Latest News
& Press Releases

The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the design of their facilities.

Corcept’s relacorilant was rejected for hypercortisolism late last year—a decision which CEO Joseph Belanoff expressed surprise with at the time.

A Phase III readout in September 2024 for rocatinlimab, on which Amgen and Kyowa Kirin were collaborating in atopic dermatitis, appeared underwhelming to analysts, with Jefferies noting that the data “came in at the lower end of efficacy and expectations.”

Opening up about drug pricing decisions is not optional for biopharma anymore. For the sake of credibility, companies should embrace it.

AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.

In what is shaping up to be a back-loaded month, the FDA is set to release a slew of regulatory decisions in February, including two that would expand the labels of blockbuster drugs.

With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”

The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.

New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better treatments.

In a Cabinet meeting, Health Secretary Robert F. Kennedy Jr. said the website could go live “probably in the next 10 days,” but an exact launch date remains unclear.

Moderna will continue to lead clinical development and manufacturing of the asset, while Recordati will handle commercialization of mRNA-3927, which is under development for the rare metabolic disorder propionic acidemia.

The pact, which could see AstraZeneca ultimately put out $18.5 billion in milestones and sales-based payments, is centered on SYH2082, a long-acting dual agonist of the GLP-1 and GIP receptors.

VINIA’s leadership position in the market validates its superior arterial dilation and blood flow performance as well as BioHarvest’s Botanical Synthesis platform technology

Leveraging its PharmaPatch™ experience, the Company is introducing PatchPrint™ to support existing microneedle patch programs and expand into on-demand personalized patch solutions, including peptide patches, branded wellness patches, manufacturing systems and commercial partnerships.

Ligand-independent mechanism of action of SignaBlok’s first-in-class TREM-1 inhibitors enables development of cell-unspecific and macrophage-targeted TREM-1 inhibitors · In experimental pancreatic cancer, macrophage-targeted but not cell-unspecific TREM-1 inhibitor: − prevents cancer recurrence, improves complete response rate and survival, when administered in a time window of 7 days after standard-of-care (SOC) chemotherapy − reverses immunosuppression and overcomes cancer resistance to anti-PD-L1 immunotherapy · Timely resolution of acute inflammation induced by SOC cancer treatments (chemotherapy, surgery, radiation, radiopharmaceuticals, etc.) can be a common approach to prevent cancer recurrence, increase response rate and survival for not only pancreatic cancer but also other hard-to-treat tumors