Amgen's Imlygic 1st FDA-Approved Oncolytic Virus Therapy

Amgen Inc. made history on Oct. 27 by gaining the FDA's approval for the first oncolytic virus therapy – Imlygic (talimogene laherparepvec), which is indicated as a local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery.

Amgen Inc. made history on Oct. 27 by gaining the FDA's approval for the first oncolytic virus therapy – Imlygic (talimogene laherparepvec), which is indicated as a local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery.

Shares of Amgen got a 1.5% boost, or a gain of $2.52, in after-hours trading on Oct. 27.

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

More from Anti-infective

Industry’s Vaccines Pipeline In A Changing Regulatory Landscape

 

More than a dozen vaccines for infectious diseases are in Phase III development across the industry, as the US regulatory environment brings increased uncertainty.

Cidara’s Fortunes Improve Quickly With Non-Vaccine Flu-Prevention Data

 
• By 

Having recently abandoned the antifungal space, Cidara’s stock soared on Phase IIb data showing that its drug-Fc conjugate prevents seasonal flu at rates from 57%-76%.

Shigella Vaccine Pipeline And Why It Matters

 
• By 

A GSK-Bharat Biotech deal on a shigella vaccine candidate has cast a spotlight on the disease, which is the second leading cause of diarrheal deaths in children below five. Scrip looks at data from Pharmaprojects, WHO and other sources to highlight why a vaccine matters and what pharma is doing.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

More from Therapy Areas

Nektar Bounces Back As Eczema Drug Rezpeg Heads For Phase III

 
• By 

Lilly-rejected candidate impresses in Phase IIb atopic dermatitis trial.

Battle For Obesity Market Shifts Gears in India: Will Wegovy Trump Mounjaro?

 

Novo Nordisk debuts Wegovy in India, gears for pole position in obesity. The Danish group’s leadership doesn’t appear too perturbed about the head start for Lilly’s Mounjaro or the imminent arrival of generic semaglutide next year.

Amgen’s MariTide Data Not The Hit Investors Sought

 
• By 

MariTide demonstrated solid 52-week weight loss in a Phase II update, but high rates of vomiting. Amgen is adjusting dosing in Phase III to seek a better tolerability profile.