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1830 to 1854 of 1898 results

Changing of the Guard begins in biotech sector


The biotechnology sector is bracing for change this year as a flurry of "biosimilar" or "biogeneric"…

BiotechnologyGenericsMarkets & MarketingNorth AmericaRegulation

Battle for share of US $8.5 billion in vitro diagnostic market


The US in-vitro diagnostic market, including immunochemistry, molecular diagnostics, point-of-care testing,…

Abbott LaboratoriesMarkets & MarketingNorth AmericaPharmaceuticalRoche

FDA accepts ciclesonide NDA from Nycomed partner Sunovion


Swiss drugmaker Nycomed, the subject of a $13.7 billion takeover bid from Japan’s Takeda (TYO:4502;…

Ciclesonide Inhalation AerosolNorth AmericaNycomedPharmaceuticalRegulationRespiratory and PulmonarySunovion

Blow for Orexigen as regulatory demands see firm put obesity drug Contrave on hold


Shares of US biotech firm Orexigen Therapeutics (Nasdaq: OREX) plunged 33% to $2.13 by afternoon trading…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulation

Johnson & Johnson faces $327 million penalty over Risperdal marketing


Civil penalties amounting to just over $327 million have been announced in the case of State of South…

Johnson & JohnsonLegalNeurologicalNorth AmericaOrtho-McNeil-JanssenPharmaceuticalRisperdal

US Biotech posts small gain in May, says Burrill


It was a quiet month for US biotech with the Burrill Biotech Select Index recording a small 2.8% gain…

BiotechnologyFinancialNorth America

US FDA says use of ARBs for hypertension does not increase risk of cancer


The US Food and Drug Administration stated yesterday that a group of drugs used to control high blood…

Cardio-vascularNorth AmericaPharmaceuticalRegulation

FDA denies Citizen Petition on generic Combivir 180-day exclusivity “First Applicant” issue


Last week, in a seven-page response, the US Food and Drug Administration denied an October 18, 2010 Citizen…

CombivirGenericsLegalLupinNorth AmericaPatentsTeva Pharmaceutical Industries

Health Canada OKs AstraZeneca’s Brilinta and new use for Merck’s Gardasil


Anglo-Swedish drug major AstraZeneca (LSE: AZN) says that Health Canada has approved Brilinta (ticagrelor…

AstraZenecaBrilintaCardio-vascularGardasilMerck & CoNorth AmericaOncologyPharmaceuticalRegulation

Progress Report 2011: Health care renewal in Canada


A new report on Canada's health care performance, released this week by the Health Council of Canada,…

HealthcareNorth AmericaPharmaceutical

CBO Director reviews potential effects of a ban on DTC advertising of new Rx drugs in USA


Direct-to-consumer (DTC) advertising of prescription drugs in the USA has elicited various concerns,…

Markets & MarketingNorth AmericaPharmaceuticalRegulation

MAP Pharma files NDA with US regulator for Levadex in migraine


MAP Pharmaceuticals (Nasdaq: MAPP) has submitted a New Drug Application to the US Food and Drug Administration…

LevadexMAP PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalRegulation

US FDA approves Optimer’s Dificid for C. difficile infection


Following a positive advisory panel recommendation last month, the US Food and Drug Administration has…

Antibiotics and Infectious diseasesCubist PharmaceuticalsDificidNorth AmericaOptimer PharmaceuticalsPharmaceuticalRegulation

US GPhA calls on House Appropriations Committee to protect funding for FDA; welcomes Solicitor General’s action


The USA’s Generic Pharmaceutical Association (GPhA) has written to House Appropriations Committee…

FinancialGenericsLegalNorth AmericaRegulation

Important implications of Abbott win in US patent ruling


US health care major Abbott Laboratories (NYSE: ABT) last week won a US appeals court ruling that will…

Abbott LaboratoriesLegalNorth AmericaPatentsPharmaceutical

Amylin wins first round in squabble with Lilly over diabetes link with Boehringer


In an initial win for US biotech firm Amylin Pharmaceuticals (Nasdaq: AMLN), the US District Court for…

AmylinBoehringer IngelheimDiabetesEli LillyExenatide InjectionLegallinagliptinNorth AmericaPharmaceuticalTradjenta

Canada’s Quebec Province overhauls cancer drug evaluation


The Canadian Province of Quebec, which has the highest incidence of new cancer cases in the country,…

North AmericaPharmaceuticalRegulation

Major stakeholders optimistic about future of drug development, but differ on defining value


Biopharmaceutical executives, managed care executives, physicians and patients with chronic illness foresee…

HealthcareNorth AmericaPharmaceuticalResearch

US Senators accuse Sanofi over lobbying FDA on generic Lovenox


US Senate Finance Committee Chairman Max Baucus (Democrat, Montana) and senior Committee Member Chuck…

Cardio-vascularGenericsLovenoxNorth AmericaPharmaceuticalRegulationSanofi

US Presidential visit to UK underlines cooperation in science, innovation and higher education


The joint statement agreed yesterday by UK Prime Minister David Cameron and US President Barack Obama,…

EuropeJohnson & JohnsonNorth AmericaPharmaceuticalResearch

FTC Files Amicus Brief with US Appeals Court to reverse pay-for-delay ruling


Continuing its battle against pay-for-delay between drug originators and generic makers, the US Federal…

GenericsLegalMerck & CoNorth AmericaPatentsPharmaceuticalSchering-Plough

1830 to 1854 of 1898 results

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