All
FDA Releases Guidance on DNA Reactive Impurities
New guidance complements ICH guidelines on impurities.
Intertek Opens GMP Pharmaceutical Stability Storage Facility in Cambridge, UK
This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.
Generic Opioids Create Policy Issues
Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.
Physician Groups Band Together on Labeling of Biosimilars
Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.
MIT Scientist to Present at BIO 2015
MIT scientist Robert Langer will speak at BIO 2015 on a panel about venture capitalism in biotechnology.
Waters Announces New Mass Spectrometry Technology
Waters announces it will introduce its new technology at the 63rd Society of Mass Spectrometry conference.
Boehringer Gains FDA Approval of COPD Treatment
Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.
Visterra Announces Partnership to Develop a Monoclonal Antibody
Visterra announces partnership with A*STAR to develop VIS513, a monoclonal antibody for the treatment of dengue fever.
EMA Upholds GVK Biosciences Suspension Recommendation
EMA confirms its recommendation to suspend medicines approved based on GVK Biosciences studies.
“Cures” Debate Far From Over
The House Energy Committee’s approval of the 21st Century Cures legislation is only a first step, with critics and collaborators alike lining up to comment.
Mitsubishi Introduces New Plastic Syringe and Vial for Parenteral Pharmaceuticals
OXY-CAPT brings together properties of plastic and glass containers through the combination of oxygen absorption and cyclic olefin copolymer (COP) high barrier layers.
Merus and Selexis Receive Grant for Bispecific Antibody Therapeutics
Merus and Selexis will combine technology platforms to produce colorectal cancer combination therapy.
Medicago Plans Vaccine Facility In Quebec City
Medicago's new production facility will make plant-based vaccines and therapeutics.
CVS Inks Deal to Acquire Omnicare for $12.7 Billion
CVS Health signed a definitive agreement to acquire Omnicare for $12.7 billion to expand its reach to assisted living and long-term care facilities.
House Committee Approves 21st Century Cures Legislation
The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.
Press Adjustments Help Prevent Tableting Problems
Adjusting the tablet press and its systems can prevent manufacturing and product quality problems.
EMA Revises Guideline on Clinical Development Requirements for Fixed Combination Products
The new guideline replaces the previous version-CHMP/EWP/240/95 Revision 1.
CMC Biologics Expands Denmark Facility
The Denmark facility will incorporate CMC’s Bioreactor 6Pack configuration in one manufacturing line.
Compounding Center to Pay $200 Million for Meningitis Outbreak
The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.
Symbiosis Launches Bulk Lyophilization Service
Symbiosis Pharmaceutical Services is now offering a new bulk lyophilization (freeze drying) service in response to increasing demand in the manufacture of bulk intermediates and APIs by lyophilization.
Janssen Expands Partnership with Rutgers for Continuous Manufacturing Research
Janssen pledges $6 million to Rutgers CSOPS for continuous manufacturing research.
Eagle Pharmaceuticals Wins Patent Approval for Rapid Infusion Method
The method patent covers the infusion of bendamustine hydrochloride for the treatment of certain blood cancers.
International Neonatal Consortium Launched
The Critical Path Institute launched a consortium to help develop therapies for newborns.
Emergent BioSolutions Enters Agreement with ProMetic Life Sciences
Emergent gives ProMetic long-term access to its Winnipeg facility.
Alexion to Build Biologics Facility in Ireland
Alexion will construct a biologics facility in Ireland that is its first outside the US.
Endo Acquires Par for $8.05 Billion
The Irish company Endo International announced that it would acquire Par Pharmaceutical for $8.05 billion.
AstraZeneca Invests $285 Million in New Facility
AstraZeneca announces that it will invest $285 million in a new manufacturing facility in Sweden.
Circassia Invests $377 Million in Asthma Specialists
UK-based Circassia invests approximately $377 million on Aerocrine and Prosonix, two companies focused on asthma.
CPhI Worldwide Announces 2015 Expert Panel
CPhI Worldwide announces the 2015 Expert Panel, including 2014 panel veterans and three new members.
FDA Approves First Spray-Dried Biologic
Raplixa fibrin sealant, the first approved spray-dried biologic, is a hemostatic agent that helps control bleeding from small blood vessels during surgery.