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DPx Launched as Provider of Pharmaceutical Services, Fine Chemicals, and Proprietary Technologies
$2.6 billion transaction combines Patheon and DSM Pharmaceutical to create CDMO, DPx.
FDA Details National Vaccine Plan
HHS plan makes progress in ensuring availability of safe vaccines.
CPhI Report Shows R&D Market Diversifying
CPhI report shows R&D market diversifying with increased partnerships, mergers, and revenue sharing models.
Impact Analytical Expands Michigan Facility
Impact Analytical's facility in Michigan adds staff and instrumentation.
Beckman Coulter Announces Partnership with Wyatt Technology
Beckman Coulter partners with Wyatt Technology to develop and market products for nanoparticle characterization.
Pfizer Initiates Voluntary Recall of Three Antidepressant Prescriptions
Pfizer initiates nationwide voluntary recall of two lots Effexor XR and one lot Greenstone's Venlafaxine HCI.
Johnson Controls Launches Integrated Laboratory Services
Johnson Controls launches Integrated Laboratory Services for R&D facility operations and scientific productivity.
FDA and EMA Extend QbD Parallel-Assessment Pilot Program
Agencies extend successful pilot program to further harmonization of QbD topics.
FDA Approves AstraZeneca Once-Weekly, Pen-Injector Diabetes Treatment
FDA approves the extended-release Bydureon Pen for the treatment of type 2 diabetes.
Novartis Recognizes Rare Disease Day
Novartis calls for more research to understand and find treatments for rare disease.
Waters Marks Ten Years of ACQUITY UPLC With the Introduction of New Products
Waters celebrates ten-year anniversary of the ACQUITY UPLC System.
FDA Releases Guidance on CMC Postapproval Changes
New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.
INTERPHEX 2014: New Partners, New Programs
Conference sessions from PDA and PharmTech expand educational opportunities at INTERPHEX 2014.
Separation of Compliance and Performance Under FDASIA
The root cause of drug shortages is mismanagement of variation.
Control Strategies for Synthetic Therapeutic Peptide APIs—Part I: Analytical Consideration
USP evaluates quality attributes for synthetic peptides.
Lilly Diabetes Donates 91 Scholarships to American Diabetes Association's Summer Camp Program
Lilly Diabetes supports the American Diabetes Association for the seventh year in a row.
MedImmune Announces Research Collaboration with UC SanFrancisco
MedImmune and AstraZeneca enter a three-year collaboration with the Clinical and Translational Science Institute at the UC San Francisco.
FDA Reports Recalls Due to Broken Tablets
Discovery of split and broken tablets led to drug recalls.
New Therapies and Screening for Hepatitis C Are Changing Treatment Landscape
Experts note hepatitis C screening is important for getting care early.
Inflammatory Diseases Explained in Artistic Designs
AbbVie launches art initiative designed to explore impact of chronic inflammatory diseases.
Cyclotron Arrival at MPI Research's Translational Imaging Center
The cyclotron is key component of MPI Research's Translational Imaging Center in Mattawan, Michigan.
Report: Branded Biopharms Most Exposed to Biosimilar Competition
Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition.
FDA Approves Orphan Drug Myalept
FDA approves the orphan drug Myalept for the treatment of leptin deficiency.
Almac Adds New Blistering Technology
Almac has added new blistering technology at their US packaging facility in Audubon, PA, as a solution to ease the transition between clinical and commercial launch of blister products.
Fluid Imaging Technologies Seeks Submissions for Research Grant
Fluid Imaging Technologies calls for submissions for its Life Sciences & Materials Research Grant.
FDA Issues Draft Guidance on NCE Exclusivity Determinations
FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.
Nuevolution Enters License Agreement with Merck
Nuevolution enters a license agreement with a subsidiary of Merck for small molecule compounds.
Ranbaxy Suspends API Shipments from Two Plants in India
Daiichi Sankyo announced suspension of API shipments from Ranbaxy's Toansa and Dewas plants; issues apology to stakeholders.
FDA and EMA Collaborate on Pharmacovigilance
FDA and EMA set up regular meetings to harmonize drug safety actions.
Actavis to Acquire Forest Laboratories
The combined company will create blockbuster product franchises in the central nervous system, gastroenterology, women's health, urology, and cardiovascular therapeutic categories.
