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The advisory committee meeting—the FDA’s first drug-related adcomm in nine months—could have been a “more conceptual discussion” about the design of AstraZeneca’s Phase 3 trial of camizestrant in HER2-negative advanced breast cancer, former cancer regulator Harpreet Singh told BioSpace.

Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year.

Summit Therapeutics planned an early interim progression-free survival readout for HARMONi-3 in the hope of enabling earlier regulatory engagement—but the early analysis delivered disappointment for the company and shareholders.

Veppanu, the first PROTAC therapy approved by the FDA, improved progression free survival by 43% versus AstraZeneca’s Faslodex but showed no such significant benefit in the intention-to-treat analysis.

Candid Therapeutics follows closely behind Neurona Therapeutics, which UCB acquired in mid-April in a potential $1.15 billion deal.

In its latest biopharma pipeline report, Deloitte warned that the growing importance of a small pool of potential mega-blockbusters raises the risk of “significant value destruction from a single program failure.”

The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for Alzheimer’s disease.

The new plant will give Novartis end-to-end capabilities centered on North Carolina, where it plans to have five facilities across three sites.

CEO Stéphane Bancel expressed confidence in Moderna’s first quarter, touting the revenue numbers as a sign of the company’s return to prosperity.

Amgen has launched a late-stage program to test the feasibility of switching patients from weekly GLP-1 injections to its own investigational obesity asset MariTide, which could open up monthly or more infrequent dosing schedules.

Alzheimer’s disease agitation could mean peak sales of over $2.1 billion for Axsome’s Auvelity, according to analysts at William Blair.

Members of the FDA’s Oncologic Drugs Advisory Committee questioned the design of AstraZeneca’s Phase 3 trial of camizestrant, which involved switching treatments at the point of mutation detection, as opposed to the current practice of changing regimens upon disease progression.

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