Industry News

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.

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 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.

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

Predictive Oncology and Cancer Research Horizons have partnered to pursue development of cancer drugs utilizing the PEDAL platform.

27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation.

FDA is seeking $7.2 billion to enhance food safety and advance medical product availability.

Sumitovant Bipharma has completed its acquisition of Myovant Sciences for approximately $1.7 billion.

Silicon Valley Bank has collapsed, leaving many biotechnology companies unsure of the future.

Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.

Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.

Vetter has become a participant of the UN Global Compact Network.

Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.

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.

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.

Lilly will cap insulin prices for patients with and without insurance at $35 per month.

WHO is appealing for US $392 million to reach 12.9 million people with essential health assistance in 2023.

Orchard Therapeutics has announced an agreement which will enable reimbursed access to Libmeldy for all eligible MLD patients in Sweden.

Moderna will leverage Life Edit’s suite of gene editing technologies to advance development of in vivo gene editing therapies.

Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.

AbbVie and Capsida have expanded their existing collaboration to advance three new gene therapy programs.