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FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

08-04-2014

US anti-virals major Gilead Sciences says that the US Food and Drug Administration has granted priority…

Anti-viralsBiotechnologyGilead SciencesledipasvirNorth AmericaRegulationsofosbuvirUSA

Sunovion’s once-daily epilepsy drug Aptiom debuts in USA

08-04-2014

USA-based Sunovion Pharmaceuticals, a subsidiary of Japanese drug major Dainippon Sumitomo, has launched…

AptiomDainippon Sumitomo PharmaMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalSunovionUSA

Starpharma expands accord with AstraZeneca

Starpharma expands accord with AstraZeneca

07-04-2014

Australian biotech firm Starpharma has signed a second, expanded agreement with Anglo-Swedish drug major…

AstraZenecaBiotechnologyOncologyResearchStarpharma

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

07-04-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

07-04-2014

US pharma major Bristol-Myers Squibb has submitted New Drug Applications with the US Food and Drug Administration…

Anti-viralsasunaprevirBristol-Myers SquibbdaclatasvirNorth AmericaPharmaceuticalRegulationUSA

Roche in deal with Oryzon to develop epigenetics-based medicines; Buys IQuum

Roche in deal with Oryzon to develop epigenetics-based medicines; Buys IQuum

07-04-2014

Swiss drug major Roche has entered to a worldwide collaboration with Spanish functional genomics firm…

BiotechnologyIQuumLicensingMergers & AcquisitionsOncologyORY-1001Oryzon GenomicsRoche

Genzyme to resubmit Lemtrada NDA for FDA review

Genzyme to resubmit Lemtrada NDA for FDA review

07-04-2014

Genzyme, the biotech subsidiary of French drug major Sanofi, said this morning that, following “constructive…

BayerBiotechnologyLemtradaNeurologicalNorth AmericaRegulationSanofiUSA

Disappointing results with Amgen’s talimogene laherparepvec in metastatic melanoma

Disappointing results with Amgen’s talimogene laherparepvec in metastatic melanoma

06-04-2014

Leading independent biotech firm Amgen has released mixed top-line results from the primary overall survival…

AmgenBiotechnologyOncologyResearchtalimogene laherparepvec

UK’s NICE says “yes” to Genzyme’s MS drug Lemtrada

04-04-2014

In final draft guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE)…

BiotechnologyGenzymeLemtradaNeurologicalNorthern EuropeRegulationSanofiUK

New funding program to support Australian biopharmaceutical manufacturing development

04-04-2014

The first round of a new pilot funding program opens this week in Queensland, Australia, with at least…

Asia-PacificAustraliaBiotechnologyDSM Biologics

Amgen and GSK end marketing agreement for osteoporosis drug Prolia

Amgen and GSK end marketing agreement for osteoporosis drug Prolia

04-04-2014

World leading independent biotech firm Amgen revealed in a Securities and Exchange Commission filing…

AmgenAnti-Arthritics/RheumaticsBiotechnologyGlaxoSmithKlineLicensingProliaXgeva

Baxter to acquire Chatham Therapeutics for $70 million

03-04-2014

USA-based Baxter International says it has agreed to acquire Chatham Therapeutics, a private biotechnology…

Baxter InternationalBiotechnologyChatham TherapeuticsHematologyMergers & Acquisitions

Fast growth forecast for South Korean pharma market

Fast growth forecast for South Korean pharma market

02-04-2014

South Korea's pharmaceuticals market was valued at $20 billion in 2012, growing from $14.5 billion in…

Asia-PacificBiosimilarsBiotechnologyMarkets & MarketingPricingResearch

Pharma is attracted to early-stage antibody deals in oncology

02-04-2014

Today, the top ten best-selling antibody therapeutics for cancer have accumulated revenues approaching…

BiotechnologyLicensingOncology

Second collaboration between FORMA Therapeutics and Celgene

02-04-2014

Privately-held drug discovery firm FORMA Therapeutics has entered a second strategic collaboration and…

BiotechnologyCelgeneFORMA TherapeuticsLicensingMergers & AcquisitionsResearch

MannKind’s diabetes drug Afrezza recommended by FDA advisory

02-04-2014

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationUSA

Unanimous FDA advisory panel backing for Cubist’s Sivextro

Unanimous FDA advisory panel backing for Cubist’s Sivextro

02-04-2014

The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee on Monday voted unanimously…

Antibiotics and Infectious diseasesCubist PharmaceuticalsNorth AmericaPharmaceuticalRegulationSivextrotedizolidUSA

FDA advisory unanimously recommends Durata’s Dalvance

FDA advisory unanimously recommends Durata’s Dalvance

01-04-2014

The US Food and Drug Anti-Infective Drugs Advisory Committee voted 12 to 0 that Durata Therapeutics’…

Antibiotics and Infectious diseasesDalvanceDermatologicalsDurata TherapeuticsNorth AmericaPharmaceuticalRegulationUSA

Prasco to market the authorized generic of Lilly’s Evista in USA

01-04-2014

Privately-held US generics firm Prasco has signed a further deal with US pharma major Eli Lilly to market…

Anti-Arthritics/RheumaticsEli LillyEvistaGenericsMarkets & MarketingNorth AmericaPrasco LaboratoriesUSA

Amarin and Kowa Pharma to co-promote Vascepa in USA

01-04-2014

US biotech firm Amarin Corp and Kowa Pharmaceuticals America, owned by Japan’s Kowa, have reached an…

AmarinBiotechnologyCardio-vascularKowa PharmaceuticalsMarkets & MarketingNorth AmericaUSAVascepa

Paul Sekhri joins Sanofi as Senior Vice President

Paul Sekhri joins Sanofi as Senior Vice President

01-04-2014

Paul Sekhri has joined French drug major Sanofi as Senior Vice President, Integrated Care effective…

BiotechnologyBoardroomPharmaceuticalSanofiUSA

Pancreatic cancer drug market in 6 major markets to see CAGR of 25% to 2017

Pancreatic cancer drug market in 6 major markets to see CAGR of 25% to 2017

01-04-2014

The global pancreatic cancer treatment market value in the six major countries (6MM: the USA, France,…

AbraxaneBiotechnologyCelgeneEuropeMarkets & MarketingOncologyUSA

Executive Q&A: Epigenomics’ chief executive Dr Thomas Taapken

Executive Q&A: Epigenomics’ chief executive Dr Thomas Taapken

01-04-2014

The Pharma Letter interviewed chief executive Dr Thomas Taapken about Epigenomics’ lead product, increasing…

BiotechnologyEpi proColonEpigenomicsGermanyInterviewsOncology

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