Sarepta Therapeutics

Despite failing to hit the primary endpoint in the Phase III EMBARK study, the company plans to file for a label expansion for its Duchenne muscular dystrophy gene therapy Elevidys.

GlaxoSmithKline, GSK

Exclusive rights to the therapy will fuel the expansion of GSK’s own hepatitis B treatment, bepirovirsen, which is currently in late-stage development, the company said.

Paxlovid

Pfizer on Tuesday reported its first quarterly loss since 2019, as demand fell for its COVID products and it recorded a hefty charge mainly from the U.S. government returning millions of doses of its antiviral treatment Paxlovid.

GE HealthCare Technologies beat Wall Street expectations for third-quarter profit as a continued recovery in demand for surgical procedures boosted sales of its medical devices.

A judge in Kansas on Monday blocked a state law requiring healthcare providers to tell patients that medication abortion can be reversed and that abortion is linked to breast cancer while he considers a legal challenge to the law by abortion providers and Planned Parenthood.

The Japanese pharma’s attention deficit/hyperactivity disorder candidate has shown significant symptom improvements in children and adolescents in two late-stage studies.

CRISPR

In a briefing document for Tuesday’s advisory committee meeting, the FDA raised concerns about the potential off-target effects of Vertex Pharmaceuticals and CRISPR Therapeutics’ investigational gene edited therapy.

swirl

With the potential FDA approval of an MDMA-based therapy for PTSD on the horizon, biopharma stakeholders are eyeing psychedelics with fresh anticipation.

With recent high-profile failures, experts say safety concerns and a lack of diversification are hindering the field—but still hold out hope for an approval.

Reviva Pharmaceuticals Holdings said on Monday its lead experimental drug to treat adults with schizophrenia helped reduce disease symptoms in a late-stage study.