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 ...
The Pulmonary-Allergy Drugs Advisory Committee (PADAC) of the US Food and Drug Administration (FDA) has recommended the approval of GlaxoSmithKline (GSK) and Theravance's umeclidinium/vilanterol as a treatment for chronic obstructive ...
Tags: Health, Medicine, Investigational Copd Drug
Israel-based oral drug delivery systems developer Oramed Pharmaceuticals has received an approval for a patent, titled 'Methods and Compositions for Oral Administrations of Proteins', from the State Intellectual Property Office of the ...
US-based biopharmaceutical firm Cubist Pharmaceuticals has completed the acquisition of Trius Therapeutics, which is focused on the development of antibiotics, for about $704m. The acquisition of Trius brings to Cubist a late-stage ...
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 ...
CardiacAssist, a US-based medical device company,has introduced the Protek17 arterial cannula, a key component of the TandemHeart temporary circulatory support platform with new features designed to improve patient safety during temporary ...
Tags: CardiacAssist, medical device
IntelligentMDx (IMDx) has received the US Food and Drug Administration (FDA) approval for its second automated molecular diagnostic test for use on Abbott's fully automated m2000 platform. The automated molecular diagnostic test detects ...
NanoString Technologies, a provider of life science tools for translational research and molecular diagnostic products, has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its Prosigna breast cancer prognostic gene ...
Activaero has entered into research collaboration with Italian pharmaceutical firm Chiesi Farmaceutici to develop an effective solution to treat patients with cystic fibrosis (CF). Under the deal, Activaero will offer its flow and volume ...
Reporters learnt from the China Food and Drug Administration (CFDA) that the government agency has approved Ginsenoside CK of Zhejiang Hisun Pharmaceutical Co., Ltd. (SHSE: 600267) to enter clinical test phase. Ginsenoside CK has ...
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 ...
ICU Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for its ChemoLock needlefree closed system transfer device (CSTD). The CSTD is approved for pharmacy applications (product code ONB), as well as patient ...
Tags: ICU Medical, FDA Approval
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 ...
Unilife, a manufacturer of injectable drug delivery systems, has won a contract from French drugmaker Sanofi to supply Unifill Finesse, a customized device from its Unifill platform of prefilled syringes, for use with the anti-thrombotic ...
Tags: Unifill Syringes, Sanofi
An official from the National Development and Reform Commission (NDRC) revealed that 80% of the more than 300 types of original drugs from foreign companies supervised by government agencies are really higher than peers in South Korea, Hong ...
Tags: Foreign Original Drugs, Health, Medicine