Industry News
UK Approves Treatment for Sleep Onset Insomnia in Children and Adolescents
The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.
H.I.G. Capital Acquires Morningside Healthcare and Morningside Pharmaceuticals
H.I.G. Capital’s portfolio company Aspire Pharma has acquired Morningside Healthcare and Morningside Pharmaceuticals.
FDA Grants Fast Track Designation to Cue Biopharma
FDA has granted Fast Track designation for CUE-101, a treatment of recurrent/metastatic head and neck squamous cell carcinoma.
Pfizer Completes Acquisition of Biohaven Pharmaceuticals
Pfizer has completed its acquisition of Biohaven Pharmaceuticals for approximately $11.6 billion.
PerkinElmer Unveils Cell Analysis Solution
PerkinElmer has unveiled a cell analysis solution to streamline cell and gene therapy research and manufacturing.
FDA Expands Patient Input on Drug Development
FDA is highlighting how the Patient-Focused Drug Development program has encouraged active involvement of many patient groups in bringing their perspectives into the process of developing, testing, and approving new medicines.
Biogen to Settle Kickbacks Lawsuit for $900 Million
Biogen has agreed to pay $900 million to settle federal and state claims that it paid kickbacks to physicians to encourage them to prescribe its drugs.
Novel Imaging Approach Reveals Key Details About Rare Eye Disease
A combination of eye imaging techniques and adaptive optics has revealed key details of choroideremia.
Actylis Debuts as an Integrated Global Specialty Ingredients Manufacturing and Sourcing Provider
Actylis combines Aceto and its 10 acquired specialists into a singular global brand.
Pfizer to Supply up to 6 Million PAXLOVID Treatment Courses for Low-and-Middle-Income Countries
Pfizer is set to supply global fund up to 6 million treatment courses of its COVID-19 oral treatment, PAXLOVID, for low-and-middle-income countries.
Congress Slated to Reauthorize User Fees Without FDA “Improvements”
Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill.
FDA and NIH Enter Rare Neurodegenerative Diseases Partnership
The Public-Private Partnership for Rare Neurodegenerative Diseases will work to enhance understanding and develop treatments for rare neurodegenerative diseases.
Lonza Expands HPAPI Multipurpose Suite
Lonza has expanded its HPAPI multipurpose suite for payload-linker manufacturing.
Clinical Trial Modernization Raises FDA Compliance Issues
Regulatory officials are addressing challenges in ensuring that clinical data can be relied on in making regulatory decisions.
CytoReason Announces Expanded Collaboration Deal with Pfizer
CytoReason has announced an expanded collaboration deal with Pfizer to deliver AI for drug discovery and development.
Civica to Invest $27.8 Million in New Testing Facility
Civica is expanding in the greater Richmond-Petersburg region and investing $27.8 million in a new testing facility.
Novo Nordisk and Microsoft Collaborate to Accelerate Drug Discovery and Development
Novo Nordisk and Microsoft are collaborating to accelerate drug discovery and development using big data and artificial intelligence.
Ensysce Biosciences and Quotient Sciences Announce Partnership
Ensysce Biosciences and Quotient Sciences are partnering to develop and test Ensysce’s novel opioid designed to prevent abuse and overdose.
EMA Recommends Approval of Enjaymo
EMA has recommended approval of Enjaymo for the treatment of hemolytic anemia in adult patients with cold agglutinin disease.
Advanced Biopharma Manufacturing Key to White House Cancer Moonshot
The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials.
WHO Grants Prequalification to GSK’s Malaria Vaccine
WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.
Salipro Biotech Obtains Patents in US and China for Direct Extraction of Membrane Proteins and Library Generation
Salipro has been granted patents in the United States and China for its proprietary technology to enable the development of therapeutics against challenging drug targets.
Charles River and Cure AP-4 Announce Manufacturing Collaboration
Charles River Laboratories and Cure AP-4 will collaborate on gene therapy manufacturing for AP-4 hereditary spastic paraplegia.
ElevateBio and the University of Pittsburgh Announce Creation of Pitt BioForge BioManufacturing Center
In partnership with the University of Pittsburgh, ElevateBio will open its next manufacturing center in the city.
SIRIO Enhances Company Strategy with Addition of Lonza’s Sara Lesina
SIRIO is enhancing its strategy for small and medium nutrition brands as Lonza’s Sara Lesina joins as GM in Europe.
FDA Approves Novel ASMD Treatment from Sanofi
Sanofi’s Xenpozyme (olipudase alfa-rpcp) is now the only approved treatment for acid sphingomyelinase deficiency.
Lonza and Touchlight Enter mRNA Collaboration
Touchlight will expand Lonza’s end-to-end offering for mRNA manufacturing with an additional, differentiated source of DNA raw material.
Hovione Expands its Continuous Manufacturing Offering and Services
Hovione has expanded its drug product offering with a new manufacturing line dedicated to continuous tableting.
FDA Authorizes Bivalent COVID-19 Boosters
FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.
Lonza Strengthens Micronization Portfolio with the Introduction of X-Ray Powder Diffraction
Lonza has introduced X-ray powder diffraction capability at its Monteggio, Switzerland site.
