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The U.K.’s core biotech cluster continues to produce world‑class science, but investors say limited talent mobility, uneven regional growth and tightening early‑ and mid‑stage capital are slowing the country’s ability to scale new companies.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
THE LATEST
The FDA has requested that Clovis Oncology limit the indication of its PARP inhibitor Rubraca as second-line maintenance therapy in recurrent ovarian cancer.
Ardelyx has moved one step closer to the possible approval of its experimental chronic kidney disease drug tenapanor following a favorable 9-4 vote from an FDA advisory committee.
Huntington’s disease might just top the list of intractable neurodegenerative diseases. BioSpace spoke with the field’s foremost experts about the challenges and how to overcome them.
In the acquisition, announced Wednesday, Kriya picks up two gene therapy programs focused on epilepsy and trigeminal neuralgia. Financial terms of the deal were not disclosed.
Tricida, Inc. is reducing its headcount by around 57% to improve its financial standing after its lead candidate failed in a Phase III trial, the company revealed in its third-quarter financial results.
AstraZeneca dosed the first patient in a Phase II portion of an ongoing trial assessing a PD-1/TIGIT bispecific antibody, triggering a $7.5 million milestone payment to partner, Compugen.
When Roche announced that gantenerumab failed to meet the primary endpoint in two Phase III studies, several of its competitors saw their stocks rise - including Biogen and Eisai.
RSV, influenza, COVID-19 and monkeypox have dominated vaccine discussions this year, but vaccines are also being developed for a host of other infectious diseases.
Neoleukin Therapeutics plans to slash its workforce by about 40% and drop NL-201, a de novo IL-2/IL-15 agonist currently in Phase I, according to its third-quarter report.
Beam Therapeutics has enrolled the first patient in a Phase I/II trial studying a gene therapy leveraging base editing in adults with severe sickle cell disease.