Strides Pharma International AG
Strides Pharma Consolidates European Business-to-Business Operations in Switzerland
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Grünenthal and Averitas Pharma announce completion of recruitment for Phase III clinical trial with QUTENZA® in post-surgical neuropathic pain
Aachen, Germany/Morristown, N.J. (ots) - - The Phase III trial AV001 aims to evaluate QUTENZA® in post-surgical neuropathic pain (PSNP), a debilitating complication of surgery occurring after approximately 10 percent of all surgical procedures[1], thus affecting more than 3 million people with surgical procedures ...
mehrFirst participants enrolled in first-in-human Phase I clinical trial with nociceptin (NOP) receptor agonist
Aachen, Germany (ots) - Today, Grünenthal announced that the first participants have been enrolled in a first-in-human Phase I clinical trial for a nociceptin (NOP) receptor agonist. The trial will include 90 healthy volunteers and aims to demonstrate a favourable safety and tolerability profile and to confirm the ...
mehrEpitomee Medical to Present the Epitomee Breakthrough Oral Delivery Platform at PODD 2024 Conference
Caesarea, Israel (ots/PRNewswire) - Epitomee Medical Ltd. (TASE: EPIT) announces today that the company leadership intends to present Epitomee's Oral Delivery of Biologics Platform at the 14th Annual PODD Conference - Partnership Opportunities in Drug Delivery, taking place in Boston, MA, October 28-29, 2024. ...
mehrNorgine Announces Appointment of New CEO Janneke van der Kamp
London (ots/PRNewswire) - Norgine (the "Company"), a leading European specialty pharmaceutical company, has today announced the appointment of Janneke van der Kamp as its new Chief Executive Officer (CEO), effective from 1 January 2025. Current CEO, Chris Bath, has stepped down from his role effective immediately. This change in leadership will support and enhance the Company's mission of bringing transformative medicines ...
mehrEpitomee Medical Announces FDA Clearance of its Capsule, Weight Management Device
Caesarea, Israel (ots/PRNewswire) - Epitomee's Ingestible Capsule, Offers a Safe and Effective Prescription Solution for Adults with BMI of 25-40 looking for Alternative Drug Free Solutions for Their Weight Management Needs alongside diet and exercise. Epitomee Medical Ltd. (TASE: EPIT), announced that the United States Food and Drug Administration (FDA) has officially ...
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New insights highlight unmet needs for people living with Lennox-Gastaut syndrome and significant burden of the disease
Brussels (ots/PRNewswire) - - New data presented at the 15th European Epilepsy Congress highlight lengthy delays in Lennox-Gastaut syndrome (LGS) diagnosis in Europe and significant disease burden from both seizure and non-seizure impairments[1] - LGS is a severe childhood-onset developmental and epileptic ...
mehrINSIGHTEC; Charles River Laboratories International, Inc.
Charles River and Insightec Announce Strategic Collaboration to Advance Therapeutic Development Utilizing Focused Ultrasound in Neuroscience
Wilmington, Mass., Miami and Haifa, Israel (ots/PRNewswire) - Collaboration stands to advance novel therapeutic applications across multiple neurologic conditions Charles River Laboratories International, Inc. (NYSE: CRL) and Insightec, a global healthcare company dedicated to using focused ultrasound to transform ...
mehrAcousia Therapeutics to present its clinical Phase 2 PROHEAR study on hearing loss treatment candidate ACOU085 at upcoming conferences
Tübingen, Germany (ots) - Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, will be presenting the ACOU085 Phase 2 PROHEAR clinical study at the HansonWade 4th Inner Ear Disorders Therapeutics Summit in Boston (MA) from August ...
mehrGrünenthal announces significant investments in its Latin America production sites, further securing reliable medicine supply for patients
Aachen, Germany (ots) - - Investment of more than €80 million to modernise Latin American production sites. - In Santiago de Chile, a 3,500-square-metre solids plant has been completely refurbished, creating a world-class manufacturing facility with a production capacity of 1.8 billion tablets annually. - In ...
mehrMedasense Announces a Strategic Agreement With Global Medical Company, Nihon Kohden Corporation
Ramat Gan, Israel (ots/PRNewswire) - Medasense, a global leader in pain monitoring solutions, is proud to announce a strategic partnership with Nihon Kohden for the exclusive distribution of its revolutionary pain monitoring device in Japan. This partnership is intended to transform pain management practices across Japanese healthcare facilities, offering a significant ...
mehrSoterios Pharma Announces Positive Topline Results from Phase II Study of STS-01 in the Treatment of Mild / Moderate Alopecia Areata
London (ots/PRNewswire) - - Once-daily topical treatment of mild / moderate alopecia areata (AA) with 1% STS-01 met the primary efficacy endpoint of >30% Severity of Alopecia Tool (SALT) score improvement compared to patients receiving placebo ...
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Schweizerischer Nationalfonds / Fonds national suisse
Breath analysis to monitor health status in intensive care
mehrMedison 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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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 ...
mehrInsightec's Groundbreaking Transcranial MR-Guided Focused Ultrasound (MRgFUS) Approved for Additional Reimbursement for Essential Tremor in Germany
Berlin (ots/PRNewswire) - Germany is latest – and largest – European country to enable substantial access to focused ultrasound, offering new hope of relief for those suffering with movement disorders Insightec, a pioneer and global leader in focused ultrasound, is pleased to announce that its transcranial ...
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 ...
mehrSHL Medical partners with SteriPack Group to set up final assembly service
Zug, Switzerland (ots) - SHL Medical, a world-leading solutions provider of advanced drug delivery systems and SteriPack Group, renowned global supplier of secondary packing and final assembly services to the pharmaceutical industry, enter a non-exclusive strategic partnership. Together, they aim to establish a pre-validated final assembly service at the SteriPack ...
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 ...
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Takeda 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 ...
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