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FDA approves Bydureon Pen for type 2 diabetes

FDA approves Bydureon Pen for type 2 diabetes

03-03-2014

Anglo-Swedish drug major AstraZeneca says the US Food and Drug Administration has approved the Bydureon…

AlkermesAmylinAstraZenecaBristol-Myers SquibbBydureonDiabetesPharmaceuticalRegulationUSA

Bayer submits marketing authorization for Eylea in Japan

Bayer submits marketing authorization for Eylea in Japan

03-03-2014

US biotech firm Regeneron Pharmaceuticals and partner Bayer’s Japanese subsidiary Bayer Yakuhin have…

BayerEyleaJapanOphthalmicsPharmaceuticalRegeneronRegulation

US orphan status for GW Pharma’s Epidiolex in Lennox-Gastaut syndrome

28-02-2014

UK-based GW Pharmaceuticals says that the Food and Drug Administration has granted orphan drug designation…

epidiolexGW PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalRegulationUSA

Amarin calls on FDA to extend Vascepa exclusivity by five years

28-02-2014

US biotech firm Amarin has filed with a federal court requesting it to order the US Food and Drug Administration…

AmarinBiotechnologyCardio-vascularGlaxoSmithKlineLegalLovazaNorth AmericaUSAVascepa

Negative NICE appraisal for Eli Lilly’s Alimta as maintenance therapy

27-02-2014

UK health care guidance body the National Institute for Health and Care Excellence (NICE) has published…

AlimtaEli LillyNorthern EuropeOncologyPharmaceuticalPricingRegulationUK

Record-breaking recoveries from US DoJ/HHS joint efforts to combat health care fraud

27-02-2014

US Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius have released…

FinancialHealthcareLegalNorth AmericaPharmaceuticalUSA

BIO urges Indiana Governor to sign Bill on interchangeable biologic medicines

27-02-2014

US trade group the Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF)…

BiosimilarsGenericsLegalNorth AmericaRegulationUSA

Cell Thera’s NHL drug Pixuvri gets backing from UK’s NICE

27-02-2014

US biotech firm Cell Therapeutics has received positive news from the UK’s drugs watchdog for use of…

BiotechnologyCell TherapeuticsNorthern EuropeOncologyPixuvriPricingRegulationUK

UK’s NICE gives green light to Bayer’s Eylea in final guidance

26-02-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has published final guidance…

BayerEyleaNorthern EuropeOphthalmicsPharmaceuticalPricingRegulationUK

US FDA approves Anika’s Monovisc for osteoarthritis pain of the knee

26-02-2014

US drugmaker Anika Therapeutics has received marketing approval for Monovisc from the US Food and Drug…

Anika TherapeuticsAnti-Arthritics/RheumaticsDePuyMonoviscNorth AmericaPharmaceuticalRegulationUSA

EMA/CHMP recommends 12 new orphan medicines over the past year

26-02-2014

Over the past 12 months, a total of 12 medicines for the treatment of rare diseases were recommended…

EuropePharmaceuticalRare diseasesRegulation

FDA approves Myalept, the first drug to treat a rare metabolic disease

FDA approves Myalept, the first drug to treat a rare metabolic disease

26-02-2014

The US Food and Drug Administration has approved Myalept (metreleptin for injection) as replacement therapy…

AstraZenecaBristol-Myers SquibbmetreleptinMyaleptNorth AmericaPharmaceuticalRare diseasesRegulationUSA

Business community welcomes European Parliament vote on counterfeit goods in transit

25-02-2014

A long list of trade organizations representing thousands of companies across all industry lines and…

EuropePatents & Trade marksPharmaceuticalRegulation

Iroko Pharma gains FDA approval for low-dose indomethacin drug Tivorbex

25-02-2014

US specialty drugmaker Iroko Pharmaceuticals has received approval from the US Food and Drug has approved…

Iroko PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalRegulationTivorbexUSA

US orphan drug market outlook 2018: Report

25-02-2014

In the largest market for orphan drugs, the USA, there was a shortage of adequate therapies for treating…

Markets & MarketingNorth AmericaPharmaceuticalRare diseasesRegulationUSA

NICE guidance will deprive UK patients with newly-diagnosed advanced melanoma of Yervoy

25-02-2014

US drug major Bristol-Myers Squibb today expressed its disappointment that the UK drugs watchdog the…

Bristol-Myers SquibbNorthern EuropeOncologyPharmaceuticalPricingRegulationUKYervoy

FDA proposed rule to change label requirements would cause dangerous confusion, raise costs

24-02-2014

The Food and Drug Administration’s Proposed Rule to change prescription drug label requirements risks…

GenericsNorth AmericaRegulationUSA

FDA Breakthrough designation for all-oral daclatasvir for chronic hepatitis C

24-02-2014

The US Food and Drug Administration has granted drug major Bristol-Myers Squibb’s investigational DCV…

Anti-viralsBristol-Myers SquibbdaclatasvirNorth AmericaPharmaceuticalRegulationUSA

Novartis gets fourth indication, DME, for Lucentis in Japan

24-02-2014

Swiss drug major Novartis says it has received approval from Japanese regulatory bodies for a fourth…

Asia-PacificJapanLucentisNovartisOphthalmicsPharmaceuticalRegulation

IQWiG now finds “major” benefit for Xtandi

24-02-2014

In an early benefit assessment under Germany’s Act on the Reform of the Market for Medicinal Products…

Astellas PharmaGermanyMedivationNorthern EuropeOncologyPharmaceuticalPricingRegulationXtandi

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