All
Merck Recalls Cholesterol Medicine Due to Packaging Defect
A packaging defect has led to Merck voluntarily recalling all lots of Liptruzet tablets in the United States.
USP Announces Revision Timeline, Effective Date for Elemental Impurities Limits and Procedures
USP announced the approval of General Notices section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements with an official date of Dec. 1, 2015.
CytomX Therapeutics and ImmunoGen to Develop Probody-Drug Conjugates
CytomX Therapeutics and ImmunoGen announce collaboration to develop probody-drug conjugate therapies for the treatment of cancer.
Eurofins Acquires the Discovery and Development Solutions Business of Merck KGaA
Eurofins acquires DDS business of Merck KGaA in order to expand discovery solutions and bioanalytical services.
MedImmune Signs Cancer Pact with Immunocore
MedImmune has entered into a research collaboration with Immunocore to develop novel cancer therapies.
LSNE Completes FDA Inspection
LSNE completes an FDA inspection of its Manchester manufacturing facility.Lyophilization Services of New England (LSNE),
FDA Releases Guidance on the Treatment of CABP
FDA releases guidance on developing drugs for the treatment of community-acquired bacterial pneumonia.
Hemispherx Biopharma Reports Clinical Potential of Treatment for Drug-Resistant Influenza Virus
Research was published describing a natural interferon-alpha for infection control and treatment of drug-resistant H7N9 influenza.
FDA Releases New Guidance on Drug Development Tools
FDA releases guidance on the qualification of drug development tools.
Zymeworks, ImClone Systems to Develop Bi-specific Antibodies
Zymeworks has entered into a licensing and collaboration agreement with ImClone Systems to develop novel bi-specific antibody oncology therapeutics.
GE Acquires Cell Culture Media and Sera Assets from Thermo Fisher Scientific
GE acquires Thermo Fisher-s HyClone cell culture media and sera products, gene modulation technologies, and magnetic beads businesses.
FDA Announces Voluntary Recall from Abrams Royal Compounding Pharmacy
Abrams Royal Pharmacy is recalling all unexpired lots of sterile products dispensed in the US.
Genzyme Receives Complete Response Letter from FDA on Lemtrada Application
Genzyme plans to appeal FDA?s decision that the multiple-sclerosis treatment is not ready for approval.
Baxter Initiates Worldwide Voluntary Recall
Baxter International recalls dextrose injection and four sodium chloride injections.
Pall Corporation to Acquire ATMI's LifeSciences Business for $185 million
Pall Corporation, a solutions provider in filtration, separation and purification, has signed a definitive agreement with ATMI to acquire ATMI's LifeSciences business unit for $185 million.
Merck and GlaxoSmithKline Collaborate on Pazopanib
Merck and GlaxoSmithKline begin clinical trial of pazopanib for the treatment of advanced renal-cell carcinoma.
Bind, Amgen Amend Pact
Bind Therapeutics amends its development and commercialization collaboration agreement with Amgen.
Pfenex Awarded Anthrax Vaccine Contract
Leidos Holdings awards Pfenex a subcontract in support of the development of an anthrax vaccine.
CMC Biologics and OncoSynergy Form Pact
CMC Biologics and OnoSynergy form an agreement from cell-line development.
Pfizer Appoints Head of Vaccines
Pfizer appoints management changes to take effect in 2014.
Pfenex Awarded Anthrax Inspection
Pfizer, Siemens Partner in Companion Diagnostics
Siemens enters agreement with Pfizer to commercialize diagnostic tests for therapeutic products across Pfizer's pipeline.
ProBioGen, Emergent BioSolutions Partner in Vaccine Manufacturing
ProBioGen signs agreement with Emergent BioSolutions for access to ProBioGen's avian AGE1.CR cell line.
FDA and European Medicines Agency Announce Generic-Drug Application Inspections Initiative
FDA and EMA launch initiative to share bioequivalence inspection information.
Pfizer, Teva Settle Patent Litigation on Viagra
Pfizer settles its litigation against Teva Pharmaceuticals regarding Pfizer's patent covering the use of Viagra.
Biogen Idec, Samsung Bioepis Target Anti-TNF Biosimilars in Europe
Biogen and Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, advance plans for anti-TNF biosimilar product candidates.
AstraZeneca Issues Statement on Competitor to Nexium
AstraZeneca issues a statement regarding the launch of esomeprazole strontium in the United States.
MedImmune Collaborates with Johns Hopkins University
AstraZeneca's MedImmune will collaborate with Johns Hopkins University in both biologics and small-molecule projects.
Merck KGaA Expands German Production Facility for Allergopharma Unit
Merck's new facility for aseptic production in Reinbek, Germany is scheduled to be completed in 2016.
Nearly 400 Drugs in Development for Infectious Diseases
Almost 400 new medicines for infectious diseases, including viral infections, bacterial infections, fungal infections and parasitic infections.
