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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

Strong new data for InterMune’s Esbriet sees the firm’s stock rocket

26-02-2014

US biotech firm InterMune has released top-line data from ASCEND, a Phase III trial evaluating pirfenidone…

BiotechnologyEsbrietInterMuneResearchRespiratory and Pulmonary

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

Indian drugmakers readying for next “Patent cliff”

24-02-2014

The strategic drug reviews, as well as mergers and acquisitions – such as Actavis buying out Forest…

Asia-PacificGenericsIndiaMergers & AcquisitionsPatentsPharmaceuticalRegulation

Positive CHMP opinion for Teva’s DuoResp Spiromax for asthma and COPD

22-02-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive…

AstraZenecaDuoResp SpiromaxPharmaceuticalRegulationRespiratory and PulmonarySymbicortTeva Pharmaceutical Industries

FDA backs Kalydeco for eight additional mutations that cause cystic fibrosis

22-02-2014

The US Food and Drug Administration approved biotech firm Vertex Pharmaceuticals’ supplemental New…

BiotechnologyKalydecoNorth AmericaRare diseasesRegulationUSAVertex

Russia to postpone transfer of domestic pharma production to GMP-standards until 2016

21-02-2014

The Russian government has decided to postpone until 2016 the requirement of domestic pharmaceutical…

Eastern EuropePharmaceuticalProductionRegulationRussia

US GPhA member support for GDUFA promise and progress

US GPhA member support for GDUFA promise and progress

21-02-2014

The US Food and Drug Administration’ Office of Generic Drugs acting director Kathleen Uhl, highlighted…

GenericsNorth AmericaRegulationUSA

Europe’s health care industry calls for balanced and transparent funding of the EU pharmacovigilance system

Europe’s health care industry calls for balanced and transparent funding of the EU pharmacovigilance system

21-02-2014

Five European health care trade groups say they support the implementation of an effective pharmacovigilance…

EuropePharmaceuticalRegulation

Positive CHMP opinion for BioMarin’s Vimizim for Morquio A syndrome

Positive CHMP opinion for BioMarin’s Vimizim for Morquio A syndrome

21-02-2014

BioMarin Pharmaceutical says that the European Medicines Agency’s Committee for Medicinal Products…

BioMarin PharmaceuticalEuropePharmaceuticalRare diseasesRegulationVimizim

GSK receives positive CHMP opinion for COPD drug Incruse

GSK receives positive CHMP opinion for COPD drug Incruse

21-02-2014

GlaxoSmithKline has announced that the European Medicines Agency’s Committee for Medicinal Products…

GlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryUKumeclidinium

NICE asks Biogen Idec for more information on Tecfidera

NICE asks Biogen Idec for more information on Tecfidera

21-02-2014

The UK’s National Institute for Health and Care Excellence (NICE) is calling on US biotech firm Biogen…

Biogen IdecBiotechnologyCNS DiseasesRegulationTecfideraUK

GSK and Theravance’s Anoro gets positive EMA panel backing for COPD

GSK and Theravance’s Anoro gets positive EMA panel backing for COPD

21-02-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended…

Anoro ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravance Biopharma

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