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Δευτέρα 24 Φεβρουαρίου 2020

Clinical Trials News

知臨集團開始商品化山藥生物活性營養片劑並在香港簽署銷售經銷協議
紐約--(BUSINESS WIRE)--(美國商業資訊)--致力於開發創新療法以解決全球未被滿足的醫療需求的生物製藥公司知臨集團(那斯達克股票代碼:APM),公布商品化其膳食補充劑,該產品適用於伴有症狀的更年期女性。補充劑由含有DOI(一種生物活性成分)的萃取山藥粉製成,乃知臨集團鑒於消費者對營養產品的追求和關注日益增長而推出的非激素產品。據估計到2030年全球將會有12億更年期或更年期後的婦女1。全球針對婦女更年期症狀的保健品市場預計在2025年會超過500億美元,2016-2025年複合成長率為16.4%2。該膳食補充劑最先會在香港商品化和銷售;公司正在尋求相關的監管許可,以期在其他主要司法管轄區域銷售該產品。 作為商品化的一部分,知臨集團透過其獨資子公司Nativus Life Sciences Limited與萬天茶行有限公司簽訂了區域經銷協議,該集團公司的總部位於香港,公司經營多種家用品牌,包括陸羽®茶包和其他保健相關產品。 透過萬天茶行,知臨集團可在銷售區域將其產品帶給更廣大的消費群。知臨集團的這一山藥生物活性保健食品片劑已開始在加拿大生產,並將很快以NativusWe
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06:15
Akili Announces Publication of AKL-T01 ADHD Pivotal Study Results in the Lancet Digital Health
BOSTON--(BUSINESS WIRE)-- #ADHD--Results of Akili's digital therapeutic pivotal trial were published today The Lancet Digital Health. The tech improved attention in kids with ADHD.
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01:30
Moderna Ships mRNA Vaccine Against Novel Coronavirus (mRNA-1273) for Phase 1 Study
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Moderna ships mRNA vaccine against novel coronavirus (mRNA-1273) to the NIH to be used in the planned Phase 1 study in the U.S.
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01:04
Sesen Bio Announces Changes to the Board of Directors as the Company Advances Toward Commercialization of Vicinium®
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sesen Bio (Nasdaq: SESN) a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced the appointment of Carrie Bourdow, chief executive officer of Trevena, Inc., and Jason Keyes, chief financial officer of Equillium, to the Company’s Board of Directors (the “Board”). In addition, Wendy L. Dixon, Ph.D., has resigned from her position as chairwoman of the Board and member of the Board.
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Mon Feb 24, 2020 23:30
Medpace Holdings, Inc. Reports Fourth Quarter and Full Year 2019 Results
CINCINNATI--(BUSINESS WIRE)--Medpace Holdings, Inc. (Nasdaq: MEDP) (“Medpace”) today announced financial results for the fourth quarter and full year ended December 31, 2019. Fourth Quarter and Full Year 2019 Financial Results Revenue for the three months ended December 31, 2019 increased 19.7% to $229.9 million, compared to $192.1 million for the comparable prior-year period. Revenue for the year ended December 31, 2019 increased 22.2% to $861.0 million, compared to $704.6 million for the year
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Mon Feb 24, 2020 23:15
Xencor Reports Fourth Quarter and Full Year 2019 Financial Results
MONROVIA, Calif.--(BUSINESS WIRE)--Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, today reported financial results for the fourth quarter and full year ended December 31, 2019 and provided a review of recent business and clinical highlights. “Throughout 2019 we made important progress advancing and expanding our portfolio. At ASH, we presented initial data from the ongoing Ph
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Mon Feb 24, 2020 23:01
Grupa Aptorum rozpoczyna komercjalizację bioaktywnych nutraceutyków w tabletkach z dioscorea opposita i podpisuje umowę dystrybucyjną w Hongkongu
NOWY JORK--(BUSINESS WIRE)--Aptorum Group Limited („Aptorum Group”), firma farmaceutyczna opracowująca nowe terapie, które odpowiadają na światowe problemy medyczne, ogłosiła wprowadzenie do sprzedaży suplementu diety dla kobiet w okresie menopauzy, borykających się z jej objawami. Suplement zawiera składnik bioaktywny wyekstrahowany ze sproszkowanego pochrzynu chińskiego, zawierający „DOI” - substancję, która wpisuje się w strategię Aptorum Group polegającą na reagowaniu na narastające trendy
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Mon Feb 24, 2020 20:41
Riassunto: Takeda annuncia che la FDA statunitense ha concesso la revisione prioritaria della richiesta supplementare di registrazione di un nuovo farmaco per ALUNBRIG® (brigatinib),....
CAMBRIDGE, Mass., e OSAKA, Giappone--(BUSINESS WIRE)--  Takeda annuncia che la FDA statunitense ha concesso la revisione prioritaria della richiesta supplementare di registrazione di un nuovo farmaco per ALUNBRIG® (brigatinib), come trattamento di prima linea del carcinoma polmonare metastatico non a piccole cellule ALK+   Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) oggi ha annunciato che la Food and Drug Administration (FDA) degli Stati Uniti ha concesso la revisione prioritaria
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Mon Feb 24, 2020 18:56
Samenvatting: Takeda kondigt prioriteitsoverzicht Amerikaanse FDA-subsidies aan voor aanvullende nieuwe geneesmiddeltoepassing voor ALUNBRIG® (brigatinib) als eerstelijnsbehandeling voor ALK + uitgezaaide non-small cell lung cancer
CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE: 4502 / NYSE: TAK) heeft vandaag aangekondigd dat de Amerikaanse Food and Drug Administration (FDA) prioriteitsbeoordeling heeft verleend voor de aanvullende aanvraag voor nieuwe geneesmiddelen van het bedrijf (sNDA) om het gebruik van ALUNBRIG (brigatinib) uit te breiden als eerstelijnsbehandeling voor patiënten met anaplastisch lymfoom kinase-positieve (ALK +) metastatische non-small cell lung cancer
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Mon Feb 24, 2020 16:37
Alydia Health Strengthens Leadership Team with Appointment of Dr. Edward Evantash as Chief Medical Officer
MENLO PARK, Calif.--(BUSINESS WIRE)-- #MaternalMortality--Alydia Health strengthens leadership team with the appointment of Dr. Edward Evantash as Chief Medical Officer.
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Mon Feb 24, 2020 16:00
Institute of Human Virology and OncoImmune Launch Clinical Trial to Lessen Effects of HIV Later in Infection
BALTIMORE--(BUSINESS WIRE)--Novel therapy reduces inflammation and cardiovascular disease seen in late-term HIV infected patients.
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Mon Feb 24, 2020 16:00
Magenta Therapeutics Completes Dosing in Phase 1 MGTA-145 Trial, Demonstrating Rapid, Single-Day First Line Stem Cell Mobilization and Collection
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of immune reset to more patients, today announced the completion of dosing in its Phase 1 trial of stem cell mobilization therapy clinical candidate, MGTA-145, as well as updated clinical data from the trial at the Transplant and Cellular Therapy (TCT) Annual Meeting in Orlando, Florida. Mobilized peripheral blood is used for the m
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Mon Feb 24, 2020 15:30
ESCAPE Bio to Present at the Cowen 40th Annual Health Care Conference
SAN FRANCISCO--(BUSINESS WIRE)--ESCAPE Bio, Inc., a clinical stage company developing novel, precisely targeted therapeutics for genetically defined neurodegenerative diseases, today announced that Julie Anne Smith, Chief Executive Officer, will present at the Cowen 40th Annual Health Care Conference on Tuesday, March 3, 2020. Presentation details Date: Tuesday, March 3, 2020 Time: 10:30 a.m. ET Location: Boston Marriott Copley Place in Boston, MA Ms. Smith will present program and corporate up
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Mon Feb 24, 2020 15:00
Noveome Biotherapeutics, Inc. to Present at the 8th Annual Neurodegenerative Drug Development Summit
PITTSBURGH--(BUSINESS WIRE)--Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced that Larry Brown, Sc.D., Executive Vice President and Chief Scientific Officer at Noveome, will present an oral presentation entitled, “Exploring Intranasal Administration to Bypass the Blood-Brain Barrier” at the 8th Annual Neurodegenerative D
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Mon Feb 24, 2020 15:00
Takeda Announces U.S. FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ Metastatic Non-Small Cell Lung Cancer
CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s supplemental New Drug Application (sNDA) to expand the use of ALUNBRIG (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ALUNBRIG is a next-generat
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Mon Feb 24, 2020 15:00
Syros to Present at Upcoming Investor Conferences in March
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced it will present at the following upcoming investor conferences: Cowen and Company 40th Annual Health Care Conference in Boston, MA on Monday, March 2, 2020 at 4:50 p.m. ET. Oppenheimer 30th Annual Healthcare Conference in New York, NY on Wednesday March 18, 2020 at 10:55 a.m. ET. Live webcasts of the presentations will be availabl
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Mon Feb 24, 2020 15:00
Aldeyra Therapeutics to Provide Update on Late-Stage Clinical Development Pipeline at 2020 Research & Development Day
LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today will host the 2020 Research & Development Day (R&D Day) with investors and financial analysts in New York City to present recent clinical development updates and market opportunities for its novel investigational new drug product candidates in dry eye disease, allergic conjunctivitis, and proliferative vitreoretinopathy. The event will include presentations from members of the Aldeyra executive
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Mon Feb 24, 2020 15:00
Pandion Announces First Subject Dosed in a Phase 1 Clinical Trial of PT101, an IL-2 Mutein Fc Fusion Therapy for Autoimmune Disease
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Pandion Announces First Subject Dosed in a Phase 1 Clinical Trial of PT101, an IL-2 Mutein Fc Fusion Therapy for Autoimmune Disease
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Mon Feb 24, 2020 15:00
Shionogi’s FETROJA® (cefiderocol) Now Available for the Treatment of Complicated Urinary Tract Infections in the U.S.
OSAKA, Japan & FLORHAM PARK, N.J.--(BUSINESS WIRE)--Shionogi’s FETROJA® (cefiderocol) now available for the treatment of complicated urinary tract infections in the U.S.
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Mon Feb 24, 2020 14:58
Concert Pharmaceuticals Selected for Late-Breaking Oral Presentation of CTP-543 Phase 2 Data in Alopecia Areata at the 2020 American Academy of Dermatology Annual Meeting
LEXINGTON, Mass.--(BUSINESS WIRE)---- $CNCE #AAD2020--Concert's CTP-543 Phase 2 data in alopecia areata was selected for an oral presentation during the late-breaking session at AAD 2020.
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Mon Feb 24, 2020 14:00
Intersect ENT Reports Fourth Quarter and Full Year 2019 Results
MENLO PARK, Calif.--(BUSINESS WIRE)--Intersect ENT Reports Fourth Quarter and Full Year 2019 Results
Business Wire Health: Clinical Trials News
Mon Feb 24, 2020 14:00
AVROBIO to Present at the Cowen and Company 40th Annual Health Care Conference
CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AVRO--AVROBIO, Inc. (NASDAQ: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced Geoff MacKay, president and CEO of AVROBIO, will present at the Cowen and Company 40th Annual Health Care Conference at 4:50 p.m. ET on Monday, March 2, 2020, at the Boston Marriott Copley Place, Boston. A live webcast of the presentation can be accessed under "Events and Presentations" in the Investors...
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Mon Feb 24, 2020 14:00
Can Fite Files Patent for Namodenoson to Overcome Drug Resistance to Checkpoint Inhibitors for Oncology Indications
PETACH TIKVA, Israel--(BUSINESS WIRE)--Can Fite Files Patent for Namodenoson to Overcome Drug Resistance to Checkpoint Inhibitors for Oncology Indications
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Mon Feb 24, 2020 14:00
Sojournix Announces Initiation of Phase 2 Clinical Trial of SJX-653, a Novel Selective NK3 Antagonist for Menopausal Hot Flashes
WALTHAM, Mass.--(BUSINESS WIRE)--Sojournix announces initiation of Phase 2 clinical trial of SJX-653, a novel selective NK3 antagonist for menopausal hot flashes.
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Mon Feb 24, 2020 14:00
Aura Biosciences Presents Updated Phase 1b/2 Clinical Data for AU-011 at the 43rd Annual Macula Society Meeting
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aura Biosciences, a clinical-stage biopharmaceutical company developing a new class of tumor targeted therapies for initial application in primary tumors such as ocular and bladder cancers, today announced the presentation of updated clinical data from its ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the first line treatment of primary choroidal melanoma, at the 43rd An
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Mon Feb 24, 2020 14:00
Epizyme Provides Business Update and Reports Fourth Quarter and Full Year 2019 Financial Results
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Epizyme Provides Business Update and Reports Fourth Quarter and Full Year 2019 Financial Results
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Mon Feb 24, 2020 13:30
Aptorum Group start commercialisering van dioscorea opposita bioactieve nutraceutische tabletten en heeft verkoopdistributieovereenkomst ondertekend in Hongkong
NEW YORK--(BUSINESS WIRE)--Aptorum Group Limited ('Aptorum Group'), een farmaceutisch bedrijf dat zich richt op de ontwikkeling van nieuwe therapieën om te voldoen aan wereldwijde onvervulde medische behoeften, kondigt de commercialisering aan van zijn voedingssupplement voor vrouwen die in de overgang zitten en gerelateerde symptomen hebben. Het supplement wordt gemaakt met het bioactieve ingrediënt dat geëxtraheerd wordt uit Chinees yampoeder dat 'DOI' bevat, wat de niet-hormonale aanpak van
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Mon Feb 24, 2020 13:00
Miroculus Unveils Its Miro Canvas System at AGBT 2020
SAN FRANCISCO--(BUSINESS WIRE)-- #NGS--Miroculus unveils Miro Canvas at AGBT 2020; first user-programmable digital microfluidics platform enabling all major NGS library prep workflows.
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Mon Feb 24, 2020 13:00
Aptorum Group démarre la commercialisation de comprimés nutraceutiques bioactifs à base de dioscorea opposita et a signé un accord de distribution et de vente à Hong Kong
NEW YORK--(BUSINESS WIRE)--Aptorum Group Limited (“Aptorum Group”), une société pharmaceutique axée sur le développement de nouveaux produits thérapeutiques visant à répondre à des besoins médicaux mondiaux non satisfaits, annonce la commercialisation de son complément alimentaire pour les femmes ménopausées et éprouvant des symptômes associés à la ménopause. Le complément est fabriqué avec l’ingrédient bioactif extrait de la poudre d’igname de Chine contenant du “DOI”, qui est l’approche non h
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Mon Feb 24, 2020 13:00
Aptorum Group Commences Commercialization of Dioscorea Opposita Bioactive Nutraceutical Tablets and Signed Sales Distribution Agreement in Hong Kong
NEW YORK--(BUSINESS WIRE)--Aptorum Group Limited (“Aptorum Group”), a pharmaceutical company focused on the development of novel therapeutics to address global unmet medical needs, announces the commercialization of its dietary supplement for women undergoing menopause and experiencing related symptoms. The supplement is made with the bioactive ingredient extracted Chinese yam powder containing “DOI”, which is Aptorum Group’s non-hormonal approach intended to meet certain growing consumer nutri
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Mon Feb 24, 2020 13:00
Aptorum Group comienza la comercialización de los comprimidos nutracéuticos bioactivos de dioscorea opposita y firma contrato de distribución de ventas en Hong Kong
NUEVA YORK--(BUSINESS WIRE)--Aptorum Group Limited (“Aptorum Group”), un compañía farmacéutica que se concentra en el desarrollo de nuevos tratamientos para abordar las necesidades médicas insatisfechas globales, anuncia la comercialización de su suplemento dietario para mujeres que atraviesan la menopausia y tienen síntomas relacionados. El suplemento se produce con el polvo chino de yam al que se extrae el principio bioactivo, que contiene “DOI”, el abordaje no hormonal de Aptorum Group que a
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Mon Feb 24, 2020 13:00
Aptorum Group inizia la commercializzazione delle compresse nutraceutiche bioattive di Dioscorea Opposita dopo aver siglato un contratto di distribuzione e vendita a Hong Kong
NEW YORK--(BUSINESS WIRE)--Aptorum Group Limited (“Aptorum Group”), una società farmaceutica focalizzata sullo sviluppo di nuove terapie per rispondere a esigenze mediche non soddisfatte in tutto il mondo, annuncia la commercializzazione del suo integratore dietetico per donne nella fase di menopausa e che accusano sintomi correlati. L’integratore viene prodotto con un ingrediente bioattivo presente nella polvere dell’estratto del tubero cinese contenente “DOI” e rappresenta l’approccio non orm
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Mon Feb 24, 2020 13:00
Aptorum Group Inicia Comercialização de Comprimidos Nutracêuticos Bioativos Dioscorea Opposita e Contrato de Distribuição de Vendas Assinado em Hong Kong
NOVA YORK--(BUSINESS WIRE)--A Aptorum Group Limited ("Aptorum Group"), uma empresa farmacêutica com foco no desenvolvimento de novas terapias para atender às necessidades médicas mundiais não atendidas, anuncia a comercialização de seu suplemento dietético para mulheres em menopausa e com sintomas relacionados. O suplemento é feito com pó de inhame chinês extraído do ingrediente bioativo contendo "DOI", que é a abordagem não hormonal da Aptorum Group, destinada a atender a certas tendências e p
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Mon Feb 24, 2020 13:00
 知临集团开始商业化山药生物活性营养片剂并在香港签署销售分销协议
纽约--(BUSINESS WIRE)--(美国商业资讯)-- 致力于开发创新疗法以解决全球未被满足的医疗需求的生物制药公司知临集团(纳斯达克股票代码:APM),公布商业化其膳食补充剂,该产品适用于伴有症状的更年期女性。补充剂由含有“DOI”(一种生物活性成分)的萃取山药粉制成,乃知临集团鉴于消费者对营养产品的追求和关注日益增长而推出的非激素产品主。据估计到2030年全球将会有12亿更年期或更年期后的妇女1。全球针对妇女更年期症状的保健品市场预计在2025年会超过500亿美元,2016-2025年复合增长率为16.4%2。该膳食补充剂最先会在香港商业化和销售;公司正在寻求相关的监管许可,以期在其他主要司法管辖区域销售该产品。 作为商业化的一部分,知临集团通过其全资子公司Nativus Life Sciences Limited与万天茶行有限公司签订了区域分销协议,该集团公司的总部位于香港,公司经营多种家用品牌,包括陆羽®茶包和其他保健相关产品。 通过万天茶行,知临集团可在销售区域将其产品带给更广大的消费群。知临集团的这一山药生物活性保健食品片剂已开始在加拿大生产,并将很快以Nativ
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Mon Feb 24, 2020 13:00
Aptorum Group beginnt Vermarktung von bioaktiven nutrazeutischen Tabletten mit Dioscorea Opposita und unterzeichnet Vertriebsvereinbarung in Hongkong
NEW YORK--(BUSINESS WIRE)--Aptorum Group Limited („Aptorum Group“), ein Pharmaunternehmen mit Fokus auf die Entwicklung neuartiger Therapeutika für ungedeckten medizinischen Bedarf weltweit, meldet die Vermarktung eines Nahrungsergänzungsmittels für Frauen in den Wechseljahren, die an damit verbundenen Beschwerden leiden. Das Mittel wird mit einem aus der chinesischen Yamswurzel gewonnenen bioaktiven „DOI“-haltigen Pulver hergestellt. Mit ihrem nicht hormonell basierten Ansatz will die Aptorum
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Mon Feb 24, 2020 13:00

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