Industry News
Considering Comparability in Cell and Gene Therapy with Michael Blackton (INTERPHEX 2023)
Michael Blackton, senior vice-president of technical operations at Elektrofi, speaks about comparability in cell and gene therapy.
Discussing Challenges in mRNA Therapeutics with Phil Challis (INTERPHEX 2023)
Phil Challis, vice-president of product development at eTheRNA, discusses four of the major challenges in working with mRNA therapeutics.
Aspect Biosystems, Novo Nordisk Partner to Develop Bioprinted Tissue Therapeutics
Aspect Biosystems and Novo Nordisk A/S have announced a collaboration, development, and license agreement to develop bioprinted tissue therapeutics.
EHA Data Leak Shows Positive J&J Cancer Treatment Findings
The leaked study summary found that Carvykti (ciltacabtagene autoleucel) reduced disease progression by 74%.
Court Ruling Leaves FDA Authority in Limbo
The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.
Indian Pharma Companies Poised for Surge?
A report from Business Standard highlighted India’s recent growth in the pharma sector.
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.
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.
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.
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.
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.
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.
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.
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.
Ingredion Announces Strategic Investments in India Expanding into High-Value Pharmaceutical Ingredients
Ingredion has completed two strategic investments in India with Amishi Drugs & Chemicals and Mannitab Pharma Specialties.
Moderna and Generation Bio Announce Strategic Collaboration
Moderna and Generation Bio have announced a strategic collaboration to develop non-viral genetic medicines.
