Aimmune Therapeutics Inc. won the qualified backing of members of the FDA's Allergenic Products Advisory Committee (adcom) during a Friday meeting held to discuss whether or not safety and efficacy data support licensure of Palforzia (AR-101), the company's oral immunotherapy (OIT) to reduce the incidence and severity of allergic reactions to peanut.
Glaxosmithkline plc has won FDA approval to market Nucala (mepolizumab) for use in children as young as 6 with severe eosinophilic asthma (EA). The therapy already had FDA approval as an add-on maintenance treatment for kids with the same condition ages 12 and older. Approval of the sBLA, submitted last November, catches the U.S. market up to the EU, where Nucala has been approved as an add-on treatment for children ages 6 to 17 since August 2018.
Shares of San Diego-based Tocagen Inc. (NASDAQ:TOCA) fell 77.7% to 93 cents Thursday after its two-part immunotherapy for people with recurrent brain cancer failed to surpass standard of care on overall survival (OS), the primary endpoint of the company's phase III Toca 5 trial. Secondary endpoints in the registrational study were also missed, showing no meaningful difference between study arms.
Anokion SA, a Swiss biotech focused on autoimmune disease, is bringing in-house a startup it spun out for a development alliance with Astellas Pharma Inc. The acquisition of Kanyos Bio Inc., announced alongside news it closed a $40 million series B financing, puts front and center KAN-101, a preclinical celiac disease drug poised for an IND filing by year-end. Together with Anokion's lead candidate, ANK-780, an antigen-specific treatment for multiple sclerosis (MS), the company anticipates having two programs in clinical development within the next 12 months.
Aveo Oncology Inc. is moving closer to a potential NDA filing for its renal cell carcinoma (RCC) drug, tivozanib, following a recently conducted analysis of the ongoing phase III trial Tivo-3. Updated results evidenced "durable improvements" for study participants, all of whom have refractory metastatic RCC, said primary investigator Brian Rini. Company shares (NASDAQ:AVEO) climbed 30.9% to 92 cents Tuesday as Aveo said it would discuss the data with the FDA, which rejected the company's first attempt at approval in RCC in the summer of 2013.
Japan's Sumitomo Dainippon Pharma Co. Ltd. plans to pay $3 billion to acquire Roivant Sciences Ltd.'s ownership interests in five biopharma companies, plus options to acquire up to six more from the prolific company-builder. The deal, slated to close in October, would give Sumitomo Dainippon controlling interests in Myovant Sciences Inc., Urovant Sciences Inc., Enzyvant Therapeutics Inc. and Altavant Sciences Inc., as well as an equity stake of more than 10% in Roivant itself.
Shares of New York-based Neurotrope Inc. (NASDAQ:NTRP) fell 77.3% to close at a record low of $1 Monday after a phase II study of its lead candidate, bryostatin-1, failed to outperform a placebo in helping people with moderate to severe Alzheimer's disease (AD) achieve improvement on a standardized measure of cognition.
Japan's Sumitomo Dainippon Pharma Co. Ltd. plans to pay $3 billion to acquire Roivant Sciences Ltd.'s ownership interests in five biopharma companies, plus options to acquire up to six more from the prolific company-builder. The deal, slated to close in October, would give Sumitomo Dainippon controlling interests in Myovant Sciences Inc., Urovant Sciences Inc., Enzyvant Therapeutics Inc. and Altavant Sciences Inc., as well as an equity stake of more than 10% in Roivant itself.
Just months after betting up to $1.58 billion on the drug discovery and early development chops of IFM Therapeutics LLC, Novartis AG is again investing in the Boston-based company. This time, it has agreed to pay IFM shareholders up to $840 million for an exclusive option to acquire a subsidiary they launched just months ago to develop new drugs for the treatment of inflammatory and autoimmune diseases, IFM Due (pronounced du-way) Inc.
The star of Abbvie Inc.'s multibillion-dollar acquisition of Stemcentrx Inc., rovalpituzumab tesirine (Rova-T), is officially dead after an interim analysis of the phase III Meru study found it failing to help people with advanced small-cell lung cancer (SCLC) live any longer than a placebo. Abbvie is terminating all further R&D of the disappointing asset.
