Cara Therapeutics Inc. (NASDAQ:CARA) and Vifor Pharma have announced that the US FDA has accepted and given Priority Review for KORSUVA™’s New Drug Application (NDA). KORSUVA (difelikefalin) is a solution for moderate-to-severe pruritus treatment in hemodialysis patients.
Phase II studies’ data supported NDA filing
The PDUFA target date has been set for 23 August 2021, and the regulatory agency confirmed that it is not planning any advisory committee meeting to discuss the NDA. Drug applications receive Priority Review from the FDA for potential therapies that, if approved, will have a considerable improvement in effectiveness or safety of diagnosis, prevention, or treatment of a serious condition relative to standard applications. Data from the pivotal Phase II trials KALM-1 carried in the US and global KALN-2 conducted globally, and supportive data from other additional 32 clinical trials will support the NDA filing.
Cara Therapeutics CEO Derek Chalmers said that the FDA acceptance and granting of the Priority Review for KORSUCA NDA is a massive milestone for the company and several hemodialysis patients battling chronic intractable pruritus. He added that the agency’s agreement to accelerate the timeline through Priority Review designation aligns with its understanding of KORSUVA’s therapeutic potential to change the treatment paradigm for the patient population. Chalmers added that they are looking forward to collaborating with the FDA through review alongside Virfor Pharma with the optimism of potential KORSUVA injection launch in the US once approved.
KORSUVA to launch in the US immediately it is approved
Stefan Schulze, Vifor Pharma CEO, said that they are delighted to receive a Priority Review from the FDA for the breakthrough therapy. Schulze said that chronic pruritus is a debilitating condition in hemodialysis patients, which impacts the quality of life significantly as well as increases hospitalization and mortality risk. The condition affects around 40% of dialysis patients globally; thus, if KORSUVA™ receives approval, there will be a medicine for the condition. This will be in line with Vifor Pharma’s vision of delivering innovative drugs to patients with significant unmet medical needs. Schulzer said that they expect to bring the new treatment to patients as soon as possible.
Trulieve Cannabis Corp (OTCMKTS: TCNNF) Reopens North Port Dispensary, Formerly Harves House of Cannabis
Trulieve Cannabis Corp (OTCMKTS: TCNNF) has announced the reopening of a North Port, Florida dispensary. This dispensary located in the Sarasota area is the 92nd Trulieve location in the state and was previously named Harvest House of Cannabis.
Trulieve reopens North Port dispensary.
When the North Port site reopens as Trulieve, it will greet Harvest patients with the same devoted personnel and high-quality service as when it closed for renovations and rebranding. Trulieve announced the completion of its purchase of Harvest Health and Recreation Inc. on October 1, with all Harvest dispensaries in Florida closed for rebranding to Trulieve. Throughout the month of October, the Company will continue to reopen Harvest sites across Florida.
The company is inviting the community to celebrate the reopening of its dispensary with all-day specials and swag giveaways. On launch day, all patients, from newcomers to long-time Trulieve patients, will be eligible for a 25% discount at the North Port facility.
Patients will find the largest assortment of CBD and THC products in Florida, including edibles, concentrates, smokable flowers, tinctures, vaporizers, topical creams, and more, in stores and online. Trulieve also provides home delivery throughout the state, as well as web-based ordering and in-store pickups.
Products available online and in-store
Trulieve’s whole product portfolio is available for online orders to aid patients with ordering, with in-store pickup or home delivery options available across the state depending on customer preference. In addition, Trulieve provides complimentary 30-minute virtual consultations with a Trulieve expert to assist with product, device, or doctor’s suggestion questions. Appointments are available on Trulieve’s website and open to all patients, even if they are new to medical cannabis or those searching for new therapeutic choices.
The company is keeping an eye on the COVID-19 situation and is committed to limiting the virus’s spread. Trulieve requires all staff, regardless of vaccination status, to put on masks in addition to following strict cleanliness and safety measures.
ILUS International Inc. (OTCMKTS: ILUS) Announces Award Of a $1 Million Contract For Phase 2 Burj 2020 Project
ILUS International Inc. (OTCMKTS: ILUS) has announced that BDC Fire which it acquired on April 12, 2021, which had received three contract awards estimated at $1.5 million, has now received a $1 million contract for phase 2 of the Burj 2020 Project.
BCD Fie receives another $1 million contract
BCD Fore had previously received a contract for fire systems installation for the Burj 2020 Tower in Dubai. The company started work on the project inQ3 2020, and the contract value for the phase is around $1 million.
The company is committed to completing the project and upcoming projects, and as a result, it is recruiting an additional 45 technicians and salespeople. Hiring more technicians puts the company in a position to apply for the lucrative A-level license for installation, supply, and maintenance of fire systems in industrial, residential, and oil fields.
ILUS Managing DirectorJohn-Paul Backwell said, “BCD Fire has achieved so much since we acquired it earlier this year and the award of this next phase of the Burj 2020 project is reward for the progress made by the ILUS and BCD teams. Obtaining the A-level license will rocket this acquisition to a whole new level. There has also been overwhelming interest from regional Fire Safety Training Companies in our new Virtual Reality Fire Extinguisher Training Courses which are being launched this month.”
FireBug and TVC received numerous purchase orders
CEO Nick Link stated, “ILUS just closed out its best quarter yet and we are looking forward to releasing an update on this in the next week or so once the team has finished consolidating the figures. FireBug and TVC have received several purchase orders during the 3rd quarter and they have been making excellent progress, but we have felt it best to provide updates on the more significant deals in the region of $1 million and upwards or noteworthy clients.”
Roche Holding Ltd (OTCMKTS: RHHBY) To Present New OCREVUS and ENSPRYNG Data at ECTRIMS 2021
Roche Holding Ltd (OTCMKTS: RHHBY) has announced that it will present new ENSPRYNG (satralizumab) and OCREVUS (ocrelizumab) data during the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis.
Roche to present ENSPRYNG and OCREVUS data
The data comprises 38 abstracts showing new long-terms safety and efficacy data for ENSPRYNG and OCREVUS and the company’s ongoing efforts to assess COVID-19’s impact on people living with multiple sclerosis. More data will shore enhanced scientific understanding of NMOSD and MS in various patient populations, ensuring access to treatment.
Roche’s chief medical officer and global product development head Levi Garraway, said, “The longer-term efficacy and safety data for both OCREVUS and ENSPRYNG reinforce e the impact of these treatments- by significantly slowing disease progression in MS and by preventing debilitating relapses in NMOSD, respectively. We continue to see that early and ongoing treatment markedly improves outcomes, and we’ll continues to use scientific and real-world insights to improve our understanding and ways to support people living with these neurological disorders.”
Roche to present data from 27 MS studies
The company will present 27 multiple sclerosis studies that include data showing earlier OCREVUS treatment continues to influence disability progression for around eight years in individuals with primary progressive MS and up to 7.5 years in patients with relapsing MS in the third phase open able trials. In addition, the company will present an updated long-term safety analysis of all clinical studies in RMS and PPMS patients that will reinforce OCREVUS’ favorable risk-benefit profile.
Roche is focused on addressing health disparities, and the company is optimistic that inclusive research will enhance outcomes and derive insights that can address treatment barriers. The company will present a subgroup analysis of three studies, including CHORDS, ENSEMBLE PLUS, and SaROD in Hispanic, Latino, and African-American populations treated with OCREVUS infusion. Roche is committed to increasing understanding of NMOSD and enhancing care for people living with the condition.