Alivia Leon is the Assistant Editor for Pharmaceutical Technology.
E&L Analytical Testing Considerations
E&L analytical testing methods can be determined through pointed consideration of the differences small- and large-molecule drug products.
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.
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.
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.
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.
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.
Considerations for Analytical Testing for E&L
Considering the differences between small- and large-molecule drug products can help determine analytical testing methods for E&L.
A New Hope for Children Living with HIV
New child-friendly treatment options and initiatives are improving the outlook of children living with HIV in Europe.
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.
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.
Harm Reduction Therapeutics and Catalent Sign Commercial Supply Agreement
Harm Reduction Therapeutics and Catalent have signed a commercial supply agreement for naloxone nasal spray to reverse opioid overdoses.
Curia and Corning Collaborate to Advance Biopharmaceutical Continuous-Flow Development
Curia is collaborating with Corning to advance biopharmaceutical continuous-flow development and manufacturing programs.
Evotec and Bristol Myers Squibb Progress Strategic Partnership
Evotec and Bristol Myers Squibb have announced progress in their strategic protein degradation partnership.
Predictive Oncology and Cancer Research Horizons Partner for Cancer Drug Development
Predictive Oncology and Cancer Research Horizons have partnered to pursue development of cancer drugs utilizing the PEDAL platform.
FDA Seeks $7.2 Billion to Protect and Advance Public Health
FDA is seeking $7.2 billion to enhance food safety and advance medical product availability.
Sumitovant Acquires Myovant for $1.7 Billion
Sumitovant Bipharma has completed its acquisition of Myovant Sciences for approximately $1.7 billion.
Biotech Companies Deal with Silicon Valley Bank Collapse
Silicon Valley Bank has collapsed, leaving many biotechnology companies unsure of the future.
Catalent Expands UpTempo AAV Platform
Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.
Vetter Joins United Nations Global Compact
Vetter has become a participant of the UN Global Compact Network.
Janssen Receives Positive Opinion for AKEEGA Plus Prednisone or Prednisolone
Janssen has received a positive opinion from EMA for AKEEGA plus prednisone or prednisolone for the treatment of BRCA1/2 gene-mutated metastatic castration resistant prostate cancer.
Considerations for Manufacturing Solid Versus Semi-solid Drugs
Manufacturers must consider key components of manufacturing solid versus semi-solid drugs to create a successful end product.