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Now Arriving: CPhI North America
Philadelphia plays host to the exhibits, conferences, and networking activities of CPhI North America on May 16-18, 2017.
Novartis Receives FDA Priority Review for CAR-T Therapy
The company received priority review for its investigational CAR-T therapy to treat leukemia.
FDA Approves First Treatment for Primary-Progressive Forms of Multiple Sclerosis
The mAb is the first approved treatment that targets the progressive form of the disease.
Parker Domnick Hunter to Manufacture Automated Bioprocessing Systems at UK Facility
The facility in Britley will now manufacture the company’s automated systems, enabling the company to better serve European markets and shorten the supply chain.
FDA Approves Dupixent for Atopic Dermatitis
FDA approved Dupixent for the treatment of atopic dermatitis amidst a preemptive lawsuit filed by Sanofi/Regeneron involving the drug and an Amgen patent covering IL-4 inhibitors.
MilliporeSigma Launches Supply Program for Single-Use Systems
The Mobius MyWay portfolio offers off-the-shelf and configured-to-order single-use assemblies.
Singapore Facility Receives FDA Warning Letter
The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.
Experts Propose Licensing Deal to Expand Access to Hep C Therapies
A new report states that wider access to new antivirals for HCV and better screening of patients would help avert 90,000 deaths by 2030.
Plasticell Collaborates with Singaporean Institutions on Stem Cell Research
The company has signed two separate agreements with the Agency for Science, Technology, and Research (A*STAR) and the Nanyang Technological University (NTU) to progress its therapeutic stem cell pipeline.
Regulators and Industry Seek Agreement on ICH Lifecycle Management Standard
Manufacturers and regulators are working to reach consensus on the harmonization of management of postapproval changes.
Permira Funds to Acquire LSNE
Permira will acquire LSNE, a CDMO for the pharmaceutical and medical device markets.
Novimmune Opens Branch Office in Basel
The Basel office will house the clinical development team and other functions to progress the company’s lead compound emapalumab.
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
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.
More Generic Drug Approvals Not Enough
Will new generic drugs bring the cost of medicines down in the way policy makers hope?
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.
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.
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.
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.
