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Recro Announces Name Change to Societal CDMO to Reflect Corporate Expansion and Transformation
Recro Pharma changed its name to Societal CDMO to reflect the company’s expansion as a result of the acquisition of IriSys.
Teva Reaches Agreement with Rhode Island to Settle Opioid-Related Claims
Teva has reached an agreement with the Attorney General of Rhode Island to settle opioid-related claims.
RINVOQ Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
FDA has approved RINVOQ as a treatment for adults with moderately to severely active ulcerative colitis who have not had an adequate response to existing treatments.
FDA Approves Opdualag for Unresectable or Metastatic Melanoma
FDA has approved Opdualag for adults and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.
Marinus Pharmaceuticals Announces FDA Approval of ZTALMY for CDKL5 Deficiency Disorder
FDA has approved ZTALMY as a treatment for seizures associated with CDKL5 deficiency disorder (CDD).
AstraZeneca’s Antibody Combination Authorized for Use in Great Britain for Prevention of COVID-19
AstraZeneca’s antibody combination has been authorized for use in Great Britain to prevent COVID-19 in high-risk populations and people for whom vaccination may not be effective.
Moderna and the Japanese Government Reach an Agreement to Supply Japan with Additional 70 Million Doses of Moderna’s COVID-19 Booster Vaccine
Moderna has reached an agreement with the Ministry of Health, Labor, and Welfare of Japan (MHLW) to supply Japan with an additional 70 million doses of its COVID-19 Booster Vaccine.
Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products
Olympia Pharmacy is voluntarily recalling eleven lots of seven compounded products due to out-of-specification results.
COVID-19 Vaccine Manufacturers Submit Appeals to FDA for Fourth Dose
Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.
physIQ and CellCarta Collaborate on Personalized Approach to Vaccine Development
physIQ and CellCarta are conducting a study to evaluate individual patient response to vaccination using wearable biosensors.
USP Medicine Supply Map Reviews Global API Manufacturing
New report released by USP offers a look into API supply-chain vulnerabilities.
Sanofi Announces €300 million Collaboration with Blackstone Life Sciences to Advance a Treatment for Multiple Myeloma
Sanofi is collaborating with Blackstone Life Sciences to accelerate the development of a treatment for multiple myeloma.
Emmes Acquires Rare-Disease CRO Casimir
Emmes has acquired Casimir, marking its fourth major acquisition.
Sanofi and Seagen Announce ADC Development Collaboration
Sanofi and Seagen have entered an agreement to investigate three cancer targets.
Catalent Completes $30 Million Project for Biopharmaceutical Development and Manufacturing in Limoges, France
Catalent has announced the completion of a $30 million project at its facility in Limoges, France focused on biopharmaceutical development and drug product manufacturing.
FDA Approves Generic Version of AstraZeneca’s Symbicort to Treat Asthma and COPD
Viatris’ new drug-device is the first FDA-approved generic version of AstraZeneca’s Symbicort.
BioMed X Institute and Merck KGaA Start Second Research Project in Immunology
BioMed X and Merck KGaA, Darmstadt, Germany announced their collaboration on a research project to study T-cells and autoimmunity.
Envirotainer and Swiss WorldCargo Use Live Monitoring of Temperature-Controlled Shipments
Envirotainer and Swiss WorldCargo have successfully completed the first commercial shipment using a new temperature-controlled air freight solution.
Novasep Invests €5.1 million in Le Mans Site to Further Expand its Production Capacity for HPAPIs
Novasep increases its production capacity for HPAPIs with an investment in its site in Le Mans, France.
EMA Recommends Updated Product Information for Moderna and Janssen COVID-19 Vaccines
EMA has recommended that possible side effects of Spikevax and Janssen COVID-19 vaccines be added to product information.
Spectrum Chemical Launches New bioCERTIFIED Products
Spectrum Chemical is adding twelve products to its bioCERTIFIED product line.
ProteoGenix Launches New Transient Expression System
ProteoGenix’s new XtenCHO Transient Expression can achieve up to ten times higher yields than market-leading CHO systems.
NIH Launches Clinical Trial of Three mRNA HIV Vaccines
NIH has launched one of the first Phase 1 clinical trials to examine mRNA technology for HIV.
Almac Pharma Services Expands Ultra-Low Temperature Solutions for Advanced Therapy Medicinal Products
CDMO Almac Pharma Services expanded its European ultra-low temperature packaging capabilities.
Federal Budget Bill Boosts FDA Funding, Supports New Research Institute
The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.
Flow Eighteen38 Receives €5 Million (US$5.58 Million) to Expand Production and Biophysical Capabilities
Flow Eighteeen38 is receiving a €5 million (US$5.58 million) investment from its parent company, FairJourney Biologics.
evitria Licenses mAbsolve Gene Silencing Technology
Evitria has entered into an agreement with mAbsolve that will allow the company to use mAbsolve’s gene silencing technology in their antibody cells.
FDA Grants Orphan Drug Designation to Soft Tissue Sarcoma Treatment
C4 Therapeutics has been granted orphan drug designation by FDA for CFT8634 for the treatment of soft tissue sarcoma.
SCG Cell Therapy and A*STAR’s BTI Collaborate to Advance Multi-Specific Antibody Development
SCG Cell Therapy has signed a collaboration agreement with A*STAR’s BTI to advance the development of antibodies for infectious diseases and cancer treatments.
Ukraine Invasion Challenges Biopharma Research and Operations
Biotech companies and medical product manufacturers have condemned the invasion of Ukraine, while also looking to maintain supplies of essential medicines.