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BOSTON, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that it has been added to the Russell 2000® Index, effective December 21, 2020, as part of the index's quarterly initial public offering (IPO) additions.

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Atea Pharmaceuticals Added to Russell 2000 Index

NEW YORK, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that a publication titled “Real-World Data on Nonmedical Use of Tramadol from Patients Evaluated for Substance Abuse Treatment in the NAVIPPRO Addiction Severity Index?Multimedia Version (ASI-MV®) Network” has been published in Drug Safety, a peer-reviewed international journal covering pharmacoepidemiology and pharmacovigilance. The publication can be accessed here.

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Avenue Therapeutics Announces Publication of Real-World Data on Nonmedical Use of Tramadol in ASI-MV Network

NEW YORK, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that a publication titled “Tramadol Non-Medical Use in Four European Countries: A Comparative Analysis” has been published in Drug and Alcohol Dependence, a peer-reviewed international journal devoted to research, reviews, commentaries, and policy analyses in the area of drug, alcohol and tobacco use and dependence. The publication can be accessed here.

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Avenue Therapeutics Announces Publication of Tramadol Non-Medical Use in Four European Countries: A Comparative Analysis

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Report from the Extraordinary General Meeting of Immunicum AB (publ) on December 18, 2020

NEW YORK, Dec. 18, 2020 (GLOBE NEWSWIRE) -- NetworkNewsAudio – Cybin Inc. (NEO: CYBN) announces the availability of a broadcast titled, “Hope on the Horizon: Psychedelics Offer Potential for Transforming Mental Health Treatments.”

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Cybin Inc. (NEO: CYBN) Looking to Solve Long-Standing Problem with MDD Treatment

COPENHAGEN, Denmark, December 18, 2020 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced top-line results from a Phase 2 clinical study evaluating the targeted immunotherapy candidate, BN-Brachyury in the treatment of advanced chordoma, a rare cancer occurring in the base of the skull and spine. While the study failed to meet its primary endpoint, it provided evidence of clinical activity.

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Bavarian Nordic Announces Top-line Results from Phase 2 Clinical Trial of BN-Brachyury in Chordoma

Drug shortage in the United States driving need for Triamcinolone Hexacetonide Drug shortage in the United States driving need for Triamcinolone Hexacetonide

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Medexus Enters into Exclusive License to Register and Commercialize Triamcinolone Hexacetonide (TH) in the United States with Ethypharm

Basel, 21 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two identically designed global phase III studies, YOSEMITE and RHINE, evaluating its investigational bispecific antibody, faricimab, in people living with diabetic macular edema (DME). Both studies met their primary endpoint and showed that faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks. Faricimab was generally well-tolerated, with no new safety signals identified. The studies each have three treatment arms, with participants randomised to receive either faricimab or aflibercept at fixed eight-week intervals, or faricimab at personalised intervals of up to 16 weeks, following a loading phase. In a secondary endpoint, across both studies, more than half of participants in the faricimab personalised dosing arms achieved an extended time between treatments of 16 weeks at year one. This is the first time any investigational medicine has achieved this level of durability in a phase III study of people with DME. Worldwide, an estimated 21 million people are living with DME, a leading cause of vision loss among working-age adults.1 Whilst anti-vascular endothelial growth factor (VEGF) monotherapy injections have significantly reduced vision loss from DME, the treatment burden associated with frequent eye injections and physician visits can lead to under-treatment and, potentially, less than optimal vision outcomes.2,3 It has been almost a decade since a medicine with a new mechanism of action has been approved to treat DME.4 Faricimab is the first investigational bispecific antibody designed for the eye.5 It targets two distinct pathways – via angiopoietin-2 (Ang-2) and VEGF-A – that drive a number of retinal conditions, including DME.6 “These positive results show that faricimab has the potential to offer lasting vision improvements for people with diabetic macular edema, while also reducing the treatment burden associated with frequent eye injections,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to discussions with global regulatory authorities, with the aim of bringing this potential new treatment option to people with this condition as soon as possible.” In addition to the YOSEMITE and RHINE studies, the phase III Rhone-X study is investigating the long-term safety and tolerability of faricimab for the treatment of DME.7 Faricimab is also being studied in the phase III TENAYA and LUCERNE studies as a potential treatment for neovascular or “wet” age-related macular degeneration (nAMD), an advanced form of AMD, which can cause rapid, severe and irreversible vision loss.8,9,10,11 Detailed results from the YOSEMITE and RHINE studies will be presented in February at Angiogenesis, Exudation, and Degeneration 2021, a medical symposium presented by Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine, and submitted for approval for the treatment of DME around the world.   About the YOSEMITE and RHINE studies 5,12,13 YOSEMITE (NCT03622580) and RHINE (NCT03622593) are two identical, randomised, multicentre, double-masked, global phase III studies, evaluating the efficacy and safety of faricimab compared to aflibercept in 1,891 people living with diabetic macular edema (940 in YOSEMITE and 951 in RHINE). The studies each have three treatment arms: faricimab 6.0 mg administered at personalised dosing intervals of up to 16 weeks; faricimab 6.0 mg administered at fixed eight-week intervals; aflibercept 2.0 mg administered at fixed eight-week intervals. In all three arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants. The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline at one year. Secondary endpoints include: safety; the percentage of participants in the personalised dosing arm receiving treatment every four, eight, 12 and 16 weeks, at week 52; the percentage of participants achieving a two-step or greater improvement from baseline in diabetic retinopathy severity at week 52; the percentage of participants achieving a gain of at least 15 letters in BCVA from baseline over time; the percentage of participants avoiding a loss of at least 15 letters in BCVA from baseline over time; and change in central subfield thickness from baseline over time. About diabetic macular edema Affecting around 21 million people globally, diabetic macular edema (DME) is a vision-threatening complication of diabetic retinopathy (DR).1 DR occurs when damage to blood vessels and the formation of new blood vessels causes blood and/or fluid to leak into the retina – a part of the eye that sends information to the brain, enabling sight.14 This leads to swelling, as well as blockage of blood supply to some areas of the retina.15 DME occurs when the damaged blood vessels leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving.14,16 The number of people with DME is expected to grow as the prevalence of diabetes increases.17 The condition is associated with blindness when left untreated and decreased quality of life.14,18 There remains a significant unmet need for more effective, longer-lasting therapies for people with DME.3 About faricimab Faricimab is the first investigational bispecific antibody designed for the eye.5 It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) – that drive a number of retinal conditions.6 Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation.3 By independently blocking both pathways, faricimab is designed to stabilise blood vessels, potentially resulting in better vision outcomes, for longer, for people living with retinal conditions.3 About Roche in Ophthalmology Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients. We have the broadest retina pipeline in Ophthalmology, covering early and late stage products, which is led by science and informed by insights from people with eye diseases. Our late stage pipeline includes two potential first-of-a-kind treatments, Port Delivery System with ranibizumab (PDS) and faricimab, which are being evaluated in a number of retinal conditions including neovascular age-related macular degeneration, diabetic macular edema and diabetic retinopathy. PDS is a permanent refillable eye implant that continuously delivers a customised formulation of ranibizumab over a period of months, potentially reducing the treatment burden associated with frequent eye injections.19,20 Faricimab is the first investigational bispecific antibody designed for the eye.5 It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) – that drive a number of retinal conditions, to stabilise blood vessels, potentially resulting in better vision, for longer.3,6 Our early stage pipeline includes gene therapies and treatments for geographic atrophy and other vision-threatening diseases, including rare and inherited conditions. Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss through Lucentis®?* (ranibizumab injection), the first treatment approved to improve vision in people with certain retinal conditions. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. *Lucentis® (ranibizumab injection) was developed by Genentech, a member of the Roche Group. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. All trademarks used or mentioned in this release are protected by law. References[1] Yau JWY, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35:556-64.[2] Zhao Y, Singh, RP. The role of anti-vascular endothelial growth factor (anti-VEGF) in the management of proliferative diabetic retinopathy. Drugs in Context. 2018;7:212532.[3] Sahni J, et al. Simultaneous inhibition of angiopoietin-2 and vascular endothelial growth factor-A with faricimab in diabetic macular edema. American Academy of Ophthalmology. 2019;126:1155–70.[4] FDA. Highlights of prescribing information, Lucentis [Internet; cited 2020 November]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf.[5] Roche data on file. [6] Khan M, et al. Targeting Angiopoietin in retinal vascular diseases: A literature review and summary of clinical trials involving faricimab. Cells. 2020;9(8):1869. [7] Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of faricimab in participants with diabetic macular edema (Rhone-X) [Internet; cited 2020 November]. Available from: https://clinicaltrials.gov/ct2/show/NCT04432831. [8] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with neovascular age-related macular degeneration (TENAYA) [Internet; cited 2020 November]. Available from: https://clinicaltrials.gov/ct2/show/NCT03823287.[9] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with neovascular age-related macular degeneration (LUCERNE) [Internet; cited 2020 November]. Available from: https://clinicaltrials.gov/ct2/show/NCT03823300. [10] Pennington KL, DeAngelis MM. Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3:34.[11] Little K., et al. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration-the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-91.[12] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab (RO6867461) in participants with diabetic macular edema (YOSEMITE) [Internet; cited 2020 November]. Available from: https://clinicaltrials.gov/ct2/show/NCT03622580. [13] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab (RO6867461) in participants with diabetic macular edema (RHINE) [Internet; cited 2020 November]. Available from: https://clinicaltrials.gov/ct2/show/NCT03622593. [14] National Eye Institute. Facts about diabetic eye disease [Internet; cited 2020 November]. Available from: https://nei.nih.gov/health/diabetic/retinopathy. [15] American Optometric Association. Diabetic retinopathy [Internet; cited 2020 November]. Available from: https://www.aoa.org/healthy-eyes/eye-and-vision-conditions/diabetic-retinopathy. [16] All About Vision. Macula Lutea [Internet; cited 2020 November]. Available from: https://www.allaboutvision.com/resources/macula. [17] Liu E, et al. Diabetic macular oedema: clinical risk factors and emerging genetic influences. Clinical and Experimental Optometry. 2017;100:569-76. [18] Park SJ, et al. Extent of exacerbation of chronic health conditions by visual impairment in terms of health-related quality of life. JAMA Ophthalmol. 2015;133:1267–75.[19] Holz FG, et al. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. The British Journal of Ophthalmology. 2015;99:220-6.[20] Campochiaro, P, et al. Primary Analysis Results of the Phase 3 Archway Trial of the Port Delivery System With Ranibizumab for Patients With Neovascular AMD. American Society of Retina Specialists Annual Meeting; 2020 Jul 24-26. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

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Roche’s faricimab meets primary endpoint and shows strong durability across two global phase III studies for diabetic macular edema, a leading cause...

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AB Science announces the success of its capital raise for a total amount of 15 million euros

SAINT-LOUIS, France and WEIL AM RHEIN, Germany and SHANGHAI, China, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Shanghai Haini Pharmaceutical Co., Ltd. (Shanghai Haini), the subsidiary of Yangtze River Pharmaceutical Group (YRPG), and Allecra Therapeutics (Allecra) today announced that the companies have signed an exclusive licensing agreement under which Shanghai Haini will manufacture, develop and commercialize cefepime/enmetazobactam within Greater China, including Mainland China with Hong Kong and Macau, and Taiwan.

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Allecra Therapeutics and Shanghai Haini Pharmaceutical Announce Exclusive Licensing Agreement for Cefepime/enmetazobactam for Greater China

VANCOUVER, Dec. 20, 2020 (GLOBE NEWSWIRE) -- BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU) is pleased to announce that further to its press release of December 8, 2020, the Company has completed its acquisition to acquire 100% of the assets in Transcend Biodynamics LLC (“Transcend”) in an all-stock transaction, for a total of 13,333,333 common shares at $0.75 per share, with the transaction valued at $10 million.

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BetterLife Closes Acquisition of Second Generation Psychedelic Assets of Transcend Biodynamics LLC

AUSTIN, Texas, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced that the company will participate in the virtual H.C. Wainwright BioConnect 2021 Conference to be held January 11-14, 2021.

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Lumos Pharma to Participate in the H.C. Wainwright BioConnect 2021 Conference

CAMBRIDGE, Mass., Dec. 18, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Nick Colangelo, President and CEO, will present the latest company overview at the 39th Annual J.P. Morgan Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, January 14, 2021 at 11:40 a.m. Eastern Time.

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Vericel to Present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021

NEW YORK, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer announced today that it has entered into a distribution agreement with Swixx BioPharma AG (“Swixx”) to be the exclusive distributor of the Company’s antibodies, DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma in Eastern Europe, including Russia. DANYELZA (naxitamab-gqgk) 40mg/10mL was approved by the U.S. Food and Drug Administration (“FDA”) on November 25, 2020 and is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. The Company plans to resubmit its (“BLA”) to the FDA for omburtamab by the end of 2020 or in early 2021.

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Y-mAbs Signs Distribution Agreement with Swixx for DANYELZA® (naxitamab-gqgk) and Omburtamab in Eastern Europe

NEW YORK, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer announced today that it has entered into a license agreement with SciClone Pharmaceuticals International Ltd (“SciClone”) to be the exclusive co-development and commercialization partner of the Company’s antibodies, DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma in China. DANYELZA (naxitamab-gqgk) 40mg/10mL was approved by the U.S. Food and Drug Administration (“FDA”) on November 25, 2020 and is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. The Company plans to resubmit its Biologics License Application (“BLA”) to the FDA for omburtamab by the end of 2020 or in early 2021.

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Y-mAbs Signs License Agreement with SciClone for DANYELZA® (naxitamab-gqgk) and Omburtamab in China

TORONTO, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Unifor, Canada's largest private-sector union and Aleafia Health Inc. (TSX: AH, OTC: ALEAF), have entered a long term partnership that through collective bargaining will seek to provide access for its members to medical cannabis coverage as part of their benefit and insurance coverage.

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Unifor and Aleafia Health partner on groundbreaking medical cannabis coverage

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Immunicum AB (publ) Publishes Prospectus for Admission to Trading of Newly Issued Shares on Nasdaq Stockholm

Acquisition Enhances Company’s Decentralized Solutions Offering by Strengthening Patient Focus Acquisition Enhances Company’s Decentralized Solutions Offering by Strengthening Patient Focus

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Syneos Health Acquires Illingworth Research Group, a Leading Provider of Clinical Research Home Health Services

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG) (“CENTOGENE” or the “Company”), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians and pharmaceutical companies, today announced the voting results of the Company’s Extraordinary General Meeting. The shareholders of the Company voted in favor of all proposals, which included the appointments of Dr. Andrin Oswald as Managing Director and Dr. Jonathan Sheldon as Supervisory Director, the reappointment of Mr. Richard Stoffelen as Managing Director, and adjustments to the compensation of the Supervisory Board.

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CENTOGENE Announces Voting Results of Extraordinary General Meeting