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Indian Pharma Companies Poised for Surge?
A report from Business Standard highlighted India’s recent growth in the pharma sector.
GSK and BELLUS Health Enter Acquisition Agreement
GSK has reached an agreement to acquire late-stage biopharmaceutical company BELLUS Health.
FDA Grants Breakthrough Therapy Designation to SAB Biotherapeutics for Influenza Immunotherapy
SAB Biotherapeutics has received both breakthrough and fast track designations from FDA for its lead antibody drug candidate for treating influenza.
FDA’s Office of New Drugs Highlights New Research Projects for Growth
Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.
Merck to Purchase Prometheus Biosciences for $10.8 Billion
Merck will acquire Prometheus Biosciences, a clinical-stage biotechnology company specializing in immune-mediated diseases, at a total equity valuation of $10.8 billion.
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.
AbbVie Receives European Commission Approval for Crohn’s Disease Therapeutic
AbbVie’s RINVOQ has received European Commission approval for the treatment of moderately to severely active Crohn’s disease.
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 Is Hiring!
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.
NextPharma Acquires Chewable Tablets Manufacturing Site in Norway
NextPharma has acquired a leading European chewable tablets manufacturing site from Takeda in Asker, Norway.
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.
Legislative Hold-Up
A further setback to the publication of the pharmaceutical legislative changes in Europe may mean time is running out for appropriate review before 2024 parliamentary elections.
FDA Approves Evkeeza for Young Children with Ultra-Rare Form of High Cholesterol
FDA has approved Evkeeza for young children with homozygous familial hypercholesterolemia.
