Astrazeneca plc has won FDA approval to market Fasenra (benralizumab) as an add-on maintenance therapy for severe, eosinophilic asthma patients, age 12 years and older. Injected every eight weeks after a run-in period, the monoclonal antibody helped trial patients achieve a reduction in their annual asthma exacerbation rates (AAER) of up to 51 percent vs. placebo.
Loxo Oncology Inc. wasn't actively seeking a partner for its two most advanced contenders for the treatment of a rare type of genetically defined cancer but, given the opportunity to nail down a potential $1.55 billion deal with Bayer AG, "we saw the financial and strategic rationale," Jacob Van Naarden, Loxo's chief business officer, told BioWorld.
Immunomolecular (IM) Therapeutics LLC, a company created to develop small-molecule therapies for the treatment of genetically defined autoimmune diseases, has revealed its lead candidate, an immunotherapy for type 1 diabetes, IMT-002. The molecule, a proprietary formulation of the D enantiomer of methyldopa, already has FDA orphan status and could enter phase I testing next year after the company files an investigational new drug application (IND) in the second quarter of 2018.
An allogeneic whole cell vaccine for the treatment of non-small-cell lung cancer (NSCLC) developed by Pique Therapeutics Inc. helped people with late-stage, second-line disease achieve a median overall survival (OS) of 12.5 months during a phase II trial, an improvement of 4.1 months over the median OS of patients who received placebo. For the 71 nonsquamous patients enrolled in the study, median OS extended to 15.5 months, besting median OS in the placebo arm by nearly 10 months.
Patient dosing has begun in the first of four pivotal trials key to The Medicines Co.'s big bet on inclisiran, a cardiovascular-focused RNAi therapy critical to the drugmaker's return to profitability.
Boehringer Ingelheim GmbH is enlisting early stage RNAi specialist Dicerna Pharmaceuticals Inc. to discover and develop new therapies for chronic liver diseases, starting with nonalcoholic steatohepatitis (NASH).
Bluebird Bio Inc. reported that new data from an ongoing phase I trial of its gene therapy, Lentiglobin, in sickle cell disease suggests that changes made to the study protocol and to manufacturing of the therapy are improving engraftment of the gene-modified stem cells. After trading as high as $161.84, company shares (NASDAQ:BLUE) ended the day Wednesday at $142.95, up $3.85, as the company detailed its third-quarter earnings and previewed clinical data it plans to present at the American Society of Hematology (ASH) meeting next month.
After more than three decades of joint adventure for Japan's Kirin Holdings Co. Ltd. (KHK) and Thousand Oaks, Calif.-based Amgen Inc., the partners are winding down a JV with a $780 million payout to redeem the Asian conglomerate's shares in the business, Kirin-Amgen Inc. The business will now become a wholly owned subsidiary of Amgen. KHK said that it will continue to develop, manufacture and sell pharmaceuticals licensed by Kirin-Amgen.
Novartis AG has proposed buying radiopharmaceuticals specialist Advanced Accelerator Applications SA (AAA) in a deal valuing the company at $3.9 billion. The transaction would add the EU-approved neuroendocrine tumor therapy Lutathera (lutetium [177Lu] oxodotreotide) to the company's portfolio, as well as a new technology platform that Novartis said has potential applications across a number of early oncology development programs.
