The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
AbbVie Terminates ADC Drug Candidate Rova for Lung Cancer
AbbVie reports that that Meru, a Phase III trial evaluating Rova-T (rovalpituzumab tesirine), a therapy for treating advanced small-cell lung cancer, is being closed and the Rova-T research...
A roundup of developments and latest news from Israel (BiomX), India (Sanofi), and United States (Aurobindo, Novo Nordisk)
Israel
BiomX Completes Construction of Clinical Phage Mfg Facility in Israel
BiomX, a microbiome developer of natural and...
GlaxoSmithKline (GSK) has agreed to acquire Sitari Pharmaceuticals, a company developing treatments for celiac disease, from Avalon Ventures, a venture-capital firm. Sitari was the first company formed under a GSK–Avalon venture collaboration,...
Takeda Pharmaceutical has issued a US recall for all doses of Natpara (parathyroid hormone), a thyroid treatment, for injection (25 mcg, 50, mcg, 75 mcg, and 100 mcg) after discussions with the US Food and Drug Administration (FDA). This recall is...
JHL Biotech, a contract development and manufacturing organization (CDMO) and developer of biosimilars, has reached a settlement agreement with Roche’s Genentech to resolve Genentech’s civil claims related to the indictment of former Genentech...
Mallinckrodt has agreed to sell its wholly owned subsidiary, BioVectra, a contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs) and intermediates, to an affiliate of HIG Capital, a private equity...
Mallinckrodt, along with its wholly owned subsidiaries, Mallinckrodt LLC and SpecGx LLC, has reached a $30-million settlement in principle with two Ohio counties in pending opioid litigation.
Mallinckrodt reached the settlement in principle with...
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...
