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US drug approvals lower than previously reported; new study

10-01-2014

The overall success rate for drugs moving through clinical trials to US Food and Drug Administration…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearchUSA

UK MPs express concerns on clinical trial data transparency and Tamiflu stockpiling

UK MPs express concerns on clinical trial data transparency and Tamiflu stockpiling

06-01-2014

The UK House of Commons Public Accounts Committee is calling for all data on drugs being prescribed in…

Anti-viralsNorthern EuropePharmaceuticalRegulationResearchRocheTamifluUK

US global share of biomedical research spending declines, as Asia gains

02-01-2014

The USA’s global share of biomedical research spending fell from 51% in 2007 to 45% in 2012, while…

Asia-PacificChinaFinancialNorth AmericaPharmaceuticalRegulationResearchUSA

Agreement by the European institutions on the text of a new EU Clinical Trial Regulation

Agreement by the European institutions on the text of a new EU Clinical Trial Regulation

20-12-2013

After detailed negotiations, the Committee of Permanent Representatives (COREPER I) the Member States…

EuropePharmaceuticalRegulationResearch

Brazil’s ANVISA and ProGenericos sign cooperation agreement

Brazil’s ANVISA and ProGenericos sign cooperation agreement

18-12-2013

Brazil's National Health Surveillance Agency, ANVISA has signed a memorandum of technical and operational…

BiosimilarsBrazilGenericsRegulationResearchSouth America

OncoMed CEO presses for better environment for biopharma innovation, at House hearings

13-12-2013

The case for encouraging biopharma innovation was presented yesterday at the US House Committee on Oversight…

BiotechnologyNorth AmericaOncoMed PharmaceuticalsPoliticsRegulationResearch

Industry and others warn on upholding competitive clinical trial authorization timelines

Industry and others warn on upholding competitive clinical trial authorization timelines

27-11-2013

Improving the attractiveness and competitiveness of Europe as a prime location for clinical research…

EuropePharmaceuticalRegulationResearch

Orexigen to resubmit US NDA for obesity drug Contrave

26-11-2013

Along with presenting new data for its weight loss drug candidate Contrave (naltrexone SR and bupropion…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulationResearchTakeda Pharmaceuticals

New legislation for regenerative medicine in Japan

New legislation for regenerative medicine in Japan

22-11-2013

The Japanese legislature (Diet) has approved new legislation targeted at regenerative medicine therapies.…

Asia-PacificBiotechnologyCytori TherapeuticsLegalRegulationResearch

Australia’s TGA streamlines adverse event reporting

21-11-2013

Australia’s medicines regulator the Therapeutic Goods Administration (TGA) has introduced a streamlined…

Asia-PacificPharmaceuticalRegulationResearch

Following talks with FDA, Sanofi drops fedratinib development

Following talks with FDA, Sanofi drops fedratinib development

18-11-2013

French drug major Sanofi this morning revealed its decision to halt all clinical trials and cancel plans…

fedratinibOncologyPharmaceuticalRegulationResearchSanofi

UK expert group calls for earlier patient access to medicines

17-11-2013

In a report published Friday (November 15) by the UK’s Medicines and Healthcare Products Regulatory…

EuropePharmaceuticalRegulationResearch

EMA staffers see excessive risk aversion in medicines regulation as a problem

EMA staffers see excessive risk aversion in medicines regulation as a problem

15-11-2013

Excessive risk aversion in regulatory decision-making on medicines is not in the best interest of patients…

EuropePharmaceuticalRegulationResearch

Sarepta plunges as FDA questions eteplirsen trial results

Sarepta plunges as FDA questions eteplirsen trial results

12-11-2013

Shares of US RNA-based drug developer Sarepta Therapeutics plummeted in pre-market trading on November…

BiotechnologydrisaperseneteplirsenGlaxoSmithKlineNorth AmericaRare diseasesRegulationResearchSarepta Therapeutics

UK study shows increasing levels of disclosure for industry-sponsored clinical trials

UK study shows increasing levels of disclosure for industry-sponsored clinical trials

12-11-2013

The publication this week of a study assessing clinical trial transparency is a baseline on the current…

EuropePharmaceuticalRegulationResearch

Curis plunges on negative CUCD-427 news; 3rd-qtr loss down

07-11-2013

Oncology focussed US biotech firm Curis saw its shares sink 21% to $3.08, after it revealed receipt of…

BiotechnologyCUCD-427CurisFinancialNorth AmericaOncologyRegulationResearch

US orphan status for Pharmalink’s Busulipo

US orphan status for Pharmalink’s Busulipo

29-10-2013

Swedish specialty pharma group Pharmalink says its product Busulipo, (busulfan), a best-in-class conditioning…

BusulipoNefeconNephrology and HepatologyNorth AmericaOncologyPharmaceuticalPharmaLinkRegulationResearch

Rigel sees clear forward path for fostamatinib but will drop R333

25-10-2013

Clinical-stage US drug developer Rigel Pharmaceuticals has announced mixed updates on two of its pipeline…

BiotechnologyDermatologicalsfostamatinibImmunologicalsR333RegulationResearchRigel Pharmaceuticals

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

25-10-2013

Merck & Co yesterday provided an overview of the clinical trial program for V503, the company’s investigational…

Merck & CoNorth AmericaPharmaceuticalRegulationResearchV503Vaccines

Ariad stops Ph III Iclusing trial on blood clot woes

18-10-2013

US biotech firm Ariad Pharmaceuticals’took another tumble, falling 35% to $2.91, as the company said…

Ariad PharmaceuticalsBiotechnologyIclusigNorth AmericaOncologyRegulationResearch

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