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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.
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.
Allergan Enters into CRISPR Territory with Editas Partnership
Under the agreement, Allergan will receive exclusive access to five of Editas’ ocular programs.
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.
Trump Nominates Scott Gottlieb to Lead FDA
The White House said President Trump will nominate Scott Gottlieb to the position of FDA commissioner.
Gerresheimer Adds Ready-to-Fill Vials to Primary Packaging Portfolio
The ready-to-fill packaging solutions for vials are based on Ompi EZ-fill packaging design.
Chairman of Senate Judiciary Committee Raises Questions Over Auvi-Q Price Tag
Senator Chuck Grassley sent a letter to the Kaléo CEO questioning the drugs high listing price.
FDA Grants Clearance for Clinical Development of UCART19
The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.
FDA Sends Warning Letter to Illinois Manufacturer
The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.
China API Facility Receives FDA Warning Letter
The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.
CDER Director Details Priorities for 2017
Dr. Janet Woodcock said implementation of Informatics Process Management is a priority during the latest Director’s Corner podcast.
BeiGene and GDD Build Biologics Facility in China
BeiGene and the Guangzhou Development District have established a joint venture to build a biologics manufacturing facility in China.
Allergopharma Begins Production at Reinbek Biopharmaceutical Facility
The company made a €42 million investment in a new building at its Reinbek site to support the production of biopharmaceuticals.
MedImmune and Sanofi Pasteur Strike Deal
The companies have entered into an agreement to develop and commercialize a mAb for the prevention of lower respiratory tract illness in young children.
Study Dismantles PhRMA’s Long-Standing Argument on Drug Pricing
A blog posted on Health Affairs on March 7, 2017 presents a study that tested PhRMA’s long-standing argument that high prices for drugs fund research and development in the pharmaceutical industry.
CPhI North America Releases Conference Program Lineup
The conference will include 55 speakers at more than 44 sessions.
EU and US Pledge to Recognize Each Other’s GMP Inspections
The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.
