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Pressure Mounts for FDA to Reform Accelerated Approval Program
An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.
Cambrex Announces Stability Storage Expansions in Ireland and Belgium
Cambrex has expanded its stability storage business, Q1 Scientific, in Ireland and Belgium.
WHO Ranks South Africa’s Vaccine Regulatory System at a Functional Level of Maturity
South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.
Societal CDMO Signs Multiple CDMO Service Agreements
Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.
Aragen to Invest in New Formulation Manufacturing Facility in Hyderabad, India
Aragen’s new 12,000 ft² facility will include various dosage form capabilities, including oral solids, liquids, topicals, and films.
Recipharm to Add High-Speed Filling Line to Wasserburg Facility
Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.
AAPS to Provide Scientific Programming Oversight for Interphex
AAPS will exclusively advise RX Global on scientific focus areas for Interphex 2023, which is set to take place at the Javits Center in New York City next spring.
EMA Recommends Adapted Spikevax Vaccine
The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.
EMA Extends Use of COVID-19 Vaccines to Children
The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.
Gilead and MacroGenics Enter $1.7 Billion Oncology Collaboration
Gilead and MacroGenics will work together on bispecific antibodies for the treatment of blood cancers.
Post-Transplant Lymphoproliferative Disease Treatment Receives Marketing Authorization Recommendation from EMA
Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.
EMA Announces Positive Indication for Takeda’s Dengue Vaccine
Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.
Merck and Moderna Enter $250 Million Cancer Vaccine Partnership
Merck has exercised a $250 million option with Moderna to jointly develop and commercialize cancer vaccine mRNA-4157/V940.
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.
