News
The results, which come on the heels of the FDA’s approval of J&J’s esketamine nasal spray Spravato as a monotherapy for treatment-resistant depression, could serve to further bolster a space hit hard by the rejection of Lykos’ MDMA-based PTSD therapy in August 2024.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
The drugmaker’s dominance of the obesity market is fueling predictions that years of growth lie ahead.
Job Trends
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the fourth quarter and full year ended December 31, 2022 and reviewed recent business highlights.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
THE LATEST
The pharma continued its clinical losing streak on Thursday with the announcement that it is discontinuing late-stage studies of the anti-PD-1 therapy in non-small cell lung cancer and cutaneous squamous cell carcinoma.
The chair of the House Committee on Oversight and Accountability wants the CEOs of CVS Caremark, Express Scripts and Optum Rx to fix statements they made in a hearing last month that contradicted the committee’s and Federal Trade Commission’s findings.
In its legal complaint, filed in the District Court for New Jersey, Regeneron alleges that Sandoz failed to provide it with relevant information required under the Biologics Price Competition and Innovation Act.
Armed with new late-stage data on reducing low-density lipoprotein cholesterol, Novartis is positioning its siRNA therapy Leqvio as a preventive treatment for atherosclerotic cardiovascular disease.
Neurocrine Biosciences’ potential competitor to Bristol Myers Squibb’s KarXT improved symptoms of schizophrenia in a Phase II trial, but only at the low dose tested.
Congress, the Federal Trade Commission and the U.S. Patent and Trademark Office are all targeting Big Pharma’s practice of filing multiple, overlapping patents that stifle generic and biosimilar competition.
Genentech’s latest layoffs are the second round of workforce reductions this year, following the company’s announcement in April that it was letting go around 3% of employees.
Quotient Therapeutics’ platform targets somatic mutations, which the startup contends can help identify a broader scope of genes potentially associated with disease phenotypes. Wednesday’s agreement is part of an existing partnership between Pfizer and Flagship Pioneering.
Navigator Medicine is looking to push its lead asset NAV-240 targeting immune-mediated diseases through to clinical studies “in the coming months,” which the startup in-licensed from a South Korean biotech for $20 million upfront.
For reasons including downsizing, avoiding retirement and a tight labor market, senior-level biopharma professionals are increasingly turning to fractional roles, according to two recruitment experts.