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NovaDel sells ZolpiMist NDA, license and IP to Amherst Pharma

23-09-2014

NovaDel Pharma has sold its insomnia drug ZolpiMist (zolpidem oral spray) New Drug Application to fellow…

Amherst PharmaceuticalsMergers & AcquisitionsNeurologicalNovaDel PharmaPharmaceuticalUSAZolpiMist

US Treasury to crack down on tax inversion M&A deals

US Treasury to crack down on tax inversion M&A deals

23-09-2014

The USA’s Department of the Treasury announced on Monday that it is taking action to reduce the tax…

FinancialMergers & AcquisitionsPharmaceuticalPoliticsUSA

Auxilium Pharma rejects Endo acquisition in favor of QLT deal

Auxilium Pharma rejects Endo acquisition in favor of QLT deal

22-09-2014

Auxilium Pharmaceuticals’ board of directors, after review of the unsolicited $2.2 billion takeover…

AuxiliumCanadaEndo InternationalMen's HealthMergers & AcquisitionsPharmaceuticalQLTUSA

Skyepharma will repay 12.7 million euros ahead of Exparel milestone

Skyepharma will repay 12.7 million euros ahead of Exparel milestone

22-09-2014

UK-based Skyepharma, an oral and inhalation drug delivery company, has given notice to CRC European Loan…

AnalgesiaExparelFinancialPacira PharmaceuticalsPharmaceuticalSkyepharmaUKUSA

Report shows Eylea and Lucentis are equally likely to be covered by payers

Report shows Eylea and Lucentis are equally likely to be covered by payers

19-09-2014

Recently launched anti-vascular endothelial growth factor (VEGF) agent Eylea (aflibercept), from USA-based…

EyleaFinancialGenentechLucentisOphthalmicsPharmaceuticalRegeneron PharmaceuticalsUSA

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

19-09-2014

The US Food and Drug Administration has approved a supplemental New Drug Application for Stendra (avanafil),…

Auxilium PharmaceuticalsMen's HealthPharmaceuticalRegulationStendraUSAVivus

FDA approves Lilly’s Trulicity to treat type 2 diabetes

FDA approves Lilly’s Trulicity to treat type 2 diabetes

19-09-2014

The US Food and Drug Administration yesterday approved pharma major Eli Lilly’s Trulicity (dulaglutide),…

BydureonDiabetesdulaglutideEli LillyPharmaceuticalRegulationTanzeumTrulicityUSAVictoza

Biogen and AbbVie report reduced disease activity with MS drug Zinbryta

Biogen and AbbVie report reduced disease activity with MS drug Zinbryta

18-09-2014

US biotech company Biogen Idec and US pharma giant AbbVie have announced the full results from the Phase…

AbbVieAvonexBiogen IdecImmune systemMultiple sclerosisNeurologicalPharmaceuticalResearchUSAZinbryta

Opportunity for emerging agents in Crohn’s disease, report finds

Opportunity for emerging agents in Crohn’s disease, report finds

18-09-2014

New research from Decision Resources Group has found that only a small proportion of patients with Crohn's…

Anti-Arthritics/RheumaticsBiosimilarsEntyvioHumiraPharmaceuticalRemicadeResearchStelaraUSAXeljanz

AACR report calls for US cancer funding to be a national priority

AACR report calls for US cancer funding to be a national priority

18-09-2014

Declining budgets have slowed the pace of research into cancer, according to a new report from the American…

AbraxaneCyramzaFinancialGazyvaImbruvicaNexavarOncologyPharmaceuticalResearchTafinlarUSAZydelig

FDA approves AstraZeneca’s Movantik for opioid-induced constipation

FDA approves AstraZeneca’s Movantik for opioid-induced constipation

17-09-2014

The US Food and Drug Administration yesterday approved Movantik (naloxegol), an oral treatment for opioid-induced…

AstraZenecaGastro-intestinalsMovantikNektar TherapeuticsPharmaceuticalRegulationUSA

Avanir shares jump 85% on positive AVP-923 clinical trial results

Avanir shares jump 85% on positive AVP-923 clinical trial results

16-09-2014

US CNS specialist Avanir Pharmaceuticals has announced positive results from the Phase II clinical trial…

AvanirAVP-923CNS DiseasesPharmaceuticalResearchUSA

Lilly to pay up to $500 million for AstraZeneca Alzheimer’s candidate

Lilly to pay up to $500 million for AstraZeneca Alzheimer’s candidate

16-09-2014

Anglo-Swedish pharma major AstraZeneca and US peer Eli Lilly have entered an agreement to jointly develop…

AstraZenecaAZD3293Eli LillyLicensingNeurologicalPharmaceuticalResearchUKUSA

FDA accepts Tuzistra XR NDA for full review

FDA accepts Tuzistra XR NDA for full review

15-09-2014

The US Food and Drug Administration has confirmed that the New Drug Application for Tuzistra XR, a prescription…

LicensingPharmaceuticalRegulationRespiratory and PulmonaryTris PharmaTuzistraUSAVernalis

FDA FOCUS: The need for open clinical trial data for FDA approval

FDA FOCUS: The need for open clinical trial data for FDA approval

15-09-2014

In the second of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies…

PharmaceuticalPharmacologyRegulationResearchUSA

Allergan says Pershing’s additional requests for meeting is not “meaningful development”

Allergan says Pershing’s additional requests for meeting is not “meaningful development”

15-09-2014

Hostile takeover target Allergan has said that value is what “really matters” in response to Pershing…

AllerganCanadaFinancialLegalPharmaceuticalUSAValeant Pharmaceuticals International

FDA at last approves weight-management drug Contrave

FDA at last approves weight-management drug Contrave

11-09-2014

After considerable delay, the US Food and Drug Administration late yesterday finally granted approval…

Arena PharmaceuticalsBelviqContraveMetabolicsOrexigen TherapeuticsPharmaceuticalQnexaRegulationTakeda PharmaceuticalsUSAVivus

US Pharma now developing 44 drugs/vaccines for HIV/AIDS

11-09-2014

The USA’s biopharmaceutical research companies are currently developing 44 medicines and vaccines for…

Anti-viralsPharmaceuticalResearchUSAVaccines

New indication for Astellas/Medivation’s Xtandi from US FDA

New indication for Astellas/Medivation’s Xtandi from US FDA

11-09-2014

The US Food and Drug Administration has approved a new indication for the use of Japanese drug major…

Astellas PharmaMedivationOncologyPharmaceuticalResearchUSAXtandi

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