search
Front > News

BioLineRX obtains FDA orphan drug status for leukemia drug

9 Sep, 2013 17:09
שלח תגובה במיילGali Weinreb

The company has obtained orphan drugs designation for BL-8040 as a therapeutic for the treatment of acute myeloid leukemia.

BiolineRX Ltd. (Nasdaq: BLRX); TASE:BLRX) has obtained orphan drugs designation from the US Food and Drug Administration (FDA) for BL-8040 as a therapeutic for the treatment of acute myeloid leukemia.

The FDA grants Orphan Drug Designation to therapeutics intended to treat rare diseases that affect no more than 200,000 people in the US. The designation entitles the sponsor to seven years market exclusivity, clinical protocol assistance with the FDA, and federal grants and tax credits.

BL-8040 is also suited for treating other cancers, but because these are larger markets, Orphan Drug Designation is inapplicable to them. BiolineRX is already conducting a Phase II clinical trial of the drug for acute myeloid leukemia.

“Currently, acute myeloid leukemia treatment options, especially in patients with a relapse of the disease, are extremely limited. BL-8040 has the potential to be a significant addition to the drug arsenal for this disease, especially when considering its promising pre-clinical results, unique biological mechanism and ability to synergize with other drugs already approved for this disease. Therefore, we are eagerly looking forward to the partial results of BL-8040′s Phase 2 study expected towards the end of 2013," said BiolineRX CEO Dr. Kinneret Savitsky.

Published by Globes [online], Israel business news - www.globes-online.com - on September 9, 2013

© Copyright of Globes Publisher Itonut (1983) Ltd. 2013

Zutacore cofounder and CEO Erez Freibach credit: Gal Bref, Moshe Filberg and Zutacore PR SoftBank teams with Israeli chip liquid cooling startup ZutaCore

The Sderot-based company has developed an innovative cooling technology that dramatically cuts energy costs for data centers.

Hearst Tower New York credit: Shutterstock Hearst Ventures shuts down Israel office

The closure is part of a global move to shut down offices outside the US, but the fund will continue investment in Israeli companies.

US President Donald Trump credit: Shutterstock US reciprocal procurement demands put Israel in a bind

Reciprocal procurement on major tenders injects billions of dollars into Israel every year and supports hundreds of local companies but Israel may need to relax them in exchange for US tariff cuts.

Israeli stocks on Wall Street credit Nasdaq, Raanan Tal, Itay Tagar, Space Cut design: Tali Bogdanovsky Despite turmoil, analysts bullish on Israel Wall Street stocks

After recent strong declines, analysts are tipping Israeli tech stocks, with relative immunity to recession and limited exposure to tariffs.

Intel's 2025 vision credit: Intel Will Intel's sell-off include Israeli assets?

After the sale of Altera, "Globes" considers whether the troubled chipmaker will sell Mobileye or its Kiryat Gat fab.

CloudShare management team credit: PR Bow River Capital buys Israeli co CloudShare

The Denver-based alternative asset manager is paying an estimated $60-80 million for the SaaS provider of AI guided solutions for complex technical training requirements.

Housing prices continue to rise credit: Tali Bogdanovsky Israel's housing price rise riddle

Despite a huge inventory of unsold new homes in central Israel and weak sales, apartment prices are still rising. "Globes" analyzes the data.

Inflation credit: Tali Bogdanovsky March CPI higher than expected, housing prices rise

The March reading brings annual inflation in Israel down to 3.3% from 3.4% at the end of February.

Ben Gurion airport credit: Tali Bogdanovsky Abundance of affordable last minute Passover flight deals

The return of foreign airlines to Israel has brought down fares dramatically even for last minute vacations.

Karish rig credit: Eyal Izhar Kesem Energy signs gas deals worth $2.8b

The power plant, scheduled to begin operating in 2029, will buy gas worth $2 billion from Energean and a further $700-800 million from the Tamar partners.

Kosher for Passover Coca Cola bottles credit: social media Why are yellow cap Coca Cola bottles different from all others?

Nostalgic Coca Cola aficionados claim that the kosher for Passover version, made from sugar cane instead of high fructose corn syrup, is the genuine taste of the soft drink.

Avigdor Willenz credit: Intel Exclusive: Avigdor Willenz's Element Labs raises $50m

The Israeli startup is developing AI processors for inference, the stage in which AI models are activated after they have already been trained.

Ilya Sutskever credit: Cadya Levy SSI hiring dozens in Israel

AI company Safe Superintelligence is hiring many dozens of people in Tel Aviv, "Globes" has learned.

Johny Srouji credit: Amos Ben Gershom GPO Apple SVP leads senior delegation of execs to Israel

Jony Srouji: I am always filled with renewed energy and optimism about our shared achievements when I visit our R&D centers here.

Israeli apartments Credit: Shutterstock Apartments sold and rented

A selection of recent real estate deals in Israel in Tel Aviv, Ramat Gan, Petah Tikva, Givat Shmuel, Tiberias and Dimona.

Infinity Tower Tel Aviv credit: Courtesy Hagag Group French investors buy 2 Tel Aviv apartments for NIS 27.5m

The two apartments are in Hagag Group's Infinity Tower in the Summeil district.

Twitter Facebook Linkedin RSS Newsletters גלובס Israel Business Conference 2018