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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.
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.
Curia and Corning Collaborate to Advance Biopharmaceutical Continuous-Flow Development
Curia is collaborating with Corning to advance biopharmaceutical continuous-flow development and manufacturing programs.
Feds to Review March-In Authority on Drug Patents
A new Interagency Working Group for Bayh-Dole will review the government’s authority to revoke licenses for medical products.
Digital Health Technologies Document Outlines Framework for FDA
The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.
Frontrunners in the Latest Stem Cell Technology
TreeFrog Therapeutics is leaping ahead in cell therapies through resources such as new technologies and investor partnerships.
Invitae and Deerfield Management Team Up on Novel Therapeutics for Rare Diseases
Under a new partnership, Invitae and Deerfield Management will harness genetic and clinical testing data from patients to discover potential novel therapeutics for treating rare diseases.
Scorpius BioManufacturing Announces New Microbial Capacity and New Interim President
In addition to a new interim president, the company is opening new microbial capacity at its San Antonio facility and has plans to construct a commercial-scale facility in Manhattan, Kan.
TrakCel and Lonza Reach Integration Milestone to Combine Cell and Gene Therapy Manufacturing, Orchestration Solutions
The combined solutions are currently available on the market.
PurePep EasyClean Services Set to Accelerate Development and Manufacturing of Peptide-based Drugs
The services are based on the company’s PurePrep EasyClean (PEC) orthogonal peptide purification technology.
Lynparza Approved in UK as Combination Therapy for Treatment of Metastatic Castration-Resistant Prostate Cancer
The decision was based on results from the PROpel Phase III trial.
European Commission Approves Dupixent as First, Only Targeted Medicine for Children with Severe Atopic Dermatitis
This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.
Sanofi Drops Lantus US List Price by 78%, Capping Out-of-Pocket Costs at $35
Sanofi intends to cut its US list price for Lantus (insulin glargine injection) by 78% and cap out-of-pocket costs at $35 for all patients with commercial insurance.
