Tango Therapeutics Inc.'s immuno-oncology (I-O) deal with Gilead Sciences Inc. brings "substantial preclinical milestone [payments], substantial enough that they move the needle for us on our financing timeline," CEO Barbara Weber told BioWorld. Read More
Shares of Strongbridge Biopharma plc (NASDAQ:SBBP) climbed 58 percent Wednesday to close at $6.40 as Novo Nordisk A/S agreed to pay $145 million plus royalties for U.S. and Canadian rights to the adult growth hormone deficiency therapy (AGHD) Macrilen (macimorelin), rights that Strongbridge itself had purchased less than a year ago from Aeterna Zentaris Inc. for $24 million up front. Novo also made an equity investment in the company. Read More
HONG KONG – A wave of bad news, not least of which is a faulty vaccines scandal in China, has hit Hong Kong-listed biotechnology stocks hard in 2018. However, on Oct. 31, Innovent Biologics Inc. debuted on the Hong Kong Stock Exchange with a surprising 19 percent price jump, breaking the curse of sharp price drops when the previous three biotech flotations first began trading. Read More
Sage Therapeutics Inc. becomes the second biopharma this week to face a joint meeting of the FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, which on Friday will review efficacy and safety data from the NDA for lead candidate brexanolone in the initial indication of postpartum depression (PPD). If the agency's briefing documents are a guide, the discussion is likely to focus on loss of consciousness (LOC) events that occurred during the drug's development program and the appropriate setting to administer the type A gamma-aminobutyric acid (GABAA) receptor modulator, which requires a 60-hour infusion. Read More
Three paraplegics who sustained spinal cord injuries many years ago are able to walk with crutches or a walker after receiving a wireless implant below their injury that mimics in real time how the brain naturally activates the spinal cord. Read More
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is seeking industry comments on a proposal to introduce a new framework for companion diagnostics. Read More
Clovis Oncology Inc., of Boulder, Colo., reported revenue of $22.8 million from sales of its ovarian cancer treatment, Rubraca (rucaparib). The company gave away drug worth an additional $9.6 million. Net loss for the quarter was $89.9 million, or $1.71 per share. Clovis ended the quarter with $604.4 million in cash, cash equivalents and available-for-sale securities. Shares of Clovis (NASDAQ:CLVS) closed down $4.98, or 30 percent, to $11.63 on Wednesday. Read More
Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said it received a notification letter from the NYSE American LLC that its plan to regain compliance with continued listing standards was accepted. Read More
Anchiano Therapeutics Ltd., of Cambridge, Mass., submitted a confidential draft registration statement for a possible IPO of American depositary shares (ADSs) in the U.S. The number of ADSs and dollar amount to be sold haven't been determined. Read More
Sartan concerns are expanding in the U.S. after N-nitrosodiethylamine (NDEA), a potential carcinogen, was found in some lots of Hauppauge, N.Y.-based Sciegen Pharmaceuticals Inc.'s irbesartan tablets, which contain API from Aurobindo Pharma Ltd., of Hyderabad, India. Lots of the finished hypertension drug and API that may contain the impurity are being recalled from the U.S. market. Read More
BioDelivery Sciences International Inc., of Raleigh, N.C., appointed James Vollins general counsel, chief compliance officer and corporate secretary and Scott Plesha president and chief commercial officer. Read More
