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Study shows benefit of new maintenance therapy for multiple myeloma


Multiple myeloma is a form of cancer where the plasma cells in the bone marrow grow out of control, causing…


FDA advisory thumbs up for Gilead's once-daily Quad for HIV


There was more good news for Gilead Sciences (Nasdaq: GILD), the world's largest maker of HIV drugs,…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalQuadRegulation

Cell Therapeutics' Pixuvri cleared in EU for NHL


US biotech firm Cell Therapeutics (Nasdaq and MTA: CTIC) last week received conditional marketing authorization…

BiotechnologyCell TherapeuticsEuropeOncologyPharmaceuticalPixuvriRegulation

UK's Proximagen boosted by US lorcaserin news with respect to its own obesity drug candidate


UK-based biotechnology firm Proximagen (AIM: PRX) saw its shares leap 20.1% to 257.5 pence, on the back…


Big pharma and biotech increasingly tackling rare and niche diseases, new report finds


Rare and niche diseases are being increasingly spotlighted by pharmaceutical and biotechnology corporations…

BiotechnologyPharmaceuticalRare diseasesResearch

Oncologists backing of combo products supporting cytotoxic market


The popularity of combination therapies in the treatment of cancer is set to increase, which will help…

BiotechnologyGemzarMarkets & MarketingOncologyPharmaceuticalTaxotere

US FDA warns on safety of Celgene's Revlimid; new Ph III trial results


The US Food and Drug Administration this week issued a notification of an increased risk of second primary…


High expectations for new US biosimilars following FDA guidance documents


In light of the upcoming FDA guidance for biosimilar approval, Novation, health care supply chain expertise…

BiotechnologyGenericsNorth AmericaPricingRegulation

US drug sponsors' regulatory experience was mixed during PDUFA IV, says Tufts CSDD


Drug sponsors experienced a mixed regulatory burden under the Food and Drug Administration Amendments…

BiotechnologyNorth AmericaPharmaceuticalRegulation

Empty pipelines drive deal valuations in pharmaceuticals sector, say IMAP


A drought of domestic growth opportunities and new products is inflating valuations for R&D companies…

BiotechnologyMergers & AcquisitionsPharmaceuticalResearch

Sandoz to emphasize need for consistent regulatory standards across all biologics at FDA hearings


Germany-based Sandoz, the generics unit of Swiss drug major Novartis (NOVN: VX) announced that Mark McCamish,…

BiotechnologyGeneralNorth AmericaNovartisRegulationResearchSandoz

GlaxoSmithKline goes on attack over Human Genome bid


UK pharma giant GlaxoSmithKline (LSE: GSK) went into attack mode this morning, taking its unsolicited…

BiotechnologyGlaxoSmithKlineHuman Genome SciencesMarkets & MarketingPharmaceutical

Intellect Neurosciences adds to its Alzheimer's development pipeline


US biopharma firm Intellect Neurosciences (OTCBB: ILNS) has announced two new programs in its Alzheimer's…

BiotechnologyIntellect NeuroscienceLicensingNeurological

Therapeutic monoclonal antibodies market - Is Biologics the answer to rising disease incidence?


Existing adoption rates and commercial success of launched monoclonal antibodies (MAbs) for therapeutics…

BiotechnologyEuropeMarkets & Marketing

Sunshine Act data collection delayed to January 2013, says USA's CMS


In a web site posting last week, The US Center for Medicare and Medicaid Services (CSM) announced that…

BiotechnologyNorth AmericaPharmaceuticalPoliticsRegulation

Life sciences M&A activity heats Up in April, says Burrill & Co


April proved to be a big month for M&A activity in the life sciences as companies announced more than…

BiotechnologyFinancialMergers & AcquisitionsPharmaceutical

US NIH debuts collaborative program with Pharma to spur therapeutic development


The US National Institutes of Health last week unveiled a collaborative program that will match researchers…

AstraZenecaBiotechnologyEli LillyNorth AmericaPfizerPharmaceuticalResearch

GAO report finds that USA's FDA has met most PDUFA performance goals


A report dated March 30 but only released earlier this week by the US Government Accountability Office…

BiotechnologyNorth AmericaPharmaceuticalRegulation

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