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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.
PwC Report Examines Data Integrity Issues in Pharma
The report examines the increased number of companies cited by regulators for data integrity issues.
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.
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.
Article Details New 3D Modeling and Data Extraction Technique
A new 3D modeling and data-extraction technique Improves X-ray crystallography analysis of proteins.
Packaging Alliance Brings Aseptic Filling Solutions to Market
The Matrix Alliance was formed by Vanrx Pharmasystems with inaugural members ARaymond Life, Daikyo Seiko, Datwyler Group, Ompi, Schott AG, Schott Kaisha and SiO2 Medical Products.
FDA Releases Draft Guidance on Evaluating Abuse Deterrence of Generic Solid Oral Opioid Drugs
The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.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.
MMIP Launches Advanced Therapy Manufacturing Taskforce
The taskforce will work to identify opportunities to advance therapy manufacturing and the supply chain in the UK.
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.
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.
Pharmapack Europe Addresses Key Industry Trends
The conference discussed key industry issues including serialization, innovation, and patient-centricity.
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.
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.
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.
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.
EMA Elects Chair of Management Board
The European Medicines Board elects Christa Wirthumer-Hoche as chair of their Management Board.
PhRMA Releases New Policy Solutions for Delivering Innovative Treatments to Patients
PhRMA says the proposals are aimed at modernizing the drug discovery and development process, promoting value-driven health care, engaging and empowering consumers, and addressing market distortions.
ANGUS Unveils a New Division
ANGUS reveals ANGUS Life Sciences as a new company division that will serve pharmaceutical, biotechnology, and agriculture markets.
GSK CEO to Retire in March 2017
Sir Andrew Witty, CEO of GlaxoSmithKline, has said that he plans to retire from the company in March 2017, after nearly ten 10 years in the position.
Spark Therapeutics Acquires Genable Technologies
The companies say the acquisition will assist in expediting the clinical development of RhoNova, a potential treatment targeting rhodopsin-linked autosomal dominant retinitis pigmentosa.
AAI Pharma and Cambridge Major Laboratories Rebrand as Alcami
With a new name formed from the legacy company names, Alcami offers development services, analytical testing, and API and finished drug development and manufacturing.
CDER Revises MAPP on Prioritization Review of ANDAs
CDER is now prioritizing review of generic drug products for which there is only one approved drug product on the market.
