The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
ScieGen Pharmaceuticals, a Hauppauge, New York-based generic pharmaceutical company, is voluntarily recalling in the US lots of its irbesartan tablets (USP 75 mg, 150 mg, and 300 mg), an anti-hypertension drug, to the consumer level. The recall is...
Sandoz, the generics arm of Novartis, has decided to not pursue its submission for a biosimilar to Roche’s Rituxan (rituximab) in the US at this time. The decision follows a request by the US Food and Drug Administration (FDA) for additional...
Following previously announced plans to restructure its R&D organization, Novo Nordisk has announced that a number of additional restructuring initiatives across functions and geographies have been initiated to support the commercial activities...
Astellas Pharma has announced the construction of new research, development, and manufacturing facilities for biologic-based modalities, including antibodies and cell therapies, in Japan and Massachusetts. The facilities will produce clinical trial...
AstraZeneca, and its global biologics research and development arm MedImmune, have formed a new multi-term agreement with Innate Pharma, a Marseille, France-based biopharmaceutical company, to build on an existing collaboration that adds to...
AstraZeneca has agreed to divest its rights in Europe to its gastroesophageal reflux disease drug, Nexium (esomeprazole), and its global rights (excluding the US and Japan) for its anti-inflammatory drug, Vimovo (naproxen/esomeprazole), to...
Gilead Sciences and Tango Therapeutics, a Cambridge, Massachusetts-based company developing cancer therapies, have partnered to discover, develop, and commercialize a pipeline of targeted immuno-oncology treatments, in a deal worth up to $1.7...
Eli Lilly and Company and Dicerna Pharmaceuticals, a Cambridge, Massachusetts-based biopharmaceutical company, have signed a multi-million-dollar pact to develop potential new medicines in the areas of cardio-metabolic disease, neurodegeneration,...
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals, a Tarrytown, New York pharmaceutical company, regarding manufacturing issues relating to a prefilled syringe form of Eylea...
Johnson & Johnson (J&J) has opened a new vaccines launch facility in Leiden, the Netherlands. The facility uses technological and manufacturing platforms that can support large-scale production of vaccines for late-stage (Phase III)...
Aspen Pharmacare, a KwaZulu-Natal, South Africa-headquartered pharmaceutical company, is planning an additional 3.4 billion rand ($235 million) capital investment at its Port Elizabeth, South Africa-based manufacturing site for sterile...
The European Medicines Agency (EMA) is evaluating four more “sartan” active pharmaceutical ingredients (APIs) in hypertension medicines marketed in the EU in addition to its ongoing investigation into impurities found in products containing the...
Glenmark Pharmaceuticals, a Mumbai, India-headquartered pharmaceutical company, plans to open its first US manufacturing facility in Monroe, North Carolina on October 30, 2018.
The Monroe, North Carolina facility is Glenmark’s first manufacturing...
GlaxoSmithKline (GSK) has opened a £54-million ($69-million) active pharmaceutical ingredient (API) production building at its site in Montrose, Scotland for respiratory inhalers.
APIs for use in GSK’s Ellipta (fluticasone furoate/vilanterol)...
As part of Pfizer’s previously announced reorganization, the company plans to reduce its global headcount by around 2% through voluntary retirements and staff reductions this year (2018) and in early 2019. Pfizer says the move is expected to...
