The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
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...
Sun Pharmaceutical Industries and Lupin Pharmaceuticals have issued separate voluntary recalls for select products due to particulate matter in vials.
Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical...
Allergan has announced it will establish a research and development (R&D) site in Cambridge, Massachusetts.The site will be led by Don Frail, PhD, Senior Vice President of Research and External Scientific Innovation (RESI) and Non-Clinical and...
AstraZeneca has announced a reorganization of its research and development (R&D) and commercial units and has changed some of its executive management for those areas.
Under the new structure, AstraZeneca will form two R&D units: one...
Torrent Pharmaceuticals, an India-based pharmaceutical company, is expanding its voluntary recall from two lots of losartan potassium tablets USP to a total of 10 lots to the consumer level due to the detection of trace amounts of an...
Akorn, a specialty generic pharmaceutical company, reports that it has received a Warning Letter, dated January 4, 2019, from the US Food and Drug Administration (FDA) related to an inspection of its Decatur, Illinois manufacturing facility in...
Novartis has made an offer to acquire CellforCure, a contract development and manufacturing organization (CDMO) producing cell and gene therapies in Europe, from LFB, a French pharmaceutical company. The announcement was made December 20,...
Fujifilm Cellular Dynamics, Inc. (FCDI), a US subsidiary of Fujifilm Corporation and a developer and manufacturer of human induced pluripotent stem (iPS) cell technologies, has announced an investment of about $21 million to open a new...
Eli Lilly and Company has agreed to acquire Loxo Oncology, a Stamford, Connecticut-based biopharmaceutical company, for $235.00 per share in cash, or approximately $8.0 billion. Loxo Oncology is focused on the development and commercialization of...
Aurobindo Pharma USA, Inc., the US-based operations of Aurobindo Pharma, a Hyderabad, India-headquartered generics and active pharmaceutical ingredient manufacturer, is conducting a voluntary recall of 80 lots of amlodipine valsartan tablets USP,...
