SAN DIEGO -- La Jolla Pharmaceutical Company (LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that it has reached agreement with the European Medicines Agency (EMA) on the design of a pivotal study of LJPC-401, La Jolla’s novel formulation of synthetic hepcidin. The pivotal study will be a randomized, controlled, multi-center study in beta thalassemia patients suffering from iron overload, a major unmet need in an orphan patient population. The primary endpoint will be a clinically relevant measurement directly related to iron overload. La Jolla plans to initiate this pivotal study in mid-2017.

 

“We very much appreciate the EMA’s support of advancing LJPC-401’s development for this major unmet need,” said George F. Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. 

Subjects with moderate to severe endometriosis experienced relief of menstrual pain and a reduction in the use of pain medication with the use of Proellex®

Proellex® subjects’ menstrual pain by BBSS decreased significantly when compared to those treated with placebo

Total pain medication use decreased 56% and non-prescription pain medication use decreased 74% in subjects treated with Proellex®

Proellex® subjects’ menstrual pain by BBSS decreased significantly when compared to those treated with placebo

Total pain medication use decreased 56% and non-prescription pain medication use decreased 74% in subjects treated with Proellex®

 

THE WOODLANDS, Texas, Sept. 07, 2016 -- Repros Therapeutics Inc.® (RPRX) today provided the results of the first course of treatment from Repros’ ongoing study of Proellex® for the treatment of premenopausal women with confirmed symptomatic endometriosis.

SOLANA BEACH, Calif., Sept. 07, 2016 -- Evoke Pharma, Inc. (EVOK) (the “Company"), a specialty pharmaceutical company focused on treatments for gastrointestinal diseases, today announced that it has completed a pre‑New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, Gimoti™, its patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The focus of this pre-NDA meeting with the FDA was the content of the regulatory, chemistry, manufacturing, and control (CMC), and non-clinical sections of the Company’s planned 505(b)(2) NDA for Gimoti.

 

Prior to the pre-NDA meeting, Evoke submitted an information package describing the proposed content and format of the regulatory, CMC, and non-clinical sections of the Gimoti NDA. The subsequent face-to-face pre-NDA meeting afforded Evoke the opportunity to gain further understanding of the FDA’s expectations regarding these key sections of the NDA.

BERKELEY, CA--( September 04, 2016) - Dynavax Technologies Corporation (DVAX) announced today that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research has cancelled the scheduled November 16, 2016, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)].

 

During recent conversations between Dynavax and the FDA, the Agency communicated decisions to enable compliance with the current Prescription Drug User Fee Act (PDUFA) date of December 15, 2016. The Agency informed Dynavax that the VRBPAC meeting was cancelled and remaining questions will be addressed between Dynavax and the review team via the normal process. The FDA informed Dynavax that it plans to provide information requests related to remaining questions in the upcoming weeks. Dynavax is prepared to address these questions expeditiously in order to enable the FDA to complete its review as soon as possible.

 

"Our dialogue with the FDA has been very open and productive, and we look forward to providing the review team with any additional information they may need to complete their review," said Eddie Gray, chief executive officer of Dynavax. "We are committed to bringing HEPLISAV-B to market as we believe it offers a better level of protection than the currently available hepatitis B vaccines."