Avalanche Biotechnologies Inc. touched off a Wall Street landslide by disclosing phase IIa results with gene therapy AVA-101 for wet age-related macular degeneration (AMD) that showed the trial's 12-month primary endpoint was met, based on ophthalmic and systemic safety. Read More
Vtv Therapeutics Inc., a new company formed by combining Transtech Pharma LLC and its affiliate High Point Pharmaceuticals LLC, has filed to raise up to $172.5 million in an IPO intended to help complete the company's formation and fund new trials of its lead programs, including a phase III study of its lead Alzheimer's disease (AD) drug candidate, azeliragon, and phase II trials of its type 2 diabetes drug candidates. Read More
PHILADELPHIA – Capturing the attention of potential investors in 30 seconds or less poses a challenge for even the most sophisticated wordsmiths when attempting to describe complicated technologies and commercial potential. Read More
PHILADELPHIA – For decades, young biotechs have circled the so-called "Valley of Death," trying not to fall into the funding chasm that can occur during the period between discovery and clinical proof of concept – the critical milestone when most venture capital (VC) firms are willing to get on board. Read More
PHILADELPHIA – Anything an antibody can do, only better: That's the big idea behind Cytomx Inc.'s Probody platform, which, despite its early stage, has landed a couple of potentially lucrative big pharma deals. Read More
SHANGHAI – Luqa Pharmaceuticals' $15 million series A financing will boost efforts to acquire, develop and commercialize products for Chinese patients in the aesthetics and quality-of-life markets. Products include pharmaceuticals and devices for both the reconstructive and elective plastic surgery market. Read More
LONDON – It is time to end the devotion to 'p' values and the randomized control phase III study, and to give greater weight to novel trial designs that draw on real world observational data and take an inductive approach to probability. Read More
WASHINGTON – Stakeholders from the health care, patient, academic and clinical industries gathered at the Develop Innovate and Advance (DIA) 2015 annual meeting here to discuss, among other things, ways to improve orphan drug development to ensure patients with rare diseases receive timely, consistent, and effective treatment for their conditions. Read More
The FDA sent two warning letters to online pharmacies demanding that they stop marketing unapproved drugs in the U.S. and selling prescription drugs without a valid prescription and outside approved risk evaluation and mitigation strategies (REMS). Read More
Kezar Life Sciences, of South San Francisco, completed a series A financing totaling $23 million. Morningside Venture, Cormorant Asset Management, EcoR1 Capital, 9W Capital Management, Omega Funds, Aju IB Investment, and private investors participated in the round. Read More
strong>Aerie Pharmaceuticals Inc., of Irvine, Calif., said the FDA has agreed in written and verbal communications that it may change the primary endpoint range of its second phase III registration trial of Rhopressa, named Rocket 2, to include patients with baseline intraocular pressures (IOPs) ranging from above 20 mmHg to below 25 mmHg. Read More
strong>Heron Therapeutics Inc., of Redwood City, Calif., has initiated a phase II trial of HTX-011, the company's lead candidate for the prevention of postoperative pain. Read More
