The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Eli Lilly and Company and AC Immune SA, a Lausanne, Switzerland-based biopharmaceutical company, have formed an agreement to research and develop tau aggregation inhibitor small molecules for the potential treatment of Alzheimer's disease (AD) and...
Akorn, a Lake Forest, Illinois-headquartered specialty generic pharmaceutical company, has announced it will move forward as an independent company following a decision from the Supreme Court of the State of Delaware to allow Fresenius Kabi AG, a...
The US Food and Drug Administration (FDA) has released two guidances, one final and one draft, to advancie the agency’s biosimilars policy framework. The guidances describe the agency’s plan to implement Congress’ direction that the FDA transition...
Gilead Sciences has appointed Daniel O’Day, currently Chief Executive Officer (CEO) of Roche Pharmaceuticals, as Chairman of the Board of Directors and CEO of Gilead, effective March 1, 2019. John C. Martin, current Chairman, Gilead Sciences’ Board...
The US Food and Drug Administration (FDA) is withdrawing a proposed rule from 2013 that, if finalized, would have allowed generic drug makers to independently—meaning, without prior FDA review and approval—update and promptly distribute new safety...
The US Food and Drug Administration (FDA) has issued final guidance, Data Integrity and Compliance With Drug CGMP, which updates a 2016 guidance for ensuring data integrity and compliance with current good manufacturing practice (CGMP), in response...
Boehringer Ingelheim (BI) has announced staff reductions in France as part of a post-integration plan of Sanofi’s animal-health business (Merial), which BI acquired in 2017. The reorganization includes the elimination of 327 positions (197 in human...
Mylan Pharmaceuticals is expanding its consumer-level voluntary US recall of valsartan-containing products to include all lots of valsartan-containing products within expiry. In November 2018, Mylan issued a voluntary recall to the consumer level...
Changzhou Qianhong Bio-pharma, a Changzhou, China-headquartered pharmaceutical company, has begun the second phase of construction of a manufacturing facility in Changzhou National Hi-Tech District, with a 1-billion yuan ($145-million)...
Lupin, a Mumbai, India-headquartered pharmaceutical company, has received 22 observations from the US Food and Drug Administration (FDA) across its three facilities in Mandideep, India, which Lupin says are “largely procedural in nature.” Lupin’s...
Janssen Pharmaceuticals, one of the pharmaceutical companies of Johnson & Johnson, and argenx, a clinical-stage biotechnology company developing differentiated antibody-based therapies for treating severe autoimmune diseases and cancer, have...
Following an announced $65-million investment in February (2018), Novo Nordisk plans to invest an additional $22 million in its finished-products manufacturing plant in Clayton, Johnston County, North Carolina. This is the company’s fourth...
Following December 5th shareholder meetings, Takeda Pharmaceutical and Shire announced that their respective shareholders have voted in favor of Takeda’s pending $62-billion acquisition of Shire. The deal is now subject to approval of a court in...
Following a previously announced strategic review, GlaxoSmithKline (GSK) has agreed to sell the Horlicks brand, its malted milk drink, and its other consumer healthcare nutrition brands to Unilever, a London, UK-based consumer goods company. As...
GlaxoSmithKline (GSK) plans to acquire Tesaro, a Waltham, Massachusetts-based oncology-focused biopharmaceutical company, for approximately $5.1 billion to accelerate the build of GSK’s pipeline and commercial capability in oncology.
Tesaro is a...
