News

Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?

The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.

If approved, Johnson & Johnson would pay $8.9 billion to resolve all current and future claims in its ongoing talc litigation.

FDA aims to address mounting criticisms of its accelerated approval pathway.

Lonza and ABL Bio are collaborating on the development and manufacture of bispecific antibody product.

Sartorius’ acquisition of Polyplus is designed to strengthen its cell and gene therapy capabilities.

A CPHI North America panel discussion forewarns that CDMO supply chains are potentially the biggest single risk to product resilience.

FDA has approved Evkeeza for young children with homozygous familial hypercholesterolemia.

Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.

Takeda plans to build a new facility in Osaka, Japan, for the manufacture of plasma-derived therapies.

Roche and Lilly will collaborate on the development of Roche Diagnostics’ Elecsys Amyloid Plasma Panel.

The Supreme Court heard oral arguments concerning the legitimacy of “genus clauses” in bio/pharma patents.

Narcan, from Emergent Solutions, will be the first naloxone product permitted for use without prescription by FDA.

PharmaBlock has opened a new R&D facility in Pennsylvania, expanding its capacity to deliver GMP projects.

Ingredion has completed two strategic investments in India with Amishi Drugs & Chemicals and Mannitab Pharma Specialties.

Moderna and Generation Bio have announced a strategic collaboration to develop non-viral genetic medicines.

Curia is collaborating with Corning to advance biopharmaceutical continuous-flow development and manufacturing programs.

A new Interagency Working Group for Bayh-Dole will review the government’s authority to revoke licenses for medical products.

TreeFrog Therapeutics is leaping ahead in cell therapies through resources such as new technologies and investor partnerships.

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.

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.

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.

BioNTech will receive an exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 mAb candidate for solid tumor indications.

Sartorius BIA Separations and Teknova will collaborate to combine their technologies in an effort to streamline the downstream purification process.

Samsung Biologics plans to invest more than ₩1.9 trillion (US$1.5 billion) in the new Incheon, South Korea, facility, which will hold a manufacturing capacity of 180,000 L.

Polyplus’ LipidBrick is designed to expand the scope of lipid nanoparticle formulation usage in mRNA therapeutics and vaccine development.

Stevanato Group will support development and production of pre-fillable syringes for use in Recipharm’s soft mist inhalers.

Evotec and Bristol Myers Squibb have announced progress in their strategic protein degradation partnership.