Industry News

The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.

A report from Business Standard highlighted India’s recent growth in the pharma sector.

SAB Biotherapeutics has received both breakthrough and fast track designations from FDA for its lead antibody drug candidate for treating influenza.

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 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.

Gamida Cell’s therapy is meant to reduce the risk of infection following stem cell transplantation.

Integrated systems combine functions.

Under this partnership, the two companies will develop bioprinted tissue therapeutics for diabetes and obesity.

The construction will expand Catalent’s clinical supply facility in Schorndorf, Germany.

The new site will include state-of-the-art cleanroom facilities, laboratories, R&D, and office spaces.

The decision was issued in a joint statement by the FDA Commissioner and Chief Scientist, and effective on April 11.

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.

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.

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.

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.

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

The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

The decision was based on results from the PROpel Phase III trial.