CNN) - Theranos decided to voluntarily withdraw its Zika virus blood test that it had submitted for Food and Drug Administration approval, the company said Wednesday.Theranos founder and CEO Elizabeth Holmes previously told CNN Chief Medical Correspondent Dr. Sanjay Gupta in an exclusive interview that the Zika test, though it's not one that would be as common as a test to check general health, was a priority for the company because it was a "really important area of blood work."More Health Headlines What to know: Zika virus Singapore Zika cases increase to 82 Zika around the world: Where do we stand? CDC urges hearing tests for babies exposed to Zika Amid Zika fears, Florida theme parks offer mosquito repellent US blood supply should be screened for Zika, FDA says First known case of sexual Zika transmission without symptoms She talked about the test at her first presentation to the American Association for Clinical Chemistry Meeting in August. The hope, she said, was to be able to run the Zika test on a new mini-lab device the company debuted at the conference.On an exclusive tour of her Silicon Valley lab in July, Holmes showed Gupta a bank of the devices being used for some of the testing that was associated with the FDA submissions.
LUXEMBOURG CITY, Luxembourg, September 1, 2016 /PRNewswire/ --Today, Alzheimer Europe announced the launch of its Clinical Trials Watch, a new service bringing together up-to-date information on clinical trials investigating drugs for the treatment and prevention of Alzheimer's and other dementias in an accessible format. To date, only phase III trials currently recruiting participants in at least two European countries are included.For this innovative new resource, Alzheimer Europe collaborated closely with members of its European Working Group of People with Dementia (EWGPWD) and consulted pharmaceutical companies conducting trials to present basic information. Information is given by country, study name and condition. Each study has been reviewed by a member of the EWGPWD and dementia-friendly versions are available for download. The content will be updated every three months based on information available on public registries.
Medimetriks Pharmaceuticals' New Drug Application for Ozenoxacin Cream, 1% Accepted for Review by FDA
PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for ozenoxacin cream, 1%, a novel, non-fluorinated quinolone in development for the treatment of impetigo. The Prescription Drug User Fee Act (PDUFA) date for the completion of FDA's review is June 22, 2017.Medimetriks licensed exclusive U.S. commercialization rights to ozenoxacin from Ferrer, a leading, privately held Spanish pharmaceutical company, in March 2014 and announced the completion of the second successful Phase 3 pivotal trial in July 2015. Both Phase 3 pivotal studies demonstrated the superiority of ozenoxacin cream, 1%, applied topically twice daily for 5 days versus placebo on both the clinical and bacteriological endpoints. In the studies, ozenoxacin demonstrated superior bacteriological cure compared to placebo as early as visit 2 (day 3-4), and showed excellent antibacterial activity against a broad range of bacteria. The studies demonstrated that ozenoxacin was safe and well tolerated in both the adult and pediatric populations aged 2 months and older. Medimetriks submitted the ozenoxacin NDA to FDA in June, 2016.
Neurocrine Announces FDA Conditional Acceptance of Proprietary Name INGREZZA™ for VMAT2 Inhibitor Valbenazine
PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name "INGREZZA™" for the Company's once-daily vesicular monoamine transporter 2 (VMAT2) inhibitor valbenazine. The Company has recently announced the submission of a New Drug Application (NDA) with the FDA for valbenazine in tardive dyskinesia and is also exploring its utility in Tourette syndrome.
Phase III Study Showed Genentech’s Cancer Immunotherapy TECENTRIQ™ (Atezolizumab) Helped People with a Specific Type of Lung Cancer Live Significantly Longer Compared to Chemotherapy
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results for TECENTRIQ from the Phase III study, OAK. The study met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemotherapy. Adverse events were consistent with what has been previously observed for TECENTRIQ. Genentech looks forward to presenting full results at an upcoming medical meeting in 2016.
Zambon Launches Xadago® (Safinamide) in Norway for Patients with Mid- to Late-Stage Parkinson’s Disease
MILAN--(BUSINESS WIRE)--Zambon S.p.A., an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, and its partner Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, today announced the launch of Xadago® (safinamide) in Norway for the treatment of mid- to late-stage Parkinson’s disease (PD).
GenSight Biologics receives Orphan Drug Designation and Advanced Therapy Medicinal Product classification in Europe for GS030 in Retinitis Pigmentosa
PARIS--(BUSINESS WIRE)--Regulatory News:GenSight Biologics (Euronext: SIGHT, FR0013183985, PEA-PME eligible), a biopharma company that discovers and develops innovative gene therapies for neurodegenerative retinal diseases and diseases of the central nervous system, today announced that the European Commission, based on a favorable recommendation from the European Medicines Agency (EMA), has granted orphan drug designation (ODD) to the Company’s product candidate GS030 for the treatment of retinitis pigmentosa. The EMA also granted Advanced Therapy Medicinal Product (ATMP) classification to GS030.
AstraZeneca Completes Aspen Agreement
ASTRAZENECA COMPLETES COMMERCIALISATION AGREEMENT WITH ASPEN FOR ANAESTHETICS PORTFOLIO 01 September 2016 07:00 BST ASTRAZENECA COMPLETES COMMERCIALISATION AGREEMENT WITH ASPEN FOR ANAESTHETICS PORTFOLIO AstraZeneca today announced that it has completed* the commercialisation agreement with Aspen Global Incorporated (AGI), part of the Aspen Group, for rights to its global anaesthetics portfolio outside the US. The agreement covers seven established medicines - Diprivan (general anaesthesia), EMLA (topical anaesthetic) and five local anaesthetics (Xylocaine/Xylocard/Xyloproct, Marcaine, Naropin, Carbocaine and Citanest). As AstraZeneca will retain a significant ongoing interest in the portfolio, the upfront payment (to be recognised in the third quarter of 2016), along with all future milestone and royalty payments, will be reported as Externalisation Revenue in the Company’s financial statements. * With the exception of Ukraine and Zimbabwe, which are subject to separate closing
Lars Rebien Sørensen to retire as CEO of Novo Nordisk; Lars Fruergaard Jørgensen appointed as successor
Novo Nordisk A/S today announced that Lars Rebien Sørensen, president and chief executive officer, will retire from the company by the end of 2016. Lars Fruergaard Jørgensen, currently executive vice president and head of Corporate Development, will succeed him, effective 1 January 2017. The company also announced a number of other executive-level changes, effective immediately. Commenting on the retirement of Lars Rebien Sørensen, Göran Ando, chairman of the Board of Directors of Novo Nordisk A/S, said: "Succeeding Lars, who during 16 years as CEO of Novo Nordisk has spearheaded Novo Nordisk into a global, very successful and highly respected pharmaceutical company, is a tall order. On behalf of Novo Nordisk's Board of Directors and the company's employees, I want to thank Lars for his outstanding leadership, steady course and commitment to Novo Nordisk through good and difficult times during his 34 years with the company."