About the 5 percent drop in overall response rate (ORR) in the expanded phase I trial with the company’s antibody-drug conjugate (ADC) for ovarian cancer, Immunogen Inc.’s chief development officer, Charles Morris, said he was “not sure I’d call it significant,” as the company made known its plan to switch its Forward 1, two-stage phase II experiment to a single-stage phase III study without blessings from the FDA – an idea that made some analysts leery. Read More
Scientists at the Roswell Park Cancer Institute have published a review arguing that the mild cold stress of mice housed under standard laboratory conditions is sufficient to skew experimental results. Read More
There’s a whole lot of explaining to do before many U.S. patients and doctors will feel comfortable with biosimilars in place of their go-to biologics. Read More
Homology Medicines Inc., formed quietly last year, held its coming-out party by disclosing the close of a $43.5 million series A preferred stock financing co-led by 5AM Ventures and Arch Venture Partners, with participation from Singapore-based investment firm Temasek along with Deerfield Management and Arch Overage Fund. Read More
Topoisomerase 1, known for its role in unwinding DNA during transcription and the target of chemotherapy drugs Camptosar (irinotecan, Pfizer Inc.) and Hycamtin (topotecan, GlaxoSmithKline plc.), plays a role in coordinating the innate immune response, and inhibiting it could be a therapeutic strategy in diseases characterized by excessive inflammation, scientists reported in the April 29, 2016, issue of Science. Read More
Theravance Biopharma Inc. priced an upsized $94.1 million public offering on Friday, saying it would sell about 4.77 million shares at $21 each as it moves to build a strong balance sheet capable of supporting two key development programs alongside further commercial efforts on Vibativ (telavancin) and advancement of the rest of its pipeline. Read More
HYDERABAD, India – A number of drug companies in India may have to repeat expensive clinical trials after Bangalore-based contract research organization (CRO) Semler Research Center Pvt. Ltd. received warnings from both the World Health Organization (WHO) and the FDA in April over data manipulation. Read More
PARIS – The long-awaited reform that would untangle red tape and speed up market access in the U.K. for innovative medications and medical devices hit a roadblock called Brexit, a British exit from the European Union (EU). Read More
The FDA granted an emergency use authorization for the Zika virus RNA qualitative real-time RT-PCR test developed by Quest Diagnostics Inc., of Madison, Wis. Read More
Ablynx NV, of Ghent, Belgium, said it received an undisclosed milestone payment from its 2005 collaboration with Novartis AG, of Basel, Switzerland, triggered by the FDA’s clearance of the investigational new drug application for a phase I study with a Nanobody that binds with an undisclosed GPCR target in inflammation. The study is expected to start in the second quarter. Read More
Immunomedics Inc., of Boston, reported objective durable responses were achieved with sacituzumab govitecan, its lead antibody-drug conjugate, in a number of patients with advanced, metastatic solid cancers, after failing multiple prior therapies, some including checkpoint inhibitors. The drug previously received breakthrough therapy designation in triple-negative breast cancer patients who have failed prior therapies for metastatic disease. Read More
Biomarin Pharmaceutical Inc., of San Rafael, Calif., reported a non-GAAP net loss of $27.2 million for the quarter, compared to a non-GAAP net loss of $25.4 million for the first quarter of last year. GAAP net loss was $85.1 million, or 53 cents per basic and diluted share, for the first quarter of 2016, compared to GAAP net loss of $67.5 million, or 43 cents per share, for the first quarter of 2015. Read More
Helix Biopharma Corp., of Aurora, Ontario, closed a private placement financing for aggregate gross proceeds of about C$4.7 million (US$3.75 million). Read More
