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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.
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In a comparison trial, BeiGene’s Brukinsa bested Janssen’s Imbruvica in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
Flagship Pioneering has committed $50 million to Montai Health, a biotech that aims to develop therapies for chronic diseases using molecules already found in nature.
GSK bolstered its position in the oligonucleotide therapeutics space through a four-year collaboration with Wave Life Sciences valued at up to $3.3 billion.
An investigational mRNA cancer vaccine developed by Moderna and Merck reached its primary efficacy endpoint, inducing a clinically meaningful improvement in recurrence-free survival.
On the heels of positive Phase IIb data in plaque psoriasis, Takeda is acquiring both the therapy and Nimbus Lakshmi, a wholly owned subsidiary, in a potentially $6 billion deal.
Developed initially to deliver cytotoxic payloads to tumors, antibody therapeutics are evolving to provide new, next-generation conjugates and treat various diseases beyond cancer.
FDA
Mirati gets the green light from the FDA for its KRAS G12C-mutated lung cancer medication.
Seagen’s top-selling drug hit the mark in another major indication.
Clovis Oncology officially files for Chapter 11 bankruptcy.
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