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EMA Recommends Three Orphan Drugs for Approval
The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.
EMA Suspends Drugs Associated with Micro Therapeutic Research Labs
The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs
Aptar Pharma’s Preservative-Free Multidose Dispenser Now Available with Allergan’s Eye-Care Medication in the US
Aptar Pharma’s ophthalmic squeeze dispenser is the first and only FDA-approved delivery system for prescription eye-treatment formulations without any preservatives.
FDA Approves Avelumab for Rare Skin Cancer
FDA approved avelumab for the treatment of patients with Merkel cell carcinoma.
Lilly Invests $850 Million in US Manufacturing Operations
The company said it plans to expand diabetes manufacturing facilities in the United States.
EMA Creates Taskforce on Big Data
The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.
Sanofi and Regeneron File Suit Against Amgen in Patent Case
Sanofi and Regeneron are asking a federal court to issue a judgment of non-infringement for Amgen’s ‘487 patent.
Regenerative Medicine Advanced Therapy Designation Launches
In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.
Another Company Receives FDA Warning Letter Citing Repeat Violations
FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.
Thermo Fisher Scientific and the Cell and Gene Therapy Catapult Form Pact to Optimize Advanced Therapy Supply Chain
Fisher BioServices will expand its CryoHub solution by co-locating it with the Cell and Gene Therapy Catapult manufacturing center for seamless supply chain management and to accelerate cell and gene therapy production.
US and Indian Pharmacopeias Collaborate on Drug Quality
The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.
Eurofins Scientific Invests in New UK Facility
The company has invested in a new pharmaceutical chemistry and microbiology facility in Scotland.
BMS and CytomX Expand Collaboration
The companies will be expanding their collaboration to discover novel therapies that will include up to eight additional targets using CytomX’s proprietary Probody platform.
Aptar Pharma Inaugurates Site Expansion in Congers, NY
Aptar Pharma’s newly-expanded site will be used to complete premium injectable elastomeric component manufacturing.
MIT Professor to Present on Continuous Manufacturing for Biologics at CPhI North America 2017
Richard D. Braatz, PhD, will discuss using mathematical models to design a continuous drug manufacturing plant and the differences between batch and continuous operations for biologics.
Hitachi Chemical Purchases PCT From Caladrius Biosciences
Caladrius is selling the remaining percentage of the subsidiary in order to focus on cell therapy development.
Lonza Adds Human and Animal Hepatocytes to Portfolio
The company announced that it would now be offering a portfolio of fresh and cryopreserved human and animal hepatocytes for ADME-Tox testing.
SpacePharma Successfully Completes In-Orbit Experiment
The company said that it has successfully completed its first in-orbit experiment using its miniature end-to-end space laboratory.
JRS Pharma Adds Povidone Product Line
Excipient manufacturer adds three tablet binding and disintegration products.
Labeling and Packaging Problems Found at China Facility
FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd. detailing CGMP deficiencies regarding API repackaging, labeling, and misbranding.
Gerresheimer Modernizes Pfreimd Site
The company is switching to a more powerful and energy-efficient technology at its production site in Pfreimd, Germany.
CMO Pfizer CentreOne Adds Highly Potent Solid Oral Dose to Portfolio
Manufacturing will be carried out at the Pfizer Newbridge, Ireland, facility, which is now part of Pfizer CentreOne’s contract manufacturing network.
Researchers Discover Structure and Mechanism of Human Antibody for Zika Virus
Human antibody for Zika virus could help in the treatment and prevention of the infection.
FDA Warns API Manufacturer about Quality and Data Integrity Issues
The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.
Good Supply Practice Advancements–Big Strides Made by Xavier Health in the Wake of the Heparin Crisis
Transparency between pharmaceutical companies and suppliers and risk assessment efforts are vital to effective supply chain practices.
Optel Vision Launches New Line of Preconfigured Serialization Products
Known as the Fast Series, the company’s new line of preconfigured track-and-trace products are designed to help pharmaceutical companies comply with serialization requirements fast.
Allergan Enters into CRISPR Territory with Editas Partnership
Under the agreement, Allergan will receive exclusive access to five of Editas’ ocular programs.
Single-Use Pumps Reduce Downtime
QF20kSU single-use pumps from Quattroflow are used for applications requiring gentle product handling, high containment, low pulsation, purity, and cleanability.
Gottlieb to Face User Fees, De-Regulation Pressures
Trump’s choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.
Global Regulators Collaborate to Improve Access to Safe Drugs
The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.
