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Avantor Partners with GeminiBio on Custom Hydrated Solutions and Cell Culture Media
Under the collaboration, Avantor and GeminiBio will offer custom cGMP solutions to enhance process efficiency and accelerate speed-to-market of novel emerging therapy modalities.
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.
MilliporeSigma Intensifies Upstream Processing with New BioContinuum Seed Train Platform Offering
MilliporeSigma’s new BioContinuum Seed Train Platform offering enables a fully closed bioprocessing environment for both fed-batch and perfusion N-production.
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.
ImmunoGen Partners with Oxford BioTherapeutics to Develop Novel ADCs
ImmunoGen has formed a research collaboration with Oxford BioTherapeutics to develop novel antibody-drug conjugates for cancers with high unmet needs.
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.
Pierre Fabre and Lonza Enter Manufacturing Agreement
Lonza will produce drug product for Pierre Fabre’s monoclonal antibody W0180.
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.
Kindeva Drug Delivery Completes Acquisition of iPharma Labs
Kindeva’s acquisition of iPharma will increase the company’s inhalation formulation outsourcing capabilities.
Aizon Launches GxP Compliant Data Processing Solution
Aizon Digitize is designed to help life science manufacturers transition data from paper to digital.
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.
Avid Bioservices Launches New Analytical and Process Development Suites at Viral Vector Facility
Avid Bioservices has expanded its viral vector development and manufacturing facility with the addition of analytical and process development suites.
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.
Batavia Biosciences Increases Capacity for Viral Vectors and Vaccine R&D in the Netherlands
Batavia Biosciences is expanding its headquarters and R&D capabilities in its Netherlands facility.
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.
SCHOTT to Triple Vial Production Capacity in the US
SCHOTT is planning to triple its ready-to-use vial production capacity in the United States to meet increasing demand for storing injectable drugs.
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.
Humanigen, PCI Pharma Services Enter Agreement for Lenzilumab Commercialization
Humanigen and PCI Pharma Servicesare partnering up for the commercialization of lenzilumab.
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.
Icosapent Ethyl Gains Nod from NICE
NICE has published its final draft guidance recommending the use of Vazkepa (icosapent ethyl) in adults to reduce heart attacks and strokes.