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EMA Recommends Eleven New Medicines
The agency’s human medicines committee recommended drugs to treat breast cancer, lupus nephritis, type 2 diabetes and more.
EMA Endorses Statement on International Collaboration of Real-World Evidence
A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.
Hospira Issues Voluntary Recall for One Lot of Propofol Injectable Emulsion, USP
Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.
I Saw the Future of Global Pharmaceutical Production in India
Guest contributor Frederic Kahn discusses the state of the Indian pharmaceutical manufacturing industry.
TFF Pharmaceuticals Expands R&D Operations with New Facility
TFF Pharmaceuticals is expanding its R&D operations with a new facility in Austin, Texas.
PerkinElmer Introduces New Cytometry Management Service
The PerkinElmer Flow Cytometry Instrument Concierge Services will provide biopharmaceutical labs with expert, on-site flow cytometry specialists.
Cytiva Acquires Chromatography Resins Manufacturing Facility in Muskegon, Michigan
Cytiva has acquired a new chromatography resins manufacturing site in the United States as part of its $1.5 billion capacity expansion investment.
Health Canada Authorizes Moderna’s COVID-19 Vaccine in Young Children
Health Canada has authorized Moderna’s COVID-19 vaccine for use in young children aged six months to five years.
Gamesmanship Escalates over FDA User Fee Legislation
US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.
Royalty Pharma Acquires Royalty Rights to COPD/Asthma Treatment for $1.6 Billion
Royalty Pharma is paying $1.6 billion for the royalty rights to Trelegy Ellipta, a treatment for COPD and asthma.
FDA Issues Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted
FDA has granted an Emergency Use Authorization to Novavax’s COVID-19 vaccine.
EMA Publishes Guidance on Preventing Medicine Shortages
The European Medicines Agency guidance highlights key principles and examples of good practices to prevent and manage shortages of human medicines.
Vertex to Acquire ViaCyte for $320 Million
Vertex’s $320 million acquisition of ViaCyte will give the company complementary capabilities for its Type 1 diabetes therapy program.
FDA Regulation of Nonprescription Drugs in Spotlight
Application for OTC contraceptive highlights efforts to broaden access to medicines.
WHO’s Science Council Calls for Equitable Expansion of Genomics
WHO’s Science Council released a report calling for a collective effort to accelerate global access to genomics.
Merck Digital Sciences Studio Supports Early-Stage Startups
Merck, known as MSD outside the United States and Canada, now offers the Merck Digital Sciences Studio, designed to enable innovative tech for drug discovery and development.
Pfizer and Touchlight Enter Patent License Agreement for Use of dbDNA
Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.
Wacker Biotech Expands Germany Site with Construction of New mRNA Competence Center
Wacker is investing more than €100 million (US$100.5 million) to expand its Halle, Germany, site with an mRNA competence center.
Coya Therapeutics Secures Rights to Exosome Engineering Technology from Carnegie Mellon University
Coya Therapeutics has secured intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids.
Bio-Rad Launches CFX Opus Deepwell Real-Time PCR Detection System
Bio-Rad’s CFX Opus Deepwell Real-Time PCR Detection System is designed to support researchers in developing nucleic acid detection assays.
Bio-Rad Launches New Chromatography Column Packs
Bio-Rad’s EconoFit Chromatography Column Packs support resin screening experiments in the development of protein purification workflows.
FDA Drug Regulation Challenged by Anti-Abortion Campaign
Some states look to block access to approved drugs.
VeriSIM Life and Mayo Clinic Team Up to Co-develop New Therapies
VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.
NRG Therapeutics and Domainex Partner on Parkinson’s Disease Drug Development Project
NRG Therapeutics and Domainex aim to develop novel small-molecule drugs to treat neurodegenerative disorders, such as Parkinson’s disease.
LG Chem Renews License with Avacta for IND Studies
LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.
Trends in International Arbitration: The Fallout from COVID-19
As a result of the disruptions caused by the COVID-19 pandemic, global arbitration has adapted to a ‘new normal’.
Process Development Struggles with Molecular Diversity
As we reach further afield in the molecular universe, we encounter new types of problems to resolve.
Bottoms Up! Research into Bowel Cancer Therapies Gain Funding Boost
Dame Deborah James’ legacy and the millions raised through her campaigning will undoubtedly be a big boost to clinical research, ultimately providing new and promising treatments for bowel cancer patients.
How Can We Come Up Short So Often?
Systemic inefficiencies in the pharmaceutical industry undermine problem-solving efforts.
Getinge Launches New DPTE-EXO with Sleeveless DPTE-BetaBag for Aseptic Transfer
Getinge’s new DPTE-EXO with Sleeveless DPTE-BetaBag is an alpha port with an external opening and an integrated funnel for automated aseptic transfer.