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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.
Study: Software Technology for CRISPR Deletion Experiments
A new software technology, CRISPETa, is designed to assist in the deletion of non-protein coding sections of DNA.
Strategizing a Shortcut to Market
Drug type, potential sales, and ownership factor in the race to get drugs to market.
UKSCB Releases Stem Cell Lines for Development
The UK Stem Cell Bank released validated stem-cell lines for researchers developing novel cell-based therapies for clinical trials.
Trump Blasts FDA “Restraints,” High Drug Prices
President Trump calls for faster FDA approvals and lower drug prices.
The Challenge of IDMP Compliance
Having an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.
Hospira Receives FDA Warning Letter for Repeated Violations
The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.
PharmaCord Launches in Louisville
The new company links and manages aspects of treatment delivery, facilitating access for patients to treatments by serving as a connector between manufacturers, patients, physicians, and payors.
FDA Readies Launch of Quality Metrics
FDA plans to initiate its quality metrics program as industry continues to push back.
Avella Specialty Pharmacy Recalls Sterile Products
Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.
Sanofi and Lonza Partner on mAb Cell Culture Facility in Switzerland
Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.
Endo Pharmaceuticals Recalls Alprostadil
The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.
Thermo to Provide Cryo-TEM Services for NovAliX’s Laboratory
Thermo Fisher Scientific will provide cryo-TEM for small-molecule and biologic drug discovery.
EMA Recommends Six Medicines for Market Approval
The agency’s CHMP recommended six drugs for market approval, including one orphan drug, during its February meeting.
Orphan Drug Natpar Receives EMA Recommendation
The agency’s CHMP recommended conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism.
Sarepta Sells Priority Review Voucher to Gilead for $125 Million
Sarepta sold the priority review voucher for Exondys 51, a controversial treatment for Duchenne Muscular Dystrophy, to Gilead.
