Proteo gets drug designation for Elafin
Elafin approved to help those with pulmonary arterial hypertension
Elafin, a drug developed by Proteo Biotech for treatment of pulmonary arterial hypertension, has received approval from the U.S. Food and Drug Administration (FDA) which could see patients receiving the drug exclusively from Proteo over the next seven years.
The designation also means that tax offers to certain development costs will be offered to the company while it operates in the US, as well as the ability to take advantage of special funding opportunities such as the US Orphan Products Grants Programme.
Pulmonary arterial hypertension is a potentially life-threatening illness that affects around 200,000 people in the US and occurs when the pressure in a patient's pulmonary arteries becomes dangerously high.
"Reversal of this obliteration is a key goal in the treatment of pulmonary arterial hypertension. We therefore propose that Elafin treatment could be a promising option for patients," said Marlene Rabinovitch, director of research at the Vera Moulton Wall Centre for Pulmonary Vascular at Stanford University School of Medicine.
Related News
-
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs... -
News Chasing new frontiers at LEAP – The National Biotechnology Strategy Keynote
On the third day of LEAP (4–7 March 2024, Riyadh Exhibition and Convention Centre, Malham, Saudi Arabia) the CPHI Middle East team hosted the Future Pharma Forum, to set the scene for an exciting new event for the pharma community, coming to Riya... -
News Pfizer maps out plans for developing new oncology therapeutics by 2030
Pfizer dilvulges plans to investors around growing their cancer portfolio, and the drugs they will be focusing on developing after their aquisition of Seagen in 2023. -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion. -
News Bernie Sanders vs Big Pharma - the latest on drug price negotiations
In a hearing in front of the US Senate, three of the biggest pharmaceutical companies in America are challenged over exorbitant prescription drug prices, with Sanders claiming their actions are limiting the population's access to affordable healthc...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance