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SGS and DiscoverX to Collaborate on the Qualification and Supply of Bioassays
The companies will provide assays for functional comparability, for use in quality control, lot release, and stability testing of biosimilars and biobetters.
GE Healthcare Launches New Research Scheme in Turkey
The new research scheme will be based in GE’s Turkey-based innovation center, and will help support the region’s biopharmaceutical industry.
Biotech Manufacturers Explore Global Access and Supply Chain Hurdles
Industry is joining with academia and global health leaders to examine new approaches to biotech manufacturing.
Boehringer Ingelheim Enters Commercial Partnership with Propeller Health
The commercial partnership aims to use digital health tools including sensors, apps, analytics, personal feedback, and education to assist patients in monitoring respiratory diseases.
FDA Approves Teva’s Cinqair for the Treatment of Severe Asthma
Cinqair is approved for patients that have a history of severe asthma attacks despite receiving their current asthma medication.
FDA Approves Ixekizumab for Treatment of Moderate-to-Severe Plaque Psoriasis
The drug is marketed by Eli Lilly in the US, and will be available at the beginning of the second quarter of 2016.
National Science Foundation Grant Goes to the Development of a Light-Scattering Technology
A $1.1-million NSF grant awarded to Advanced Polymer Monitoring Technologies will be used for the development of a characterization technology for monitoring aggregation in biopharmaceuticals.
PwC Report Examines Data Integrity Issues in Pharma
The report examines the increased number of companies cited by regulators for data integrity issues.
Bristol-Myers Squibb Collaborates with Bioprocessing Institute in Ireland
A team of Bristol-Myers Squibb scientists will work in a new laboratory at the National Institute of Bioprocessing Research and Training facility in Dublin, Ireland.
Novo Nordisk Builds Manufacturing Facility in North Carolina
Novo Nordisk broke ground on a facility in Clayton, NC, to manufacture APIs for GLP-1 and insulin medicines.
Article Details New 3D Modeling and Data Extraction Technique
A new 3D modeling and data-extraction technique Improves X-ray crystallography analysis of proteins.
FDA Releases Draft Guidance on Evaluating Abuse Deterrence of Generic Solid Oral Opioid Drugs
The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.
CMC Biologics and IDT Biologika Collaborate on ADC Manufacturing
Collaboration will provide for unified development and manufacture of antibody drug conjugates.
Vetter Breaks Ground on New Production Facility
The company broke ground on a $79 million production facility at its Ravensburg Schuetzenstrasse site.
Inhalational Anthrax Treatment, Anthim, Receives FDA Approval
The BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.
Novasep and GTP Partner on Monoclonal Antibody Development
The partnership aims to facilitate the development of therapeutic and diagnostic candidates for European biopharmaceutical clients.
Market Opportunities to be Explored at CPhI Japan
Generic drugs, market access, and foreign manufacturing are conference topics at CPhI Japan 2016.
BioOutsource Introduces Biosimilarity Assays for Lucentis, Stelara, and Actemra
The ready-to-use assays are specifically designed for companies looking to characterize their biosimilar products in the pipeline.
Pharmapack Europe Addresses Key Industry Trends
The conference discussed key industry issues including serialization, innovation, and patient-centricity.
Pfizer Joins the Human Vaccines Project
The Human Vaccines Project brings together academic research centers, industrial partners, nonprofit organizations, and governments to address the primary scientific barriers to developing new vaccines and immunotherapies.
FDA Enhances Label Warnings for Immediate-Release Opioids
The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.
Hospira Recalls Sodium Bicarbonate Injection
Hospira recalls one lot of 8.4% Sodium Bicarbonate Injection, USP, due to particulate matter found within a single-dose glass fliptop vial.
European Pharmacopoeia Revises WFI Monograph
The agency now allows production of water for injection by non-distillation technologies.
Cellectis and MabQuest Collaborate on New Class of Monoclonal Antibodies
The new class of mAbs differs from approved anti-PD 1 mAbs because they do not block the PD-1-PD-L1 interaction.
Studies Demonstrate Remsima Efficacy and Safety Following Switch from Infliximab
The studies, conducted across eight countries with nearly 600 inflammatory bowel disease (IBD) patients, further support claims by Celltrion that Remsima is highly similar its reference product.
FDA Issues Warning Letter to Indian Facility
The agency cited Emcure Pharmaceuticals with CGMP violations.
Gyros AB and Protein Technologies Merge to Form Gyros Protein Technologies AB
The merger creates a provider of sample prep, synthesis, and bioanalytical tools for biotherapeutics discovery, development, and manufacturing.
NIH Investigational Dengue Vaccine Proves 100% Effective
During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.
FDA Approvals Kovaltry for the Treatment of Hemophilia A
Kovaltry is an unmodified, full-length recombinant factor VII product used to treat hemophilia A in adults and children.
EMA Elects Chair of Management Board
The European Medicines Board elects Christa Wirthumer-Hoche as chair of their Management Board.
