Thursday, October 4, 2018
Roche’s Genentech announces FDA approval of Hemlibra for Hemophilia A
Genentech, a member of the Roche Group, announced that the U.S. FDA has approved Hemlibra for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A without factor VIII inhibitors. Hemlibra is now the only prophylactic treatment for people with hemophilia A with and without factor VIII inhibitors that can be administered subcutaneously and at multiple dosing options. This approval is based on positive results from the Phase III HAVEN 3 and HAVEN 4 studies. Hemlibra prophylaxis led to statistically significant and clinically meaningful reductions in treated bleeds compared to no prophylaxis and across all other bleed-related endpoints in the HAVEN 3 study, and showed a clinically meaningful control of bleeding in the HAVEN 4 study. Hemlibra is now available to people in the U.S. who have hemophilia A without factor VIII inhibitors.
https://thefly.com/landingPageNews.php?id=2799953
Novocure Announces 55 Presentations at European Association of Neuro-Oncology
Highlights include a data analysis of EF-14 that demonstrated an increased dose of Tumor Treating Fields to the tumor bed improved overall survival in GBM patients as well as safety data from a surveillance study
Novocure (NASDAQ: NVCR) announced today 55 presentations on Tumor Treating Fields at the European Association of Neuro-Oncology (EANO) Meeting 2018, Oct. 10 through Oct. 14, in Stockholm. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. The volume of Tumor Treating Fields presentations marks a record number of abstracts for Novocure at this conference.
Highlights include a retrospective data analysis from Novocure’s EF-14 phase 3 pivotal trial in newly diagnosed glioblastoma (GBM) that demonstrated an increased dose of Tumor Treating Fields to the tumor bed improved overall survival in GBM patients; and safety data on the use of Tumor Treating Fields as a treatment for GBM from a surveillance study, supporting EF-14 trial results.
Novocure also will host a scientific lunchtime symposium on Tumor Treating Fields at the meeting.
“We continue to evaluate the data from our EF-14 trial and apply what we learn to the development of Tumor Treating Fields,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “The focus on Tumor Treating Fields at scientific conferences continues to grow each year, demonstrating an increased interest in our therapy among the scientific community. We are proud of the work we have done to generate increased awareness of the potential benefits of Tumor Treating Fields with the scientific community and look forward to presenting at the EANO Meeting.”
Oral Presentation
(OS5.5) Surveillance data demonstrates the tolerability of tumor treating fields in pediatric glioma patients. A. Kinzel. 12:03 to 12:15 p.m. CEST Saturday, Oct. 13.
Invited Oral Presentation
Optune when to use and when not? A. Hottinger. 8:34 to 08:51 a.m. CEST Friday, Oct. 12.
Scientific Lunchtime Symposium
Glioblastoma therapy with Tumor Treating Fields (Optune®). 12:50 to 2:20 p.m. CEST Friday, Oct. 12.
+ Poster Presentations
Resmed Launches Brightree CARE App for Home Health and Hospice Aides
App enables aides to document care visits from aides’ mobile devices
Brightree®, the leading provider of cloud-based software to help post-acute care companies improve business performance and patient outcomes, announced today the release of its new BrightreeCARE app.
BrightreeCARE, free on the Apple App Store and Google Play store, enables home health and hospice aides to easily document their visits on their smart device, without having to carry additional equipment.
“The BrightreeCARE app has made our staff more mobile, flexible and efficient – plus significantly improved our patients’ satisfaction rates,” said Tarrah Lowry-Schreiner, CEO of Sangre de Cristo Hospice and Palliative Care in Colorado. “Our aides are able to easily maneuver in a patient’s location without being tied down to an iPad or other larger device. Their phone can easily be placed in their pocket to give the patient the care indicated on their Care Plan.”
“Our staff is also thankful for the instant updates when visits are changed or added to their schedule, just by glancing at their BrightreeCARE app,” Lowry-Schreiner said.
“This powerful app is comprehensive, easy-to-use and tailored to the individual aides’ needs,” said Bob Dean, vice president and general manager of Brightree’s Home Health, Hospice & Private Duty business. “Supporting a bring your own device strategy, the application helps agencies incorporate aides into the EMR making them more productive and compliant to the patient’s care plan.”
Availability
All Brightree customers can download and use the BrightreeCARE app today. Aides can also experience the app with a hands-on demo at the National Association of Home Care & Hospice (NAHC) in Grapevine, Texas, October 7–10, 2018.
About Brightree
Brightree LLC, a wholly owned subsidiary of ResMed (NYSE: RMD) (ASX: RMD), is the leading provider of cloud-based software to improve clinical and business performance of post-acute care companies. Ranked one of the top 100 health care IT companies in the U.S., Brightree serves more than 2,500 organizations in the HME, home health, hospice, orthotic and prosthetic, HME pharmacy, home infusion, and rehabilitation home care segments.
AmeriCann To Operate Large-Scale Cannabis Manufacturing Unit in Mass.
Company to Produce Branded Cannabis Beverages, Vaporizer Products, Edible and Non-Edible Products and Concentrates
AmeriCann, Inc. (OTCQB: ACAN), an agricultural-technology company that is developing the next generation of eco-friendly start-of-the-art greenhouse cannabis cultivation and processing properties, has announced plans to own and operate a large-scale cannabis manufacturing and processing facility at its 52-acre Massachusetts Medical Cannabis Center (MMCC) in Freetown, MA.
The company has commenced construction on the first phase of the MMCC and recently released designs for the second phase. The second phase includes AmeriCann’s manufacturing facility which is designed to provide support to the entire MMCC project, as well as to other licensed cannabis cultivators throughout Massachusetts.
“Participating directly as an operator allows us to have a larger impact and greater flexibility in meeting consumer and patient demand throughout the country,” said Tim Keogh, CEO of AmeriCann.
AmeriCann’s manufacturing facility is designed to produce branded consumer packaged goods including cannabis beverages, vaporizer products, edible products, non-edible products and concentrates at the state-of-the-art facility.
The company plans to replicate the brands, technology and innovations developed at its MMCC project to new markets as a multi-state operator.
Infused products are becoming an increasingly larger segment of total cannabis sales in regulated markets. According to the Wall Street Journal, “Interest in cannabis as an ingredient in food and drinks in on an upswing; beer brewing giant Constellation Brands, Inc. (NYSE: STZ) recently took a $4 billion stake in Canadian marijuana grower Canopy Growth Corp., (NYSE: CPG) which makes cannabis infused drinks and other products.”
“In Colorado, consumers purchased 12.2 million marijuana infused products in 2017, stated Ben Barton, CFO of AmeriCann. “AmeriCann’s advanced processing and production facility in Massachusetts should play a large role in meeting similar levels of cannabis consumer’s needs in Massachusetts for a consistent supply of a variety of trusted, reliable branded products.”
Industry experts believe that the pending Massachusetts adult-use market, in conjunction with its existing medical program will exceed $1 billion by 2020. As the first approved adult-use cannabis market on the Eastern US, Massachusetts has the potential to become the epicenter for cannabis innovation and research.
About Massachusetts Medical Cannabis Center
Massachusetts Medical Cannabis Center (MMCC), a one million square foot sustainable greenhouse facility in Freetown, Mass. The first phase of the facility is scheduled to open and be ready for cannabis cultivation, processing, and infused product production in the spring of 2019. Once fully developed, the MMCC design calls for a research facility, a training center, corporate offices, a quality-assurance laboratory, and a facility for manufacturing cannabis-infused food, nutraceuticals and consumer packaged cannabis goods. AmeriCann intends to open similar facilities in states in which cannabis is legal for medical and adult use.
HIV Treatments That Could Make Redfield’s Prediction Reality to Beat AIDS
In April, Dr. Robert Redfield, the new head of the U.S. Centers for Disease Control and Prevention, boldly predicted that the AIDS epidemic can be defeated by 2025. This morning Merck, Janssen and Gilead Sciences all released clinical data for HIV treatments that could make Redfield’s prediction a reality.
Janssen released 96-week data for Symtuza, a triple-combination medication for HIV-1 that showed patients who are virologically suppressed and switched to Symtuza, maintained high virologic suppression for up to 96 weeks. Data showed that 91 percent of Symtuza patients were able to maintain that suppression. Only 1 percent of patients experienced low virologic failure at 96 weeks, Janssen reported. The positive 96-week data followed earlier reports that showed the single-pill treatment was effective at suppressing the virus for 24 and 48 weeks.
Joseph Eron, a professor of AIDS research at the University of North Carolina at Chapel Hill and a trial investigator, said the results from the Phase III study shows Symtuza “can offer clinically appropriate people living with HIV a single-tablet option that may help them maintain high rates of virologic suppression over time.”
Symtuza was well tolerated by patients, with only 2 percent of subjects experiencing an adverse event of Grade 3 or Grade 4.
Symtuza was approved by the U.S. Food and Drug Administration (FDA) in July for HIV-1 based on the 48-week data. Trial data showed that up to 95 percent of participating patients achieved or maintained virologic suppression.
Not to be outdone, Gilead Sciences released 96-week data from its Phase III study of Biktarvy that showed the medication was not inferior to a regimen of abacavir/dolutegravir/lamivudine. The patients in this late-stage trial were treatment-naïve adults. Data showed that at 96 weeks, 87.9 percent of patients taking Biktarvy showed non-inferiority against 89.8 percent of patients on the abacavir/dolutegravir/lamivudine arm. Biktarvy was well tolerated through Week 96, Gilead said. The company added that the study, known as 1489, will remain randomized and blinded through 144 weeks.
Biktarvy, a once-per-day treatment, was approved by the FDA in February as a complete regimen to treat HIV-1 in adults who haven’t been treated with antiretrovirals or to replace the current antiretroviral regimen in patients who are virologically suppressed on a stable antiretroviral regimen for at least three months.
UNC scientist David Wohl, the lead author of the study, said the Phase III data “underscores the role of Biktarvy as a first-line treatment option for appropriate adults living with HIV who are new to therapy. In addition, Biktarvy was shown to have less nausea with a similar bone and renal safety profile to the comparator through 96 weeks.”
Merck also showcased data from its study of HIV patients who switched to Delstrigo, its once-per-day triple combination treatment. The Phase III DRIVE SHIFT trial included HIV-1 adults who demonstrated virological suppression for at least six months on a stable antiretroviral treatment regimen. Merck said the study met its primary endpoint of non-inferiority as measured by the number of patients who switched to Delstrigo compared to those who remained on the baseline treatment.
Princy Kumar head of Georgetown University School of Medicines’ Division of Infectious Diseases, said the Phase III data builds on the existing profile of Delstrigo as a therapy for treatment-naïve patients. Kumar said the data suggests that Delstrigo has the potential to address a broader population of HIV-1 patients.
The FDA approved Delstrigo in August, alongside another HIV treatment, Pifeltro. Clinical data showed that patients who took Delstrigo, which is a combination of doravirine, lamivudine and tenofovir disoproxil fumarate, demonstrated sustained viral suppression through 48 weeks. Data showed that 84 percent of the patients on Delstrigo achieved viral suppression.
Guardant Health indicated to open at $26.50, IPO priced at $19.00
Guardant Health (GH) priced 12.5M shares at $19.00. The deal priced above the $15.00-$17.00 range, as expected. JPMorgan and BofA/Merrill acted as joint book running managers for the offering.
https://thefly.com/landingPageNews.php?id=2799867
Novo Nordisk pullback on Lilly data likely overdone, says Deutsche Bank
Deutsche Bank analyst Tim Race noted that Novo Nordisk (NVO) shares have reacted to “strong” diabetes trial data from competitor Eli Lilly (LLY), but at first glance he thinks the move seems overdone. While a potential meaningful competitor creates a new overhang, the risk needs to be placed in to context, said the analyst, who noted the Phase 2 data will need to be confirmed in extensive Phase 3 trials before it is able to impact Novo’s growth prospects. From what he understands, Phase 3 trials would commence in 2019, suggesting a potential 2023 launch of Lilly’s LY3298176, which should give Novo time to adjust and react, Race tells investors. He maintains a Buy rating on Novo Nordisk shares.
https://thefly.com/landingPageNews.php?id=2799911
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