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Alexion, AstraZeneca Acquire Genomic Medicines Company
Alexion’s acquisition of LogicBio is designed to accelerate the company’s growth in genomic medicines.
FDA Authorizes Bivalent COVID-19 Boosters for Children Ages Five and Older
FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.
CRB Releases Trends and Insights Report
CRB’s Horizons: Life Sciences report covers challenges facing manufacturers and how to keep pace with rapid innovation.
FDA Expands Oversight of Cell and Gene Therapies
CBER maps modernization plan to handle surge in research and applications.
Cytiva Acquires CEVEC, Boosts Cell Line Development Capabilities
Cytiva’s acquisition of CEVEC Pharmaceuticals strengthens the company’s cell line development and biomanufacturing capabilities.
Amphista Therapeutics Enters Targeted Protein Degradation Partnership with Domainex
Amphista Therapeutics and Domainex will work together to develop treatments focusing on targeted protein degradation.
OGT Launches New Panel and Workflow Solutions
OGT has launched the SureSeq Myeloid Plus panel and OGT Universal NGS Complete Workflow.
Thermo Fisher Scientific Launches Large-Scale Cell Culture Harvesting Solution
Thermo Fisher’s new centrifuge technology is designed to enable efficient, sustainable cell culture harvesting.
Freudenberg Medical Launches HelixFlex TPE Tubing
Freudenberg Medical’s Heflix TPE tubing is a high purity TPE intended for bioprocessing applications.
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.
Citius Pharmaceuticals Announces Clinical Collaboration with the University of Pittsburgh
Citius and the University of Pittsburgh will investigate I/ONTAK in combination with pembrolizumab for treatment of recurrent or metastatic solid tumors.
Forge Biologics Launches Plasmid DNA Manufacturing Services
Forge Biologics will offer three grades of plasmid manufacturing services at its Columbus, Ohio, location.
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.
Novo Nordisk and Octagon Therapeutics Enter Inflammatory Disease Research Collaboration
The collaboration will use Octagon’s functional target discovery approach and novel chemistry strategy in disease areas in which Novo Nordisk has specific expertise.
Alcami Adds Solid-State Characterization Capabilities to North Carolina Laboratory
The dedicated solid-state research and development suite is designed to promote discovery of novel polymorph, salt, and cocrystal forms.
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.
EC Approves Vabysmo for Two Leading Causes of Vision Loss
EC has approved Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss.
Roquette Acquires Indian Excipient Manufacturer
Roquette’s acquisition of Crest Cellulose is designed to reinforce its presence in India and other countries in Asia.
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.
FDA Approves Bluebird Bio’s $3 Million CALD Treatment
FDA granted accelerated approval to Skysona (elivaldogene autotemcel), which is designed to slow the progression of neurologic dysfunction in adolescents with CALD.
Lonza Expands HPAPI Multipurpose Suite
Lonza has expanded its HPAPI multipurpose suite for payload-linker manufacturing.
Boehringer Ingelheim Adopts Virtuosi VR Education Platform
Boehringer Ingelheim will use Virtuosi to train employees at three aseptic sites across its network.
