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BIO urges US FDA to release guidance on biosimilars

BIO urges US FDA to release guidance on biosimilars

08-01-2015

The US trade group the Biotechnology Industry Organization (BIO) has called on the Food and Drug Administration…

BiosimilarsBiotechnologyRegulationUSA

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

08-01-2015

The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC), in a unanimous vote, recommended…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarxio

FDA grants Soligenix Fast Track status for SGX301

FDA grants Soligenix Fast Track status for SGX301

07-01-2015

Late-stage biopharma company Soligenix has said that its SGX301 (synthetic hypericin) development program…

OncologyPharmaceuticalRegulationSGX301SoligenixUSA

Shield Therapeutics' MAA for Ferracru accepted for review by EMA

Shield Therapeutics' MAA for Ferracru accepted for review by EMA

07-01-2015

Independent UK pharma company Shield Therapeutics has received acceptance for review of the Marketing…

FerracruHematologyPharmaceuticalRegulationShield TherapeuticsUK

CHMP recommends approval of Newron/Zambon's Xadago for Parkinson's disease

CHMP recommends approval of Newron/Zambon's Xadago for Parkinson's disease

07-01-2015

Italy-based Newron Pharmaceuticals and its partner Zambon have received a recommendation from the Euroean…

ItalyNeurologicalNewron PharmaceuticalsPharmaceuticalRegulationXadagoZambon

Health Canada instigates quarantine of products from Sri Krishna Pharmaceuticals

Health Canada instigates quarantine of products from Sri Krishna Pharmaceuticals

07-01-2015

At Health Canada's request, Canadian importers have agreed to quarantine health products made with active…

CanadaGenericsIndiaItalyRegulationSri Krishna Pharmaceuticals

FDA staffers back approval of Novartis' biosimilar of Amgen's Neupogen

FDA staffers back approval of Novartis' biosimilar of Amgen's Neupogen

06-01-2015

In briefing papers ahead of an advisory committee meeting, agency staff at the US Food and Drug Administration…

AmgenBiosimilarsBiotechnologyImmunologicalsNeupogenNovartisRegulationUSA

Leo Pharma files for US approval of first aerosol foam for psoriasis

06-01-2015

Independent Danish dermatology specialist Leo Pharma has submitted a New Drug Application to the US Food…

BetamethasonecalcipotrienecalcipotriolDermatologicalsLEO PharmaPharmaceuticalRegulationUSA

“Achievements and goals are endless in health care,” says head of Turkey’s AİFD

05-01-2015

Secretary general and chief operating officer of Turkey’s Association of Research-Based Pharmaceutical…

BiosimilarsHealthcarePharmaceuticalRegulationResearchTurkey

Daiichi Sankyo gets Japanese approval for Methylene Blue

05-01-2015

Japanese drug major Daiichi Sankyo has received approval in Japan for the manufacture and marketing of…

Daiichi SankyoHematologyJapanMethylene Blue InjectionPharmaceuticalProvepharmRegulation

EXPERT VIEW: Strengthening market access through insight-driven real-world evidence

EXPERT VIEW: Strengthening market access through insight-driven real-world evidence

05-01-2015

Growing demand for access to health care alongside advances in science and technology has led to heightened…

EnbrelGlobalPharmaceuticalRegulationSenior Consulting

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

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