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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.
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.
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.
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.
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.
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.
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.
Shimadzu Launches European Innovation Center
The innovations-oriented Think Tank combines academic-scientific and technical expertise to use Shimadzu’s expertise to provide even more customer-focused service.
Covering Global Regulations in a Quality System
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.
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.
