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Month: April 2020

Smile Direct Club Granted Patent for SmileShop Retail Concept and Treatment Process As Shops Plan to Reopen

Ensures no clear aligner competitor will be able to duplicate SDC unique model for 18 yearsCompany puts increased safety measures, social distancing in place to protect customers as locations target rolling reopening datesNASHVILLE, Tenn., April 28, 2020 (GLOBE NEWSWIRE) — SmileDirectClub today announced it has been issued a patent for its SmileShop intellectual property from the United States Patent & Trademark Office (”USPTO”). The patent, U.S. Patent No. 10,636,522, further strengthens the telehealth dentistry pioneer’s efforts to bring affordable, accessible oral care to more people through its unique and innovative teledentistry platform and direct-to-consumer business model. The patent ensures no clear aligner competitor will be able to duplicate SmileDirectClub’s unique model for 18 years.“This patent designation is...

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Clearside Biomedical Revises NDA Resubmission Timeline and XIPERE™ Commercial Partnership with Bausch Health

– Management to Host Webcast and Conference Call Today at 8:30 A.M. ET –ALPHARETTA, Ga., April 28, 2020 (GLOBE NEWSWIRE) — Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today an update to the XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) New Drug Application (NDA) resubmission timeline and to its commercialization and development partnership with Bausch Health Companies Inc. (“Bausch Health”) and Bausch + Lomb, its leading global eye health business.As previously disclosed, the contract manufacturing organization (CMO) for XIPERE has been completing certain requalification activities within its facility. While these manufacturing...

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Quarterly Report January – March 2020

First quarter 2020Net sales were MSEK 2,572 (2,806), which was a reduction by eleven percent organically.Adjusted EBITA was MSEK 81 (113) and the adjusted EBITA margin was 3.1 (4.0) percent.The coronavirus had a very tangible negative effect on net sales and the result in the first quarter and is expected to have a considerably greater negative effect in the second quarter.The Group currently has a good liquidity buffer, both in the form of existing cash as well as unutilized credit lines, that amounts to more than SEK 1.2 billion.The result before tax was MSEK 28 (73).The net result was MSEK 15 (50) or SEK 0.43 (1.40) per share.Operating cash flow was MSEK 356 (390), of which acquisitions were MSEK 0 (-5).In light of the enhanced financial uncertainty due to the outbreak of the coronavirus, and as a precautionary measure, the Board considers...

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RedHill Biopharma Strengthens Coverage for Talicia® with Preferred Brand Position on Prime Therapeutics NetResults™ National Formulary

Talicia® is the first and only FDA-approved rifabutin-based therapy for H. pylori infection, designed as a first-line option to address the high resistance of H. pylori bacteria to standard-of-care therapies—H. pylori bacterial infection is a Group 1 carcinogen and the strongest risk factor for gastric cancer; H. pylori affects approximately 35% of the U.S. population—Prime Therapeutics is a pharmacy benefit manager (PBM) serving 23 Blue Cross and Blue Shield Plans and more than 30 million members nationallyTEL-AVIV, Israel and RALEIGH, N.C., April 28, 2020 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that Prime Therapeutics, a pharmacy benefit manager (PBM) serving 23 Blue Cross and Blue Shield Plans and more than 30 million...

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Inspire Medical Systems, Inc. to Report First Quarter 2020 Financial Results on May 5, 2020

MINNEAPOLIS, April 28, 2020 (GLOBE NEWSWIRE) — Inspire Medical Systems, Inc. (NYSE: INSP) (“Inspire”), a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea, today announced that it will release financial results for the first quarter 2020 after the close of trading on Tuesday, May 5.  Inspire’s management team will host a corresponding conference call beginning at 5:00 p.m. Eastern Time to discuss the financial results and recent business developments.About Inspire Medical SystemsInspire is a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first and only FDA-approved...

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Champignon Selected as Headline Partner for PSYCH: The Psychedelics Symposium at Prohibition Partners LIVE

VANCOUVER, British Columbia, April 28, 2020 (GLOBE NEWSWIRE) — Champignon Brands Inc. (“Champignon” or the “Company”) (CSE: SHRM) (FWB: 496) (OTCQB: SHRMF), a human optimization sciences company focused on applying novel and natural treatment protocols to address a broad range of disorders and deficiencies with an emphasis on psychedelic medicine, is pleased to announce it has been selected as the Headline Partner for Prohibition Partners LIVE’s PSYCH: The Psychedelics Symposium (“PSYCH”), scheduled to take place June 22 – 23, 2020.PSYCH is architected and moderated by Prohibition Partners LIVE and will be this year’s most significant psychedelics virtual conference, bringing together key stakeholders at the forefront of the industry to share unparalleled insights and intelligence. Thought leaders from the worlds of health care,...

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Champignon a été sélectionné par Prohibition Partners LIVE comme partenaire principal pour PSYCH : The Psychedelics Symposium

VANCOUVER, Colombie-Britannique, 28 avr. 2020 (GLOBE NEWSWIRE) — Champignon Brands Inc. (« Champignon » ou la « société ») (CSE : SHRM) (FWB : 496) (OTCQB : SHRMF), une société des sciences de l’optimisation humaine concentrée sur l’application de nouveaux protocoles de traitement naturels mettant l’accent sur la médecine psychédélique afin de traiter un large éventail de troubles et de carences, a le plaisir d’annoncer qu’elle a été sélectionnée par Prohibition Partners LIVE, comme partenaire principal pour son évènement PSYCH : The Psychedelics Symposium (« PSYCH »), qui doit se dérouler du 22 au 23 juin 2020.PSYCH est architecturé et modéré par Prohibition Partners LIVE et sera la conférence virtuelle la plus importante cette année portant sur les psychédéliques, réunissant les principaux acteurs de l’industrie afin de partager...

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PCI Biotech: Invitation to Q1 2020 results presentation

Oslo, Norway, 28 April 2020 – PCI Biotech’s Q1 2020 interim report will be released on 6 May, 2020 at 07.00 CEST. The interim report and presentation will be made available on www.newsweb.no and on the company’s webpage, www.pcibiotech.com.A results presentation (in English) will be held through a webcast at 08.30 CEST the same day. The webcast can be accessed through www.pcibiotech.com and it will be possible to post questions through the webcast console.For further information, please contact:Ronny Skuggedal, CFOEmail: rs@pcibiotech.noMobile: +47 9400 5757About PCI Biotech         PCI Biotech is a biopharmaceutical late stage clinical development company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform....

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Balchem Releases 2019 Sustainability Report

NEW HAMPTON, N.Y., April 28, 2020 (GLOBE NEWSWIRE) — Balchem Corporation (NASDAQ: BCPC) today released its 2019 Sustainability Report, which captures the Company’s commitment to managing our Environmental, Social and Governance (ESG) performance.  This report demonstrates the Company’s continuing commitment to provide our employees, customers, shareholders and the communities within which we operate with information on Balchem’s sustainability initiatives.“I am very proud of the progress Balchem has made to drive forward our sustainability objectives, communicate our successes, and identify areas of priority which are included in this report,” said Ted Harris, Chairman and Chief Executive Officer. “Our strategy remains unchanged and we remain focused on our two main objectives: providing innovative solutions for the...

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Affimed Reports 2019 Financial Results and Recent Operational Progress

AFM24: First patient dosed in first-in-human clinical study for advanced EGFR-expressing solid tumors, including colon, lung and other cancersAFM13: Initiated registration-directed study in relapsed/refractory peripheral T cell lymphoma; received FDA orphan drug designation for the treatment of T cell lymphomaCMO and CSO appointments strengthen executive management team and position company to continue its leadership in innate immunityGenentech collaboration: Affimed received milestone payment triggered by Genentech’s selection of final target; ongoing collaboration on track with multiple programs progressingRaised €29.5 million in net proceeds from a public equity offering in November 2019Heidelberg, Germany, April 28, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back...

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