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Biogen and Sage Therapeutics’ investigational neuroactive steroid did not significantly improve upper limb tremors in patients with essential tremor, the companies announced Wednesday.

AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.

Executives from the three largest pharmacy benefit manager companies testified Tuesday before Congress that rising drug prices in the U.S. are due to pharma companies taking advantage of market exclusivities and excessive charges.

Third Arc Bio, led by three former Johnson & Johnson executives, is advancing a portfolio of multifunctional antibodies for cancer and inflammatory and immune-mediated diseases.

Despite early 2024 optimism, BioSpace’s Job Market Trends report outlines a still sluggish situation in the biopharma industry, Novartis and J&J announce Q2 earnings, GLP-1 market leaders expand into China and the Cassava Sciences saga continues.

While supportive of Amylyx’s acquisition of a GLP-1 drug, analysts say the company’s future hinges on key upcoming readouts from multiple products in its pipeline.

In the largest study of its kind, GSK’s two-drug regimen Dovato demonstrated non-inferior efficacy compared to Gilead Sciences’ three-drug regimen Biktarvy for the treatment of HIV-1.

Merck’s clesrovimab lowered the risk of medically attended lower respiratory infections associated with RSV infection when used in infants, according to topline results announced Tuesday.

The acquisition of the contract development and manufacturing organization will allow Agilent Technologies to provide a one-stop source for gene-editing services for its customers.

Allarity Therapeutics announced Monday that the Securities and Exchange Commission has made a preliminary determination recommending an enforcement action against the company for alleged violations of federal securities laws.

The Department of Health and Human Services’ Office of the Inspector General found that bluebird bio’s fertility support program for its gene therapies could potentially violate federal anti-kickback statutes.

The South Korean company’s Epysqli is now FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome in the U.S., having grabbed the lead in the Soliris biosimilar market in Europe.

66.6% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p = 0.0046) FDA issues Biologics Licensing Application (BLA) number for OST-HER2 in preparation for anticipated BLA filing for the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma following August 27, 2025 End of Phase 2 Meeting Company responds to FDA correspondences seeking to align approval metrics for Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy designation (BTD) and Biologics Licensing Application via Accelerated Approval Program Company’s NYSE American listing included in the Russell Microcap, Russell Microcap Value and Russell Microcap Growth indexes