Schweizerischer Nationalfonds / Fonds national suisse
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Medison Pharma; Alnylam Pharmaceuticals
Medison Pharma and Alnylam Pharmaceuticals Announce Expansion of their Multi-Regional Partnership in Europe and Israel to Commercialize RNAi Therapeutics in additional LATAM and APAC markets including Australia
Zug, Switzerland (ots/PRNewswire) - - The expanded partnership will allow Alnylam and Medison to help accelerate access for patients in multiple regions under one global alliance - Medison, the creator and leader of the multi-regional partnership category, will utilize its unique, unified platform for efficient ...
mehrNorgine B.V. submits Marketing Authorisation Application via Project Orbis for eflornithine (difluoromethylornithine [DFMO]) in high-risk neuroblastoma
Amsterdam (ots/PRNewswire) - Norgine B.V. today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in Australia, Switzerland and the United Kingdom. This milestone supports Norgine's efforts to ...
mehrIsotopia Molecular Imaging Ltd. is thrilled to announce that Isoprotrace®, has received marketing authorization in the Netherlands (RVG 130527)
Petach Tikva, Israel (ots/PRNewswire) - Isotopia Molecular Imaging Ltd. is thrilled to announce that Isoprotrace®, our PSMA -11 kit, has received marketing authorization in the Netherlands (RVG 130527). This landmark approval marks a significant milestone in our ongoing commitment to improve healthcare and patient ...
mehrNorgine receives positive CHMP opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia
Amsterdam (ots/PRNewswire) - Norgine B.V. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia. The ...
mehrFennec Pharmaceuticals and Norgine Enter into Exclusive Licensing Agreement to Commercialize PEDMARQSI in Europe, Australia, and New Zealand
Research Triangle Park, N.C. and Uxbridge, England (ots/PRNewswire) - Agreement pairs Norgine's commercial expertise and leading European footprint with PEDMARQSI™, the first and only approved therapy in the European Union and U.K. for reducing the risk of cisplatin-induced hearing loss in pediatric patients with ...
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FDX Fluid Dynamix and Fraunhofer IPK to Collaborate with Lonza on Novel Nanoparticle Formulation Technology Platform FDmiX
mehr Epitomee® announces the filing of a novel Weight Loss Capsule for FDA clearance
Caesarea, Israel (ots/PRNewswire) - Epitomee® (TASE: EPIT) announced today that on February 27, 2024, it has submitted its Weight Loss Capsule for FDA clearance in the USA, reaching a significant milestone in the company's journey. The Epitomee® capsule offers an innovative, orally administered, drug free, and clinically proven as effective and safe solution, for ...
mehrHearing loss company Acousia announces first patient enrolled in its Phase 2 PROHEAR-Study
Tübingen, Germany (ots) - Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, just announced the randomization of the first patient for the PROHEAR-Study. The PROHEAR-Study is a placebo-controlled, Phase 2a study with split-body design, which investigates the otoprotective efficacy ...
mehrAcousia Therapeutics attracts new investor on its path to make hearing loss a treatable disease
Tübingen (ots) - - German pioneer biotech accelerates hearing loss solution development with fresh capital boost Acousia Therapeutics GmbH, a clinical-stage biotech company developing drug candidates against acute and chronic forms of hearing loss, proudly announces Esperante Ventures as the latest addition to its esteemed group of investors. The infusion of fresh ...
mehrMedison Pharma Announces Agreement with Regeneron Pharmaceuticals to Commercialize Libtayo® (cemiplimab) in Multiple Countries
Zug, Switzerland (ots/PRNewswire) - - Libtayo (cemiplimab) is a leading PD-1 inhibitor that has shown efficacy in the treatment of certain patients with cutaneous squamous cell carcinoma, advanced basal cell carcinoma, advanced non-small cell lung cancer and advanced cervical cancer, and is approved by regulatory ...
mehrTakeda Pharma Vertrieb GmbH & Co. KG
The European Commission Approves Label Update for TAKHZYRO® (lanadelumab), Expanding Its Use to a Broader Group of Paediatric Patients with Recurrent Attacks of Hereditary Angioedema (HAE)
Zurich (ots/PRNewswire) - - TAKHZYRO® is the First Routine Prevention Treatment of HAE Approved in the EU for Patients Under the Age of Six. - The therapeutical indication for TAKHZYRO® has been extended to patients aged 2 years and older.1 - Offers a New Preventative Treatment Option for young HAE patients with ...
mehrIpsen and Medison Pharma Announce Health Canada Approval of Bylvay™ (odevixibat) for the treatment of pruritus due to Progressive Familial Intrahepatic Cholestasis (PFIC)
Zug, Switzerland and Paris (ots/PRNewswire) - Bylvay (odevixibat) is the first and only oral treatment available in Canada for the treatment of pruritus due to this rare genetic condition Today, Ipsen (Euronext: IPN) (ADR: IPSEY), a global biopharmaceutical company focused on transformative medicines in oncology, ...
mehrSoterios Pharma completes Phase II enrolment for STS-01 in mild / moderate (patchy) alopecia areata
London (ots/PRNewswire) - Soterios Pharma, a privately held clinical-stage pharmaceutical company, announced today that it has completed target enrolment for its Phase II trial with STS-01 for mild / moderate (patchy) alopecia areata. Final results of the study are anticipated to be available in Q2 2024. David Fleet, CEO of Soterios Pharma, said, "This represents an ...
mehrHearing Loss Company Acousia Therapeutics Green Lighted for Game-Changing Phase 2 Trial
Tübingen, Germany (ots/PRNewswire) - Acousia Therapeutics, a pioneer clinical-stage biotech company focused on the development of novel drug therapies for the prevention and treatment of acute and chronic forms of hearing loss, received approval from the German regulatory authorities (BfArM) for its groundbreaking Phase 2 clinical trial of the etiology-agnostic ...
mehrHearing Loss Company Acousia Therapeutics Green Lighted for Game-Changing Phase 2 Trial
Tübingen, Germany (ots) - Acousia Therapeutics, a pioneer clinical-stage biotech company focused on the development of novel drug therapies for the prevention and treatment of acute and chronic forms of hearing loss, received approval from the German regulatory authorities (BfArM) for its groundbreaking Phase 2 clinical trial of the etiology-agnostic otoprotectant ...
mehrTakeda Receives Positive CHMP Opinion Recommending Approval of Lanadelumab for Routine Prevention of Recurrent Attacks of Hereditary Angioedema (HAE) in Patients Aged 2 years and Older
Zurich (ots/PRNewswire) - - If Approved, Lanadelumab Will be the First Long-Term Prophylactic Treatment of HAE Available in the EU for Patients Under the Age of Six. - Positive Opinion Based on Pivotal Study SHP643-301, Evaluating the Safety Profile and Pharmacokinetics (PK) of Lanadelumab, in Combination with ...
mehrHearing loss company Acousia Therapeutics to present key learnings and data from lead development programs at US and European meetings in August and September
Tübingen, Germany (ots) - Acousia Therapeutics GmbH to share key learnings and data from its lead candidate development programs — clinical stage ACOU085 and late preclinical stage ACOU082 — during four presentations at industry and research meetings from August 29 to September 5. From August 29–31, Acousia ...
mehrSuccessful FDA inspection at Aurisco's manufacturing site in Yangzhou, China
Yangzhou, China (ots/PRNewswire) - Aurisco Pharmaceutical today announced that its cGMP manufacturing plant in Yangzhou has successfully passed a USFDA inspection. Aurisco Pharmaceutical announced today that its API and FDF plant in Yangzhou, China has successfully passed a cGMP inspection by the US Food and Drug Administration (USFDA). The inspection, carried out by ...
mehrGrünenthal and Kyowa Kirin International Announce Successful Completion of Deal to Enter Joint Venture Collaboration
Aachen, Germany and Tokyo, Japan (ots) - - The Joint Venture Collaboration includes a portfolio of 13 brands across six therapeutic areas, with the majority of revenue resulting from pain management medicines - The new enterprise will be branded as Grünenthal Meds. Grünenthal owns a 51 percent majority share and ...
mehrArtilysin® - A Groundbreaking "Green Pharma" Solution
mehrD&A Pharma : Despite the latest alarming figures on alcohol dependence, France is delaying the use of sodium oxybate, which has been prescribed for almost 30 years in Italy and Austria
Paris (ots/PRNewswire) - At the beginning of June, the health authorities hammered it home once again: "The health, social and economic consequences of alcohol consumption represent a burden for French society." The results are alarming: every year in France, alcohol is the cause of 49,000 deaths and an estimated ...
mehrCroma-Pharma announces enrollment of first patient in hyaluronic acid dermal filler clinical trial in China
Vienna (ots/PRNewswire) - Croma-Pharma® ('Croma') announced today that in June the first patient will be enrolled in the clinical trial1 for the approval of its hyaluronic acid dermal filler Princess® Volume Plus Lidocaine2 in China. The randomised, multi-centre, evaluator blinded, parallel group, active ...
mehrCroma-Pharma: Launch of topical anaesthetic Pliaglis® in Europe
Vienna (ots/PRNewswire) - Croma-Pharma, a global player and challenger in the dynamically growing, minimally invasive aesthetics market, announces that it will launch Pliaglis®, a topical local anaesthetic for superficial dermatological procedures, in its European core markets including Germany, the United Kingdom ("UK"), and Ireland. Further markets including Brazil will follow by the end of 2023. The anaesthetic cream ...
mehrDEBIOPHARM SHARES ONCOLOGY PROGRAM UPDATES AT ASCO 2023 FOR NOVEL WEE1 INHIBITOR, AND FIRST-IN-CLASS CA IX THERANOSTIC APPROACH
Lausanne, Switzerland (ots) - - Debiopharm will highlight diversified approaches and commitment to improving outcomes for patients with cancer at the 2023 American Society of Clinical Oncology Conference - A poster presentation and discussion will cover promising interim results with Debio 0123, a potent, highly ...
mehrAstrasana and Clever Leaves Partner to Establish International Supply Agreement For Medical Cannabis Extracts in Czech Republic and Switzerland
mehrGrünenthal’s resiniferatoxin receives Breakthrough Therapy Designation from U.S. FDA for pain associated with osteoarthritis of the knee
Aachen (ots) - - Knee osteoarthritis is a progressive condition affecting over 360 million people worldwide and may have severe symptoms, including pain. - Grünenthal is running a global Phase III programme to investigate the efficacy and safety of intra-articular injections of resiniferatoxin, a non-opioid ...
mehrAmicogen and Lysando: Novel approach for the treatment of mastitis in dairy cows
mehrHovione and H&T Presspart extend partnership to advance high efficiency device technology for Dry Powder Inhalation formulation delivery
Lisbon, Portugal (ots/PRNewswire) - Hovione, the specialist integrated CDMO, leader in spray drying and particle engineering, and H&T Presspart have entered in a strategic partnership to advance the development of Presspart's Sunriser© Capsule-based Dry Powder Inhaler platform. The demand for inhalable drugs that ...
mehrAurisco Expands Oligonucleotide Capacity and Launches New Website
SETÚBAL, Portugal (ots/PRNewswire) - The New State-of-Art OligoPilot 2000™ solid-phase synthesizer adds cGMP manufacturing capacity to support and accelerate clinical and commercial oligonucleotide programs. The new website shows how R&D and Innovation is the driving force of its sustainable growth, featuring its technologies, capabilities, services and products, including Oligonucleotides, peptides and small molecules ...
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