Although it's likely premature to use the word "trend" when talking about the industry overall, Novartis AG has been plenty active in business development, snatching up Endocyte Inc. for $2.1 billion most recently. Read More
SAN FRANCISCO – Dynamic as ever in the wake of this summer's mixed news on Biogen Inc. and Eisai Co. Ltd.'s anti-beta-amyloid approach, drug developers in the Alzheimer's field are increasingly looking to genetics and biomarkers as they seek new paths of attack for the global scourge. Now, with the success of precision approaches in cancer, scientists are also beginning to think about combination approaches to the complex neurodegenerative disease, representatives of Denali Therapeutics Inc., E-Scape Bio Inc., Alkahest Inc. and Neurotrope Inc. said Thursday at the BIO Investor Forum. Read More
The most comprehensive analysis of the largest functional genomic dataset of primary acute myeloid leukemia (AML) tumor biopsies to date has revealed important new information about biology and potential translational approaches that could translate into new clinical treatment approaches. Read More
HONG KONG – Antibody specialist Hifibio Therapeutics Inc. has picked up French immuno-oncology company H-Immune Therapeutics SAS in a deal that adds pipeline programs, a platform technology and expertise in an increasingly competitive field. Read More
Phasebio Pharmaceuticals Inc., of Malvern, Pa., priced its IPO of 9.2 million shares at $5 apiece for gross proceeds of $46 million. Citigroup, Cowen and Stifel acted as joint book-running managers, while Needham & Co. LLC acted as co-manager. Shares began trading on Nasdaq Thursday under the ticker PHAS and closed flat. Read More
Aelix Therapeutics SL, of Barcelona, Spain, signed a clinical research collaboration with Gilead Sciences Inc., of Foster City, Calif., to jointly evaluate investigational products in a clinical study aimed at achieving a functional cure of HIV infection. The collaboration will enable the conduct of an experiment to investigate the safety, tolerability, immunogenicity and efficacy of a regimen containing Aelix's HTI T-cell vaccine and Gilead´s Toll-like receptor 7 agonist, vesatolimod, in HIV-infected individuals on antiretroviral therapy. Read More
The FDA submitted a proposal to the International Council for Harmonisation (ICH) recommending the development of internationally harmonized guidelines on scientific and technical standards for generic drugs. The FDA specifically asked ICH to develop a series of guidelines on standards for demonstrating equivalence for both noncomplex dosage forms and for more complex dosage forms and drug products. Read More
Shares of Proteostasis Therapeutics Inc. (NASDAQ:PTI) roared Thursday, spiking to an 18-month high of $10.38, following an update on three cohorts covering 21 patients from the company's ongoing phase I study of combination doublet, PTI-801/PTI-808, in individuals with cystic fibrosis (CF). The stock closed at $10.35 for a gain of $8.46, or 447.6 percent. Volume of nearly 92.6 million shares was some 580 times the company's three-month moving average. Read More
