Pharma News

Shire has entered into a definitive agreement with Servier to sell its Oncology business for $2.4 billion.

• Shire
• Servier

AK Medical Holdings, a Beijing orthopedic implant maker, has paid $24 million to acquire JRI Orthopedics, UK. Upon completion, JRI Orthopaedics will become a wholly-owned subsidiary of the Hong Kong Stock Exchange-listed AK Medical.

• AK
• Medical
• JRI
• Orthopedics

The U.S. Food and Drug Administration (FDA) finalized two separate guidances for next-generation sequencing technologies. The regulatory agency said the new guidelines will help accelerate the development of individualized genetic-based medicine as person

• FDA
• test

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

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

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

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

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

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

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

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

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

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

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

Events firm UBM’s bioprocessing and manufacturing expo, bioLIVE, which will debut this October alongside CPhI Worldwide trade fair in Madrid, is introducing a biologics manufacturing and processing league table, which will rank the perception of the...

• UBM
• Biopharma

The Turkish drive for a spot in the global pharmaceutical sector will involve investment incentives by the government in the form of rev...

• Turkey
• Pharmaceutical

The FDA has granted Clovis Oncology’s rucaparib a new use in ovarian cancer, approving the PARP inhibitor as a maintenance therapy for women with recurrent disease.

• PARP
• Clovis
• FDA

Mumbai-based Lupin has said the UK health regulator has completed the inspection of its Goa facility without making any critical observations. In a stock market filing, Lupin announced the successful completion of the inspection by the UK MHRA at its ...

• UK
• Lupin

US-based Ionis Pharmaceuticals, the leader in antisense therapeutics, recently announced that it has licensed IONIS-AZ6-2.5-LRx, or AZD2693, to AstraZeneca following advancement of the drug into development.

• AstraZeneca
• Ionis
• Pharma

Lupin has said that its Pithampur unit 2 manufacturing facility located in Indore has been cleared by Health Canada after a review. “Following the review, Health Canada has maintained the compliant rating for unit 2 at Pithampur (Indore) ...

• Lupin
• Canada