AbbVie announced that MAVIRET is now reimbursed in Alberta, Saskatchewan and the Non-Insured Health Benefits Program. MAVIRET is a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus infection across all major genotypes. In Alberta, MAVIRET is listed effective April 1, 2019, under Special Authorization on the AB Health Drug Benefit List for treatment-naive or treatment-experienced adult patients with chronic hepatitis C infection who meet all of the following criteria. Prescribed by or in consultation with a hepatologist, gastroenterologist or infectious disease specialist; AND Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6; AND Laboratory confirmed quantitative HCV RNA value within the last 6 months; AND Fibrosis stage of F0 or greater. In Saskatchewan, MAVIRET is listed effective April 1, 2019, on the Saskatchewan formulary as an Exception Drug Status product, for treatment naive and treatment experienced adult patients with chronic hepatitis C infection according to the following criteria: Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5 or 6; AND Laboratory confirmed quantitative HCV RNA value within the last six months; AND Treatment is prescribed by a hepatologist, gastroenterologist or an infectious disease specialist or other prescriber experienced in the treatment of hepatitis C as determined by the Drug Plan. For the Non-Insured Health Benefits program, MAVIRET is listed effective April 1, 2019, under Limited Use on the NIHB Drug Benefit List for treatment-naive or treatment-experienced adult patients with chronic hepatitis C infection who meet all of the following criteria: Prescribed by or in consultation with a hepatologist, gastroenterologist or infectious disease specialist; AND Laboratory confirmed hepatitis C genotype 1, 2, 3, 5, 6; AND Laboratory confirmed quantitative HCV RNA value within the last 6 months; AND Fibrosis stage of F0 or greater.
Thursday, April 4, 2019
Tonix to Expand Phase 3 Program Beyond PTSD to Include Fibromyalgia
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced today the expansion of the TNX-102 SL 5.6 mg program beyond posttraumatic stress disorder (PTSD) to include Phase 3 development for TNX-102 SL* in fibromyalgia. TNX-102 SL or Tonmya®** is Tonix’s lead Phase 3 program in PTSD with the Phase 3 RECOVERY trial actively enrolling military and civilian PTSD participants.
In a recent Clinical Guidance meeting with the U.S. Food and Drug Administration (FDA), Tonix received clear guidance and support to advance the development of TNX-102 SL, a non-opioid centrally-acting analgesic, for the management of fibromyalgia. Acceptable study design features were discussed to establish the safety and efficacy of TNX-102 SL 5.6 mg in a pivotal study to support the fibromyalgia indication.
A lower dose of TNX-102 SL (2.8 mg) taken daily at bedtime was studied previously in fibromyalgia in a Phase 2 study and a Phase 3 study. Both studies showed clinical benefits especially in the quality of sleep improvement, however, primary analyses on pain reduction were not statistically significant. Additional data developed by Tonix in the PTSD program showed that TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) demonstrated acceptable tolerability with additional clinical benefit in pain reduction for trial participants with PTSD. There were no serious and/or unexpected adverse events reported; the most common adverse events were mostly related to local administration site reactions, such as oral hypoaesthesia and abnormal product taste.
Shineco in Pact with China Region Government on Industrial Hemp Planting
Shineco, Inc. (“Shineco” or the “Company”;NASDAQ: TYHT), a producer and distributor of Chinese herbal medicines, organic agricultural produce, specialized textiles, and various health and well-being focused plant-based products in China, announced today that the Company, through its wholly owned subsidiary Tenjove NewHemp Biotech Co., Ltd. (“TNB”), entered into a strategic cooperation agreement (the “Agreement”) with the Xingshan People’s Government of Hegang City of Heilongjiang Province (the “Government”).
Pursuant to the Agreement, both parties agree to actively promote the development of a complete industrial chain for industrial hemp including cultivation, harvesting, initial processing and fine extraction to form a local industry integration model and to achieve a new industrial scale economy.
As part of the Agreement, both parties plan to develop a 20,000 mu (approximately 3,295 acres) high-quality industrial hemp project and expect to complete the cultivation of the first 500 mu in 2019. Besides conducting joint research and development on several new varieties of industrial hemp, both parties also agree to establish an industrial hemp farm, a CBD Extraction Industrial Park, an Industrial Hemp Research Center affiliated with the China’s Academy of Science, and an Industrial Hemp Workstation sponsored by the City of Hegang of Heilongjiang Province.
Orgenesis announces collaboration with Digilab for live cell printing
Orgenesis announced that it has entered into a collaboration agreement with Digilab to develop a live cell printing process and systems designed to automate the production of three-dimensional live cellular structures and tissues. Under the agreement, Orgenesis will have the exclusive rights to co-develop the process and systems required for its therapeutic collaboration programs and to utilize, market and distribute the new cell printer systems and related products.
https://thefly.com/landingPageNews.php?id=2888669
https://thefly.com/landingPageNews.php?id=2888669
U.S. to wrap case against Insys execs tied to opioid crisis
Prosecutors on Thursday will present their closing arguments in the trial of the wealthy founder of pharmaceutical company Insys Therapeutics Inc and four colleagues accused of contributing to the U.S. opioid epidemic by bribing doctors to prescribe an addictive fentanyl spray.
John Kapoor, who served as the Arizona-based drugmaker’s chairman, and his co-defendants are the first executives of a painkiller manufacturer to face trial for conduct that authorities say was tied to the deadly opioid crisis.
Prosecutors say Kapoor oversaw a wide-ranging scheme to bribe doctors nationwide by retaining them to act as speakers at poorly-attended sham events at restaurants ostensibly meant to educate clinicians about its fentanyl spray, Subsys.
The U.S. Food and Drug Administration has only approved Subsys for use in treating severe pain in cancer patients. Yet prosecutors says doctors who took bribes often prescribed Subsys to patients without cancer, helping boost sales at Insys.
Prosecutors said Kapoor also sought to defraud insurers into paying for Subsys. He is alleged to have had help from 2012 to 2015 from his co-defendants, former Insys executives and managers Michael Gurry, Richard Simon, Sunrise Lee and Joseph Rowan.
All five have pleaded not guilty to racketeering conspiracy. Lawyers for Kapoor acknowledge that Insys paid doctors but contend that he believed they really were being paid to talk up the product’s benefits.
Beth Wilkinson, Kapoor’s lead attorney, told jurors at the trial’s start in January that he had no idea about any “side deals” that were being cut with doctors.
Kapoor’s 2017 arrest came the same day U.S. President Donald Trump declared the opioid crisis a public health emergency. In 2017, a record 47,600 people died of opioid-related overdoses, according to the U.S. Centers for Disease Control and Prevention.
Two top former executives – Michael Babich, Insys’ chief executive from 2011 to 2015, and Alec Burlakoff, its ex-vice president of sales – testified against Kapoor after pleading guilty to carrying out the scheme at his direction.
Babich, who joined Insys in 2007 after helping manage investments for Kapoor at the pharmaceutical industry veteran’s family office, told jurors Kapoor wanted a “return on investment” from paying doctors to act as speakers.
Much of the trial’s testimony focused on how Insys marketed Subsys to doctors. One witness testified that Lee, a former stripper who became a regional sales director, gave a doctor a lap dance at a Chicago club one time while promoting Subsys.
Perrigo price target lowered to $46 from $51 at SunTrust
SunTrust analyst Gregg Gilbert lowered his price target on Perrigo to $46 and kept his Hold rating, saying his analysis suggests that the earnings dilution from the sale or spin of its Rx Pharma business would be “significant” at over 20%. The analyst adds that his new price target is based on the company’s “more conservative growth assumptions” as he looks ahead to more specifics on the separation of its Rx business at the May 9th Investor Day.
Puma Biotechnology expands cohorts in Phase II SUMMIT trial of neratinib
Puma Biotechnology has expanded two additional cohorts from the Phase II SUMMIT clinical trial investigating its lead drug candidate neratinib in patients with solid tumors who have an activating EGFR or HER2 mutation. The cohorts that have been expanded are HER2 mutant patients with metastatic salivary gland cancer and patients with EGFR exon 18 mutation-positive lung cancer. The Phase II SUMMIT basket trial is an open-label, multi-center, multi-histology, international study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating EGFR, HER2 or HER4 mutations. The salivary gland cancer patients initially entered the study in the “other solid tumors with a HER2 mutation” cohort, and due to the preliminary activity seen in the trial, the Company has expanded a separate salivary gland cancer cohort pursuant to the protocol for the trial. The expanded HER2-mutant salivary gland cancer cohort and the expanded EGFR exon 18 mutant lung cancer cohort will each now enroll approximately 18 patients.
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