GlobeNewswire - Industry News on Pharmaceuticals Contains the last 20 releases uuid:05bceb19-93b6-4cc9-8636-0e0694d3265f;id=7440 2021-02-27T07:00:00Z newsdesk@globenewswire.com (NewsDesk) http://www.yebxqs.cn/LegacyRss?Length=4 newsdesk@globenewswire.com http://www.yebxqs.cn/news-release/2021/02/27/2183794/0/en/Annual-financial-report-2020.html Annual financial report 2020 2021-02-27T07:00:00Z 2021-02-27T22:08:40Z FINANCIERE DE TUBIZE SA/NV

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2183794 en GlobeNewswire Inc. Financière de Tubize SA Sat, 27 Feb 2021 07:00 GMT Annual report
http://www.yebxqs.cn/news-release/2021/02/27/2183794/0/fr/Rapport-financier-annuel-2020.html Rapport financier annuel 2020 2021-02-27T07:00:00Z 2021-02-27T22:08:40Z FINANCIERE DE TUBIZE SA

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2183794 fr GlobeNewswire Inc. Financière de Tubize SA Sat, 27 Feb 2021 07:00 GMT Annual report
http://www.yebxqs.cn/news-release/2021/02/27/2183794/0/nl/aarlijks-financieel-verslag-2020.html aarlijks financieel verslag 2020 2021-02-27T07:00:00Z 2021-02-27T22:08:40Z FINANCIERE DE TUBIZE NV

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2183794 nl GlobeNewswire Inc. Financière de Tubize SA Sat, 27 Feb 2021 07:00 GMT Annual report
http://www.yebxqs.cn/news-release/2021/02/27/2183782/0/en/Imara-to-Webcast-Conference-Call-of-Full-Year-2020-Financial-Results-and-Business-Highlights.html Imara to Webcast Conference Call of Full Year 2020 Financial Results and Business Highlights 2021-02-27T02:30:00Z 2021-02-27T22:08:40Z BOSTON, Feb. 26, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (Nasdaq: IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin, today announced that the company will host a conference call and live webcast on Friday, March 5, 2021 at 8:30 a.m. ET to discuss its financial results for the year ended December 31, 2020 and review recent business highlights.

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2183782 en GlobeNewswire Inc. Imara, Inc. Sat, 27 Feb 2021 02:31 GMT Calendar of Events
http://www.yebxqs.cn/news-release/2021/02/26/2183646/0/en/Roche-SARS-CoV-2-Rapid-Antigen-Test-receives-special-approval-for-at-home-patient-self-testing-using-nasal-swabs-in-Germany.html Roche SARS-CoV-2 Rapid Antigen Test receives special approval for at-home patient self-testing using nasal swabs in Germany 2021-02-26T17:30:00Z 2021-02-27T22:08:40Z Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has been granted special approval by the German Federal Institute for Drugs and Medical Devices (BfArM) to offer the SARS-CoV-2 Rapid Antigen Test using a simple nasal swab for patient self-testing in Germany.

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2183646 en GlobeNewswire Inc. F. Hoffmann-La Roche Ltd Fri, 26 Feb 2021 17:30 GMT Company Announcement Press releases
http://www.yebxqs.cn/news-release/2021/02/26/2183426/0/en/Albireo-Spotlights-Global-Patient-Communities-on-Rare-Disease-Day.html Albireo Spotlights Global Patient Communities on Rare Disease Day 2021-02-26T13:30:00Z 2021-02-27T22:08:40Z – Calls to unite global communities affected by rare diseases –

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2183426 en GlobeNewswire Inc. Albireo Pharma, Inc. Fri, 26 Feb 2021 13:30 GMT Company Announcement
http://www.yebxqs.cn/news-release/2021/02/26/2183340/0/en/Assembly-Biosciences-and-Arbutus-Biopharma-Initiate-Phase-2-Clinical-Trial-of-Triple-Combination-Therapy-for-the-Treatment-of-Chronic-Hepatitis-B-Virus.html Assembly Biosciences and Arbutus Biopharma Initiate Phase 2 Clinical Trial of Triple Combination Therapy for the Treatment of Chronic Hepatitis B Virus 2021-02-26T12:30:00Z 2021-02-27T22:08:40Z Trial will evaluate Assembly’s core inhibitor candidate, vebicorvir, with Arbutus’ RNAi therapeutic candidate, AB-729, and standard-of-care NrtI therapy

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2183340 en GlobeNewswire Inc. Arbutus Biopharma Corporation Fri, 26 Feb 2021 12:31 GMT Health Arbutus Biopharma Assembly Biosciences Biopharma BIOTECHNOLOGY HBV Edgar
http://www.yebxqs.cn/news-release/2021/02/26/2183414/0/en/Cronos-Group-Reports-2020-Fourth-Quarter-and-Full-Year-Results.html Cronos Group Reports 2020 Fourth Quarter and Full-Year Results 2021-02-26T12:30:00Z 2021-02-27T22:08:40Z Announces plans to launch Happy Dance? in ULTA Beauty?

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2183414 en GlobeNewswire Inc. Cronos Group Inc. Fri, 26 Feb 2021 13:20 GMT Earnings Releases and Operating Results
http://www.yebxqs.cn/news-release/2021/02/26/2183317/0/en/EMA-issues-advice-on-casirivimab-and-imdevimab-antibody-cocktail-for-the-treatment-of-mild-to-moderate-COVID-19.html EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19 2021-02-26T12:12:00Z 2021-02-27T22:08:40Z Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) confirmed today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a scientific opinion supporting the use of the investigational antibody cocktail, casirivimab and imdevimab, as a treatment option for patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.

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2183317 en GlobeNewswire Inc. F. Hoffmann-La Roche Ltd Fri, 26 Feb 2021 12:12 GMT Company Announcement Press releases
http://www.yebxqs.cn/news-release/2021/02/26/2183310/0/en/Ascendis-Pharma-A-S-Announces-New-Outgrow-GHD-Educational-Resource-to-Support-Rare-Disease-Day-2021.html Ascendis Pharma A/S Announces New “Outgrow GHD” Educational Resource to Support Rare Disease Day 2021 2021-02-26T12:05:00Z 2021-02-27T22:08:40Z COPENHAGEN, Denmark, Feb. 26, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced the launch of Outgrow GHD, a new online educational resource designed to help caregivers of children with growth hormone deficiency (GHD) in the United States (U.S.) navigate their personal GHD journeys.

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2183310 en GlobeNewswire Inc. Ascendis Pharma Fri, 26 Feb 2021 12:05 GMT Product / Services Announcement
http://www.yebxqs.cn/news-release/2021/02/26/2183262/0/en/Roche-receives-positive-CHMP-opinion-for-Evrysdi-the-first-and-only-at-home-spinal-muscular-atrophy-SMA-treatment-with-proven-efficacy-in-adults-children-and-infants-two-months-and.html Roche receives positive CHMP opinion for Evrysdi, the first and only at home spinal muscular atrophy (SMA) treatment with proven efficacy in adults, children and infants two months and older 2021-02-26T11:30:00Z 2021-02-27T22:08:40Z Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Evrysdi? (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. SMA is a leading genetic cause of death in infants and 5q SMA is the most common form of the disease. SMA causes progressive muscle weakness and atrophy, and significant unmet need remains, particularly in adults living with this condition.

The CHMP recommendation was completed under the accelerated assessment pathway, which is offered to medicines deemed to be of major interest for public health and therapeutic innovation. A final decision regarding approval is expected from the European Commission in the next two months and will be applicable to all 27 European Union member states, as well as Iceland, Norway, and Liechtenstein. Evrysdi was approved by the U.S. Food and Drug Administration (FDA) in August 2020.

“Our close partnership with the SMA community has enabled the development of the first ‘at-home’ treatment for SMA in infants, children and adults with varying levels of disease severity, the majority of whom remain untreated,” said Levi Garraway, M.D., Ph. D., Roche’s Chief Medical Officer and Head of Global Product Development. “If approved, Evrysdi would represent a much-needed therapeutic option and we expect it to become the treatment of choice for people living with SMA and their families."

The CHMP recommendation is based on data from two clinical studies designed to represent a broad spectrum of people living with SMA: FIREFISH in symptomatic Type 1 infants aged 2 to 7 months and SUNFISH in symptomatic Type 2 and 3 children and adults aged 2 to 25 years. SUNFISH is the first and only placebo-controlled trial to include adults with Types 2 and 3 SMA.

In FIREFISH, 29% (12/41; p<0.0001 compared to natural history) of infants treated with Evrysdi for 12 months were able to sit without support for at least five seconds, as assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition. This is a key motor milestone never achieved in the natural history of Type 1 SMA. In addition, 93% of infants were alive and 85% were event-free (alive with no permanent ventilation). Furthermore, 5% (2/41) of infants were able to stand with support, as measured by the Hammersmith Infant Neurological Examination, and 83% were able to feed orally. Ninety per cent (37/41) had a CHOP-INTEND* score increase of at least 4 points, with 56% (23/41) achieving a score above 40; the median increase was 20 points. The median age at enrolment was 5.3 months. A liquid medicine, Evrysdi is administered daily at home by mouth or feeding tube.

In SUNFISH, children and adults treated with Evrysdi experienced a clinically meaningful and statistically significant improvement in motor function at 12 months (1.55 point mean difference; p=0.0156) compared to placebo (1.36 points [95% CI: 0.61, 2.11]; -0.19 points [95% CI: -1.22, 0.84], respectively), as measured by a change from baseline in the Motor Function Measure-32 (MFM-32) total score. Children and adults also experienced significant improvement in upper limb function, a key secondary endpoint, at 12 months (1.59 point mean difference; p=0.0469) compared to placebo (1.61 points [95% CI: 1.00, 2.22]; 0.02 points [95% CI: -0.83, 0.87] respectively), as measured by a change from baseline in the Revised Upper Limb Module (RULM). The median age at enrolment was nine years.

Evrysdi demonstrated a favourable efficacy and safety profile, with the safety profile established across the FIREFISH and SUNFISH trials. The most common adverse events were upper respiratory tract infection, pneumonia, nasopharyngitis, pyrexia, constipation, rhinitis, diarrhoea, headache, cough and vomiting. There were no treatment-related safety findings leading to withdrawal from either study.

Evrysdi is designed to treat SMA by increasing and sustaining the production of the survival motor neuron (SMN) protein. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.

More than 2,500 patients have now been treated with Evrysdi in clinical trials, compassionate use and real world settings, with patients ranging from birth to over 70 years of age and including those previously treated with other SMA-targeting therapies. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.

Roche is actively engaged with reimbursement and assessment bodies in European countries to enable broad and rapid access to patients in need. Reimbursement dossiers are being submitted in many countries in advance of an expected European Commission decision to minimise any delay in patient access.

*Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders

About Evrysdi? (risdiplam)
Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.

Evrysdi has been approved in seven countries (US, Chile, Brazil, Ukraine, South Korea, Georgia and Russia) and submitted in a further 30 countries.

Evrysdi is currently being evaluated in four multicentre trials in people with SMA:

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2183262 en GlobeNewswire Inc. F. Hoffmann-La Roche Ltd Fri, 26 Feb 2021 11:30 GMT Company Announcement Press releases
http://www.yebxqs.cn/news-release/2021/02/26/2183241/0/en/Amphastar-Pharmaceuticals-to-Present-at-the-Raymond-James-2021-Institutional-Healthcare-Conference.html Amphastar Pharmaceuticals to Present at the Raymond James 2021 Institutional Healthcare Conference 2021-02-26T11:01:00Z 2021-02-27T22:08:40Z RANCHO CUCAMONGA, Calif., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced today that Bill Peters, CFO, Dan Dischner, V.P of Corporate Communications and HR, Tony Marrs, Sr. V.P Regulatory Affairs and Clinical Operations, and Jacob Liawatidewi, Executive V.P. Corporate Administration Center and Sales & Marketing, will participate in an Analyst-Moderated fireside chat at the Raymond James 2021 Institutional Healthcare Conference on Tuesday, March 2, 2021 at 1:20 pm Eastern time.

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2183241 en GlobeNewswire Inc. Amphastar Pharmaceuticals, Inc. Fri, 26 Feb 2021 11:01 GMT Calendar of Events
http://www.yebxqs.cn/news-release/2021/02/26/2183128/0/sv/Corline-Biomedical-AB-publicerar-bokslutskommunik%C3%A9-f%C3%B6r-2020.html Corline Biomedical AB publicerar bokslutskommuniké f?r 2020 2021-02-26T07:45:00Z 2021-02-27T22:08:40Z Corline Biomedical AB (”Corline”) publicerar h?rmed bokslutskommuniké f?r det fj?rde kvartalet och r?kenskaps?ret 2020. Nedan f?ljer en kort sammanfattning av bokslutskommunikén. Fullst?ndig bokslutskommuniké finns tillg?nglig p? Corlines hemsida (www.corline.se) samt som bifogad fil.

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2183128 sv GlobeNewswire Inc. Corline Biomedical AB Fri, 26 Feb 2021 07:45 GMT Company Announcement Interim information European Regulatory News Corline Kidney transplantation pharma development Renaparin ex vivo treatment medical device coating Medical device industry
http://www.yebxqs.cn/news-release/2021/02/26/2183107/0/en/Issue-of-Equity-on-Exercise-of-Options-Vesting-of-Performance-Share-Awards.html Issue of Equity on Exercise of Options/Vesting of Performance Share Awards 2021-02-26T07:00:00Z 2021-02-27T22:08:40Z Acacia Pharma Group plc

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2183107 en GlobeNewswire Inc. Acacia Pharma Group plc Fri, 26 Feb 2021 07:00 GMT Company Announcement Other News European Regulatory News
http://www.yebxqs.cn/news-release/2021/02/26/2183109/0/en/Transparency-Notification.html Transparency Notification 2021-02-26T07:00:00Z 2021-02-27T22:08:40Z THIS ANNOUNCEMENT CONTAINS REGULATED INFORMATION.

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2183109 en GlobeNewswire Inc. Acacia Pharma Group plc Fri, 26 Feb 2021 07:00 GMT Other News European Regulatory News
http://www.yebxqs.cn/news-release/2021/02/26/2183101/0/en/Olainfarm-Group-lays-a-strong-foundation-for-sustainable-development.html Olainfarm Group lays a strong foundation for sustainable development 2021-02-26T06:54:00Z 2021-02-27T22:08:40Z “Covid-19 is having a significant impact on the global healthcare and pharmaceutical industries. Our values ??and care for the society remain unchanged in this difficult time, we strive to improve people's health and quality of life. In accordance with the Olainfarm Group's five-year strategy "Forward", in 2020 an unprecedented transformation of the Group was initiated with the goal of making internal processes more effective for sustainable growth. Despite the challenges caused by Covid-19 we have managed to build a strong foundation. Moving towards strengthening and expansion characterizes Olainfarm Group's approach for the year 2021 and beyond. This will be based on significant investments in research and development, in particular - by fostering the development and acquisition of FDFs,” says Jeroen Weites, Chairperson of the Management Board of JSC Olainfarm.

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2183101 en GlobeNewswire Inc. Olainfarm Fri, 26 Feb 2021 06:54 GMT Earnings Releases and Operating Results European Regulatory News
http://www.yebxqs.cn/news-release/2021/02/26/2183101/0/lv/Olainfarm-grupa-izveido-sp%C4%93c%C4%ABgu-pamatu-ilgtsp%C4%93j%C4%ABgai-att%C4%ABst%C4%ABbai.html Olainfarm grupa izveido spēcīgu pamatu ilgtspējīgai attīstībai 2021-02-26T06:54:00Z 2021-02-27T22:08:40Z “Covid-19 būtiski ietekmē veselības un farmācijas nozari visā pasaulē. Mūsu vērtības un rūpes par sabiedrību ?ajā sare??ītajā laikā paliek nemainīgas – uzlabot cilvēku veselību un dzīves kvalitāti.? Saska?ā ar Olainfarm grupas piecgades stratē?iju “Uz priek?u”, 2020. gadā ir uzsākta vēl nebijusi Grupas transformācija ar mēr?i efektivizēt iek?ējos procesus ilgtspējīgai izaugsmei. Neskatoties uz Covid-19 izaicinājumiem, mums ir izdevies izveidot spēcīgu pamatu. Nostiprināt un papla?ināt ir virziens, kas raksturo Olainfarm grupas pieeju 2021. gadam un uz priek?u. Tam pamatā būs nozīmīgas investīcijas pētniecībā un attīstībā, īpa?i veicinot gatavo zā?u formu izstrādi un iegādi,” saka Jerūns Veitess, AS “Olainfarm” valdes priek?sēdētājs.

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2183101 lv GlobeNewswire Inc. Olainfarm Fri, 26 Feb 2021 06:54 GMT Earnings Releases and Operating Results European Regulatory News
http://www.yebxqs.cn/news-release/2021/02/25/2183012/0/en/Theratechnologies-to-Present-at-the-H-C-Wainwright-Global-Life-Sciences-Conference.html Theratechnologies to Present at the H.C. Wainwright Global Life Sciences Conference 2021-02-25T21:43:32Z 2021-02-27T22:08:40Z MONTREAL, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that Paul Levesque, President and Chief Executive Officer, will present at the H.C. Wainwright Global Life Sciences Conference being held virtually March 9 – 10, 2021.

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2183012 en GlobeNewswire Inc. Theratechnologies Thu, 25 Feb 2021 21:44 GMT Calendar of Events Health Trade Show
http://www.yebxqs.cn/news-release/2021/02/25/2183012/0/fr/Therathechnologies-pr%C3%A9sentera-au-H-C-Wainwright-Global-Life-Sciences-Conference.html Therathechnologies présentera au H.C. Wainwright Global Life Sciences Conference 2021-02-25T21:43:32Z 2021-02-27T22:08:40Z MONTRÉAL, 25 févr. 2021 (GLOBE NEWSWIRE) -- Theratechnologies inc. (Theratechnologies) (TSX?: TH) (NASDAQ?: THTX), une société biopharmaceutique axée sur le développement et la commercialisation de traitements innovateurs, a annoncé aujourd’hui que Paul Lévesque, président et chef de la direction, présentera au H.C. Wainwright Global Life Sciences Conference qui se tiendra virtuellement les 9 et 10 mars 2021.

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2183012 fr GlobeNewswire Inc. Theratechnologies Thu, 25 Feb 2021 21:44 GMT Calendar of Events Health Trade Show
http://www.yebxqs.cn/news-release/2021/02/25/2182931/0/en/Assembly-Biosciences-Reports-Fourth-Quarter-and-Year-End-2020-Financial-Results-and-Recent-Highlights.html Assembly Biosciences Reports Fourth Quarter and Year End 2020 Financial Results and Recent Highlights 2021-02-25T21:05:00Z 2021-02-27T22:08:40Z SOUTH SAN FRANCISCO, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV), today reported financial results and recent highlights for the fourth quarter and year ended December 31, 2020.

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2182931 en GlobeNewswire Inc. Assembly Biosciences, Inc. Thu, 25 Feb 2021 21:05 GMT Earnings Releases and Operating Results
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