DURHAM, N.C., Oct. 7, 2015 – Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced today preliminary data from liver transplant patients who received brincidofovir for adenovirus infection through the ongoing AdVise trial and the brincidofovir expanded access program. These data will be presented at IDWeek in San Diego.
Chimerix Presents Preliminary Data on Brincidofovir in Liver Transplant Recipients With Adenovirus Infections at IDWeek in San Diego
CoLucid Pharmaceuticals Announces Initiation of Phase 3 Long-Term, Open-Label Trial of Lasmiditan in Migraine.
CAMBRIDGE, Mass., Oct. 8, 2015 – CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches in adults, announced today that the first patient has been randomized in the Company's GLADIATOR study, a Phase 3 long-term, open-label trial of lasmiditan.
The objective of GLADIATOR is to evaluate the safety and efficacy of lasmiditan, as well as resource utilization, functional outcomes and disability. Migraine patients who complete CoLucid's ongoing first Phase 3 pivotal trial, SAMURAI, as well as the Company's second Phase 3 pivotal trial, scheduled to commence in the first half of 2016, will be eligible to enroll in GLADIATOR. GLADIATOR is expected to enroll up to a total of 2,580 subjects, who will be randomized to receive 100 mg or 200 mg of lasmiditan, and treated for up to eight migraine attacks per month for one year.
Medtronic TYRX(TM) Neuro Absorbable Antibacterial Envelope now Available for Use with Implantable Neurostimulators
Dublin – October 7, 2015 – Medtronic plc today announced the first implants of the TYRX(TM) Absorbable Antibacterial Envelope with Medtronic Deep Brain Stimulation (DBS) systems. The implants were conducted by Francisco Ponce, M.D., director, Barrow Center for Neuromodulation, at the Barrow Neurological Institute in Phoenix. Medtronic recently received FDA clearance for the TYRX Neuro Absorbable Antibacterial Envelope for use with implantable neurostimulators (INS), and the product is now commercially available across the United States as an option for use with all DBS systems. In the coming months, Medtronic also plans to make the TYRX Absorbable Antibacterial Envelope available as an option for use with implantable neurostimulators to treat chronic pain and bladder and bowel control disorders.
The TYRX Absorbable Antibacterial Envelope is a mesh envelope that securely holds an INS or cardiac implantable electronic device (CIED). It is designed to stabilize the device after implantation while releasing two antimicrobial agents, minocycline and rifampin, over a minimum of seven days to help prevent surgical-site infections, which are associated with substantial morbidity, mortality and cost.
Wake Forest Baptist Medical Center Creates $15 Million Program to Develop Life Science Technologies
WINSTON-SALEM, N.C. – Oct. 7, 2015 – Wake Forest Baptist Medical Center today announced the creation of a Technology Development Program, a $15 million program to develop the ideas, discoveries and inventions of the faculty and staff of the Medical Center into life science technologies having the potential to benefit patients in the community and worldwide. The new program is in partnership with leading life science investment firm Pappas Capital, in Durham. Funds will be managed by Pappas in collaboration with Wake Forest Innovations to advance clinically important life science technologies for licensing to established companies or startups.
Anthera Announces Initiation of the SOLUTION Clinical Study of Oral Sollpura(R) (liprotamase) Unit-Matched Therapy of Non-Porcine Origin in People With Cystic Fibrosis
HAYWARD, CA, Oct. 2, 2015 – Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced the initiation of the SOLUTION (Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in People With Cystic Fibrosis) Phase 3 clinical study evaluating the efficacy and safety of Sollpura® (liprotamase), a microbial derived, biotech pancreatic enzyme replacement therapy (PERT), compared to an approved, porcine-derived, enteric-coated product for the treatment of exocrine pancreatic insufficiency (EPI).
Study to enroll approximately 130 patients with exocrine pancreatic insufficiency
More than 50 clinical sites around the United States and Europe are expected to participate
Anthera to host reception at the North American Cystic Fibrosis Conference to discuss the SOLUTION program.
Liquidia Technologies and GlaxoSmithKline Advance Existing Collaboration; GlaxoSmithKline Exercises Option for Inhaled Therapeutics
RESEARCH TRIANGLE PARK, N.C., Sept. 30, 2015 -- Liquidia Technologies today announced that GlaxoSmithKline (GSK) has exercised its option under a Collaboration and Option Agreement signed in 2012 to exclusively license the right to research, develop, and commercialize inhaled therapeutics derived from the company's proprietary PRINT® technology. Through this collaboration, Liquidia and GSK will continue to work together with the goal of advancing inhaled therapeutics into clinical studies.
Afferent Pharmaceuticals Announces Positive Results in Phase 2b Chronic Cough Trial
SAN MATEO, Calif – September 28, 2015 – Afferent Pharmaceuticals, a leader in the development of small molecule compounds targeting P2X3 for the treatment of poorly managed and common neurogenic disorders, such as chronic cough, today announced positive top-line results from its Phase 2b dose escalation clinical trial of AF-219 in chronic cough patients. AF-219 is a selective, non-narcotic and orally administered P2X3 antagonist that targets the mechanism by which certain nerve fibers become hyper-sensitized and can lead to chronic and debilitating symptoms. The results of this clinical trial will be presented at a scientific meeting in the future.
CardioDx Expands Patient Access to the Corus(R) CAD Test Through National Agreement With Quest Diagnostics
CardioDx Also Separately Raises $20 Million in New Financing to Support the Company's Commercial Growth and Operations
Redwood City, CA, September 16, 2015 – CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, today announced a national specimen-draw agreement with Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, that will expand patient and clinician access to the Corus CAD lab-developed blood test for aiding the assessment of obstructive coronary artery disease (CAD)*.
Under a multi-year agreement, clinicians will be able to order blood draws on patients for testing through Quest's approximately 2,200 patient service centers and 4,000 phlebotomists in physician offices in the United States. Samples will be forwarded to CardioDx's CLIA-certified laboratory (in Redwood City, Calif.) for testing.
TESARO Announces U.S. FDA Approval of VARUBI™ (rolapitant) for Nausea and Vomiting Associated with Cancer Chemotherapy
Waltham, Mass., Sept. 2, 2015 – TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved VARUBI™ (rolapitant) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
Chimerix and BARDA Announce Continued Partnership in the Development of Brincidofovir for Smallpox
$17.0 Million Awarded in Latest Contract Extension
DURHAM, N.C., Sept. 2, 2014 – Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals, today announced an award of $17.0 million through the extension of its contract with the Biomedical Advanced Research and Development Authority (BARDA) for the development of its broad spectrum antiviral brincidofovir (BCV, CMX001) as a medical countermeasure to treat smallpox. Chimerix received the initial award in February 2011 which supported early research and development of brincidofovir in animal models of smallpox (Contract Number HHSO100201100013C). This contract extension provides an additional $17.0 million to Chimerix for a period of 15 months, and will support Phase 3 trials expected to initiate in the second half of 2014.
