Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine. Additionally, the FDA has granted fast track designation for fremanezumab for the prevention of cluster headache.
Boston biotech resTORbio has pocketed another $40 million from a second-round financing that it hopes gives it enough cash to move its lead candidate for respiratory tract infections in elderly patients into phase 3.
There is no proven intervention for preventing late-life dementia. Researchers from the Minnesota Evidence-based Practice Center (EPC) reviewed published research to determine if physical activity, prescription medications, over-the-counter vitamins and supplements, or cognitive training interventions could help to prevent dementia in patients who did not have it at the time of the studies. The vast majority of research showed that none of the interventions worked. Findings from four systematic evidence reviews are published in Annals of Internal Medicine.
FITBIT SPENT ITS first decade selling activity trackers. With its latest moves, the company is starting to look less like a gear maker selling pricey accessories to fitness buffs and more like a medical-device company, catering to hospitals, patients, and health insurers. The company’s business-to-business arm, called Health Solutions, is now addressing four health conditions—sleep disorders including sleep apnea, diabetes, cardiovascular health and mental health—for employers, health insurers, healthcare providers, and researchers.
The Montreal-based startup ODS Medical is developing a handheld surgical guidance tool to improve accuracy in cancer surgery. Based on a set of advanced optical techniques, such as Raman spectroscopy, intrinsic fluorescence and diffuse reflectance spectroscopy, together with sophisticated machine learning algorithms, their laser technology measure scattered light to provide more specific information about the molecular makeup of the targeted brain tissue.
Virtual Incision’s RASD weighs just two pounds and is designed to perform the procedure through a smaller incision, potentially reducing recovery time and mitigating the risk of surgical complications.
Kyn is led by an Atlas entrepreneur-in-residence Mark Manfredi, who was previously chief scientific officer at Raze Therapeutics (also an Atlas-funded startup). Raze raised a $24 million Series A in 2014, but the company appears to have wound down pretty quickly. The website is no longer active, and Manfredi said Raze still has some assets and collaborations, but no longer employs anyone. Atlas’ Bruce Booth says the underlying cancer metabolism biology was too complicated to warrant further investment. Before Raze, Manfredi was VP of oncology biology at Takeda.
Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated the United States Phase I bridging clinical trial of fruquintinib. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) 1, 2 and 3, that has met its primary endpoint in several Phase II and III clinical trials in China for the treatment of colorectal, lung and gastric cancers. The clinical study in the U.S. is a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. The first drug dose was administered earlier this month. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03251378.
Medimetriks Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Xepi (ozenoxacin) Cream, 1%, a new chemical entity for the treatment of impetigo in patients two months of age and older when applied topically twice daily for 5 days. In the U.S., impetigo is estimated to account for approximately 10% of skin problems observed in pediatric clinics and is considered the most common bacterial skin infection.
New US research has found a link between taking certain medications for Attention Deficit Hyperactivity Disorder (ADHD) during pregnancy and an increased risk of birth defects in children.
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