agreement covers litigation facing the company with 24 state attorneys general, analogous officials from five US territories, and plaintiffs’...
