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Baxter Issues Recall Due to Particulate Matter
Baxter Healthcare has initiated a nationwide recall of more than 20,000 containers of a pre-mixed beta blocker due to the presence of particulate matter.
EMA Recommends 39 Drugs in First Half of 2014
The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.
FDA Publishes Guidance on ANDA Submissions
FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.
Biotech Industry Forms International Council
New International Council on Biotechnology Associations advocates biotechnology growth.
Catalent Marks 40 Years in Japan with New Investments and Country Leader
Catalent appoints a new country leader and expands facilities.
Hospira Acquires Orchid's API Manufacturing and R&D Facilities
Hospira acquires assets from Orchid Chemicals & Pharmaceuticals for $218 million.
FDA Approves Drug for Non-Hodgkin Lymphoma
The FDA approved Beleodaq for the treatment of patients with peripheral T-cell lymphoma.
Novartis Personalized Cell Therapy Receives FDA Breakthrough Therapy Designation
FDA grants breakthrough therapy designation to Novartis chimeric antigen receptor therapy.
Multifactor Non-linear Modeling for Accelerated Stability Analysis and Prediction
The right approach can provide a clear, statistically defendable method for determining dissolution and accelerated stability.
FDA Urged to Preserve Biosimilar Naming Conventions
Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.
Benefits and Risks of Drug Information on Social Media
FDA draft guidances seek to maintain accurate drug information for patients in new media.
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.
Securing the Supply Chain
Regulators and industry leaders take on the task of securing the drug supply chain.
Kentucky Oncology Practice Pleads Guilty to Buying and Selling Unapproved Drugs
The oncology center and its manager were charged with obtaining and selling unapproved, potentially counterfeit, cancer-treatment drugs.
FDA Outlines Guidance and Rules for Compounding Drug Products
FDA releases guidance documents and rules on requirements for compounding human drug products.
Sandoz Commits to New UN Program to Combat Child Mortality
Sandoz will supply antibiotic to developing countries as part of the United Nations' Every Newborn Action Plan.
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
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.
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.
Biotage Launches Accelerated Chromatographic Isolation
Biotage has launched a purification technology, Accelerated Chromatographic Isolation (ACI), which converts simple flash purification into a faster and more economical way to isolate pure compounds.
Outcome Report on European Collaboration between Regulators and HTA Bodies
This work marks the first joint project between regulators and HTA bodies on a European level and is part of their ongoing dialogue to support policymaker decisions in the future.
Onyx to Invest in Continuous Flow Technology
Onyx Scientific has announced plans to invest in continuous flow manufacturing to allow its customers to explore alternatives during product research and development programs.
PolySciTech's SpinSwiper Could Speed Up Production of Controlled-Release Microparticles
PolySciTech's new launch, SpinSwiper, has the potential to speed up microparticle production.
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.
Study Demonstrates Performance of SMARTag Platform
New toxicology study demonstrates decreased mortality and better tolerability of ADC generated with Smartag platform versus conventional technology.
Covance MarketPlace Connects Biotech with Potential Partners
Covance MarketPlace is designed to enable partnerships between the company';s emerging biotechnology and established pharmaceutical clients.
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.
Frontage Labs Plans Expansion of CMC Facility
Frontage Labs will expand its CMC facility in Exton, PA.
