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09.11.2020 – 14:07

Merck KGaA
Merck Announces Out-Licensing Agreement for Investigational Atacicept with Vera Therapeutics

Darmstadt, Germany (ots/PRNewswire) - Not intended for UK and US based media - Merck out-licenses Phase IIb-ready atacicept to Vera Therapeutics - Phase IIa trial conducted by Merck shows promising results in IgA nephropathy (IgAN), also known as "Berger's disease" - Out-licencing deal includes 10% equity in Vera Therapeutics and up to EUR 605 million in development ...

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05.11.2020 – 16:06

Novo Nordisk A/S
Semaglutide 2.4 mg injection demonstrated significant weight loss versus placebo when added to intensive behavioural therapy

Bagsværd, Denmark (ots/PRNewswire) - Results of a phase 3a trial showed that investigational drug semaglutide 2.4 mg once-weekly subcutaneous as an adjunct to intensive behavioural therapy (IBT) demonstrated significantly more body weight loss compared to placebo plus IBT.[i] The STEP 3 phase 3a trial investigated ...

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15.10.2020 – 22:18

Servier
Galapagos and Servier report topline results for ROCCELLA Phase 2 clinical trial with GLPG1972/S201086 in knee osteoarthritis patients

Mechelen, Belgium and Paris (ots/PRNewswire) - Servier and Galapagos NV report that no signal of activity was observed in the topline results in their ROCCELLA Phase 2 trial with GLPG1972/S201086. ROCCELLA is a global, double-blind, placebo-controlled, dose ranging trial evaluating the efficacy and safety of three ...

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13.10.2020 – 13:44

Stada Arzneimittel
Enyzmatica and STADA extend agreement on ViruProtect to Russia, Poland, Ukraine and CIS countries

Press Release Enyzmatica and STADA extend agreement on ViruProtect to Russia, Poland, Ukraine and CIS countries - Enzymatica has licensed to STADA exclusive rights to market and sell the common cold spray ViruProtect® (ColdZyme®) Coldspray in ...
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01.10.2020 – 14:00

Debiopharm International SA
DEBIOPHARM LAUNCHES TRILYNX - A LARGE-SCALE PHASE III CLINICAL TRIAL TO FURTHER EVALUATE XEVINAPANT IN THE TREATMENT OF HEAD & NECK CANCER

Lausanne, Switzerland (ots) - First patient dosed in the randomized, placebo-controlled Phase III study of xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in high-risk patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) Debiopharm (www.debiopharm.com), a ...

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30.09.2020 – 13:00

BrainRepair UG

Regulatory breakthrough for BrainRepair UG start-up - Stem cell treatment for newborns /EMA Orphan Drug Designation is followed by agreement on Paediatric Investigation Plan

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15.09.2020 – 08:58

Stada Arzneimittel
STADA's US partner Supernus submits NDA for apomorphine infusion pump

Press release STADA‘s US partner Supernus submits NDA for apomorphine infusion pump - STADA’s US commercial partner Supernus files New Drug Application (NDA) with US Food and Drug Administration for an apomorphine infusion pump (SPN-830). - The NDA filing for SPN-830 for continuous treatment of ...
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11.09.2020 – 14:00

Merck KGaA
New MAVENCLAD® Data at ACTRIMS-ECTRIMS MSVirtual2020 Meeting Highlight Rapid Onset of Action and Compelling Post-Approval Safety

Darmstadt, Germany (ots/PRNewswire) - In MAGNIFY-MS, patients experienced a rapid onset of action from end of Month 1 that was significant in all study periods versus baseline Post-approval safety analysis showed no increased risk of viral respiratory infections and lower rates of malignancy than in the clinical ...

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10.09.2020 – 14:00

Merck KGaA
Merck Announces Positive Phase II Results for Investigational Sonelokinab (M1095) in Patients with Moderate to Severe Chronic Plaque-Type Psoriasis

Darmstadt, Germany (ots/PRNewswire) - Not intended for UK and US based media - Sonelokinab is an investigational IL-17 A/F Nanobody®, which neutralizes both IL-17A and IL-17F - Phase II study was facilitated by Avillion as part of an innovative co-development model Merck, a leading science and technology company, ...

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03.09.2020 – 14:00

Merck KGaA
Merck to Showcase New Data at ACTRIMS-ECTRIMS MSVirtual2020 Meeting, Furthering Innovation in Multiple Sclerosis

Darmstadt, Germany (ots/PRNewswire) - Not intended for UK and US based media - Company to present 54 abstracts across its MS portfolio - MAVENCLAD® (cladribine tablets), Rebif® (interferon beta-1a) and investigational evobrutinib - New long-term data and real-world evidence further characterise efficacy and safety ...

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17.08.2020 – 16:38

Fördergesellschaft IZB mbH

KOPIE VON: Inspirational talks form SIRION Biotech, CLS Behring and the German Accelerator at the 13th Biotech Press Lounge at the IZB

In the IZB you can find over 50 biotech start-ups
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13.06.2020 – 17:00

Novo Nordisk A/S
Switching to Ozempic® from another GLP-1 RA significantly reduced blood sugar and weight in people with type 2 diabetes in routine clinical practice

Bagsværd, Denmark (ots/PRNewswire) - This material is intended for global medical media only, excl US. For journalistic assessment and preparation before publication. - A separate real-world study showed that people with type 2 diabetes on two oral antidiabetic drugs who intensified with a glucagon-like peptide-1 ...

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04.06.2020 – 14:16

Synformulas GmbH

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Innovation: Intelligent bacteria demonstrate high efficacy in the treatment of widespread disease irritable bowel syndrome with typical symptoms of recurrent diarrhoea, abdominal pain, bloating and constipation

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19.05.2020 – 13:00

TauRx Therapeutics
TauRx Reveals Study Results That Offers New Hope for Treatment of Patients With Dementia

Aberdeen, Scotland and Singapore (ots/PRNewswire) - Minimum dose of hydromethylthionine could slow clinical decline and brain atrophy in behavioural variant Fronto-Temporal Dementia as well as Alzheimer's Disease In a paper published online in the Journal of Alzheimer's Disease (https://doi.org/10.3233/JAD-191173), TauRx reported that the drug it is developing for the ...

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31.03.2020 – 18:00

Novo Nordisk A/S
Saxenda® Demonstrated Improvements in BMI and Body Weight in Adolescents With Obesity

Bagsværd, Denmark (ots/PRNewswire) - Novo Nordisk today announced that the New England Journal of Medicine published results of a phase 3 trial evaluating the investigational use of Saxenda® (liraglutide 3.0 mg) in adolescents (aged ...

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13.01.2020 – 11:43

COMPASS Pathways
COMPASS Pathways Granted Patent Covering Use of Its Psilocybin Formulation in Addressing Treatment-resistant Depression

London (ots/PRNewswire) - COMPASS Pathways, a mental health care company, announced today that it has been granted US Patent No 10,519,175, relating to methods of treating drug-resistant depression with a psilocybin formulation, by the US Patent and Trademark Office. The patent covers the use of COMPASS's ...

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06.01.2020 – 10:00

Kyowa Kirin International PLC
Kyowa Kirin Announces Marketing Authorisation Application for Istradefylline Validated by European Medicines Agency

Tokyo (ots/PRNewswire) - Kyowa Kirin Co., Ltd. (TSE: 4151) President and CEO: Masashi Miyamoto, "Kyowa Kirin") today announces that its marketing authorisation application (MAA) for istradefylline (KW-6002) as an adjunctive treatment to levodopa-based regimens in adult patients with Parkinson's disease (PD) ...

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12.12.2019 – 09:00

COMPASS Pathways
COMPASS Pathways and King's College London Announce Results From Psilocybin Study In Healthy Volunteers

London (ots/PRNewswire) - COMP360 (psilocybin) was well tolerated in healthy volunteers and results support further investigation of simultaneous 1:1 therapeutic administration design COMPASS Pathways, a mental health care company, has reported that its COMP360 (psilocybin) was well-tolerated when administered to ...

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24.06.2019 – 14:00

Merck KGaA
Merck to Showcase New Data Across MS Portfolio at EAN 2019

Darmstadt, Germany (ots/PRNewswire) - Not intended for UK or U.S. based media - Company to present 16 abstracts on MAVENCLAD® (cladribine tablets), Rebif® (interferon beta-1a) and investigational evobrutinib at the 5th Congress of the European Academy of Neurology - Presentations include new data on the long-term efficacy and safety of MAVENCLAD®, new safety data for Rebif® and the 48-week analysis from the Phase 2 ...

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11.06.2019 – 20:45

Novo Nordisk A/S
Oral semaglutide demonstrated cardiovascular safety in people with type 2 diabetes and established cardiovascular disease or high cardiovascular risk in PIONEER 6 trial

San Francisco (ots/PRNewswire) - Novo Nordisk today announced that the PIONEER 6 trial achieved its primary endpoint by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with oral semaglutide compared with placebo, both in addition to standard of care. The primary endpoint was defined as ...

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08.06.2019 – 17:45

Novo Nordisk A/S
Oral semaglutide showed superior reductions in blood sugar vs Jardiance® and non-inferior blood sugar reductions vs Victoza® in adults with type 2 diabetes at 26 weeks

San Francisco (ots/PRNewswire) - Abstracts 54-OR and 55-OR Secondary data at 52 weeks demonstrated statistically significant blood sugar reductions and statistically significant reduction of body weight vs both Jardiance® and Victoza® Findings presented today from two phase 3a clinical trials evaluated oral ...

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30.04.2019 – 14:05

Merck KGaA
Merck to Present New Data on Mavenclad®, Rebif® and the Investigational Therapy Evobrutinib at the AAN Annual Meeting 2019

Darmstadt, Germany (ots/PRNewswire) - Not intended for U.S. or U.K. based media - 20 abstracts will be presented during the AAN Annual Meeting 2019 to demonstrate Merck's commitment and clinical development program in multiple sclerosis Merck, a leading science and technology company, today announced that data from ...

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02.04.2019 – 13:44

Daiichi Sankyo
Bempedoic Acid CLEAR Serenity Study Results Published in the JAHA Demonstrated Significant LDL-Cholesterol Lowering and Reduced hsCRP in Statin Intolerant Patients

Munich and Ann Arbor, Michigan (ots/PRNewswire) - - Bempedoic acid is an oral, once-daily ATP citrate lyase (ACL) inhibitor that reduces cholesterol and fatty acid synthesis in the liver - Bempedoic acid significantly reduced LDL-Cholesterol (LDL-C) vs placebo at week 12 (primary endpoint, absolute reduction ...

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25.03.2019 – 12:04

Merck KGaA
MAVENCLAD® (Cladribine Tablets) Approved As The First Short-Course Oral Treatment for Relapsing Remitting Multiple Sclerosis in Switzerland

Darmstadt, Germany (ots/PRNewswire) - - MAVENCLAD® is now approved in 52 countries worldwide - Approval brings forward new treatment option with a novel mechanism for highly active relapsing multiple sclerosis in Switzerland - Approval based on extensive clinical development program capturing more than 10,000 ...

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19.03.2019 – 09:59

Daiichi Sankyo Europe GmbH
CLEAR Wisdom Demonstrated First-in-class, Oral, Once-daily, ACL Inhibitor Bempedoic Acid Significantly Lowered LDL-Cholesterol and Reduced hsCRP

Munich and Ann Arbor, Michigan (ots/PRNewswire) - - Late-Breaking Presentation of Final Results of Bempedoic Acid Pivotal Phase 3 CLEAR Wisdom at the American College of Cardiology (ACC) 2019 Scientific Sessions - Over 52-Weeks, Bempedoic Acid was Observed to be Safe, Well-Tolerated and Adverse Event Profile was ...

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04.03.2019 – 14:01

Novo Nordisk A/S
Ozempic® Superior in Lowering Blood Sugar and Weight Vs Placebo, Both in Combination with SGLT-2 Inhibitors

Bagsværd, Denmark (ots/PRNewswire) - Novo Nordisk today announced publication of results from the SUSTAIN 9 Phase 3b trial in The Lancet Diabetes & Endocrinology. The objective of this 30 week trial was to assess the efficacy and safety of Ozempic® (semaglutide) 1.0 mg when added to SGLT-2 inhibitor (SGLT-2i) ...

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28.02.2019 – 13:00

Daiichi Sankyo Europe GmbH
Daiichi Sankyo Europe and Esperion Announce Validation of the Marketing Authorisation Application (MAA) for Bempedoic Acid and the Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet

Munich and Ann Arbor, Michigan (ots/PRNewswire) - - Application is based on results of a robust development programme, which demonstrated that bempedoic acid was well tolerated and efficacious for chronic use - Bempedoic acid is a first-in-class, oral, once-daily ATP Citrate Lyase (ACL) inhibitor that reduces ...

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07.01.2019 – 08:01

Daiichi Sankyo Europe GmbH
Daiichi Sankyo Europe Enters into European Licensing Agreement with Esperion for Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet

Munich (ots/PRNewswire) - - Daiichi Sankyo Europe will market oral bempedoic acid and bempedoic acid / ezetimibe combination tablet in the European Economic Area and Switzerland - Bempedoic acid is a first-in-class, oral, once-daily ATP Citrate Lyase (ACL) inhibitor that reduces cholesterol and fatty acid synthesis ...

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18.10.2018 – 07:01

UCB Pharma
UCB Accelerates Anti-FcRn Rozanolixizumab in Myasthenia Gravis Into Confirmatory Development Phase

Brussels (ots/PRNewswire) - - Positive outcomes in proof-of-concept study with subcutaneous rozanolixizumab in patients with myasthenia gravis (MG): clinically meaningful improvement in multiple disease-related endpoints - Strong 68% mean reduction of Serum IgG and IgG Autoantibodies observed - Safety profile ...

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29.06.2018 – 01:02

Astellas Pharma Europe Limited
Results From Pivotal Phase 3 PROSPER Trial of XTANDI[TM] (enzalutamide) in Men With Non-Metastatic Castration-Resistant Prostate Cancer Published in New England Journal of Medicine

Tokyo (ots/PRNewswire) - Results show enzalutamide plus androgen deprivation therapy significantly reduced the risk of developing metastases or death by 71 percent compared to placebo plus androgen deprivation therapy[i] FOR EMEA MEDICAL MEDIA ONLY - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji ...

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