1. Scrip
  2. >>Therapy Areas
  3. >>Anti-infective

Protalix/Pfizer first in US with plant cell-based recombinant therapeutic protein

 
• By Donna Young

For Protalix BioTherapeutics and Pfizer, the US FDA's 1 May marketing clearance of Elelyso (taliglucerase alfa), an enzyme replacement therapy (ERT) for Gaucher disease, puts the firms in the record books for gaining the first US approval of a recombinant therapeutic protein made in a plant organism – carrot cells, to be exact.

For Protalix BioTherapeutics and Pfizer, the US FDA's 1 May marketing clearance of Elelyso (taliglucerase alfa), an enzyme replacement therapy (ERT) for Gaucher disease, puts the firms in the record books for gaining the first US approval of a recombinant therapeutic protein made in a plant organism – carrot cells, to be exact.

Investors basked in the glory of the much awaited victory, with shares of Protalix soaring 23% in after-hours trading on...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Anti-infective

Gilead’s Yeytuo, Lilly’s Kisunla Headline CHMP Positive Opinions

 
• By Alaric DeArment

Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.

Memo Therapeutics Plans BK Virus Therapy Phase III Despite Trial Miss

 
• By Manas Mishra

Pointing to data that show a benefit in reducing viral load and the histological signs of the infection, Memo says its drug, potravitug, could become the first therapy to treat BK polyomavirus in kidney transplant recipients.

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

 
• By Alaric DeArment

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.

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

 
• By Dexter Jie Yan

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 Therapeutic Category

Memo Therapeutics Plans BK Virus Therapy Phase III Despite Trial Miss

 
• By Manas Mishra

Pointing to data that show a benefit in reducing viral load and the histological signs of the infection, Memo says its drug, potravitug, could become the first therapy to treat BK polyomavirus in kidney transplant recipients.

Viking Rapidly Advancing Oral And Injectable VK2735 For Obesity

 
• By Joseph Haas

In its Q2 update, Viking reported that Phase III trials of subcutaneous VK2735 are under way, and that it expects Phase II data for an oral formulation before year’s end.

Leo Looks To Grow In US After Hand Eczema Cream Approval

 
• By Kevin Grogan

The Danish medical dermatology specialist doubles boosts its sales force ahead of the launch of Anzupgo.