The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
As part of the implementation of the European Union’s Falsified Medicines Directive, the European Medicines Agency (EMA) has highlighted that most prescription medicines and some over-the-counter medicines supplied in the European Union (EU) are...
The European Medicines Agency (EMA) has announced that companies that make “sartan” blood-pressure medicines (also known as angiotensin II receptor blockers) are now required to review their manufacturing processes so that they do not produce...
Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has formed a worldwide collaboration and license agreement, worth up to $440 million, with MeiraGTx, a New York- and London-based clinical stage...
Merck KGaA has announced a $70-million investment to expand its research and development (R&D) facility in Billerica, Massachusetts. The new building will span 145,000 square feet and provide new laboratory and collaborative working space to...
Celgene and Triphase Accelerator, a Toronto based oncology-focused drug-development company, together with FACIT, Triphase’s majority shareholder and a collaboration partner for research companies and investors, have formed a strategic...
GlaxoSmithKline (GSK) and Merck KGaA have entered into a global strategic alliance, worth up to $4.2 billion, to jointly develop and commercialize M7824 (bintrafusp alfa), an investigational bifunctional fusion protein immunotherapy for treating...
Pfizer has formed a manufacturing pact with Medochemie, a Limassol, Cyprus-based generics pharmaceutical and consumer healthcare company, under which Medochemie will be manufacturing select Pfizer medicines in Vietnam. The companies announced the...
AstraZeneca plans to close two biomanufacturing plants in Colorado, one in Boulder and another in Longmont, due to what the company said is part of a global restructuring to streamline its biologics production and improve the efficiency of its...
Pfizer is ending manufacturing at two injectable manufacturing plants in India, one in Irungattukottai (IKKT) and another in Aurangabad, due to what the company says is a decline in demand for products manufactured at the plants. Pfizer had...
The US Food and Drug Administration (FDA) has approved the first generic of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder), a respiratory drug and one of the company’s top-selling drugs (Advair/Seretide)...
The US Food and Drug Administration (FDA) has issued draft guidance and outlined future guidances to improve the so-called Orange Book, officially known as the Approved Drug Products with Therapeutic Equivalence Evaluations Publication, which...
The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said that the agency plans to advance policies, including the issuance of guidances, to promote drug competition and patient access for complex generic drugs. These are drugs...
Purdue Pharma and Alivio Therapeutics, a Boston-based pharmaceutical company focused on targeted disease immunomodulation for treating chronic and acute inflammatory disorders, have formed a $275-million pact ($14.75 million upfront and $260...
Neurocrine Biosciences, a San Diego, California-based pharmaceutical company developing small molecules for treating neurological and endocrine-related disorders, and Voyager Therapeutics, a Cambridge, Massachusetts company developing gene...
Amid the continuing uncertainty regarding a plan for the UK to withdraw from the European Union (EU) (i.e., Brexit), the European Medicines Agency (EMA) is proceeding with its previously announced plans to relocate from its current headquarters in...
