The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
GlaxoSmithKline (GSK) has opened two continuous pharmaceutical manufacturing facilities in Jurong, Singapore following a S$130-million (US $96-million) investment.
The new facilities include two continuous manufacturing facilities and an expansion...
The US Food and Drug Administration (FDA) has issued a Form 483 to Biocon’s insulin glargine manufacturing facilities in Malaysia following a pre-approval inspection conducted by the agency between June 24 and July 5, 2019. The inspection covered...
The US Food and Drug Administration (FDA) has issued a Warning Letter to Aurobindo Pharma for its drug-manufacturing facility in Srikakulam District, Andhra Pradesh, India, citing deviations from current good manufacturing practice (cGMP) for...
A federal district court judge has ruled in favor of Novartis in granting a temporary injunction barring generic competition for Novartis’ Gilenya (fingolimod hydrochloride), a multiple sclerosis drug. Global product sales of Gilenya in 2018 were...
Novartis has completed its acquisition of Takeda’s Xiidra (lifitegrast ophthalmic solution), a prescription drug for treating dry eye, in a $5.3-billion deal that includes $3.4 billion upfront and up to $1.9 billion in potential milestone payments....
Pfizer has completed its acquisition of Therachon Holding AG, a privately held clinical-stage biotechnology company, in a deal worth up to $810 million.
Under the agreement, Pfizer acquired Therachon for $340 million with an additional $470...
Bristol-Myers Squibb (BMS) has completed its previously announced divestiture of its consumer healthcare business, UPSA, to Taisho Pharmaceutical, an over-the-counter drug company in Japan, for $1.6 billion. BMS had announced the sale to Taisho in...
Pfizer has announced the election of Scott Gottlieb, MD, the former US Food and Drug Administration (FDA) Commissioner, to its Board of Directors, effective with its announcement on June 27, 2019. Dr. Gottlieb was also appointed to the Regulatory...
Glenmark Pharmaceuticals, a generics pharmaceutical company, has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding manufacturing issues relating to its new drug application (NDA) for Ryaltris...
Gilead Sciences and Carna BioSciences, a biopharmaceutical company developing kinase inhibitor drugs for oncology, autoimmune, and neurological diseases, have entered into a research and development collaboration to develop and commercialize...
Akorn, a specialty generic pharmaceutical company, has received a Warning Letter from the US Food and Drug Administration (FDA) related to an inspection by the FDA of its Somerset, New Jersey manufacturing facility conducted in July and August...
The US Food and Drug Administration (FDA) has issued a Form 483 with four observations to Sun Pharmaceutical Industries following a pre-approval inspection of the company’s facility in Halol, Gujarat, India, which was from June 3, 2019 to June 11,...
New Haven, Connecticut-based Valisure, an online pharmacy, has submitted a citizen petition to the US Food and Drug Administration (FDA) to request that the FDA take certain actions following the company detecting levels of an impurity,...
Gilead and Nurix Therapeutics, a drug-discovery company specializing in the body’s natural process to control protein levels, have entered into a global collaboration to discover, develop and commercialize targeted protein degradation drugs for...
Bristol-Myers Squibb (BMS) has provided an update on the approval process and timeline for its pending $74-billion acquisition of Celgene. To allow the transaction to close on a timely basis in light of concerns expressed by the US Federal Trade...
