A multiple-sclerosis drug that was at the center of Sanofi SA's SAN.FR +1.12% $20 billion takeover battle for Genzyme Corp. three years ago was approved for sale in Europe on Tuesday, the drug's first regulatory approval world-wide. The ...
arGEN-X, a clinical stage human monoclonal antibody therapeutics company, cin its SIMPLE Antibody research program collaboration with Shire Pharmaceuticals' Human Genetic Therapies division. The milestone, which was the first ...
The US Food and Drug Administration (FDA) has approved breakthrough therapy designation for Danish biotechnology company Genmab and British pharmaceutical company GlaxoSmithKline’s (GSK) Arzerra (ofatumumab) in combination with ...
Tags: therapy designation, Medicine
Plexcera Therapeutics has received approval from Mount Sinai Innovation Partners (MSIP), part of the Icahn School of Medicine, to develop recombinant human acid ceramidase (rhAC) for treatment of diseases caused by genetic or ...
Tags: Plexcera, Cystic Fibrosis
Champions Oncology (Champions), a developer of advanced technology solutions and services to personalize the development and use of oncology drugs, has signed a new discovery and drug development partnership with Teva Pharmaceutical ...
Tags: Champions Oncology
US-based Boston Scientific has completed the patient enrolment in the EVOLVE II clinical trial, designed to assess the safety and effectiveness of SYNERGY stent system and support the US Food and Drug Administration and Japanese regulatory ...
Tags: Clinical Trial, Medicine
Richter-Helm, a full-service biopharmaceutical contract development and manufacturing organization, has announced that the US Food and Drug Administration has approved two Richter-Helm facilities in Hamburg and at Bovenau (to the north of ...
One of the world's top-selling drugs—GlaxoSmithKline PLC's $8-billion-a-year asthma treatment Advair—became more vulnerable to generic competition after the U.S. Food and Drug Administration issued guidance on the regulatory ...
US-based Moirai Orthopaedics has obtained CE Mark approval for its new Pyrocarbon Implant Replacement (PIR) system, designed to treat patients with focal chondral and osteochondral defects of the medial femoral condyle of the knee. The ...
Celgene has received approval from the US Food and Drug Administration (FDA) for its drug 'Abraxane' to treat patients with late-stage adenocarcinoma of the pancreas. Adenocarcinoma is a sub-type of exocrine tumors which accounts for ...
T2 Biosystems has initiated the direcT2 clinical trial of T2Candida, designed for the rapid and sensitive identification of five species of Candida. The direcT2 trial will provide data to support a regulatory submission for T2Candida. ...
Tags: T2 Biosystems, Clinical Trial
Clinverse has entered into a partnership with OmniComm Systems to combine its automated payment system 'ClinPay' with the latter's electronic data capture (EDC) system. The ClinPay system automates sponsor payments to clinical vendors, ...
Medtronic has unveiled new data from the Global SYMPLICITY Registry, a multi-centre, prospective, observational registry designed to collect comprehensive data evaluating procedural and long-term safety of the Symplicity renal denervation ...
Tags: Medtronic, Symplicity Registry
HeartWare International has received the U.S. Food and Drug Administration (FDA) approval to enroll supplemental patient cohort for ENDURANCE, a pivotal destination therapy clinical study. HeartWare will enroll up to 286 patients ...
Edwards Lifesciences has obtained the reimbursement for its Sapien XT transcatheter aortic valve implant from Japan's Central Social Insurance Medical Council (Chuikyo) after the recommendation made by the Japanese Ministry of Health, Labor ...
Tags: XT Valve, Edwards Lifesciences