News

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.

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.

Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.

Under a technology licensing agreement with Bhami Research Laboratory, Catalent intends to develop formulations that will allow for the delivery of high-concentration biologics subcutaneously.

The collaboration between Genuv and Celltrion will utilize Genuv's proprietary mouse platform for antibody discovery.

Pfizer will acquire all outstanding shares of Seagen for a total of $43 billion.

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.

Sotatercept, a drug candidate acquired by Merck in an $11.5 billion acquisition, showed statistically significant improvements in various measures.

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.

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

AstraZeneca has entered into a global exclusive license agreement with KYM Biosciences for CMG901, which is being investigated as a gastric cancer treatment.

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.