Clinigen Group plc, of Burton on Trent, UK, extended and renegotiated an exclusive U.S. license and distribution agreement covering its lead product, the antiviral Foscavir (foscarnet sodium), with Hospira Inc., of Lake Forest, Ill. Read More
Trevi Therapeutics Inc., of New Haven, Conn., has begun a pivotal study of its oral extended-release opioid Nalbuphine ER in patients with prurigo nodularis, a condition characterized by itchy skin nodules. Read More
Biolinerx Ltd., of Jerusalem, reported positive preclinical results, online in PLoS One, for BL-9020, a monoclonal antibody for the treatment of type 1 diabetes. BL-9020 is designed to prevent immune-mediated destruction of insulin-producing beta cells in the pancreas. Read More
Ampliphi Biosciences Corp., of Richmond, Va., said it entered into definitive purchase agreements of common stock and warrants with a group of institutional accredited investors, including both existing and new investors, as well as with its strategic alliance partner Intrexon Corp., of Germantown, Md., to raise approximately $13 million in a private placement. Read More
The FDA issued a revision of its 2009 draft guidance on formal meetings between the agency and sponsors on the development and review of new drugs and biologics. The new draft, published in Wednesday's Federal Register, discusses good meeting management practices and describes standardized procedures for requesting, preparing for, scheduling, conducting and documenting formal meetings. Read More
DUBLIN – Nordic Nanovector ASA is seeking NOK400 million (US$48.7 million) in what would be the Nordic region's first significant biotech IPO of 2015. Read More
If precision medicine is to be the future of health care in the U.S., the FDA must stop dragging its feet on qualifying biomarkers necessary to develop targeted therapies and track disease advancement, according to a report released Wednesday by the Manhattan Institute for Policy Research. Read More
Antibodies have exquisite specificity for their antigens, a quality that has led to their use to target other payloads to specific cell types. When they are targeted to other biological or chemical molecules, antibodies can deliver cargo to only those cell types that express a specific surface receptor. Read More
LONDON – Merck and Co. Inc.'s melanoma treatment pembrolizumab has become the first drug to qualify for the UK's Early Access to Medicines Scheme (EAMS), under which innovative products are being accelerated to patients in advance of European marketing approval. Read More
BOGOTA, Colombia – In a decision that caused a stir here, the Council of State Colombia, a court of last resort, not only opened the doors for unregistered drugs to enter the country, but also makes it possible for doctors to use drugs beyond their registered scope. Read More
SHANGHAI – Hutchison Medipharma Ltd. (HMP) has gone from running a marathon to a sprint. HMP's pipeline has quickly grown from seven clinical trials to 16, 13 of which are phase Ib/II studies with 10 being in potential breakthrough therapy indications. Read More
Trying to translate discovery research and early clinical data into phase III success has proved the bane for drug developers working in Alzheimer's disease. But executives at Agenebio Inc., which is gearing up to start a phase III study in the second half of this year with lead product AGB101, think their approach will be up to the task. Read More
