Puma's Likely Neratinib EU Knockback May Be Temporary

A positive opinion on the marketing application for Puma's neratinib in the EU is unlikely next month after a recent discussion with regulators failed to satisfy risk-benefit concerns, but more data on controlling diarrhea are expected shortly.

Scales of Justice
The risks and benefits of neratinib are being weighed • Source: Shutterstock

Puma Biotechnology Inc.'s announcement on Jan. 23 that its new anticancer kinase inhibitor and lead product, neratinib, was unlikely to receive a positive opinion from the EU's top advisory panel, the Committee for Medicinal Products for Human Use (CHMP) came as a surprise to commentators and showed, once again, that regulatory approval in one major market may not automatically translate into approval in another.

Neratinib oral tablets (Nerlynx) were approved by the US FDA in July 2017, but Puma reported on Jan. 23, 2018...

More from New Products

Moderna’s Spikevax Wins Pediatric Approval, But With Narrower Label

 

The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.

Bayer Bags First Global Okay For Hot Flashes Therapy

 
• By 

Lynkuet will compete with Astellas's Veozah/Veoza

In Brief: Soleno To Raise $200m To Boost Vykat XR Launch

 
• By 

Soleno Therapeutics will raise about $200m gross proceeds from an offering of 2.35m of its common stock to fund the commercialization of Vykat XR, which became the first drug for Prader-Willi syndrome to gain US approval on March 26.

Four Chinese Firms Snag Global First-In-Class Approvals In China

 

Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.

More from Scrip

China’s Biotechs Were The Small-Cap Rising Stars In H1 2025

 

The list of small-cap companies with the fastest-rising share prices so far this year is dominated by Chinese companies, underscoring their growing contribution to the global biopharma ecosystem.

In Brief: Soleno To Raise $200m To Boost Vykat XR Launch

 
• By 

Soleno Therapeutics will raise about $200m gross proceeds from an offering of 2.35m of its common stock to fund the commercialization of Vykat XR, which became the first drug for Prader-Willi syndrome to gain US approval on March 26.

Glenmark Chief On IGI’s Landmark Trispecific Deal: Strong Data Excited AbbVie

 

Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.