Startup Glycomine Lands $115M for Clinical Trial in Ultra-Rare Disease With No Approved Drugs

Glycomine’s lead program is an experimental treatment for PMM2-CDG, an ultra-rare enzyme deficiency often misdiagnosed as cerebral palsy. With encouraging results from an open-label Phase 2 study, the biotech startup is now preparing for a placebo-controlled test that could potentially support a regulatory submission. The post Startup Glycomine Lands $115M for Clinical Trial in Ultra-Rare…

Read More

FDA Voucher Leads to Speedy Approval of Boehringer Drug for First-Line Use in Lung Cancer

The label expansion for Boehringer Ingelheim’s Hernexeos was made under an FDA pilot program that accelerates regulatory review of products with national interest. The daily pill is now approved as a first-line treatment for HER2-positive non-small lung cancer, an indication with few treatment options. The post FDA Voucher Leads to Speedy Approval of Boehringer Drug…

Read More

Neuroscience Biotech Alkermes Sees Narcolepsy R&D as Launchpad for a Range of New Fatigue Therapies

Alkermes is chasing Takeda Pharmaceutical, whose orexin receptor-targeting pill is on track to become first in a new class of narcolepsy medicines. Blair Jackson, chief operating officer of the neuroscience biotech, says Alkermes’s drug offers advantages and also paves the way to bring orexin agonism to other indications. The post Neuroscience Biotech Alkermes Sees Narcolepsy…

Read More