US regulators are undertaking a speedy review of Shire’s lanadelumab (SHP643) for the prevention of angioedema attacks in patients 12 years and older with hereditary angioedema (HAE).
The flu is a bit of a stealth microbe. Infected people may shed significant amounts of flu virus simply by breathing, scientists have discovered.
GSK delivers improvements in sales, margins and cash flow in 2017:Total EPS 31.4p, +67% AER, +36% CER; Adjusted EPS 111.8p, +11% AER, +4% CER
Genentech’s PD-L1 inhibitor Tecentriq continues to show off its versatility. Monday, the Roche subsidiary announced a combination of Tecentriq and Avastin (bevacizumab) was significantly beneficial to patients with advanced or metastatic renal cell carcinoma (mRCC) who have not received prior systemic active or experimental therapy.
The EMA has accepted the Marketing Authorization Application for romosozumab in the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture.
Scientists at the National University of Science and Technology (NUST) MISIS in Russia have developed a new membrane test strip for quantitative immune chromatography rapid tests to rapidly and accurately detect an acute myocardial infarction by analysing blood for the presence of disease markers.
Five Prime Therapeutics, Inc. (FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, announced that a development milestone for cabiralizumab has been achieved, triggering a $25 million payment from Bristol-Myers Squibb Company (BMS) (BMY) under the license and collaboration agreement between the companies established in 2015. The milestone was triggered by initiation of a multi-arm Phase 2 clinical trial (NCT03336216), sponsored by Bristol-Myers Squibb Company, evaluating cabiralizumab and Opdivo® (nivolumab) with and without chemotherapy in patients with advanced pancreatic cancer. “Effective treatment for patients with pancreatic cancer remains a significant unmet need and is a cancer for which existing immunotherapies have not been successful to date,” said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. “We are encouraged by the preliminary data presented at SITC 2017 and are pleased to see this trial underway.” The Phase 2 trial is expected to enroll approximately 160 ...
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has put forward seven new medicines for approval in the region, including new treatment options for haemophilia A, diabetes, and a very rare genetic disorder.
Pandion Therapeutics, Inc., a biotechnology company developing bispecific antibody therapeutics to achieve localized immunomodulation, today announced the completion of a $58 million Series A financing. This funding will be used to advance its initial drug programs for autoimmune and inflammatory diseases toward the clinic, as well as to continue building the company’s technology platform and pipeline. Polaris Partners, the founding investor that provided the initial seed funding, co-led the Series A financing along with Versant Ventures and Roche Venture Fund. SR One and BioInnovation Capital also participated in the round.
Aspyrian Therapeutics Inc. announces successful advances in RM-1929 clinical development in recurrent Head and Neck Cancer, including Fast Track designation granted by the FDA, initiation of clinical studies in Japan, and plans to start pivotal studies, which will incorporate the evaluation of anti-cancer immune responses, in early 2018.
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