On October 4, 2015, Ministers of the 12 Trans-Pacific Partnership (TPP) countries announced conclusion of their negotiations. The summary of the TPP Agreement is as follows: Disclaimer: The Following Summary of the Trans-Pacific ...
Tags: goods, services, trad, investment
Afrezza hopes that its inhalable insulin product will be a gamechanger for diabetics. (Image courtesy Afrezza). Insulin injections may soon be a thing of the past if Mannkind Corp.'s inhalable insulin product, Afrezza, is approved by ...
Anika Therapeutics (ANIK) has received marketing approval for MONOVISC from the US Food and Drug Administration (FDA) for the treatment of patients suffering from osteoarthritis (OA) of the knee. MONOVISC is a single injection supplement ...
Tags: FDA Approval, Anika
Salix Pharmaceuticals and Pharming Group have announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) Action Date to 16 July 2014 for the Biologics License Application (BLA) for the ...
Tags: Drug, Pharming Group
DiaSorin, a biotechnology company, has received all the marketing approvals for hepatitis, retroviral and syphilis assays on its Liaison XL platform for the Chinese market. DiaSorin is now entering the hepatitis B, hepatitis C and ...
Tags: DiaSorin, HCV, HIV, pre-surgical screening testing
AtheroMed has obtained marketing approval from the US Food and Drug Administration (FDA) for its Phoenix atherectomy system for treating peripheral artery disease (PAD). Phoenix atherectomy system is a peripheral atherectomy catheter ...
Tags: FDA, pPAD, debulked material, Archimedes Screw
Cardica, a medical device company, has received 510(k) approval from the US Food and Drug Administration (FDA) for its MicroCutter Xchange 30 device and blue staple cartridge for medium thickness tissue. The company has designed the ...
Tags: Cardica, medical device
Baxter International has filed an application to the US Food and Drug Administration (FDA) for a pediatric indication for Rixubis [Coagulation Factor IX (Recombinant)] to treat hemophilia B. The submission was based on a Phase II/III ...
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir) 400mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection ...
Tags: Gilead Sciences, Chronic Hepatitis
Echo Therapeutics, a medical device company, has reported positive results from its clinical trial of the Symphony CGM wireless continuous glucose monitoring system in surgical patients in hospital critical care units. Echo Therapeutics ...
The European Medicines Agency (EMA) has fully validated and granted accelerated assessment to Boehringer Ingelheim's application for European marketing authorization of faldaprevir, a potent second generation oral protease inhibitor. ...
Otsuka Pharmaceutical and H. Lundbeck have announced marketing authorization approval from the European Commission for Abilify Maintena (aripiprazole), an intramuscular (IM) once-monthly injectable formulation for maintenance treatment of ...
Canada-based Titan Medical has recently commenced tissue testing that was successful in assessing and measuring the functionality of the SPORT (single port orifice robotic technology) surgical system. The company will perform a sequence ...
Novocure announced that the US Food and Drug Administration (FDA) has approved the NovoTAL (Transducer Array Layout) system through a premarket approval (PMA) supplement. The NovoTAL System allows certified physicians to use the ...
Tags: Novotal System
Antares Pharma, a provider of self-injection drug delivery technology, has received a US Patent, entitled 'Prefilled Syringe Jet Injector', which will help in protecting its auto injector technology and product pipeline including the VIBEX ...