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: MT-Connect Sponsor Issues Guidance on MDR

In assessing changes to MDR due for 2020, Forum MedTech Pharma states that safety and quality must take priority over speed. CEO Dr Matthias Schier considers, however, that implementing changes in the form of the new MDR and IVDR poses challenges for...

MDR Guidance
2018-04-16

: Drug Waste Flushed into World's Freshwater Ecosystems to Rise 65% by 2050

It's no surprise that chemicals can get flushed into our water supply from the pills we take. But as the world's population grows, the rampant consumption of pharmaceuticals has become an emerging threat to the world's freshwater ecosystems, researcher...

Environment Drug Waste
2018-04-13

: Emergent Completes Market Authorization

Emergent BioSolutions has successfully completed the Mutual Recognition Procedure (MRP) for market authorization of BioThrax® (Anthrax Vaccine Adsorbed) in five Concerned Member States (CMS) within the European Union (EU), including Italy, the...

Emergent Market Pharmaceutical
2018-04-13

: Catalent Bolsters Clinical Supply Capabilities

Catalent Pharma Solutions has completed a $5.5 million expansion program at its more than 200,000 square foot Philadelphia, PA, site to provide additional clinical packaging and storage capacity.

Catalent Pharma Expansions
2018-04-13

: Novartis’ Afinitor Disperz Wins New TSC-Related Approval

Novartis’ Afinitor Disperz has become the first medicine to be specifically approved by US regulators to treat patients aged two years and above with tuberous sclerosis complex (TSC)-associated partial-onset seizures.

Novartis Afinitor Disperz
2018-04-12

: EU Regulators Expand Reach of Sobi’s Kineret

European regulators have expanded the scope of Sobi’s Kineret to include the treatment of Still’s disease, a rare, systemic, multi-organ, auto-inflammatory disorder that affects around 25,000 children and adults in the EU.

EU Kineret
2018-04-12

: India: Pharma Exports from Telangana Go up By 38%

Pharma exports, which account for 44 per cent of total merchandise exports from Telangana, are set to soar with the setting up of a new pharma city. According to the recently released Socio-Economic Outlook 2018, sector-wise analysis of merchandise...

India Export
2018-04-12

: India: National Digital Database of Domestic Pharma Manufacturers in The Offing

India’s drug regulatory body, Central Drugs Standard Control Organisation (CDSCO), is reportedly creating a national digital database of pharmaceutical manufacturers and their medicines so that regulators can be more effective when acting on problems...

India Pharma
2018-04-12

: EU, Australia Clear Biocon-Mylan Biosimilar Insulin Glargine

Bengaluru-based biotech firm, Biocon, said that its co-developed biosimilar insulin glargine Semglee has received marketing approval from the European Commission. Biocon has developed this biosimilar with Mylan. Semglee 100 units/ml 3 ml is a ...

EU Australia Biocon
2018-04-12

: Dr. Reddy's Labs Appoints Erez Israeli as New COO

Dr. Reddy’s Laboratories Ltd. has named Mr. Erez Israeli, former President and CEO of Enzymotec, as the new Chief Operating Officer (COO) and Global Head of Generics & PSAI. The incumbent COO, Mr. Abhijit Mukherjee, retired on March 31.

Dr. Reddy’s Laboratories People
2018-04-12

: CDSCO's New Intelligence Cell to Check Illegal Activity in Pharma Sector

India’s central drug regulator, Central Drugs Standard Control Organisation (CDSCO), has set up a nine-member intelligence cell to track illegal activity in the country’s pharmaceutical sector. This includes gathering information on the medicines and...

India CDSCO
2018-04-12

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