All
Novartis Receives Third FDA Breakthrough Designation
FDA has granted Novartis breakthrough therapy designation to BYM338 for sporadic inclusion body myositis.
INTERPHEX and PDA Announce Sponsorship Agreement
INTERPHEX and the Parenteral Drug Association (PDA) announced a three-year sponsorship agreement, which aligns the objectives of both organizations to service key needs of the global pharmaceutical and biopharmaceutical industry.
FDA Reviews Outdated Guidance Documents
CDER withdraws some outdated guidance documents and makes plans to finalize others.
EMD Millipore, PharmaCell Collaborate on Large-Scale Bioreactor Production of Stem Cells
EMD Millipore and PharmaCell have entered into a collaboration to develop optimized large-scale expansion and harvest of HepaRG cells using bioreactor technology.
Alice E. Till Selected AAPS President-Elect
Till, a PhRMA vice president, will lead AAPS starting in November; Executive Council and Section leadership positions were also announced.
Amgen and Servier Complete Product Collaboration Transaction
Amgen, Servier collaborate ivabraline and other cardiovascular products.
FDA Warns of Possible Contamination of Sterile Products from Compounding Pharmacy
FDA receives adverse event reports related to calcium gluconate infusions.
NIH, Lacks Family Reach Understanding on Genomic Data of HeLa cells
New NIH policy requires researchers to apply for access to the full genome sequence data from HeLa cells.
ScinoPharm, Sundia MediTech Partner for Pharma Outsourcing in China
ScinoPharm Changshu Pharmaceuticals and Sundia MediTech form an alliance for contract research and manufacturing services in mainland China.
Lonza Licenses Gene Expression Technology to Sorrento
The companies sign a nonexclusive research license agreement, giving Sorrento's access to Lonza's GS Xceed Gene Expression System.
Gallus Biopharmaceuticals Enters Clinical Supply Agreement with Genzyme for Niemann Pick Type B Disease
Gallus Biopharmaceuticals has signed a development and manufacturing supply agreement with Genzyme.
FDA Issues Final Guidance for Oversight of Clinical Investigations
The guidance describes a risk-based approach to monitoring of clinical trials.
Oncobiologics and InVentive Health Clinical Form Biosimilars Pact
The companies initially focused on five biosimilar products.
LSNE Successfully Completes MHRA Inspection
Lyophilization Services of New England (LSNE) received a Certificate of GMP Compliance for its New Hampshire facility.
uniQure to Build Therapy Production Plant in US to Leverage AAV Manufacturing Strength
uniQure B.V. announced it has commenced build-out of a 55,000 ft2 US manufacturing plant in Lexington, Mass.
Rentschler to Produce Apeiron's Monoclonal Antibody APN311
Rentschler Biotechnologie will manufacture GMP material for advanced clinical studies and market supply of Apeiron's lead program, APN311.
Pfizer Licenses Potelligent CHOK1SV Cell Line
The licensed cell line combines BioWa's engineered glycosylation Potelligent Technology with Lonza's GS Gene Expression System.
Grant Funds Development of a Novel Malaria Vaccine
iQur and the Edward Jenner Institute for Vaccine Research announced that that they will receive a grant of 152,000 EUR ($201,523) from the Technology Strategy Board's Biocatalyst fund to develop a novel malaria vaccine.
Immunovaccine Secures $5 Million Loan to Support Clinical Stage Cancer Vaccines
A loan from the Province of Nova Scotia will support Immunovaccine's clinical studies through 2016.
iQur Leads Major European Project to Develop a Universal Influenza Virus Vaccine
iQur announced that it has been granted 5 million EUR ($6.6 million) by the European Union Framework 7 fund to develop a universal influenza vaccine.
ICH Guideline for Elemental Impurities Moves to Step 2b
A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.
Convergence Pharmaceuticals Receives Orphan-Drug Designation for Nav1.7 Blocking Pain Drug CNV1014802
Designation granted by FDA for the treatment of trigeminal neuralgia.
FDA Publishes Generic-Drug User Fees
FDA releases FY 2014 generic-drug user fees.
EMA Reorganizes
EMA restructures organization.
EMA Seeks Public Consult on Bioequivalence Concept Paper
EMA releases concept paper on development of product-specific guidance on demonstration of bioequivalence.
Pfizer to Create Separate, Internal, Innovative and Value Businesses
Pfizer has announced plans to internally separate its commercial operations into three business segments.
New Modular Vaccine Design Combines Existing Vaccine Technologies
A new method of vaccine design, called the Multiple Antigen Presentation System (MAPS), may result in vaccines that bring together the benefits of whole-cell and acellular or defined subunit vaccination.
Bristol-Myers Squibb and Samsung BioLogics Announce Biopharmaceutical Manufacturing Relationship
Bristol-Myers Squibb Company and Samsung BioLogics announced the companies have entered into a 10-year agreement.
Wyeth Fined $490.9 Million for Unlawful Marketing of Rapamune
Wyeth Pharmaceuticals has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by FDA.
Scientists Discover New Targets for Breast Cancer
Scientists at A*STAR's Genome Institute of Singapore (GIS) have identified genes that could be potential targets for anticancer agents in the treatment of aggressive breast cancer.
