The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
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...
Novartis’ Sandoz, Mylan, Amgen, and Samsung Bioepis have launched in the European Union (EU) biosimilars to AbbVie’s Humira (adalimumab), an anti-inflammatory drug and AbbVie’s top-selling drug with global 2017 sales of $18.43 billion. The four...
Novartis has agreed to acquire Endocyte, a West Lafayette, Indiana-based biopharmaceutical company developing targeted therapeutics for cancer treatment, for $24 per share, or a total equity value of approximately $2.1 billion, in cash. The...
Merck KGaA has opened a new EUR 63-million ($72-million) packaging center at its headquarters in Darmstadt, Germany.
The new 15,000-square-meter facility will be dedicated to packaging and shipping the company’s current portfolio of medicines to...
Merck & Co. plans to build a second biomanufacturing manufacturing facility at its site in Carlow, Ireland that will focus on producing vaccines and biologics. It will also expand warehouse and laboratory services at the site.
The facility...
Shire has opened its more-than-$1-billion plasma manufacturing plant near Covington, Georgia.
The more than one-million-square-foot facility will add approximately 30% capacity to Shire’s internal plasma manufacturing network once fully...
As part of the US Food and Drug Administration’s (FDA) efforts to promote drug competition and patient access, the agency has issued two draft guidances to advance the development of complex generic drugs. Complex generics are drugs that, by nature...
Roche has partnered with Ionis Pharmaceuticals, a Carlsbad, California-based pharmaceutical company, to develop Ionis’ antisense drug candidate for treating complement-mediated diseases, in a deal worth up to $760 million.
The collaboration will...
