Industry News
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.
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.
FDA Regulation of Nonprescription Drugs in Spotlight
Application for OTC contraceptive highlights efforts to broaden access to medicines.
FDA Drug Regulation Challenged by Anti-Abortion Campaign
Some states look to block access to approved drugs.
US Government to Support Expansion of Croda Lipid Systems Capability
Croda has entered into an agreement with the US government to support the expansion of its lipid systems capability.
FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses
Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.
Cosentyx Receives Expanded Approvals in EU for Use in Childhood Arthritic Conditions
The European Commission has approved Cosentyx for the treatment of various childhood arthritic conditions.
Xenpozyme Approved by EC for the Treatment of ASMD
The European Commission has approved Xenpozyme as the first treatment for ASMD.
FDA Releases Action Plan for Rare Neurodegenerative Diseases
The action plan will span over five years and will fulfill a requirement of the Accelerating Access to Critical Therapies for ALS Act.
Regulators Seek More Drug Effects Research Related to Pregnancy and Lactation
Regulators wish to expand and clarify methods for obtaining information on medicines used by or needed for pregnant and lactating individuals through clinical trials and postapproval studies.
First Successful Efficacy Study Against Omicron With COVID-19 Vaccine
The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.
Echosens and Novo Nordisk Announce Partnership to Combat NASH
The partnership between Echosens and Novo Nordisk is intended to increase awareness and early diagnosis of non-alcoholic steatohepatitis (NASH).
MHRA Updates Guidance on Handling of Approved or Pending DCP and MRP
The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.
Novartis to Invest $250 Million for R&D of Neglected Tropical Diseases
Novartis will endorse the Kigali Declaration on neglected tropical diseases and invest $250 million for R&D.
GSK Announces £1 Billion R&D Investment in Fighting Infectious Diseases in Lower-Income Countries
GSK will invest £1 billion in furthering R&D in malaria, tuberculosis, and HIV, as well as neglected tropical diseases.
FDA Leaders Seek to Build Public Trust in Science and Gain Support for Regulation
FDA is at a pivotal moment because of important gains in medical treatment based on science.
Sustainable Medicines Packaging Award Winners to be Announced at Connect in Pharma
Connect in Pharma will host an awards ceremony to showcase innovations in sustainable pharmaceutical packaging.
EMA Starts Rolling Review of Adapted COVID-19 Vaccines
The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.
International Collaboration on Pharmaceutical Regulations
Lessons learned from the COVID-19 pandemic about the benefits of international collaboration were discussed in a May 2022 workshop.
Orbit Discovery Awarded Innovate UK Grant
Orbit Discovery has been awarded the Innovate UK Grant to expand high throughput cell-based functional screening platform capabilities in peptide drug discovery.
FDA Authorizes COVID-19 Vaccines for Individuals Six Months and Older
FDA has issued an Emergency Use Authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as six months old.
Aptamer Group Signs Deal with Flip Gene Therapeutics
Aptamer Group has signed a deal with Flip Gene Therapeutics to support the development of inducible gene therapies.
Boehringer Ingelheim to Acquire Trutino Biosciences
Boehringer Ingelheim has signed an option to acquire Trutino Biosciences.
FDA User Fee Legislation Advances in Senate
Measure tackles infant formula, cosmetics, diagnostics plus drug development and access.
MHRA to Play Greater Role in International Medicines Regulation
MHRA has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.
Researchers Invent New Material that Can Capture and Release Biomolecules
A new polymer surface material has been invented by researchers in Sweden that uses electrical signals to both capture and release biomolecules.
FDA Publishes Guidance on Regenerative Medicine Therapies
The new draft guidance describes a standards recognition program for regenerative medicine therapies.
FDA Publishes Draft Quality Risk Management Guidance
The draft ICH Q9(R1) document details the importance of quality risk management principles.
