Press Releases

AIkido Pharma Inc. announced the formation of a wholly owned subsidiary with the purpose of making strategic investments and acquisitions across the fintech and financial services industries. The new subsidiary is expected to be the centerpiece of a long-range plan to diversify AIkido's business beyond biotechnology, in order to reduce volatility and mitigate risk while increasing revenue and enhancing shareholder value. The new subsidiary will leverage the extensive capital mar

Astellas Pharma Inc. announced that the US Food and Drug Administration (FDA) has placed a clinical hold on the FORTIS Phase 1/2 trial following the occurrence of a serious adverse event (SAE) of peripheral sensory neuropathy in one of the trial participants. FORTIS is a clinical trial evaluating AT845, an investigational adeno-associated virus (AAV) gene replacement therapy in adults with Late-Onset Pompe Disease. The FDA informed Astellas that it did not have sufficient informatio

BridgeBio Pharma, Inc., a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced promising pharmacodynamic data from the first two participants dosed in CANaspire, its Phase 1/2 clinical trial of BBP-812, an investigational intravenous (IV) adeno-associated virus serotype 9 (AAV9) gene therapy for the treatment of Canavan disease. Canavan disease is an ultra-rare and fatal disease with no approved therapies. “Taken together, these r

Astellas Pharma Inc. today announced a New Drug Application (NDA) for fezolinetant has been submitted to the U.S. Food and Drug Administration (FDA). Fezolinetant is an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 "In the United States, 60% to 80% of individuals experience VMS durin

Pharma Intelligence, a leading provider of specialist intelligence, data and software for clinical trials, development and regulatory compliance, announces that it has rebranded to become Citeline. The rebrand follows leading global growth investor Warburg Pincus’ recent acquisition of the business from Informa PLC (LSE:INF.L), the international markets knowledge services and business intelligence group. The rebrand to become Citeline reflects the company’s commitment to

Xenon Pharmaceuticals Inc., a neurology-focused biopharmaceutical company, today announced new, compelling efficacy data supporting the late-stage, Phase 3 development of XEN1101. Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer, stated, “We have generated additional efficacy data from sub-group analyses of our Phase 2b X-TOLE trial, which further support our Phase 3 development plans for XEN1101. A ‘time course to efficacy’ analysis shows that

Avesthagen Limited, a biotechnology major that specializes in predictive, preventive and personalized healthcare through the convergence of food, pharma and population genetics, has entered into a four-year strategic alliance with Wipro Limited, a leading global information technology, consulting and business process services company, for making its genetic testing portfolio commercial. The portfolio includes genome panels offering highly specific, disease-centric analysis for conditions incl

SureCo, a pioneer of programs and solutions that promote great health while lowering health care costs and improving the quality of care, today announced Enrollme by SureCo is now available for large group employers. By providing a digital marketplace that makes it easy for employees to explore healthcare plans, Enrollme enables individuals to choose the one that best fits their needs and drive contributions to that plan with no packages to build and no open enrollment to manage. &q

Veracyte, Inc.today announced that findings from a new meta-analysis provide real-world evidence that the Afirma Genomic Sequencing Classifier (GSC) can accurately rule out thyroid cancer in patients with indeterminate thyroid nodules and that, when the test deems a nodule as suspicious, the patient’s risk of malignancy is consistent, and higher than that reported in the test’s original clinical validation (CV) study. The findings were presented for the first time at the ENDO 2022

The International Association of Industrial Accident Boards and Commissions (IAIABC) has appointed two Harvard MedTech executives to its committees. Harvard MedTech Senior Vice President and Chief Medical Officer Gerry Stanley, M.D., P-CEO, and Mark Moore, Senior Vice President, Market Partnerships, have both been appointed to serve on the Work Disability Prevention and Return to Work committee. In addition, Dr. Stanley will serve on Medical Issues committee of IAIABC, and Mark Moor