Latest News in the pharma Industry

Policy & Regulation

VivaGel BV granted QIDP and Fast Track designation by FDA

VivaGel BV granted QIDP and Fast Track designation by FDA

14 Jan 2017

Product receives designations for both the BV treatment and prevention indications.

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FDA grants Fast-Track Designation to RHB-104 for nontuberculous mycobacteria infections

FDA grants Fast-Track Designation to RHB-104 for nontuberculous mycobacteria infections

12 Jan 2017

RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation.

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US Court of Appeals rules in Lilly's favour on Alimta vitamin regimen patent

US Court of Appeals rules in Lilly's favour on Alimta vitamin regimen patent

12 Jan 2017

If the patent is ultimately upheld through all remaining challenges, Alimta would maintain US exclusivity until May 2022.

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FDA accepts BLA for Mylan and Biocon's proposed biosimilar trastuzumab

FDA accepts BLA for Mylan and Biocon's proposed biosimilar trastuzumab

11 Jan 2017

If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the US.

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Cardinal Health reaches $20 million settlement with West Virginia

Cardinal Health reaches $20 million settlement with West Virginia

9 Jan 2017

Company collaborating with all participants in the pharma supply chain to tackle to the epidemic of prescription drug abuse.

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FDA accepts for filing sNDA for Liletta 52 mg

FDA accepts for filing sNDA for Liletta 52 mg

4 Jan 2017

Application seeks to extend duration of use up to 4 years for Liletta.

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BioNet receives Thai FDA approval of the world's only available recombinant monovalent acellular Pertussis vaccine

BioNet receives Thai FDA approval of the world's only available recombinant monovalent acellular Pertussis vaccine

29 Dec 2016

BioNet's vaccine is the first recombinant monovalent Pertussis vaccine in the world to receive a MAA for booster indication in adolescents and adults.

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Positive Phase III results of Genentech’s investigational medicine Ocrevus

Positive Phase III results of Genentech’s investigational medicine Ocrevus

28 Dec 2016

Ocrevus is the first and only investigational medicine to show superior efficacy versus comparators in both relapsing and primary progressive multiple sclerosis in clinical studies.

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FDA approves Shire's Adynovate

FDA approves Shire's Adynovate

28 Dec 2016

New FDA-approved indications for Adynovate provides more hemophilia A patients access to proven prophylaxis with a simple, twice-weekly dosing schedule.

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FDA places clinical hold on several Phase I trials of Vadastuximab Talirine

FDA places clinical hold on several Phase I trials of Vadastuximab Talirine

28 Dec 2016

Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events.

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FDA approves first drug for spinal muscular atrophy

FDA approves first drug for spinal muscular atrophy

26 Dec 2016

Spinraza improved motor function in SMA patients.

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Cardinal Health agrees to pay $44 million to the Department of Justice

Cardinal Health agrees to pay $44 million to the Department of Justice

26 Dec 2016

Payment resolves the outstanding civil penalty portion of the company's 2012 administrative settlement with this US DEA.

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