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US House Energy & Commerce Committee releases 21 Century Cures Act discussion draft

US House Energy & Commerce Committee releases 21 Century Cures Act discussion draft

28-01-2015

The promised January 2015 release of a discussion draft of legislation to implement the 21st Century…

PatentsPharmaceuticalPoliticsResearchUSA

Amgen and Onyx submit Kyprolis sNDA and marketing authorization application in USA and EU

Amgen and Onyx submit Kyprolis sNDA and marketing authorization application in USA and EU

28-01-2015

USA-based Amgen, the world’s leading independent biotech firm, and its subsidiary Onyx Pharmaceuticals…

AmgenKyprolisOncologyOnyx PharmaceuticalsPharmaceuticalRegulationUSA

iCura Vision licenses macular degeneration portfolio from Columbia Technology Ventures

iCura Vision licenses macular degeneration portfolio from Columbia Technology Ventures

28-01-2015

Ophthalmic specialist iCura Vision has licensed the intellectual property portfolio and associated research…

iCura VisionLicensingOphthalmicsPharmaceuticalUSA

Fourth quarter Bristol-Myers Squibb results disappoint

Fourth quarter Bristol-Myers Squibb results disappoint

27-01-2015

Although the fourth quarter financial results from US drug major Bristol-Myers Squibb beat analyst estimates,…

Bristol-Myers SquibbFinancialPharmaceuticalUnited StatesUSA

US FDA approves Symplmed and Servier’s Prestalia

US FDA approves Symplmed and Servier’s Prestalia

27-01-2015

Privately-held US drugmaker Symplmed Pharmaceuticals says that the US Food and Drug Administration has…

Cardio-vascularPharmaceuticalPrestaliaRegulationServierSymplmedUSA

The FDA should innovate to respond to new health economy, says PwC survey

The FDA should innovate to respond to new health economy, says PwC survey

27-01-2015

Health care product manufacturers are now much more willing to have their products judged based on economic…

FDAFood and Drug AdministrationPharmaceuticalPwCRegulationUSA

Rockwell's Triferic cleared for marketing by US FDA

26-01-2015

The US Food and Drug Administration has approved US biopharma company Rockwell Medical’s Triferic (ferric…

Nephrology and HepatologyPharmaceuticalRegulationRockwell MedicalTrifericUSA

Nicox holds successful pre-NDA meeting with FDA for AC-170

Nicox holds successful pre-NDA meeting with FDA for AC-170

26-01-2015

French ophthalmics company Nicox has held a positive pre-New Drug Application meeting with the US Food…

AC-170NicOxOphthalmicsPharmaceuticalRegulationUSA

Novartis’ meningitis B vaccine Bexsero approved by US FDA

Novartis’ meningitis B vaccine Bexsero approved by US FDA

24-01-2015

On Friday, the US Food and Drug Administration granted accelerated approval of Swiss pharma giant Novartis’…

BexseroNovartisPharmaceuticalRegulationUSAVaccines

US Senator plans legislation to advance medical research

23-01-2015

In remarks at the Families USA Health Action Conference in Washington DC on January 22, US Senator Elizabeth…

FinancialLegalPharmaceuticalResearchUSA

FDA's anti-infective committee recommends Astellas' Cresemba

FDA's anti-infective committee recommends Astellas' Cresemba

23-01-2015

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

Antibiotics and Infectious diseasesAstellasCresembaPharmaceuticalRegulationUSA

High hopes for President Obama’s Indian visit for pharma

High hopes for President Obama’s Indian visit for pharma

23-01-2015

This January 26, India's Republic Day is set to be a momentous one with the country hosting the US President…

IndiaPatentsPharmaceuticalPoliticsUSA

Merck & Co drops marketing of hepatitis C drug Victrelis in USA

Merck & Co drops marketing of hepatitis C drug Victrelis in USA

22-01-2015

In an open letter to pharmacy professions, US pharma giant Merck & Co has advised that it is voluntarily…

Anti-viralsMarkets & MarketingMerck & CoPharmaceuticalUSAVictrelis

US and EU regulatory filings for UCB’s antiepileptic brivaracetam

US and EU regulatory filings for UCB’s antiepileptic brivaracetam

21-01-2015

Belgium’s largest pharma company UCB today announced regulatory filings in the USA and the European…

BRIVARACETAMEuropeNeurologicalPharmaceuticalRegulationUCBUSA

Supreme Court reverses Federal Circuit Court judgment on '808 patent in Teva's Copaxone

Supreme Court reverses Federal Circuit Court judgment on '808 patent in Teva's Copaxone

21-01-2015

The US Supreme Court has reversed the Federal Circuit Court’s judgment on Israel-based Teva Pharmaceutical…

CopaxoneLegalNeurologicalPharmaceuticalTevaUSA

Life sciences companies unprepared for whistleblower lawsuits, survey finds

Life sciences companies unprepared for whistleblower lawsuits, survey finds

21-01-2015

Although health care and life sciences companies are aware that they could be hit with federal “whistleblower”…

DissentFoley Hoag LLPLegalPharmaceuticalUSA

Salix reportedly pursing acquisition, pushed by shareholders

Salix reportedly pursing acquisition, pushed by shareholders

21-01-2015

USA-based Salix Pharmaceuticals is reportedly pursuing acquisition by a large drugmaker.

Mergers & AcquisitionsPharmaceuticalReutersSalix PharmaceuticalsUSA

US FTC approves final order preserving in nicotine patches market competition

US FTC approves final order preserving in nicotine patches market competition

21-01-2015

Following a public comment period, the USA’s Federal Trade Commission has approved a final order settling…

GlaxoSmithKlineHabitrolMergers & AcquisitionsNeurologicalNovartisPharmaceuticalRegulationUSA

Bristol-Myers to promote Caforio to CEO post; other appointments

Bristol-Myers to promote Caforio to CEO post; other appointments

21-01-2015

US pharma major Bristol-Myers Squibb yesterday announced a number of leadership changes approved by its…

BoardroomBristol-Myers SquibbManagementPharmaceuticalUSA

FDA approves Fresenius Kabi’s neostigmine methylsulfate injection

FDA approves Fresenius Kabi’s neostigmine methylsulfate injection

20-01-2015

Fresenius Kabi, a unit of the Germany-headquartered Fresenius Group, has received approval from the US…

FreseniusFresenius Kabineostigmine methylsulfateNeurologicalPharmaceuticalRegulationUSA

US Medicare/Medicaid Administrator quits job

US Medicare/Medicaid Administrator quits job

19-01-2015

Marilyn Tavenner, the Administrator of the USA's Centers for Medicare and Medicaid Services, who supervised…

HealthcareManagementPharmaceuticalThe New York TimesUSA

Court orders SIGA to pay $195,000 in case brought by PharmAthene for Tecovirimat

Court orders SIGA to pay $195,000 in case brought by PharmAthene for Tecovirimat

16-01-2015

The Delaware Court of Chancery has entered its Final Order and Judgment in the case brought by US pharma…

Anti-viralsLegalPharmaceuticalPharmAtheneSIGA TechnologiesTecovirimatUSA

Depomed pays over $1 billion for US rights to Janssen’s Nucynta franchise

Depomed pays over $1 billion for US rights to Janssen’s Nucynta franchise

16-01-2015

US specialty drugmaker Depomed has entered into a definitive agreement to acquire the US rights to the…

DepomedGrunenthalJanssenJohnson & JohnsonLicensingNeurologicalNucyntaPharmaceuticalUSA

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