FDA is considering banning online sales of e-cigarettes: Gottlieb

U.S. regulators are considering banning the online sales of e-cigarettes, the head of the Food & Drug Administration Scott Gottlieb said on Tuesday.

Gottlieb, speaking on a panel discussion on vaping that was arranged by Axios, said that the agency will release its next steps on e-cigarettes as well as data on teen vaping in November.

Earlier this month the agency said it was considering banning flavored e-cigarettes as demand from young people has increased.

https://www.reuters.com/article/us-usa-healthcare-ecigarettes/fda-is-considering-banning-online-sales-of-e-cigarettes-gottlieb-idUSKCN1M51VC

Aurinia completes enrollment of AURORA phase 3 lupus trial

Aurinia Pharmaceuticals announced that it has completed enrollment for the AURORA Phase 3 trial ahead of schedule. The target enrollment of 324 patients was surpassed due to high patient demand with 358 lupus nephritis patients randomized in sites across 27 countries. The AURORA clinical trial is a global, double-blind, placebo-controlled study to evaluate whether voclosporin when added to background therapy of mycophenolate mofetil /CellCept can increase speed of and overall renal response rates in the presence of low dose steroids. The primary endpoint for the study is complete renal response at 52 weeks, after which patients can choose to enroll into a 104-week blinded extension study.
https://thefly.com/landingPageNews.php?id=2795397

Sol-Gel expects top-line results for Epsolay in 2019

Sol-Gel Technologies announced that it has completed enrollment of half of the patients in its pivotal Phase III clinical trials of Epsolay in subjects with papulopustular rosacea, a chronic, inflammatory skin condition that most often affects the face. Epsolay is a once-daily topical cream containing encapsulated benzoyl peroxide, 5%, using Sol-Gel’s proprietary microencapsulation technology. The pivotal Phase III clinical program is being conducted in accordance with Special Protocol Assessmentagreements with the U.S. Food and Drug Administration and consists of two randomized, multi-center, double-blind, vehicle-controlled clinical trials at 50 sites in the United States. Each pivotal trial is planned to enroll 350 subjects in a 2:1 ratio of Epsolay in comparison to its vehicle, with a power of greater than 99%. The primary efficacy endpoints for both trials are success in Investigator Global Assessment, defined as a two-grade reduction in IGA on a scale of 0 to 4 with “clear” or “almost clear”at week 12, and a reduction in mean inflammatory lesion count at week 12. “The progress we have made with patient enrollment in these trials and the high interest expressed by both the patients and physicians highlights the unmet medical need for a new safe and efficacious rosacea treatment,” said Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “Our goal is to advance Epsolay as a potential treatment option for papulopustular
https://thefly.com/landingPageNews.php?id=2795401

Verastem and CSPC Pharma sign license agreement to develop COPIKTRA in China

Verastem and CSPC Pharmaceutical Group announced their entry into an exclusive licensing agreement for CSPC to develop and commercialize Verastem Oncology’s COPIKTRA (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, for the treatment of all oncology indications in China. COPIKTRA received approval from the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies. COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies. The indication in FL is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in trials. Under the terms of the agreement, Verastem Oncology shall receive an upfront payment of $15M. Verastem Oncology is also entitled to receive additional development milestone payments of $30M, plus potential sales milestone payments and double-digit percentage royalties based on future net sales of COPIKTRA in China. CSPC will receive exclusive rights to develop and commercialize COPIKTRA and hold the marketing authorization and product license for COPIKTRA in China. CSPC will have the right to collaborate with Verastem Oncology on certain global development and clinical trial activities and will share pro-rata in the cost.
https://thefly.com/landingPageNews.php?id=2795429

MorphoSys says licensee Janssen began Phase 3 study

MorphoSys  announced that its licensee Janssen Research has initiated a phase 3 clinical trial of guselkumab in pediatric patients suffering from chronic plaque psoriasis. According to clinicaltrials.gov, the trial, PROTOSTAR, is expected to enroll approximately 125 children between 6 and 18 years of age with plaque psoriasis and will evaluate the efficacy, safety and pharmacokinetics of guselkumab against etanercept and placebo. Guselkumab is a fully human anti-IL-23 monoclonal antibody developed by Janssen, and was generated utilizing MorphoSys’s proprietary HuCAL antibody technology. Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys AG, said: “We are very pleased that our licensee Janssen has started phase 3 development for the treatment of chronic plaque psoriasis in children. If successful, we hope that this study will contribute to providing more therapeutic options to this patient group.”
https://thefly.com/landingPageNews.php?id=2795435

Abbott 1-Year Results Show Portico Valve Safely Cut Severe Aortic Stenosis

One-Year Results from Real-World Study Showed Abbott’s Portico™ Transcatheter Aortic Valve Safely and Successfully Reduced Severe Aortic Stenosis

– Late-breaking data from real-world experience with the first fully repositionable and retrievable valve were consistent with previous results, and support that Portico can be successfully used in various anatomies in a real-world setting

– Patients who received a Portico aortic heart valve had low rates of stroke, death and valve leak; and improved heart failure symptoms, quality of life and functional capacity

– The minimally invasive Portico procedure allows doctors to replace a diseased or damaged aortic heart valve without major surgery

Abbott (NYSE: ABT) today announced one-year results from a real-world, international, multicenter, 941-patient study of the company’s Portico™ transcatheter aortic valve replacement (TAVR) system in patients with symptomatic, severe aortic stenosis – a life-threatening narrowing of the heart’s aortic valve. At one year, implantation with the Portico valve was safe and associated with low rates of stroke, death and leaks between patients’ natural heart tissue and the Portico valve.

The one-year results from the PORTICO I study were presented during a late-breaking session at the 30th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation in San Diego, and simultaneously published in the Journal of the American College of Cardiology. Results at one year were consistent with 30-day results reported earlier this year; with data used to support CE Mark; and with data and results from other commercially available TAVR valves. Portico is under investigation in the United States.

The Portico transcatheter valve is a minimally invasive alternative to surgical aortic valve replacement for patients diagnosed with severe aortic stenosis who are high-risk candidates for open-heart surgery. Aortic stenosis is a common and life-threatening valve disease in which the aortic valve opening in the heart narrows and restricts blood flow from the left ventricle to the aorta. More than one in eight people aged 75 and older have moderate or severe aortic stenosis,[1] which reduces the heart’s pumping ability. Most patients don’t have symptoms for decades, but once symptoms appear, the prognosis is poor without surgical treatment,[2] manifesting in shortness of breath, fatigue, and ultimately heart failure.[3]

‘Portico offers physicians the ability to safely and successfully treat patients suffering from symptomatic, severe aortic stenosis with a high level of confidence,’ said Lars Sondergaard, M.D., DMSc, Rigshospitalet, Copenhagen, Denmarkand principal investigator of the study. ‘These one-year results in a real-world setting give us assurance that Portico is an excellent and important treatment option for patients with severe aortic stenosis who are at increased risk for open-heart surgery.’

https://www.marketscreener.com/ABBOTT-LABORATORIES-11506/news/Abbott-Laboratories-One-Year-Results-from-Real-World-Study-Showed-Abbott-s-Portico-trade-Transcat-27316623/

NY agency expresses concerns about proposed Aetna, CVS Health deal

In a letter dated September 17 that was made public on September 24, New York Department of Financial Services Superintendent Maria Vullo told Connecticut Insurance Department Commissioner Katharine Wade that NYDFS has “identified several key issues” with the proposed acquisition of Aetna (AET) by CVS Health (CVS) “that may be harmful to both New York and Connecticut consumers and markets.” The proposed acquisition of health insurer by a PBM “raises significant market competition concerns” regarding Aetna having an unfair competitive advantage, Vullo’s letter states. In afternoon trading, shares of Aetna are down 1.3% to $200.69. Shares of Express Scripts (ESRX), which is waiting for regulatory approval of its agreement to be acquired by Cigna (CI), is down about 1% as well.
https://thefly.com/landingPageNews.php?id=2795371