The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
The US Department of Justice (DOJ) and the US Drug Enforcement Administration (DEA) have proposed a reduction for controlled substances that may be manufactured in the US in 2019. The proposal decreases manufacturing quotas for six opioids for 2019...
Catalent has completed its previously announced acquisition of Juniper Pharmaceuticals, a Boston, Massachusetts-headquartered specialty pharmaceutical company with contract development and manufacturing services, for $133 million. The companies...
Astellas Pharma has acquired Quethera, a Cambridge, UK-headquartered gene-therapy company focused on developing treatments for ocular disorders, such as glaucoma, in a deal worth up to £85 million ($108 million).
Through this transaction, Astellas...
Emergent BioSolutions, a Rockville, Maryland-based specialty biopharmaceutical company and contract manufacturer, has agreed to acquire PaxVax, a Redwood City, California-based company focused on specialty vaccines for existing and emerging...
Mylan has formed a strategic review committee to evaluate alternatives for its businesses following weak second-quarter performance in its North American segment. Mylan says the profile of the company has changed over the last several years by...
Perrigo has announced plans to separate the company's prescription pharmaceuticals (Rx) business following a strategic portfolio review. The move follows continuing weak performance in the company’s Rx business, which accounted for approximately...
ANI Pharmaceuticals, a Baudette, Minnesota-headquartered specialty pharmaceutical company, has acquired WellSpring Pharma Services, an Oakville, Canada-headquartered contract development and manufacturing organization (CDMO) of drug products, for...
Pfizer has formed a deal with Antares Pharma, an Ewing, New Jersey-based pharmaceutical company, to develop a combination drug-device rescue pen. This rescue pen will use the Antares QuickShot auto injector and an undisclosed Pfizer...
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, and bluebird bio, a Cambridge, Massachusetts-based clinical-stage gene-therapy company, have partnered to apply their technology platforms to the discovery,...
The US Food and Drug Administration (FDA) has approved the first generic drugs to receive a competitive generic therapy (CGT) designation. This new approval pathway by the FDA was created to expedite the development and review of a generic drug for...
The European Commission (EC) has approved Pfizer’s Trazimera (trastuzumab), a biosimilar to Roche’s Herceptin (trastuzumab), for treating certain types of breast and gastric cancers. Herceptin had global 2017 sales of CHF 7.01 billion ($7.5...
The European Medicines Agency (EMA) has announced it is expecting a 30% loss in staff as it prepares to move its headquarters to Amsterdam, the Netherlands, a move it is making as part of its preparations for the United Kingdom's (UK) withdrawal...
Bayer has agreed to sell its global prescription dermatology unit to LEO Pharma, a Ballerup, Denmark-headquartered specialist in dermatology care. The portfolio to be acquired includes branded topical prescription treatments for acne, fungal skin...
The US Food and Drug Administration (FDA) has awarded a total of $6 million to three universities to study and recommend improvements for continuous manufacturing for drug substances and drug products. The awardees are Rutgers University, The...
Amgen has broken ground for a new biomanufacturing plant that will be constructed at its West Greenwich, Rhode Island campus. The new plant, worth up to $200 million, will manufacture products for the US and global markets.
Amgen has labeled the...
