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Pharma associations strongly support Senate bill on FDA User Fees sequestration exemptions

05-08-2013

In the USA last week, Mark Pryor (Democrat, Arkansas), chairman of the Senate Appropriations Subcommittee…

BiotechnologyFinancialGenericsLegalNorth AmericaPharmaceuticalPolitics

Bipartisan Bill exempting FDA user fees from sequestration introduced in USA

22-07-2013

A bipartisan group of US House of Representatives Members last week introduced the FDA Safety Over Sequestration…

BiotechnologyFinancialLegalNorth AmericaPharmaceuticalPolitics

US Court denies re-hearing of Arzerra patent case

16-07-2013

Danish drugmaker Genmab (OMX: GEN) says that the US Court of Appeals for the Federal Circuit has declined…

ArzerraBiogen IdecBiotechnologyGenentechGenmabGlaxoSmithKlineLegalNorth AmericaOncologyPatentsPharmaceutical

PDL files for arbitration for alleged royalties underpayments by Genentech

11-06-2013

USA-based PDL BioPharma (Nasdaq: PDLI) revealed today (June 11) that it has filed a Notice of Arbitration…

BiotechnologyFinancialGenentechLegalPDL BioPharmaPharmaceuticalRoche

Appeals Court rules against EMD Serono over Rebif deal with Pfizer

16-04-2013

Germany's Merck KGaA (MRK: DE) says that a Pennsylvania appeals court has ruled against Merck in deciding…

BiotechnologyEMD SeronoLegalMarkets & MarketingMerck KGaANeurologicalNorth AmericaPfizerPharmaceuticalRebif

Italy's antitrust body investigating Roche and Novartis for alleged cartel

21-02-2013

The Italian antitrust authority has opened a cartel investigation of Swiss drug majors Novartis (NOVN:…

AvastinBiotechnologyEuropeGenentechLegalLucentisNovartisOphthalmicsPharmaceuticalRoche

US government takes steps to expose financial ties between drugmakers and doctors

05-02-2013

After more than a year of prodding from the Senate Special Committee on Aging, the USA's federal government…

BiotechnologyFinancialLegalNorth AmericaPharmaceuticalResearch

US Senator Grassley urges White House to finish Sunshine Act regulations

23-01-2013

US Senator Chuck Grassley (Republican, Iowa) is urging the White House to finalize the Physician Payments…

BiotechnologyLegalNorth AmericaPharmaceuticalRegulation

European Parliament approves unitary patent rules

12-12-2012

Following the historic vote yesterday in the European Union Parliament to approve the unitary patent…

BiotechnologyEuropeLegalPatentsPharmaceutical

Alnylam and Tekmira restructure relationship and settle all litigation in $65 million deal

14-11-2012

USA-based Alnylam Pharmaceuticals (Nasdaq: ALNY) says it has restructured its relationship with Canadian…

Alnylam PharmaceuticalsBiotechnologyFinancialLegalLicensingPharmaceuticalTekmira Pharmaceuticals

"New" CDER Exclusivity Board focuses on clarity and consistency of exclusivity decisions

07-11-2012

The US Food and Drug Administration recently announced that the agency has established within the Center…

BiotechnologyLegalNorth AmericaPatentsPharmaceuticalRegulation

New US bill would provide exclusivity add-on for significant drug combos

04-10-2012

Legislation co-sponsored in the USA by Representatives Brian Bilbray (Republican, California), Carolyn…

BiotechnologyLegalNorth AmericaPharmaceuticalRegulation

US House and Senate reconcile PDUFA reauthorization legislation

20-06-2012

The US Congress has released a reconciled Prescription Drug User Fee Act (PDUFA) reauthorization bill…

BiotechnologyLegalNorth AmericaPharmaceuticalPoliticsRegulation

US Senate passing of FDA Safety and Innovation Act lauded by biotech and pharma industry

28-05-2012

The US Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes…

BiotechnologyFinancialLegalNorth AmericaPharmaceuticalPoliticsRegulation

Pharma companies "must be held fully accountable for defrauding US government," says Public Citizen

23-05-2012

Public Citizen strongly supports a measure proposed by US Senator Bernie Sanders (Independent, Vermont)…

BiotechnologyLegalMarkets & MarketingNorth AmericaPharmaceuticalPolitics

US Senators Burr and Coburn introduce legislation to reform FDA

19-04-2012

US Senators Richard Burr (Republican, North Carolina) and Tom Coburn (Republican, Oklahoma) this week…

BiotechnologyLegalNorth AmericaPharmaceuticalPoliticsRegulation

Bipartisan Bill to strengthen testing of pediatric drugs launched in USA

29-03-2012

US Representative Mike Rogers (Republican, Michigan) this week introduced bipartisan legislation with…

BiotechnologyLegalNorth AmericaPharmaceuticalRegulationResearch

GSK settles with Genentech over ofatumumab patents

28-03-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) has agreed a settlement with Genentech, a unit of Roche (ROG:…

ArzerraBiotechnologyGenentechGenmabGlaxoSmithKlineLegalOfatumumab InjectionOncologyPatentsPharmaceuticalRoche

New IP legislation will encourage medical research in Australia, says trade group

20-03-2012

New legislation overhauling the Australian patent system will encourage medical research and bring Australia…

Asia-PacificBiotechnologyLegalPatentsPharmaceuticalResearch

Roche unit in partial patent deal with Regeneron over Eylea; new indication for Avastin

04-01-2012

Regeneron Pharmaceuticals (Nasdaq: REGN) says it has entered into a non-exclusive license and partial…

AvastinBiotechnologyEuropeEyleaGenentechLegalNorth AmericaOncologyOphthalmicsPatentsPharmaceuticalRegeneronRegulationRoche

Intellect Neurosciences appeals European patent decision

15-12-2011

US neuro drug discovery firm Intellect Neurosciences (OTCBB: ILNS) says that it has filed an appeal regarding…

bapineuzumabBiotechnologyElanIntellect NeuroscienceLegalNeurologicalPatentsPfizerPharmaceutical

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