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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

New biologics and biosimilars approval guidelines in Mexico


In Mexico, new guidelines are now in effect for the market authorization of biologics and biosimilars,…

BiotechnologyGenericsRegulationSouth America

Genzyme gains FDA and EMA approval for Irish production plant


US biotech firm Genzyme, a subsidiary of French drug major Sanofi (Euronext: SAN) said yesterday that…


Unmet needs in orphan diseases therapy offer opportunity for Big Pharma; report


Patients suffering from orphan diseases can look forward to a wider range of drug options in the future,…

BiotechnologyMarkets & MarketingPharmaceuticalRare diseasesResearch

Patient perspectives influencing drug development


Support is growing for increased collaboration between pharmaceutical companies and patients in research…


Biogen Idec 1st-qtr sales up 7% but fail to match expectations


US biotech company Biogen Idec (Nasdaq: BIIB) post first-quarter 2012 sales of $1.29 billion, a rise…

Biogen IdecBiotechnologyFinancial

New business model to relaunch the BioPharma industry, from ADL


Traditionally, clinical diagnoses and treatments have focused on diseases and cures. For every ailment,…

BiotechnologyManagementMarkets & MarketingPharmaceutical

Actelion's macitentan meets primary endpoint in pivotal Phase III PAH study


Europe's largest biotech company, Actelion (SIX: ATLN), says that initial analysis indicates that the…

ActelionBiotechnologymacitentanResearchRespiratory and Pulmonary

Biopharmaceuticals "no longer a growth market" in Germany


After years of consistent growth, the German biopharmaceuticals market came to a juddering halt last…

BiotechnologyEuropeMarkets & MarketingPharmaceuticalPoliticsPricingRegulation

FDA stalls Amgen's Xgeva sBLA for prevention of bone metastases


USA-based Amgen (Nasdaq: AMGN) revealed on Friday that the US Food and Drug Administration has issued…

AmgenBiotechnologyNorth AmericaOncologyRegulationXgeva

BIO asks US House Committee on Ways and Means to extend critical tax provisions; backs Obama Bioeconomy Blueprint


US trade group the Biotechnology Industry Organization (BIO) has submitted a statement for the record…

BiotechnologyFinancialNorth AmericaPolitics

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