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More than 430 New Medicines in Development for Chronic Diseases
PhRMA announced 430 new medicines in development to treat chronic diseases affecting older Americans.
FDA Issues Warning Letter to GSK Biologicals
GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.
National Bioscience Report Reveals Positive Trends for Bioscience Industry
According to the National Bioscience Report, the US bioscience industry is on course for continued growth.
FDA Approves Antibiotic Treatment
FDA approved Cubist's treatment for skin infections including MRSA.
NIH launches 3D Print Exchange for Researchers
NIH launched 3D Print Exchange, a public website promoting health and science applications of 3D printing.
Shire Confirms Rejection of AbbVie Proposal
Shire reports that AbbVie offer undervalued company.
Arecor and CPI Partner to Enhance Biologics' Compatibility with Containers
Arecor and the Center for Process Innovation (CPI) Biologics are working on a project to enhance the compatibility of biologics with their containers.
FDA Issues Warning Letter to Tianjin Zhongan Pharmaceutical
FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.
Verizon Extends Cloud Data Management Services to Pharmaceutical Sector
New services manage clinical or drug manufacturing data in the Verizon cloud or from data centers.
EDQM Releases 2013 Annual Report
EDQM details the agency?s accomplishments in 2013.
Big Pharma Industry Shrinks While Biotech Booms
Big pharma employment dropped by 3% between 2003 and 2013, according to a new jobs report published by EP Vantage.
FDA Issues Warning Letter to API Manufacturer Apotex Pharmachem India
FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.
NIH and NSF Collaborate on Biomedical Innovation
The National Institutes of Health and the National Science Foundation set up biomedical innovation and business program.
FDA Talks Social Media
FDA issues guidance on the use of social media in regards to prescription drugs.
Hospira Issues Recall Due to Visible Particulates in Vials
Hospira announces a voluntary nationwide recall due to particulates from a glass defect.
ISPE Announces Quality Metrics Pilot Launch
ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.
FDA Issues Guidance on Identifying Suspect Drugs
FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.
FDA Licenses First US Facility for Cell-Culture Influenza Vaccines
Novartis facility becomes the first US site licensed by the FDA to produce cell-culture influenza vaccines.
Catalent and AAPS Announce Winners of Annual Academic Competition
Catalent and AAPS announce the five winners of its annual academic competition.
Research Firm Predicts Negative Impact of Biosimilars
A new report from GlobalData states that biosimilars will overtake the market share after 2019.
Total Facility Solutions Opens Hygienic Fabrication Center
The fabrication facility will supply modular construction to the US life-science market.
Glenmark Pharmaceuticals Opens Monoclonal Antibody Manufacturing Facility
The new mAb manufacturing facility in Switzerland will supply material for clinical development.
FDA Releases Draft Guidance on ANDA Submissions
Draft guidance from FDA includes information essential for the completion of ANDA applications.
Cellectis Enters Agreement With CELLforCURE
Cellectis enters an agreement with CELLforCURE for cGMP clinical manufacturing of allogeneic T-cells.
Merck to Acquire Idenix
Merck acquires Idenix Pharmaceuticals for $3.85 billion.
EMA Changes Guideline on Drug Name Acceptability
EMA publishes revised guideline on the acceptability of names for drugs.
Wockhardt Cited by FDA for Quality Control Failures
FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.
Sartorius Stedim Biotech Launches New Generation of Single-Use Bags, Flexsafe
Innovative polyethylene film sets new benchmark
Roche Acquires Genia Technologies
Genia's DNA-sequencing platform will strengthen Roche's pipeline.
Provence Technologies Acquires Synprosis
Provence Technologies? strengthens its expertise in therapeutic chemistry with acquisition of Synprosis.