Life Sciences

Univercells raises $18.8M to commercialize low-cost biologics manufacturing platform

July 20, 2018

Right after releasing positive results for its novel affordable vaccine manufacturing technology, Belgium’s Univercells closed a €16 million ($18.8 million) series B backed by funds on three continents. Univercells said the money will support the continued development of its cost-efficient biologics manufacturing platform, with the..

Ovid, Takeda add 2 rare epilepsies to rare drug pact

July 19, 2018

A year after Takeda tied up with Ovid Therapeutics to advance its epilepsy drug TAK-935, the pair is announcing two phase 2 trials in rare pediatric epilepsies and an extension trial for patients with developmental and epileptic encephalopathies (DEEs). The companies partnered in 2017 to push the drug forward..

Novartis runs into Kymriah production glitch in new DLBCL indication

July 19, 2018

Novartis, whose personalized CAR-T cancer treatment Kymriah won an approval in May to treat relapsed large B-cell lymphoma, said today it has run into some manufacturing issues around that condition. Liz Barrett, CEO of Novartis Oncology, said during the company’s second-quarter earnings call that a..

This Robot Detects Lung Cancer Better Than Any Human Doctor–and That’s Just for Starters

Endoscopies rely on a physician’s steady hands operating a long camera as it’s manually fed into, and manipulated within, a patient’s body. Co-founder Fred Moll and his team at Redwood City, California-based Auris Health spent six years building the Monarch Platform, a robotic system that helps doctors..

Pfizer halts production at India injectables plant after FDA again finds issues

July 18, 2018

Pfizer has again suspended production at a long-troubled sterile injectables plant in India that the FDA has twice before cited for manufacturing and testing issues. The agency recently outlined problems in a highly redacted, 32-page Form 483 following an inspection of the plant in Irungattukottai, India, a..

Roche’s new single-dose flu drug bolsters its case in people at high risk of complications

July 18, 2018

Roche’s expected Tamiflu replacement has already shown solid efficacy in otherwise healthy people. Now, a phase 3 study also showed that this new flu drug worked in people at high risk for serious flu complications, padding the drug’s case of helping Roche reclaim ground lost to..

Amgen, UCB refile for romosozumab approval 1 year after safety scare sunk submission

July 17, 2018

Amgen and UCB have re-filed for FDA approval of osteoporosis drug romosozumab one year after the agency rejected a submission on safety grounds. The revised filing pools all the phase 3 data in a bid to show the sclerostin-targeting antibody has a positive risk-benefit profile. Romosozumab looked..

FDA AdComm backs GlaxoSmithKline’s 1-shot P. vivax malaria therapy

July 17, 2018

GlaxoSmithKline is close to ending a six-decade drought in relapse-preventing therapies for Plasmodium vivax—one of the most common forms of malaria—after its new drug tafenoquine cleared an FDA advisory committee. The panel backed the efficacy of the tafenoquine regimen by 13 votes to zero, and..

Brexit ambition is ‘fine’ but execution is key, says Brexit Health Alliance

July 16, 2018

The co-chair of the Brexit Health Alliance, Niall Dickson, has welcomed the ambition of the government’s Brexit white paper but warned that execution will be key. “The ambition is fine – but we await the execution,” said Dickson, who is Chief Executive of the NHS Confederation…

Despite looming resistance crisis, Novartis ducks out of antibiotics research

July 12, 2018

Novartis is the latest big pharma player to decide that developing new anti-infectives isn’t on its priority list. The company is shutting down antibacterial and antiviral research at its Novartis Institutes for Biomedical Research campus in Emeryville, California, with the loss of 140 jobs, and..