Revive Therapeutics Ltd. Submits Pre-IND Meeting Request to the US FDA for its Gout Drug Candidate, REV-002

TORONTO, ONTARIO - Revive Therapeutics Ltd. (TSX VENTURE:RVV) ("Revive") announced today it has submitted a pre-Investigational New Drug (pre-IND) meeting request to the US Food and Drug Administration (FDA) for its gout drug candidate, REV-002.

Revive has requested an initial meeting with the US FDA to review Revive's proposed clinical development plan required for approval of REV-002.

"This request marks another important step in Revive's program to obtain US FDA approval for REV-002 in the treatment of gout," said Fabio Chianelli, Chief Executive Officer of Revive.

Read more: Revive Therapeutics Ltd ( RVV )

MONTREAL, QC - April 29, 2014 (Investorideas.com Biotech Newswire) Sunshine Biopharma, Inc. (OTCQB: SBFM), a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer today announced that it has entered into an Investment Agreement with Dutchess Opportunity Fund, II, LP ("Dutchess"). Dutchess has agreed to purchase up to $2.5 million of shares of Sunshine's Common Stock over a three-year commitment period. Under the terms of the Investment Agreement Sunshine may, from time to time, as needed and in its sole discretion, submit a notice to sell newly-issued shares of its Common Stock to Dutchess at 90% of the VWAP (volume weighted average price) during the 5 days preceding the date of such notice. The Investment Agreement does not impose any restrictions on Sunshine's operating activities.

Read more: Biotech News Alert: Sunshine Biopharma (OTCQB: SBFM) Secures Funding for Its Adva-27a Anticancer...

XOMA Finalizes Plans for Gevokizumab Phase 3 Clinical Program in Pyoderma Gangrenosum

BERKELEY, Calif., April 28, 2014  -- XOMA Corporation (XOMA), a leader in the discovery and development of therapeutic antibodies, announced today that based on its meeting with the U.S Food and Drug Administration (FDA), the Company is finalizing its plans for a gevokizumab Phase 3 program in pyoderma gangrenosum (PG), a rare neutrophilic dermatosis of painful expanding necrotic skin ulcers. During the meeting, the Company and the FDA reviewed the data generated from XOMA's pilot trial in six PG patients. The pilot study was designed to determine if gevokizumab, an IL-1 beta modulating antibody, should be explored in pivotal studies in patients with active PG. XOMA is incorporating the FDA's verbal and written responses regarding the clinical design of the studies into a final Phase 3 program, which it will submit to the Agency for any final comments.

Read more: XOMA Corporation ( XOMA )

Amicus Therapeutics Announces Positive 12- and 24-Month Data From Phase 3 Fabry Monotherapy Study 011

Migalastat Demonstrated Statistically Significant (p=0.013) and Durable Substrate Reductions on 12-Month Pre-Specified Primary Analysis in Fabry Patients with Amenable Mutations
Statistically Significant (p
Important Fabry Disease Biomarker, Plasma Lyso-Gb3
Kidney Function Remained Stable Up to 24 Months in Fabry Patients with Amenable Mutations
85% of Patients with Amenable Mutations Completing Month 24Remain in Ongoing Voluntary Extension Study (Study 041)
Conference Call and Webcast Today at 8:00 a.m. ET

CRANBURY, N.J., April 29, 2014 -- Amicus Therapeutics (FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced positive 12- and 24-month data from its first Phase 3 study (Study 011) of the oral small molecule chaperone migalastat HCl ("migalastat") monotherapy in Fabry patients with amenable mutations. Detailed results are available in a slide presentation that will be shared by the Amicus management team on a conference call today at 8:00 a.m. ET. Please visit http://ir.amicustherapeutics.com/events.cfm.

Read more: Amicus Therapeutics ( FOLD )

Galena Biopharma Announces Department of Defense Grant for NeuVax(TM) (nelipepimut-S) Clinical Trial

  • Phase 2 study in neoadjuvant, HER2 3+ Breast Cancer Patients to commence in 2014
  • New study supports ongoing Phase 3 PRESENT study and Phase 2b in HER2 1+ and 2+ patients

PORTLAND, Ore., April 28, 2014 - Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced the Department of Defense (DoD) will provide funding towards a new clinical trial with NeuVax to prevent breast cancer recurrence in high-risk HER2 3+ patients.

Read more: Galena Biopharma ( GALE )