The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Sumitomo Dainippon Pharma, and Roivant Sciences, a New York-based healthcare company, have entered into a non-binding memorandum of understanding for a broad alliance to transfer ownership interests in five Roviant biopharmaceutical subsidiaries to...
Vertex Pharmaceuticals has agreed to acquire Semma Therapeutics, a privately held biotechnology company specializing in Type 1 diabetes treatments, for $950 million in cash.
Semma has developed a therapeutic approach to address the causal human...
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) over manufacturing issues for a new drug application filed by Biocon and Mylan for a biosimilar to Sanofi’s diabetes drug, Lantus (insulin glargine). The FDA...
Allergan and its US subsidiaries have reached a $5.0-million settlement with Summit and Cuyahoga Counties in Ohio relating to pending opioid litigation. The company was scheduled for a trial in October 2019 in Cleveland, Ohio in federal opioid...
Sandoz, the generics arm of Novartis, has partnered with Polpharma Biologics, a European developer and manufacturer of biosimilars and biologic drugs, for global commercialization of a proposed biosimilar of Biogen’s Tysabri (natalizumab), a drug...
Roche has extended its tender offer period relating to its pending $4.3-billion acquisition of Spark Therapeutics, a Philadelphia-based gene-therapy company, from September 3, 2019 to October 1, 2019. Roche had previously extended the offer period...
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have published a joint analysis that shows the two are aligned in more than 90% of marketing authorization decisions for new medicines. This is one of the findings of...
Celgene and Immatics Biotechnologies, a clinical-stage pharmaceutical company developing T-cell redirecting cancer immunotherapies, have formed a strategic collaboration and option agreement to develop adoptive cell therapies targeting multiple...
A roundup of developments and latest news from China (iBio, CC-Pharma), Japan (Neopharma, Lupin) and United States (Glenmark, Strides Pharma).
China
iBio and CC-Pharming Expand Business Collaboration in China
iBio, a plant-based contract...
SWK Holdings Corporation, a life-science specialty finance company, has acquired Enteris BioPharma, a company specializing in oral peptide drug-delivery technology, for $21.5 million. SWK acquired Enteris BioPharma from Victory Park Capital through...
Boehringer Ingelheim (BI) reports that Allan Hillgrove, member of the company’s Board of Managing Directors responsible for the Human Pharma and the Biopharma business, will retire at the end of this year and will be succeeded by Dr. Carine...
The US Food and Drug Administration (FDA) has provided an update to the agency’s ongoing investigation surrounding voluntary recalls of multiple generic “sartan”-containing products, angiotensin II receptor blockers (ARBs), used to treat high blood...
Johnson & Johnson (J&J) and its Janssen Pharmaceutical Companies say they will appeal a $572-million civil judgement entered in Cleveland County District Court in the State of Oklahoma’s lawsuit against opioid...
Amgen has agreed to acquire worldwide rights to Celgene’s psoriasis drug, Otezla (apremilast), for $13.4 billion in cash in connection with Celgene’s pending $74-billion merger with Bristol-Myers Squibb (BMS). BMS had previously announced (June...
Gilead Sciences and Galapagos NV, a Mechelen, Belgium-based small-molecule drug company, have closed their previously announced global research and development collaboration agreement in a deal worth more than $5.0 billion.
Under the agreement,...
