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Pharmaceutical Business Review

FDA approves Eliquis for DVT and PE treatment The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb and Pfizer’s supplemental new drug application (sNDA) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). News
FDA approves Eliquis for DVT and PE treatment By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb and Pfizer’s supplemental new drug application (sNDA) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
News EISAI seeks approval to expand antiepilepsy agent Fycompa as adjunctive cure of primary generalised tonic-clonic seizures By PBR Staff Writer
Eisai announced today that it has submitted applications to regulatory authorities in the U.S. and Europe (the FDA and EMA respectively) for the indication expansion of its in-house developed antiepileptic drug Fycompa as an adjunctive treatment of primary generalized tonic-clonic seizures (PGTC).
Regulatory Affairs > News Paradigm collaborates with TESARO on molecular profiling By PBR Staff Writer
Paradigm today announced a collaboration with TESARO.
Contract Research & Services > Contract Services > News
Glenmark starts IND-enabling studies of new bispecific antibody By PBR Staff Writer
Glenmark Pharmaceuticals has started the investigational new drug (IND)-enabling studies of a new bispecific antibody.
Drug Research > Drug Discovery & Development > News Lannett agrees to purchase two generic pharmaceutical products By PBR Staff Writer
Lannett has signed an agreement to acquire abbreviated new drug applications (ANDAs) for two generic pharmaceutical products.
Contract Research & Services > Contract Services > News Mitsubishi Tanabe Pharma, Astrazeneca partner on diabetic nephropathy research By PBR Staff Writer
Japan-based Mitsubishi Thnabe Pharma (MTPC) has collaborated with AstraZeneca to carry out research on diabetic nephropathy.
Drug Research > Drug Discovery & Development > News

Latest News and Insight by Sector

Production & Manufacturing

Regeneus, Cryosite to jointly manufacture human stem cell products
By PBR Staff Writer
Regeneus has signed an agreement with Cryosite to collaborate on the development and manufacture of new stem cell products for human applications.
Production & Manufacturing > Manufacturing > News
7-Keto supplement brand sold to InterHealth
Humanetics, a leading researcher, developer and marketer of pharmaceuticals, medical foods and branded nutraceutical ingredients, announced today that it has sold its 7-Keto dietary ingredient brand to InterHealth Nutraceuticals of Benica, CA.
Production & Manufacturing > OTC > News

Drug Research

Glenmark starts IND-enabling studies of new bispecific antibody
By PBR Staff Writer
Glenmark Pharmaceuticals has started the investigational new drug (IND)-enabling studies of a new bispecific antibody.
Drug Research > Drug Discovery & Development > News
Mitsubishi Tanabe Pharma, Astrazeneca partner on diabetic nephropathy research
By PBR Staff Writer
Japan-based Mitsubishi Thnabe Pharma (MTPC) has collaborated with AstraZeneca to carry out research on diabetic nephropathy.
Drug Research > Drug Discovery & Development > News

Inward Investment

Recipharm to buy Corvette Pharmaceutical Services for $160m
By PBR Staff Writer
Swedish contract development and manufacturing organisation Recipharm has agreed to purchase Milan based Corvette Pharmaceutical Services Group (Corvette) from Italian private equity group LBO Italia Investimenti.
Contract Research & Services > Contract Research > News
Novartis agrees to acquire 15% stake in Gamida Cell
By PBR Staff Writer
Swiss drugmaker Novartis Pharma has signed an agreement to acquire 15% stake in Gamida Cell for $35m.
Inward Investment > News

Packaging

Biologics adds frozen storage capabilities to clinical research services
By PBR Staff Writer
Biologics’ Clinical Research Services has announced the addition of frozen storage capabilities to its state-of-the-art facilities and cold-chain packaging and distribution.
Packaging > News
ATMI, D-Lab launch new Sterile Pyrofree vials
By PBR Staff Writer
US-based technology firm ATMI in partnership with Disposable Lab (D-Lab), a French contract-manufacturing company, has launched a line of pyrogen-free vials in order to meet biopharmaceutical filling and final packaging needs.
Packaging > News

Contract Research & Services

Lannett agrees to purchase two generic pharmaceutical products
By PBR Staff Writer
Lannett has signed an agreement to acquire abbreviated new drug applications (ANDAs) for two generic pharmaceutical products.
Contract Research & Services > Contract Services > News

Automation

Novan’s Nitricil technology demonstrates efficacy against multi-drug resistant pathogens
By PBR Staff Writer
Novan Therapeutics’ Nitricil platform technology has proven to be effective against most of the multi-drug resistant pathogens infecting civilian and military health care providers worldwide.
Automation > IT & Software > News
EastGate augments sub-micron self-nanoemulsifying platform technology
By PBR Staff Writer
US-based pharmaceutical firm EastGate Acquisitions is augmenting its self-emulsifying sub-micron platform technology to include a broad spectrum of delivery options, which are directed towards improving patient compliance.
Automation > IT & Software > News

Regulatory Affairs

EISAI seeks approval to expand antiepilepsy agent Fycompa as adjunctive cure of primary generalised tonic-clonic seizures
By PBR Staff Writer
Eisai announced today that it has submitted applications to regulatory authorities in the U.S. and Europe (the FDA and EMA respectively) for the indication expansion of its in-house developed antiepileptic drug Fycompa as an adjunctive treatment of primary generalized tonic-clonic seizures (PGTC).
Regulatory Affairs > News
FDA authorizes Kronus ZnT8Ab Elisa Assay for marketing
By PBR Staff Writer
The US Food and Drug Administration (FDA) has authorized the marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that helps in determination of Type 1 Diabetes.
Regulatory Affairs > News

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