Today, the U.S. Food and Drug Administration finalized its efforts to streamline the process used by physicians to request expanded access, often called “compassionate use,” to investigational drugs and biologics for their patients. As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their serious disease or condition.
Access to investigational treatments requires the active cooperation of the FDA, industry, and health care professionals in order to be successful. But we know that navigating that process can be challenging and time consuming, and we are committed to reducing the procedural burdens on physicians and patients whenever possible. read more
What It’s Like to Be a Working Woman in Japan
Two years ago, I arrived in Japan from Australia with a stomach full of butterflies—and not just because it was a new job, a new country and a new culture for me. I was also four months pregnant. Given all the things I’d heard about Japan—including its legendary long working hours—I was worried about how I would be perceived. Would it be frowned upon that I took maternity leave? How long could I take off without upsetting my colleagues? – read more
ASTRAZENECA COMPLETES US LICENSING AGREEMENT WITH IRONWOOD PHARMACEUTICALS FOR LESINURAD
AstraZeneca today announced that it has completed the licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to Zurampic (lesinurad) and the fixed-dose combination of lesinurad and allopurinol. Zurampic is approved in the US, in combination with a xanthine oxidase inhibitor, for the treatment of hyperuricemia associated with uncontrolled gout. The fixed-dose combination will be submitted for regulatory review in the second half of 2016.
EISAI INC. ENTERS INTO COLLABORATION AGREEMENT TO CO-PROMOTE EISAI’S ANTICANCER AGENT LENVIMA® IN COMBINATION WITH EVEROLIMUS AS TREATMENT FOR ADVANCED RENAL CELL CARCINOMA IN THE UNITED STATES
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.S. subsidiary Eisai Inc. has entered into an agreement with Novartis Pharmaceuticals Corporation (Novartis), a U.S. affiliate of Novartis AG (Headquarters: Basel, Switzerland, CEO: Joseph Jimenez), to collaborate on commercial and medical affairs activities (including the provision of scientific evidence to healthcare professionals) for Eisai’s in-house developed novel anticancer agent Lenvima® (lenvatinib mesylate) and the anticancer agent everolimus in the United States. read more
MiNA Therapeutics Announces Initiation of Phase I Clinical Study of MTL-CEBPA in Patients with Liver Cancer | EON: Enhanced Online News
MiNA Therapeutics Announces Initiation of Phase I Clinical Study of MTL-CEBPA in Patients with Liver Cancer | EON: Enhanced Online News LONDON–(EON: Enhanced Online News)–MiNA Therapeutics, the pioneer in RNA activation therapeutics, today announced the initiation and first patient treated in the OUTREACH Phase I clinical study of their lead program, MTL-CEBPA, in severe liver cancer. read more
PAREXEL Named Company of the Year for the Pharmaceuticals Industry with a Gold Stevie from the American Business Awards
Bayer and Orion Expand Clinical Development Program for BAY-1841788 (ODM-201) in Prostate Cancer
PR Newswire for Journalists | Bayer and Orion Expand Clinical Development Program for BAY-1841788 (ODM-201) in Prostate Cancer
WHIPPANY, N.J., June 3, 2016 /PRNewswire/ — Bayer and Orion Corporation today announced the expansion of the global clinical development program for the investigational androgen receptor (AR) antagonist BAY-1841788 (ODM-201) in the area of prostate cancer. The Phase III study ARASENS will evaluate the compound in combination with standard androgen deprivation therapy (ADT) and the chemotherapy docetaxel in men with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC), who are starting first line hormone therapy. The compound, BAY-1841788 (ODM-201), is an investigational oral AR-antagonist currently in Phase III development for high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). The ARASENS clinical trial is expected to start enrolling patients towards the end of 2016.
Seattle Children’s T-Cell Immunotherapy Clinical Trial for Children With Relapsed Leukemia Shows 93% Complete Remission Rate
PR Newswire for Journalists | Seattle Children’s T-Cell Immunotherapy Clinical Trial for Children With Relapsed Leukemia Shows 93% Complete Remission Rate
Seattle Children’s announced today that 39 of 42 patients treated in a Phase 1 clinical trial using genetically reprogrammed T cells to treat relapsed or refractory acute lymphoblastic leukemia (ALL) have achieved complete remission, showing no detectable leukemia cells in the most sensitive tests. Patients treated in the trial, known as Pediatric Leukemia Adoptive Therapy-02 (PLAT-02), had less than a 20% chance of survival upon enrollment using current treatments. Seattle Children’s will launch Phase 2 of the trial this month, with the aim to enroll 70 patients in the next year. read more
AmpliPhi Biosciences to be Granted European Patent Covering the Use of Phage Therapy to Resensitize Bacterial Infections To Antibiotics
SAN DIEGO–(EON: Enhanced Online News)–AmpliPhi Biosciences Corporation (NYSEMKT: APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today announced that the European Patent Office has issued a decision to grant AmpliPhi patent No. 2136826, for the “Beneficial effects of bacteriophage treatments”. A corresponding patent has been granted in Australia and a species-specific patent for Pseudomonas aeruginosa has been granted in the United States. Additional patents are pending in Canada, Japan and the United States. read more