Regulation - Legal

Filter

Current filters:

Legal

Popular Filters

1 to 25 of 91 results

FDA consent decree with Ascend Labs backed by federal judge

FDA consent decree with Ascend Labs backed by federal judge

15-10-2014

A federal judge from the US District Court for the Southern District of Ohio entered a consent decree…

Ascend LaboratoriesGenericsLegalProductionRegulationUSA

UK Bioscience Forum: Incentivize investors to hold their investment for more than 10 years

UK Bioscience Forum: Incentivize investors to hold their investment for more than 10 years

08-10-2014

One of the main messages from the keynote speech at the UK Bioscience Forum by Paul Drayson, chief executive…

BiotechnologyLegalLicensingPatents & Trade marksProductionRegulationResearchSocial IssuesUK

Actavis files ANDA for generic of Purdue's Butrans

Actavis files ANDA for generic of Purdue's Butrans

26-09-2014

Ireland-headquartered generics major Actavis has filed an Abbreviated New Drug Application with the US…

ActavisAnalgesiaBuprenorphineButransGenericsLegalPurdue PharmaRegulationUSA

Bill to increase competition for generic drugs introduced in USA

Bill to increase competition for generic drugs introduced in USA

19-09-2014

US Representatives Steve Stivers (Republican, Ohio) Peter Welch (Democrat, Vermont) on Thursday joined…

GenericsLegalPoliticsRegulationUSA

GPhA calls for feedback and dialogue on US generic legislation

GPhA calls for feedback and dialogue on US generic legislation

18-09-2014

The US Generic Pharmaceutical Association (GPhA) has identified areas in which the Generic Drug User…

GenericsGPhALegalRegulationUSA

Compromised vials of Roche's MabThera found in Germany

Compromised vials of Roche's MabThera found in Germany

15-09-2014

Swiss drug major Roche has said that compromised vials of its arthritis and cancer drug MabThera had…

GermanyHerceptinLegalMabTheraOncologyPharmaceuticalProductionRegulationRoche

Australia's federal court rules that companies can patent genetic material

Australia's federal court rules that companies can patent genetic material

05-09-2014

The Full Bench of the Federal Court of Australia has decided a private company may hold a patent on a…

AustraliaBiotechnologyIntellectual propertyLegalPatentsPharmaceutical sciencesRegulation

Actavis confirms patent challenge for generic Neupro

Actavis confirms patent challenge for generic Neupro

23-08-2014

Ireland-headquartered generics major Actavis on Friday confirmed that it has filed an Abbreviated New…

ActavisGenericsLegalNeuproNeurologicalPatentsRegulationUCBUSA

US Pharma and BIO appeal Alameda Ordinance on drug disposal

US Pharma and BIO appeal Alameda Ordinance on drug disposal

15-07-2014

The counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), joined by the Biotechnology…

LegalPharmaceuticalRegulationUSA

Medac’s Rasuvo approved for RA while Antares’ injunction is denied

Medac’s Rasuvo approved for RA while Antares’ injunction is denied

14-07-2014

USA-based Medac Pharma, a wholly-owned subsidiary of privately-held German firm medac GmbH, says that…

Antares PharmaAnti-Arthritics/RheumaticsLegalMedac PharmaPharmaceuticalRasuvoRegulationUSA

EUCOPE slams French plans to cut spending through off-label drugs

EUCOPE slams French plans to cut spending through off-label drugs

12-07-2014

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) says it is very concerned about legislative…

AvastinEuropeFranceLegalOphthalmicsPharmaceuticalRegulationRoche

France adopts draft law on off-label use of drugs

France adopts draft law on off-label use of drugs

09-07-2014

The French National Assembly yesterday voted on the draft law proposal, which would potentially allow…

AvastinDraft law proposalEuropeFranceLegalOphthalmicsPharmaceuticalRegulationRoche

Teva files citizen petition with FDA regarding Copaxone complexity

Teva files citizen petition with FDA regarding Copaxone complexity

03-07-2014

Teva Pharmaceutical Industries says it has filed a citizen petition regarding the approvability of purported…

CopaxoneLegalNeurologicalPatentsPharmaceuticalRegulationTeva Pharmaceutical IndustriesUSA

FTC amicus brief: Improper use of restricted drug distribution programs may impede generic competition

FTC amicus brief: Improper use of restricted drug distribution programs may impede generic competition

20-06-2014

The US Federal Trade Commission has filed an amicus brief in the New Jersey US District Court explaining…

CelgeneGenericsLegalMylanPharmaceuticalRegulationUSA

EMA to focus on pharmacovigilance and supporting development in 2014

EMA to focus on pharmacovigilance and supporting development in 2014

19-03-2014

The European Medicines Agency has published its work program for 2014 with a focus on legislative developments.

EuropeLegalPharmaceuticalRegulation

BIO urges Indiana Governor to sign Bill on interchangeable biologic medicines

27-02-2014

US trade group the Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF)…

BiosimilarsGenericsLegalNorth AmericaRegulationUSA

AHF claims victory over FDA on Gilead’s PrEP

19-02-2014

The USA-based AIDS Healthcare Foundation (AHF) says it has won another key legal victory late last week…

Anti-viralsBiotechnologyGilead SciencesLegalNorth AmericaRegulationTruvadaUSA

China’s pharma blacklist could be weakened by inconsistent enforcement

China’s pharma blacklist could be weakened by inconsistent enforcement

29-01-2014

Though Chinese regulators are pushing ahead with a blacklisting system to combat bribery in pharmaceutical…

ChinaLegalPharmaceuticalRegulation

Proposed US legislation on biosimilars welcomed by BIO and WBBA

Proposed US legislation on biosimilars welcomed by BIO and WBBA

23-01-2014

The USA’s Biotechnology Industry Organization (BIO) and the Washington Biotechnology & Biomedical Association…

BiosimilarsGenericsLegalNorth AmericaRegulationUSA

Brazil Court annuls marketing approval for sub-standard Taxotere biosimilar

Brazil Court annuls marketing approval for sub-standard Taxotere biosimilar

28-11-2013

The Superior Court of Justice in Brazil recently annulled marketing approval for a sub-standard biosimilar…

BiosimilarsDoxelibGenericsLegalLibra LaboratoryOncologyRegulationSanofiSouth AmericaTaxotere

1 to 25 of 91 results

Back to top