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Pharmexcil calls on India exporters to express concerns on proposed US Drug Safety Enhancement Act


India’s Pharmaceutical Export Promotion Council (Pharmexcil) has asked the country’s exporters…

Asia-PacificNorth AmericaPharmaceuticalRegulation

US pharma and FDA near agreement on PDUFA reauthorization, with 6% hike in user fees


After many months of negotiations with the Food and Drug Administration, the USA’s pharmaceutical…

BiotechnologyFinancialNorth AmericaPharmaceuticalRegulation

EFPIA supports full transparency of clinical data, but with reservations


The European Medicines Agency has carried out a consultation on increased transparency and access to…


US FTC long-awaited final report finds brand-name firms use leverage of authorized generic entry to delay competition


The USA’s Federal Trade Commission this week issued its final report, titled Authorized Generic…

GenericsLegalNorth AmericaPharmaceuticalRegulation

Erbitux and Gilenya added to Australia’s PBS listing


More than 400,000 Australians will benefit from new subsidized medicines, effective September 1, as Minister…

Asia-PacificErbituxGilenyaMerck KGaANeurologicalNovartisOncologyPharmaceuticalPricingRegulation

Roche’s Tarceva Oked in EU for first-line use in a genetically distinct type of lung cancer


Swiss drug major Roche (ROG: SIX) says that the European Commission has approved Tarceva (erlotinib)…


PCMA outlines $100 billion in Rx drug savings in USA


As the USA’s Joint Select Committee on Deficit Reduction examines options to reduce the deficit…

BiotechnologyGenericsHealthcareNorth AmericaPharmaceuticalPricingRegulation

Astellas files for OAB drug mirabegron in USA and Europe


Japanese drug major Astellas Pharma (TYO: 4503) says it has submitted a New Drug Application and Market…

Astellas PharmaBetanisGastro-intestinalsmirabegronPharmaceuticalRegulation

Long-term outlook and predictability key to successful medicines policy for Australia, conference told


A predictable regulatory and reimbursement environment, and a long-term policy outlook are essential…


Public Citizen petitions US FDA to amend generic drug labeling regulations in the wake of Mensing


The US Food and Drug Administration should revise its regulations to allow generic drug manufacturers…

GenericsNorth AmericaPharmaceuticalRegulation

US FDA stalls Novartis Ilaris approval for gouty arthritis, calling for more clinical data


There was a big disappointment, albeit not unexpected, for Swiss drug major Novartis (NOVN: VX) when…

Anti-Arthritics/RheumaticsIlarisNorth AmericaNovartisPharmaceuticalRegulation

NuPathe slumps as US FDA calls for more info on migraine patch Zelrix


Shares in USA-based NuPathe (Nasdaq: PATH) plunged as much as 56% to $1.80 in morning trading yesterday…

NeurologicalNorth AmericaNuPathePharmaceuticalRegulationZeltrix

US FDA approves Pfizer lung cancer drug Xalkori and companion diagnostic from Abbott


The US Food and Drug Administration has approved global drugs behemoth Pfizer’s (NYSE: PFE) Xalkori…

Abbott LaboratoriescrizotinibNorth AmericaOncologyPfizerPharmaceuticalRegulationXalkori

Boehringer and Lilly’s Trajenta approved for type 2 diabetes in Europe


Following a positive European Medicines Agency advisory committee recommendation two is months ago, Independent…

Boehringer IngelheimDiabetesEli LillyEuropePharmaceuticalRegulationTradjentaTrajenta

US FDA approves Shire’s Firazyr to treat acute attacks of hereditary angioedema


After a near unanimous recommendation from an advisory panel earlier this year (The Pharma Letter June…

FirazyrNorth AmericaPharmaceuticalRare diseasesRegulationShire

United Thera’s oral PAH drug treprostinil fails in Ph III study


US biotech firm United Therapeutics (Nasdaq: UTHR) says that preliminary results from its FREEDOM-C(2)…

BiotechnologyRegulationResearchRespiratory and PulmonaryTreprostinilUnited Therapeutics

Shire drops Dermagraft for venous leg ulcers, after Ph III failure


Ireland-headquartered drugmaker Shire (LSE: SHP) says that Advanced BioHealing (ABH), the USA-based regenerative…

Advanced BioHealingBiotechnologyDermagraftDermatologicalsPharmaceuticalRegulationResearchShire

Allergan gets US FDA nod for Botox to treat form of urinary incontinence


There was a boost for US specialty drug firm Allergan (NYSE: AGN) yesterday when the company revealed…

AllerganBotoxNeurologicalNorth AmericaPharmaceuticalRegulation

Spain hopes to save 2.4 billion euros by ordering doctors to Rx generics


As part of moves to reduce the nation’s budget deficit, Spain’s socialist government has passed…


US govt tightens financial conflict of interest rules for medical researchers


The US Department of Health and Human Services this week issued an updated Final Rule on conflict of…

FinancialNorth AmericaPharmaceuticalRegulationResearch

2451 to 2475 of 2536 results

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