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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.
SAFC Expansions Address Significant Need for Enhanced Manufacturing Capabilities
SAFC’s new ADC wing in St. Louis, MO will feature commercial-scale manufacture of antibody-drug conjugates, and its Carlsbad, CA site will offer enhanced gene-therapy services.
European Fine Chemicals Group to Hold Annual Dinner during CPhI 2015
The dinner will be held on Oct. 14, 2015 during CPhI Worldwide, at the Prado Museum in Madrid.
Rx-360 Establishes Working Group in India
Supply chain consortium establishes a working group to address quality problems in India.
CPhI Istanbul 2015 Scheduled for June 3–5
CPhI Istanbul to feature materials, manufacturing, packaging and contract services solutions.
FDA Advisory Panel Questions Clinical Meaningfulness of Vertex’s Cystic Fibrosis Drug Combo
FDA concludes Orkambi demonstrates a clinical benefit over placebo, but questions the magnitude of the improvement.
Pall to be Acquired by Danaher
Pall has agreed to be acquired by Danaher for $127.20 per share.
Eli Lilly Announces New Innovation Center
Eli Lilly announces that it will establish a drug delivery and device center in Cambridge, Massachusetts.
Juno Expands CAR T-cell Pipeline with $59 Million Acquisition
Juno Therapeutics announces that it will expand its cellular therapies pipeline with the acquisition of Stage Cell Therapeutics for €52.5 million.
Pluristem’s PLX Cells Satisfy Prerequisites for Fast-Track Approval in Japan
Pluristem Therapeutics announces that Japan’s Pharmaceuticals and Medical Devices Agency agreed with its methods for the manufacture of PLX-PAD cells.
Pfizer Acquires Minority Interest in AM-Pharma
Pfizer acquires minority equity stake in AM-Pharma and secures option to acquire remaining equity.
Baxter BioScience Expands Oncology Business
With acquisition of Oncaspar portfolio for leukemia from Sigma-Tau Finanziaria, Baxter BioScience adds an oncology infrastructure and biologic.
Meggle Introduces New High-Functionality Excipient
CombiLac is a lactose-based, co-processed excipient, designed to ease oral solid dosage form development and manufacture in direct compression.
Amphenol Introduces New Advanced Validation System
The new Kaye Validator AVS combines accurate sensor measurements with all GMP requirements for calibration and traceability.
CPhI Istanbul 2015 Puts Turkey in Spotlight
Turkey continues to dominate the MENA pharma region as regional manufactures expand at double-digit pace with the arrival of international players.
FDA Releases Q&A on Biosimilars
The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.