Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n°159

Posts Tagged ‘pharmaceutical’

Spectrum Pharmaceuticals Announces the Completion of the Sale of its Marketed Portfolio

Posted by fidest press agency su mercoledì, 6 marzo 2019

Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today completed the sale of its portfolio of seven FDA-approved hematology/oncology products to Acrotech Biopharma L.L.C., a step-down subsidiary of Aurobindo Pharma Limited, India.“The completion of this sale marks a significant pivot point in Spectrum’s history as we focus our efforts on our two promising late stage assets, ROLONTIS® and poziotinib,” stated Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “This transaction puts us in a strong capital position for the next chapter of our growth.”Under the terms of the agreement, Acrotech will make a $158.8 million up-front cash payment which represents the original payment of $160 million less certain purchase price adjustments for certain R&D activities. In addition, the company is eligible to receive up to $140 million in milestone payments. Spectrum has also reduced its staff by approximately 40 percent with the majority of impacted staff transitioning to Acrotech. Spectrum has retained a core group of commercial leadership talent to launch ROLONTIS® and poziotinib.The seven products included in the sale are: FUSILEV® (levoleucovorin), FOLOTYN® (pralatrexate injection), ZEVALIN® (ibritumomab tiuxetan), MARQIBO® (vinCRIStine sulfate LIPOSOME injection), BELEODAQ® (belinostat) for injection, EVOMELA® (melphalan) for injection, and KHAPZORYTM (levoleucovorin).Jefferies LLC acted as exclusive financial advisor to Spectrum. Paul Hastings LLP acted as exclusive legal counsel to Spectrum.

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BioSim Pharmaceuticals to Attend JP Morgan Healthcare Conference in San Francisco

Posted by fidest press agency su sabato, 15 dicembre 2018

Held annually alongside Biotech Showcase and OneMed Forum, the JP Morgan conference is one of the largest and most informative healthcare symposiums in the industry. BioSim will be meeting throughout the conference to update suppliers and interested parties on state of their research and development program.BioSim’s ACTH Gelatin Depot 80 IU/mL product is a copy of the branded drug H.P. ACTHAR®, manufactured by Mallinckrodt Plc (NYSE: MNK) which in 2014 purchased the previous owner, Questcor Pharmaceuticals (NASDAQ:QCOR) through a tax inversion valued at over $5 billion dollars. The injectable drug treats infantile spasms and rare autoimmune disorders like nephrotic syndrome and multiple sclerosis. BioSim has been advancing its ACTH (Corticotropin) Gel since 2012. With significant research and development, coupled with recent government guidance, its product has been demonstrated in-vitro and in-vivo to perform like ACTHAR. Over the past few decades, the market for specialty biopharmaceutical products for rare diseases has blossomed. For established companies like Teva (NYSE:Teva) and Cipla (NSE: CIPLA), as well as niche players like Depomed and Zydus Cadilla (NSE: CADILAHC), the US market continues to see rapid growth. BioSim has positioned itself to take advantage of that change, all with the goal of lowering the cost of medicine for America’s Healthcare System.

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Two Day Course: Veterinary Pharmaceutical Submissions in the EU

Posted by fidest press agency su lunedì, 14 maggio 2018

The “Veterinary Pharmaceutical Submissions in the EU” conference has been added to ResearchAndMarkets.com’s offering.Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, Detailed and Critical Summaries and regulatory submissions. This practical two-day In-house course will take participants through all of the constituent parts of the application for marketing authorisation for a veterinary medicinal product for which a marketing authorisation is sought in the European Union, including the Maximum Residue Limits dossier.Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, Detailed and Critical Summaries and regulatory submissions. An important part of the course will be devoted to working on case studies in the workshop sessions. The course will provide a comprehensive introduction to the entire regulatory dossier for a veterinary medicinal product in the European Union.

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Concert Pharmaceuticals Announces Advancement of Novel Drug Candidate in Schizophrenia

Posted by fidest press agency su domenica, 4 marzo 2018

Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced the next development candidate in its product pipeline with the selection of CTP-692, a novel drug for adjunctive treatment of schizophrenia, a devastating, chronic illness with significant unmet need. CTP-692 is a deuterated form of D-serine, an endogenous, required co-agonist of the N-methyl-D-aspartate (NMDA) receptor. NMDA receptor hypofunction is believed to contribute to the pathophysiology of schizophrenia and enhancement of D-serine levels is believed to benefit individuals with schizophrenia. CTP-692 is being developed as a potential adjunctive therapy to antipsychotic medicines with the potential to improve positive and negative symptoms as well as cognitive function in these patients. The Company intends to complete preclinical evaluation and advance CTP-692 into clinical development by year-end 2018.“We see neuropsychiatry as an area in which our team is well-positioned to broaden and expand our pipeline and apply our deuterium chemistry technology to create innovative medicines with differentiated therapeutic properties,” said Roger Tung, Ph.D., President and CEO of Concert Pharmaceuticals. “Our newest development candidate, CTP-692, represents an exciting opportunity to improve upon the existing standard-of-care with the potential to make a meaningful difference for patients with schizophrenia.”Despite its therapeutic potential as an adjunctive antipsychotic medication, the development of D-serine has been limited by safety concerns. D-serine has been shown to cause nephrotoxicity in preclinical testing. In addition, laboratory findings suggesting a possible renal safety signal were observed in some patients who received D-serine in clinical studies.CTP-692 has the potential to improve the safety profile of D-serine. In preclinical evaluation, Concert found that selective deuterium modification increased D-serine exposure and substantially reduced evidence of renal impairment. As a result, the Company believes that it can explore a wider exposure range to achieve optimal therapeutic levels in the clinic with a much lower risk of renal toxicity. These results support the further advancement of CTP-692.

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Pharmaceutical Grade Sodium Chloride Market

Posted by fidest press agency su sabato, 30 dicembre 2017

Pharmaceutical grade sodium chloride or pharmaceutical salt is a screened, granular, white crystalline sodium chloride manufactured under stringent process control procedures. This form of sodium chloride is mainly used in peritoneal dialysis, mechanical cleansing solutions, ORS and others. North America is expected to have the largest market for pharmaceutical grade sodium chloride. Globally increasing cases of chronic diseases is expected to remain key growth driver for pharmaceutical industry during the period of study.This report identifies the global pharmaceutical grade sodium chloride market size in for the year 2015-2017, and forecast of the same for year 2022. It also highlights the potential growth opportunities in the coming years, while also reviewing the market drivers, restraints, growth indicators, challenges, market dynamics, competitive landscape and other key aspects with respect to global pharmaceutical grade sodium chloride market.Geographically North America dominated the global pharmaceutical grade sodium chloride market owing to presence of large number of pharmaceutical industry players and higher demand from the well-developed healthcare industry in the region. North America was followed by Asia-Pacific and Europe as the second and third largest markets for pharmaceutical grade sodium chloride. However Asia-Pacific is expected to remain the fastest growing market during the period of study driven by rapidly expanding pharmaceutical industrial base and rapidly growing healthcare sector and medical tourism in the region as a result of low cost for treatments as compared to developed nations.

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Teva Names Kåre Schultz as President and Chief Executive Officer

Posted by fidest press agency su sabato, 16 settembre 2017

Teva_PharmaceuticalTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that its Board of Directors has named Kåre Schultz to become the Company’s President and Chief Executive Officer. Mr. Schultz will succeed Dr. Yitzhak Peterburg, who will continue to serve as Interim Chief Executive Officer until Mr. Schultz joins the Company. Today’s leadership announcement represents the successful completion of the global search process to identify the best leader for the Company and was executed by the Teva Board of Directors, with the assistance of Heidrick & Struggles. Mr. Schultz will be relocating to Israel and based out of the Company’s Petah Tikva headquarters.Mr. Schultz is a seasoned veteran in the healthcare industry with a distinguished, nearly thirty year career in global pharmaceutical and healthcare companies. Over the course of his career, Mr. Schultz has developed a unique perspective overseeing generic and specialty drug portfolios, while managing complex business operations around the world. He most recently served as the President and Chief Executive Officer of H. Lundbeck A/S, where he is credited with leading significant restructuring initiatives and launching a robust turnaround strategy focused on driving a sustainable global cost structure and operational model. As a result of his leadership, the company is on track to achieve all-time high revenue and earnings. Prior to his role as President and CEO of H. Lundbeck A/S, Mr. Shultz served as Chief Operating Officer of Novo Nordisk, where he had a key role in building the company into one of the world’s best-performing drugmakers and implementing a metrics-focused approach to the company’s operations.“With extensive global pharmaceutical experience, a strong track record executing corporate turnaround strategies, driving growth and international expansion at low incremental cost and delivering on promises to shareholders, as well as a commitment to a culture of compliance, Kåre is the right leader to take Teva to the next level,” said Dr. Sol J. Barer, Chairman of Teva’s Board of Directors. “Kåre has deep insight into the global pharmaceutical industry and a keen knowledge of the generic and specialty drug markets. His proven strategic, financial and operational capabilities and his strong commitment to growth will enhance value for all stakeholders and position Teva for long-term success. He brings a strong sense of corporate citizenship, and his disciplined commitment to excellence makes him a clear professional and cultural fit with our company. We are pleased to welcome a world-class leader of Kåre’s stature to Teva and look forward to working closely with him to build the Teva of the future for shareholders, employees and patients around the world.”Mr. Schultz said, “I am honored to join Teva, an iconic company that I have long admired during my career. What drew me to Teva, and what makes Teva different from its peers, is its unique commitment to growing an extensive global reach while continuing to provide new and high-quality treatments for patients and an innovative culture for its employees. I am proud to be joining a company that helps millions of patients around the world on a daily basis with its broad range of generic and specialty drugs and solutions. I look forward to working closely with the entire team at Teva to build a future of success for the Company and its stakeholders.”Dr. Barer continued, “On behalf of the Board, I want to thank Yitzhak for taking on the role of interim CEO during this critical period. Yitzhak’s leadership and insight have greatly helped the Company remain focused on the execution of its key strategic priorities.”Dr. Yitzhak Peterburg said, “We are delivering on the commitments we have made over the last several months. We are optimizing our operations and geographical footprint while focusing our resources on the specialty and generics pipeline assets that offer the most attractive return on investment. In addition, we are on course to hit our target of generating at least $2 billion from the sale of non-core assets, which we will use to strengthen Teva’s balance sheet. It is a privilege to lead Teva and I look forward to continuing to do so during this time, and will work with Kåre to ensure a seamless transition once he joins.”

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Milano: Master internazionale in Pharmaceutical Medicine

Posted by fidest press agency su domenica, 18 dicembre 2016

università studi milanoMilano Grazie alla collaborazione tra Novartis e Università degli Studi di Milano nasce il Master internazionale in Pharmaceutical Medicine – presentatoa Milano – che propone una formazione avanzata, basata sul dialogo tra accademia, ricerca di base e industria farmaceutica, nella consapevolezza comune che la collaborazione è vitale per tutti gli attori e che, come le migliori esperienze internazionali dimostrano, contribuisce a rendere il sistema più dinamico e competitivo.Gli studenti, selezionati in questi giorni da un bando internazionale, saranno calati da subito direttamente nella realtà della ricerca. Le lezioni teoriche si terranno, infatti, presso il Centro Daccò dell’Istituto Mario Negri, che rappresenta un esempio unico di struttura in grado di accogliere e sviluppare tutte le fasi di un progetto di ricerca clinica e dove professionalità diverse (medici, infermieri, biologi, farmacologi, bioingegneri, tecnici di laboratorio, esperti di statistica, informatici) lavorano in stretta collaborazione per valutare lo stato di salute del paziente, raccogliere i dati degli studi e rielaborarli al fine di determinare l’efficacia di nuove strategie terapeutiche.Fase fondamentale della caratterizzazione del nuovo Master è il tirocinio, che sarà svolto presso la sede di Novartis, struttura d’eccellenza della ricerca e sviluppo di nuovi farmaci, che conferma con il sostegno a questa iniziativa il proprio impegno a valorizzare i giovani talenti delle bioscienze e a promuovere nuovi modelli imprenditoriali grazie alla sinergia tra accademia, industria, non profit, istituzioni e investitori.
Il master inizierà il 31 marzo 2017 e avrà una durata di 12 mesi, corrispondente a 1500 ore, e si articolerà tra lezioni frontali, attività di gruppo e tirocinio. Per gli studenti più meritevoli saranno rese disponibili 3 borse di studio, a totale copertura dei costi.Attraverso questa iniziativa i giovani laureati hanno l’opportunità di comprendere e sperimentare concretamente come le competenze scientifiche si possono tradurre in soluzioni di elevato valore economico e sociale, coniugando le esigenze della pratica clinica alle finalità industriali. Nell’ambito del Master, grande rilevanza viene data anche alla preparazione sulle procedure e le dinamiche dell’interazione tra accademia, industria e autorità regolatorie durante le diverse fasi di sviluppo del farmaco.Commenta Gianluca Vago, Rettore dell’Università Statale di Milano: “E’ significativo che questo Master nasca a Milano e in Lombardia, realtà che si è affermata come hub farmaceutico europeo e che si sta sempre più caratterizzando a livello internazionale come punto di riferimento per le nuove terapie mediche avanzate. Questa iniziativa rafforza il profilo fortemente orientato all’innovazione del nostro territorio e conferma l’impegno della Statale a creare sinergie in grado di sostenere con progetti come questo l’offerta di un approccio diagnostico e terapeutico all’avanguardia, che trasformi il meglio della ricerca scientifica in aiuto di cura per chi è malato.”“Oggi le frontiere della medicina delineano nuove straordinarie sfide, alle quali il mondo della ricerca e sviluppo farmacologico è chiamato a dare risposta”, sottolinea Guido Guidi, Head of Pharma Region Europe, Novartis. “Ci troviamo di fronte a un cambio epocale di paradigma, nel quale novità come la medicina di precisione e le Advanced Medical Therapies impongono una riformulazione di tutto il percorso della terapia: dalla ricerca di base allo sviluppo in tutte le sue fasi, fino all’utilizzo nelle cure. E, di conseguenza, anche i criteri relativi ad accesso, regolamentazione e pricing & reimbursement devono essere radicalmente rivisti. Per dare risposta a queste richieste, Novartis crede fermamente nella necessità di creare anche nuovi percorsi rivolti ai giovani laureati, per metterli in condizione di acquisire le competenze necessarie per ridisegnare la medicina del futuro”. “Il Master integra in un unico curriculum tutti gli aspetti e le competenze coinvolti nel processo di ricerca e sviluppo di un nuovo farmaco, abbattendo le barriere tra ricerca di base, applicata e quella industriale”, aggiunge Giuseppe Remuzzi, ordinario di Nefrologia alla Statale, coordinatore delle Ricerche all’Istituto Mario Negri di Bergamo e coordinatore del Master. “Diamo ai nostri studenti la possibilità di un percorso formativo basato sull’acquisizione di un forte background scientifico, un approccio alla ricerca rigoroso e critico, l’esperienza pratica e la conoscenza della realtà dell’industria, tutti passaggi essenziali per il successo dello sviluppo di nuove terapie”.

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Bayer ottiene il via libera alla classe Cnn per BAY 81-8973, farmaco per il Trattamento dell’Emofilia A

Posted by fidest press agency su venerdì, 20 maggio 2016

bayer_healthcareBayer ha ottenuto la classe C non negoziata, “classe C (nn)”, da AIFA per Bay 81-8973 (octocog alfa), farmaco per il trattamento dell’Emofilia A nei pazienti di tutte le fascie d’età. Bay 81-8973 è un fattore VIII ricombinante, non modificato, a catena intera, che negli studi clinici ha dimostrato di mantenere l’emostasi e di proteggere dai sanguinamenti i pazienti con Emofilia A, quando usato in regime di profilassi due o tre volte a settimana.“Questa approvazione è un ulteriore passo avanti nel nostro lungo percorso per portare terapie innovative sul mercato,” dice il Dr. Franco Pamparana, Direttore Medico di Bayer Pharmaceuticals. “Siamo entusiasti di lanciare Bay 81-8973 come nuova opzione di trattamento per i pazienti con Emofilia A. Con questo farmaco Bayer conferma l’impegno a lungo termine nei confronti della Comunità Emofilica”.“Bay 81-8973 rappresenta un passo in avanti nella cura dell’emofilia,” aggiunge la. Dr.ssa Elena Santagostino, responsabile dell’unità operativa emofilia, presso l’IRCCS Fondazione Cà Granda, Ospedale Maggiore Policlinico di Milano e coordinatrice del programma di studi Leopold in Italia. “Gli studi clinici registrativi del programma Leopold sono stati condotti in un’ampio ed eterogeneo gruppo di persone con Emofilia A e hanno dimostrato che Bay 81-8973 può essere utilizzato non solo tre volte alla settimana, ma anche, in alcune fasce di pazienti, due volte alla settimana”. L’approvazione si è basata sui risultati del Programma di Sviluppo Clinico LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease), che si compone di tre studi clinici multinazionali, disegnati per valutare la farmacocinetica, l’efficacia e la sicurezza di Bay 81-8973. Nel complesso queste sperimentazioni hanno valutato Bay 81-8973 in più di 200 fra bambini ed adulti con Emofilia A grave, provenienti da 60 centri per il trattamento dell’emofilia in 25 paesi nel mondo.Nei prossimi mesi l’iter regolatorio di Bay 81-8973 proseguirà fino al raggiungimento della classe A, classe per i farmaci a carico dal Servizio Sanitario Nazionale.
Bay 81-8973 si aggiunge al portafoglio di Bayer in ematologia che già include rFVIII FS, attualmente sul mercato in più di 70 paesi nel mondo, e che vede in pipeline anche il fattore VIII ricombinante long-acting. Bayer sta inoltre valutando, sia in sviluppo preclinico, sia nelle prime fasi di sviluppo clinico, approcci terapeutici alternativi, tra cui la terapia genica del fattore VIII e il blocco della via inibitoria del fattore tissutale (Tissue Factor Pathway Inhibitor –TFPI), per l’emofilia e per altri disordini ematologici.
L’emofilia colpisce circa 400.000 persone nel mondo ed è una patologia principalmente ereditaria in cui una delle proteine necessarie per la formazione dei coaguli di sangue è mancante o carente. L’emofilia A è il più comune tipo di emofilia; in questo caso è assente o presente in quantità ridotta il fattore VIII. L’emofilia A colpisce 1 persona su 10.000, per un totale di più di 30.000 persone in Europa. Nel tempo, l’emofilia A a causa di sanguinamenti continui o spontanei, specialmente nei muscoli, nelle articolazioni o negli organi interni può portare a quadri di artropatia invalidanti.

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