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In 2014, FDA approved highest number of new drugs in 18 years

In 2014, FDA approved highest number of new drugs in 18 years

04-01-2015

The US Food and Drug Administration's Center for Drug Evaluation and Research approved 41 novel medicines…

AstraZenecaGilead SciencesPharmaceuticalRegulationUSA

Hospira gains US FDA backing for non-opioid analgesic Dyloject

Hospira gains US FDA backing for non-opioid analgesic Dyloject

31-12-2014

US injectable drugs and infusion technologies specialist Hospira has received approval from the US Food…

DylojectHospiraNeurologicalPharmaceuticalRegulationUSA

US FDA approves wider use for Vertex’ Kalydeco

US FDA approves wider use for Vertex’ Kalydeco

30-12-2014

US biotech firm Vertex Pharmaceuticals says the US Food and Drug Administration has approved a supplemental…

BiotechnologyKalydecoRare diseasesRegulationUSAVertex Pharmaceuticals

UK’s NICE says cost of Celgene’s Abraxane is not justified by its limited benefit

UK’s NICE says cost of Celgene’s Abraxane is not justified by its limited benefit

30-12-2014

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has today published…

AbraxaneCelgene CorpOncologyPharmaceuticalRegulationUK

Sumitomo Dainippon’s lurasidone meets primary endpoint in Ph III study

30-12-2014

Japanese drug major Sumitomo Dainippon Pharma has released positive preliminary findings from a Phase…

Dainippon Sumitomo PharmaJapanLatudalurasidoneNeurologicalPharmaceuticalRegulationResearch

BioMarin’s Vimizim approved in Japan for Morquio A syndrome

BioMarin’s Vimizim approved in Japan for Morquio A syndrome

29-12-2014

US biotech firm BioMarin Pharmaceutical has received approval from Japan’s Ministry of Health, Labor…

BioMarin PharmaceuticalBiotechnologyJapanRare diseasesRegulationVimizim

Newron and Zambon re-submit NDA for safinamide following Refusal to File

Newron and Zambon re-submit NDA for safinamide following Refusal to File

29-12-2014

Clinical-stage biopharma company Newron and its commercial development partner, fellow Italy-based pharma…

NeurologicalNewron PharmaPharmaceuticalRegulationsafinamideUSAZambon

Roche receives Emergency Use Authorization from FDA for its LightMix Ebola Zaire rRT-PCR Test

Roche receives Emergency Use Authorization from FDA for its LightMix Ebola Zaire rRT-PCR Test

29-12-2014

Swiss drug major Roche has received Emergency Use Authorization for its LightMix Ebola Zaire rRT-PCR…

Anti-viralsPharmaceuticalRegulationRocheWest Africa

First ever regulatory approval of Novartis' Cosentyx, in Japan

First ever regulatory approval of Novartis' Cosentyx, in Japan

26-12-2014

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Swiss pharma giant Novartis’…

Anti-Arthritics/RheumaticsBiotechnologyCosentyxDermatologicalsJapanNovartisRegulation

FDA approves Teva’s Granix and Galderma’s Soolantra

FDA approves Teva’s Granix and Galderma’s Soolantra

24-12-2014

The Food and Drug Administration has approved Israeli generics giant Teva Pharmaceutical Industries’…

DermatologicalsGaldermaGranixIvermectinPharmaceuticalRare diseasesRegulationSoolantraTeva Pharmaceutcal IndustriesUSA

US health care predictions from Steven Burrill

US health care predictions from Steven Burrill

24-12-2014

US politics will continue to be characterized by partisanship as the Republican majorities in the House…

BiosimilarsBiotechnologyHealthcarePoliticsRegulationUSA

Novo Nordisk’s obesity drug Saxenda approved by FDA

Novo Nordisk’s obesity drug Saxenda approved by FDA

24-12-2014

Continuing its rush of year-end drug approvals, the US Food and Drug Administration late yesterday approved…

MetabolicsNovo NordiskPharmaceuticalRegulationSaxendaUSA

Actelion submits New Drug Application to the FDA for pulmonary arterial hypertension drug Uptravi

Actelion submits New Drug Application to the FDA for pulmonary arterial hypertension drug Uptravi

23-12-2014

Swiss biotech company Actelion has submitted a New Drug Application to the US Food and Drug Administration…

ActelionCardio-vascularPharmaceuticalRegulationselexipagSwitzerland

NICE opens consultation on Millennium’s Crohn’s drug Entyvio

23-12-2014

In draft guidance issued today, UK health costs watchdog the National Institute for Health and Care Excellence…

BiotechnologyEntyvioGastro-intestinalsMillennium PharmaceuticalsPricingRegulationTakeda PharmaceuticalUK

Novartis' Alcon granted additional pediatric indication by the European Commission for Travatan

Novartis' Alcon granted additional pediatric indication by the European Commission for Travatan

23-12-2014

Eyecare specialist Alcon, the second-largest division of Swiss drug major Novartis, has been granted…

AlconNovartisOphthalmicsPharmaceuticalRegulationTravatanUSA

BioCryst's Rapivab approved by FDA to treat influenza

BioCryst's Rapivab approved by FDA to treat influenza

23-12-2014

USA-based BioCryst Pharmaceuticals has received approval from the US Food and Drug Administration for…

Antibiotics and Infectious diseasesBioCryst PharmaceuticalsperamivirPharmaceuticalRegulationUSA

FDA approves Bristol-Myers Squibb’s Opdivo for advanced melanoma

FDA approves Bristol-Myers Squibb’s Opdivo for advanced melanoma

23-12-2014

The US Food and Drug Administration yesterday granted accelerated approval to US pharma major Bristol-Myers…

Bristol-Myers SquibbKeytrudaMerck & CoOncologyOpdivoPharmaceuticalRegulationUSA

Ukraine’s new Health Minister outlines priorities at meeting with APRAD

Ukraine’s new Health Minister outlines priorities at meeting with APRAD

22-12-2014

At the instance of Association of Pharmaceutical Research and Development (APRAD), the Ministry of Health…

PharmaceuticalPoliticsPricingRegulationUkraine

AstraZeneca’s Lynparza gains FDA approval

AstraZeneca’s Lynparza gains FDA approval

20-12-2014

The US Food and Drug Administration has granted accelerated approved for Anglo-Swedish drug major AstraZeneca’s…

AstraZenecaLynparzaOncologyPharmaceuticalRegulationUSA

FDA approves fourth hepatitis C drug, AbbVie’s Viekira Pak

FDA approves fourth hepatitis C drug, AbbVie’s Viekira Pak

20-12-2014

The US Food and Drug Administration on Friday confirmed the much anticipated approval of US pharma company…

AbbVieAnti-viralsPharmaceuticalRegulationUSAViekira Pak

FDA approves new antibacterial drug Zerbaxa

20-12-2014

The US Food and Drug Administration has approved Cubist Pharmaceuticals’Zerbaxa (ceftolozane/tazobactam)…

Antibiotics and Infectious diseasesCubist PharmaceuticalsMerck & CoPharmaceuticalRegulationUSAZerbaxa

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