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Moderna and Merck Announce Positive Findings from Personalized Vaccine Study
Moderna and Merck reported that a combination therapy involving pembrolizumab and an mRNA demonstrated a 44% reduction in recurrence or death in cancer patients compared to non-combination treatments.
FDA Approves Gamida Cell’s Cell Therapy for Treating Blood Cancers
Gamida Cell’s therapy is meant to reduce the risk of infection following stem cell transplantation.
INTERPHEX Returns to NYC
Integrated systems combine functions.
Avid Bioservices Expands Mammalian Cell Capacity
Avid Bioservices has launched new CGMP mammalian cell manufacturing suites at its Myford, Calif., facility.
Caribou Biosciences Gets FDA Granted Fast Track Designation for Allogeneic CAR-T Cell Therapy
FDA has granted fast track designation to Caribou Biosciences for its allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma.
Novo Nordisk and Aspect Biosystems Enter Strategic Partnership
Under this partnership, the two companies will develop bioprinted tissue therapeutics for diabetes and obesity.
Catalent Begins Construction of New $20 Million Expansion to Germany Facility
The construction will expand Catalent’s clinical supply facility in Schorndorf, Germany.
Ginkgo Bioworks Acquires AAV Capsid Technology and Forms Partnership for Next-Gen CAR-T Cell Therapies
Ginkgo Bioworks has acquired StrideBio's AAV capsid discovery and engineering platform and has formed a partnership with WARF for development of next-gen cell therapies.
AnaBios Acquires Cell Systems, Expands Human Cell Portfolio for Drug Discovery
The acquisition of Cell Systems will bolster AnaBios’ portfolio of human tissue and cells for use in drug discovery.
Forecyte Bio Opens New GMP Facility in Shanghai
Forecyte Bio has opened a new GMP facility in Shanghai just two months after its sister site in the United States.
Meissner to Invest $250 Million in New Manufacturing Facility in US
The new site will include state-of-the-art cleanroom facilities, laboratories, R&D, and office spaces.
FDA Commissioner and Chief Scientist Withdraw Approval of Makena
The decision was issued in a joint statement by the FDA Commissioner and Chief Scientist, and effective on April 11.
New Expansion for BalanCD CHO Media Platform Portfolio for Bioprocessing
The BalanCD CHO media portfolio is designed to ensure maximized growth, viability, and productivity of CHO cell lines.
Pharma Leaders Rebuke Federal Judge’s Ruling on FDA Authority
A document signed by members of more than 400 companies and investment firms decries the decision made by a federal judge concerning mifepristone, a medication used in abortions.
FDA Regulatory Authority Under Attack
Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?
FDA Wants You!
The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.
J&J Proposes $8.9 Billion Payment in Talc Powder Litigation
If approved, Johnson & Johnson would pay $8.9 billion to resolve all current and future claims in its ongoing talc litigation.
FDA Backs Randomized Trials for Accelerated Drug Approval
FDA aims to address mounting criticisms of its accelerated approval pathway.
Lonza and ABL Bio Collaborate on Bispecific Antibody Product
Lonza and ABL Bio are collaborating on the development and manufacture of bispecific antibody product.
Sartorius to Acquire Polyplus in $2.6 Billion Deal
Sartorius’ acquisition of Polyplus is designed to strengthen its cell and gene therapy capabilities.
Suppliers’ Supply Chains and Continuous Manufacturing Pose Big Risks for US CDMOs
A CPHI North America panel discussion forewarns that CDMO supply chains are potentially the biggest single risk to product resilience.
FDA Approves Evkeeza for Young Children with Ultra-Rare Form of High Cholesterol
FDA has approved Evkeeza for young children with homozygous familial hypercholesterolemia.
Takeda Gets Approval in Japan for Entyvio Subcutaneous Injection
Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.
Exothera Partners with Remedium to Scale-Up Manufacturing of Gene Therapy Drug Candidate
CDMO Exothera and biotech company Remedium are joining forces to scale up the manufacturing process for Remedium’s lead gene therapy candidate for treating osteoarthritis.
Takeda to Invest ¥100 Billion (US$754 Million) into New Plasma Therapy Manufacturing Facility
Takeda plans to build a new facility in Osaka, Japan, for the manufacture of plasma-derived therapies.
Roche Collaborates with Lilly to Enhance Early Diagnosis of Alzheimer’s Disease
Roche and Lilly will collaborate on the development of Roche Diagnostics’ Elecsys Amyloid Plasma Panel.
Downstream Technologies Continue to Transform the Industry
Downstream processing will continue to see shifts with the incorporation of modern, efficient technologies.
US Supreme Court Weighs Biologics Patents in Amgen vs. Sanofi Case
The Supreme Court heard oral arguments concerning the legitimacy of “genus clauses” in bio/pharma patents.
FDA Approves First Over-the-Counter Naloxone Nasal Spray
Narcan, from Emergent Solutions, will be the first naloxone product permitted for use without prescription by FDA.
PharmaBlock Opens New R&D Facility in Pennsylvania
PharmaBlock has opened a new R&D facility in Pennsylvania, expanding its capacity to deliver GMP projects.
