NORTH CHICAGO, Ill., Jan. 28, 2016 /PRNewswire/ — AbbVie (NYSE:ABBV), a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational agent venetoclax in combination with hypomethylating agents (HMAs) for the treatment of patients with untreated (treatment-naïve) acute myeloid leukemia (AML) who are ineligible to receive standard induction therapy (high-dose chemotherapy). Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed by AbbVie in partnership with Genentech and Roche. read more
FDA Classifies St. Jude Medical Field Action For 447 Of The Company’s Optisure High Voltage Leads As A Class 1 Advisory In The U.S.
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that a previously communicated voluntary global field safety action related to the company’s Optisure™ Dual Coil Defibrillation Leads has now been classified as a Class 1 Advisory by the U.S. Food and Drug Administration. The Class 1 Advisory relates to a limited and well-defined group of 447 Optisure leads, 278 of which were distributed in the U.S., which may have been damaged during a manufacturing step. The company has received no reports of lead malfunction or patient injury related to this issue and all physicians with patients impacted by this advisory have been notified.read more
Medivir initiates phase IIa study of MIV-711 in knee osteoarthritis
HUDDINGE, Sweden–(BUSINESS WIRE)–Medivir AB (Nasdaq Stockholm: MVIR ) today announces the enrolment of the first patient into a randomized double-blind phase IIa clinical study of the in-house developed cathepsin K inhibitor MIV-711 in patients with moderate knee osteoarthritis (OA). The phase IIa study will enrol 240 patients into 3 arms, each with approximately 80 patients, and compare MIV-711 dosed at 100mg or 200 mg once daily against placebo. The key objectives are to assess the effect of six months of treatment with MIV-711 on knee joint clinical pain and on knee OA, assessed using magnetic resonance imaging, as well as the safety and tolerability of MIV-711. Timing of data from the study is on plan and expected to be available in the third quarter of 2017. Further information on the trial planning and conduct can be found on www.clinicaltrialsregister.eu .
Incyte Announces Decision to Stop Phase 2 Sub-study of Ruxolitinib Plus Regorafenib in Patients with Metastatic Colorectal Cancer and High CRP
WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq: INCY) announced today that the Phase 2 sub-study of ruxolitinib or placebo in combination with regorafenib in patients with relapsed or refractory metastatic colorectal cancer (CRC) and high C-reactive protein (CRP) will be stopped early. The decision to stop the sub-study was made after a planned interim analysis of the high CRP subgroup demonstrated that ruxolitinib plus regorafenib did not show a sufficient level of efficacy to warrant continuation. read more
Sinovac Biotech Announces Issuance of GMP Certificate for EV71 Vaccine
BEIJING, Jan. 28, 2016 /PRNewswire/ — Sinovac Biotech Ltd. (SVA), a leading provider of biopharmaceutical products in China, announced today that the China Food and Drug Administration (“CFDA”) has issued the Good Manufacturing Practices (“GMP”) certificate to Sinovac for the Company’s Enterovirus 71 (“EV71”) vaccine read more
Health Canada approves Amgen’s new multiple myeloma treatment Kyprolis™ (carfilzomib)
In the ASPIRE clinical trial Kyprolis demonstrated improved progression-free survival for relapsed patients1
MISSISSAUGA, ON, Jan. 28, 2016 /CNW/ – Amgen Canada Inc. today announced that Health Canada has approved Kyprolis™ (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy.1
In the ASPIRE clinical trial, on which the approval was based, the median progression-free survival (PFS) for patients receiving Kyprolis, lenalidomide, and low dose dexamethasone was 26.3 months (95 per cent CI: 23.3 to 30.5 months) vs. 17.6 months (95 per cent CI: 15.0 to 20.6 months) in the lenalidomide and low dose dexamethasone arm.1
Mundipharma Appointed as Development and Marketing Partner for flutiform(R) in Mexico, Central and South America
SINGAPORE, Jan. 28, 2016 /PRNewswire/ — Mundipharma International Corporation Limited has announced that it has entered into agreements with Skyepharma PLC (LSE SKP), the expert oral and inhalation drug development company, and Sanofi Winthrop Industrie (“Sanofi”) to transfer the exclusive development, licensing and marketing rights for flutiform® for Mexico, Central and South America (“Territory”) to the Mundipharma network of independent associated companies (“Mundipharma”).
For more information please visit: www.mundipharma.com.sg
Stemedica Cell Technologies Announces Completion of Enrollment in Phase I/IIa Clinical Trial for Ischemic Stroke
/PRNewswire/ — Stemedica Cell Technologies, Inc. announced completion of enrollment into “A Phase I/IIa, Multi-Center, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Ischemic Stroke.” This study focused on patients who were at least six months post-stroke with significant functional or neurologic impairment (defined as confined to a wheelchair or required to have home nursing care or assistance with the general activities of daily living). In addition, inclusion criteria specified that patients have no substantial improvement in neurologic or functional deficits for the two months prior to enrollment in the study. read more
Neuralstem Presented Cell Therapy Update At Phacilitate Cell & Gene Therapy World Conference
/PRNewswire/ — Neuralstem, Inc. (Nasdaq: CUR), a biopharmaceutical company using neural stem cell technology to develop regenerative therapies and small molecule pharmaceutical drugs for CNS diseases and disorders, announced that Karl Johe, Ph.D., Neuralstem’s Chairman and Chief Scientific Officer, provided an update on the company’s ongoing NSI-566 cell therapy clinical programs at the Phacilitate Cell & Gene Therapy World conference in Washington D.C.
The presentation reviewed the company’s NSI-566 human spinal cord-derived neural stem cells investigational trials for the treatment of amyotrophic lateral sclerosis (ALS), chronic spinal cord injury (cSCI), and motor deficits due to ischemic stroke. Dr. Johe highlighted the consistent biological activity and multiple modes of therapeutic actions, including the rescue of motor neurons, motor improvement, and neuronal integration in NSI-566 animal and human clinical data. He concluded that the collective trial data analysis showed the cells consistently demonstrated biological activity in all three indications. read more