Amicus Therapeutics Provides Positive Global Regulatory Updates From EMA and FDA Meetings for Fabry Monotherapy

MAA Submission for Full Approval Planned in European Union -- Company to Accelerate Submission Timeline for MAA Filing to 2Q15
NDA Submission for Accelerated Approval (Subpart H) Planned in United States for 2H15
Conference Call and Webcast Today at 8:00 a.m. ET

CRANBURY, N.J., March 19, 2015 -- Amicus Therapeutics (FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced that it has met very recently with regulatory authorities in Europe and the U.S. to discuss the approval pathways for the oral small molecule pharmacological chaperone migalastat HCl ("migalastat") as a precision medicine monotherapy for Fabry patients who have amenable genetic mutations.

Read more: Amicus Therapeutics ( FOLD )

Coronado Biosciences Announces Exclusive Licensing Agreement With NeuPharma to Develop and Commercialize Novel Covalent 3rd Generation EGFR Inhibitors

NEW YORK, March 19, 2015  -- Coronado Biosciences, Inc. (CNDO) announced today the execution of an exclusive license agreement with NeuPharma, Inc. to develop and commercialize novel irreversible, 3rd Generation EGFR inhibitors on a worldwide basis outside of certain Asian countries. The program is currently in pre-clinical development. Under the terms of the agreement, Coronado will pay NeuPharma an up-front licensing fee as well as make development and sales-based milestone payments and will pay a tiered single digit royalty on net sales.

Read more: Coronado Biosciences Inc ( CNDO )

Can-Fite Completes Development of Commercial Biomarker Test to Predict Patients' Response to Company Drugs

Patented blood test to be used in clinical trials and as a companion diagnostic for Can-Fite's Drugs

PETACH TIKVA, Israel, March 18, 2015 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company with a pipeline of proprietary small molecule drugs that are being developed to treat inflammatory diseases, cancer and sexual dysfunction, announced today it has completed the development of a commercial predictive biomarker blood test kit for the A3 adenosine receptor (A3AR). The biomarker test can be used at any molecular biology lab, where a small blood sample from a prospective patient would be tested and within just a few hours, results indicate if the patient would benefit from treatment with Can-Fite's drugs, which are currently in clinical trials for rheumatoid arthritis, psoriasis, and liver cancer.

Read more: Can-Fite BioPharma Ltd ( CANF )

U.S. Food and Drug Administration Approves Cholbam for the Treatment of Rare Bile Acid Synthesis Disorders and Grants Rare Pediatric Disease Priority Review Voucher

Retrophin Will Acquire Worldwide Rights

SAN DIEGO--(BUSINESS WIRE)-- Retrophin, Inc. (RTRX) announced today that the U.S. Food and Drug Administration (FDA) has approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).

Read more: Retrophin Inc ( RTRX )

Potential of Anisina to Become Major New Chemotherapy Confirmed by Coda Study

SYDNEY, March 18, 2015-- Novogen announced on 18th March, 2015 that one of its oncology pipeline drug candidates, Anisina (ATM-3507), has achieved a major milestone in its development, confirming the concept that comprehensive destruction of a cancer cell's cytoskeleton can deliver a powerful anti-cancer effect.

Dr Kelly was interviewed by Channel 7 health reporter, Dr Andrew Rochford about Anisina's potential.  To view the interview click here… or visit the Novogen website.

The cytoskeleton (cell skeletal structure) is a common and validated target for anti-cancer therapy. The most commonly used drugs in chemotherapy target the cytoskeleton by destabilising one of its two key components, the microtubules. These drugs are known as 'anti-mitotics' and include the taxanes (paclitaxel, docetaxel) and the vinca alkaloids (vincristine, vinblastine). Collectively, these anti-mitotics have dominated chemotherapy for the past 30 years and look set to do so for many years to come.

Read more: Novogen Limited ( NVGN )