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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 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.
Zauberkugel: Pfizer’s Seagen Acquisition
What can we take away from Pfifzer's acquisition of Seagen?
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.
Who’s Got Game?
Direct-to-consumer drug advertising has developed as a cottage industry which has been used to increase prescriptions immensely.
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.
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.
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.
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.
CPHI Awards Open for Entries in Multiple Categories
Three new awards have been added to the roster for 2023 and include some specific highlights that have occurred over the past few years.
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.
