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FDA issues CRL on empagliflozin, noting manufacturing deficiencies

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

05-03-2014

There was disappointment today for US drug major Eli Lilly and family-owned German pharma firm Boehringer…

Boehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaPharmaceuticalProductionRegulationUSA

Titan Pharma in general agreement with FDA on pathway for Probuphine

Titan Pharma in general agreement with FDA on pathway for Probuphine

04-03-2014

California, USA-based Titan Pharma and its partner, Braeburn Pharmaceuticals, have agreed in principle…

Braeburn PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalProbuphineRegulationResearchTitan PharmaceuticalsUSA

RedHill Biopharma and IntelGenx respond to CRL on rizatriptan

04-03-2014

Emerging Israeli biotech firm RedHill Biopharma, together with Canadian drug delivery specialist IntelGenx,…

BiotechnologyIntelGenxNeurologicalNorth AmericaRedHill BiopharmaRegulationUSA

Teva gains approval for generic Evista in the USA

Teva gains approval for generic Evista in the USA

04-03-2014

Israel-based Teva Pharmaceutical Industries says it has received approval from the US Food and Drug Administration…

Anti-Arthritics/RheumaticsEli LillyEvistaGenericsNorth AmericaRegulationTeva Pharmaceutical IndustriesUSA

France’s AAA makes acquisition, gains orphan status for Gallium-68 DOTATATE

04-03-2014

French molecular nuclear medicines specialist Advanced Accelerator Applications SA (AAA) has acquired…

Advanced Accelerator ApplicationsGallium-68 DOTATATEMergers & AcquisitionsPharmaceuticalRegulation

UK’s NICE does U-turn on Pfizer’s Inlyta for advanced kidney cancer

UK’s NICE does U-turn on Pfizer’s Inlyta for advanced kidney cancer

04-03-2014

UK drug watchdog the National Institute for Health and Care Excellence (NICE) this morning published…

InlytaNorthern EuropeOncologyPharmaceuticalPricingRegulationRocheUK

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

GSK files for US approval for Promacta for severe aplastic anemia

GSK files for US approval for Promacta for severe aplastic anemia

02-03-2014

UK pharma giant GlaxoSmithKline has submitted a supplemental New Drug Application to the US Food and…

GlaxoSmithKlineLigand PharmaceuticalsNorth AmericaOncologyPharmaceuticalPromactaRare diseasesRegulationUSA

Actavis challenges Multaq and Colcrys patents

02-03-2014

Ireland-headquartered generic drugmaker Actavis revealed on Friday (February 28) that French pharma giant…

ActavisAnti-Arthritics/RheumaticsCardio-vascularColcrysGenericsLegalMultaqNorth AmericaPatents & Trade marksRegulationSanofiTakeda PharmaceuticalsUSA

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

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

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

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

27-02-2014

Despite citing the need for further safety studies, both US and EU regulators have lauded the immunogenicity…

Anti-viralsBiotechnologyDynavax TechnologiesHeplisavRegulationResearchVaccines

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

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