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Roche to Acquire Seragon Pharmaceuticals
Genentech's $1.7 billion acquisition of Seargon Pharmaceutical includes portfolio of investigational next-generation oral selective estrogen receptor degraders.
FDA Urged to Preserve Biosimilar Naming Conventions
Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.
BIO 2014 Breaks Partner Meeting Record
BIO 2014 hosted more than 29,000 one-to-one partnering meetings.
EMD Serono and Mersana to Develop Next-Generation Antibody-Drug Conjugates
The collaboration will use Mersana Therapeutics Fleximer technology for antibody-drug conjugates.
EMA Revises Guidance on Advanced Therapies
European Medicines Agency clarifies advanced-therapy medicinal products classification.
FDA Outlines Guidance and Rules for Compounding Drug Products
FDA releases guidance documents and rules on requirements for compounding human drug products.
Merck Collaborates with Bionomics on Alzheimer's Treatments
Merck funds Bionomics with $20 million to progress therapies for cognitive impairment caused by central nervous system disorders
BMS Recalls Coumadin Vials Due to Particulate Matter
Bristol-Myers Squibb issues a voluntary US recall of Coumadin (warfarin sodium) for injection due to presence of particulate matter.
GSK Offers $1 Million Award for Healthcare Innovations
GSK and Save the Children announce criteria for awards that recognize innovation in healthcare for the world"s poorest children.
Covance MarketPlace Connects Biotech with Potential Partners
Covance MarketPlace is designed to enable partnerships between the company's emerging biotechnology and established pharmaceutical clients.
Study Demonstrates Performance of SMARTag Platform
New toxicology study demonstrates decreased mortality and better tolerability of ADC generated with Smartag platform versus conventional technology.
Cytovance Biologics Manufactures AM0010 for ARMO BioSciences
Cytovance Biologics completes GMP manufacture of ARMO BioSciences' lead product.
Aesica Pharmaceuticals S.r.I. Implements Serialization System
Aesica Pharmaceuticals S.r.I. collaborates with QAD to meet China's Food and Drug Administration's shortened serialization deadline.
Rentschler Invests in New Stainless-Steel Bioreactors
Rentschler plans to build two stainless-steel bioreactors to target market supply.
Medicenna Therapeutics Selects Kalon Biotherapeutics To Manufacture New Cancer Drug
Medicenna Therapeutics selects Kalon Biotherapeutics to manufacture a new brain cancer drug for children and adults.
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.