Industry News
UK Government Awards £15.9 million grant to Chemical Producer Croda
UK government has awarded chemical producer Croda a £15.9 million grant to increase the UK’s capacity to manufacture key vaccine ingredients.
Symbiosis Successfully Completes UK Research and Innovation Project to Enhance Supply Chain for ATMPs
Symbiosis announced the successful completion of UK Research and Innovation project to enhance the manufacturing supply chain for ATMPs within the UK.
NCI Awards ATCC Task Order to Provide Cancer Epidemiology Services to Research Community
Under the two-year task order, ATCC will continue to support the DCEG MEAS program in receiving, processing, storing, analyzing, and distributing clinical specimens from different cancer types.
Research Shows that Junk DNA Encodes Essential Immune and Metabolism Instructions
Researchers from the Telomere-to-Telomere Consortium have discovered new properties about junk DNA that could have wide-reaching implications.
Sanofi and IGM Biosciences Announce Collaboration Agreement
Sanofi and IGM Biosciences have announced a collaboration agreement for oncology, immunology, and inflammation targets.
Patent Rights Battles Escalate as Debate over Drug Costs and Access Drags On
Consumer advocates continue to press for initiatives to lower drug prices by revising or reducing patent protections.
Pfizer Issues Voluntary Recall of Blood Pressure Tablets Due to High Levels of Nitrosamine
Pfizer has issued a voluntary nationwide recall on lots of Accuretic tablets due to high levels of nitrosamine.
Novavax and Serum Institute of India Announce Emergency Use Authorization of Novavax’ COVID-19 Vaccine in Adolescents Ages 12 to 18 in India
Novavax’ COVID-19 vaccine has been granted emergency use authorization for use in the adolescent population ages 12–18 in India.
EMA Recommends EU Approval of Roche’s Polivy Combination for Diffuse Large B-Cell Lymphoma
EMA has recommended the approval of Roche’s Polivy plus R-CHP for the treatment of previously untreated diffuse large B-cell lymphoma in the EU.
Huma and AstraZeneca Partner to Accelerate Innovation for Digital-First Patient Care
Huma has acquired AstraZeneca’s digital health platform, and AstraZeneca has become a shareholder of Huma in a partnership to accelerate digital-first patient care.
FDA Grants Breakthrough Therapy Designation for Pfizer Respiratory Syncytial Virus Vaccine Candidate
Pfizer’s respiratory syncytial virus vaccine candidate has received Breakthrough Therapy Designation from FDA for the prevention of RS in older adults.
EMA Grants Recommendation for New Gene Therapy to Treat Adult Patients with Multiple Myeloma
EMA has recommended a conditional marketing authorization for a new gene therapy to treat adult patients with multiple myeloma.
FDA and Congress Re-Examine Accelerated Approval Program
Congress is considering revising and improving policies related to drug development and regulation for possible inclusion in broader legislation to reauthorize FDA user fees.
Gamma Biosciences and Mirus Bio to Develop Lipid-Polymer Nanocomplexes
Gamma Biosciences has announced an initiative through its subsidiary, Mirus Bio, to develop lipid-polymer nanocomplexes for improve mRNA delivery solutions.
Roquette Invests €25 million for Polyols at its Site in Lestrem, France
Roquette is investing €25 million at its site in Lestrem, France to strengthen its position in the polyols market.
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).
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.
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.
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.
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.
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.
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.
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.
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.
Life Science Executives Issue Call to Cut Business Ties with Russia
Various executives in the life sciences industry have started a petition calling for “complete economic disengagement” with Russia.
Novo Nordisk Expands Research Collaboration in Novel Delivery Technologies for Biologic Medicines
Novo Nordisk will expand its existing research collaboration in novel delivery technologies with MIT and Brigham and Women’s Hospital.
Curia Enters Cooperative Agreement with US Government to Expand Sterile Fill/Finish Capability
Curia and the US government have entered into a cooperative agreement to expand fill/finish capability for injectable medicines.