NEW DELHI – In what may end up as a landmark $1.3 billion deal, China’s Shanghai Fosun Pharmaceutical (Group) Ltd. is set to acquire Indian injectables specialist Gland Pharma Ltd. Read More
Interim results from the open-label phase I/II study of BMN 270, Biomarin Pharmaceutical Inc.’s gene therapy to treat severe hemophilia A, showed the candidate outperformed expectations both in terms of efficacy, as measured by factor VIII (fVIII) expression and clinical improvements. Read More
Antibodies aimed at the protein tau, which accumulates during the later stages of Alzheimer’s disease (AD), do not need to engage immune cells to clear the protein, and they were less toxic to neurons in cell culture experiments than antibodies that did bind to immune cells as well as tau. Read More
An expected, FDA approval of the type 2 diabetes drug Adlyxin (lixisenatide) finally arrived for Sanofi SA, following initial withdrawal of a new drug application in late 2013 as the French drugmaker sought to establish cardiovascular safety of the GLP-1 receptor agonist. Read More
U.S. Center for Device and Radiological Health (CDRH) officials expounded on two crucial guidance documents that describe the FDA’s regulation of next-generation sequencing (NGS), as the agency aims to optimize its oversight of the technology and fulfill its role within President Obama’s Precision Medicine Initiative. Read More
HYDERABAD, India – Following feedback from industry, health policy experts and the public, India recently updated its draft guidelines for biosimilars, narrowing down the conditions for waivers of late-stage trials and expanding some testing criteria. Read More
Following up on a letter they sent to Theranos Inc. earlier this month, Democrat leaders of the House Energy and Commerce Committee wrote to the FDA and CMS this week seeking more information about the agencies’ inspections and oversight of the Palo Alto, Calif.-based company’s laboratories and blood tests. Read More
Aytu Bioscience Inc., of Englewood, Colo., entered a $10.5 million common stock purchase agreement with Lincoln Park Capital Fund LLC (LPC), a Chicago-based institutional investor. Upon execution of the agreement, LPC initially purchased 133,690 shares of common stock for $500,000. Read More
Vivus Inc., of Mountain View, Calif., said it filed a lawsuit in the U.S. District Court for the District of New Jersey against Hetero USA Inc. and Hyderabad, India-based Hetero Labs Ltd. in response to an abbreviated new drug application (ANDA), filed by Hetero, seeking to market and sell generic versions of the currently approved doses of Stendra (avanafil) tablets prior to the expiration of U.S. Patents 6,656,935 and 7,501,409, which are listed in the FDA’s Orange Book. Read More
International Stem Cell Corp., of Carlsbad, Calif., said the first patient in the phase I trial has undergone a successful intracranial transplant of ISC-hpNSC as a treatment for Parkinson’s disease. Read More
Alexion Pharmaceuticals Inc., of New Haven, Conn., posted total revenues of $753 million for the second quarter, an 18 percent increase over the same period in 2015. Read More
