The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
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The US Food and Drug Administration (FDA) has issued draft guidance and outlined future guidances to improve the so-called Orange Book, officially known as the Approved Drug Products with Therapeutic Equivalence Evaluations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...
Immunomedics, a Morris Plains, New Jersey-based clinical-stage biopharmaceutical company with a focus on antibody-drug conjugates (ADCs), has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for manufacturing...
GlaxoSmithKline (GSK) has initiated a succession plan for a new chairman following the announcement by its current chairman, Philip Hampton, of his intention to step down as non-executive Chairman. Philip was appointed to the company’s Board of...
GlaxoSmithKline (GSK) has completed its $5.1-billion acquisition of Tesaro, an oncology-focused company based in Waltham, Massachusetts. The deal was announced in December 2018.
Tesaro is a commercial-stage biopharmaceutical company, with a...
Genentech, a member of the Roche Group, has appointed Alexander Hardy, currently Head of Global Product Strategy, as chief executive officer (CEO), effective March 1, 2019. He succeeds Bill Anderson, who was recently appointed CEO, Roche...
Recalls of “sartan”-containing drugs continues with Torrent Pharmaceuticals, an Ahmedabad, India-based pharmaceutical company, expanding its voluntary recall of select lots of losartan potassium tablets, and Prinston Pharmaceutical, a Cranbury, New...
