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High expectations for new US biosimilars following FDA guidance documents

10-05-2012

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

10-05-2012

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

10-05-2012

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

10-05-2012

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

09-05-2012

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

08-05-2012

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?

08-05-2012

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

08-05-2012

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

07-05-2012

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

07-05-2012

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

04-05-2012

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

04-05-2012

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

03-05-2012

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

BiotechnologyEuropeGenzymeLumizymeMyozymeRegulationSanofi

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

03-05-2012

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

02-05-2012

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

BiotechnologyPharmaceuticalRegulationResearch

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

02-05-2012

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

01-05-2012

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

01-05-2012

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

ActelionBiotechnologymacitentanResearchRespiratory and Pulmonary

2201 to 2225 of 2444 results

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