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Info Lactofferin Global Lactoferrin and Lactoperoxidase Market:Asia Pacific is expected to show a substantial growth by 2015 - 2021 - www.industrytoday.co.uk/market-resear... ter info dus -
Some of the major players operating in lactoferrin and lactoperoxidase market includes Agennix Inc, Fonterra Co-Operative Group Ltd, Milei Gmbh, Pharming Group NV, Ingredia SA, Morinaga Milk Industry Co Ltd, Taradon Laboratory Sprl and Ventria Bioscience Inc among others. - See more at: www.industrytoday.co.uk/market-resear... MAJOR PLAYER, klinkt goed
Amicus to proceed with NDA filing for migalastat for Fabry after meeting with FDA Sep 15 2015, Amicus Therapeutics (NASDAQ:FOLD) intends to submit a New Drug Application (NDA) to the FDA in Q4 seeking approval for lead product candidate migalastat in Fabry disease (FD), an inherited lysosomal storage disorder caused by a deficiency in an enzyme called alpha-galactosidase A which leads to the accumulation of a type of fat in the body's cells. The condition, affecting one in 40,000 to 60,000 males, leads to progressive kidney damage, heart attack and stroke.Based on FDA feedback in a recent pre-NDA meeting, the application will use the reduction in disease substrate (kidney interstitial capillary GL-3) as the primary endpoint. The filing will also include the protocol for a Phase 4 study of the effect of migalastat on gastrointestinal symptoms associated with FD. The NDA will be reviewed under the FDA's Accelerated Approval pathway.The current standard of care treatment for FD is enzyme replacement therapy (ERT). Migalastat, being a pharmacological chaperone, has a unique mechanism of action. Many FD sufferers produce some alpha-galactosidase A that is capable of degrading substrate but the genetic mutation prevents it from being delivered to lysosomes in sufficient amounts to reduce GL-3 (type of fat). Migalastat binds to and stabilizes alpha-galactosidase A which increases its trafficking to lysosomes (acts as a "chaperone") which increases the breakdown of GL-3. As many as 50% of FD patients have the amenable mutations to respond to migalastat monotherapy.The company is developing a next-generation therapy that combines migalastat with ERT that will potentially enable all FD patients to benefit from migalastat treatment. n.b. Ook bij Pharming staat een produkt tegen deze ziekte op stapel.
Global Fibrin Glue Market: North America dominates the global market by 2015 to 2021 September 9th, 2015 Persistence Market Research Pvt. Ltd ?Releases Surgical sealants are used after surgeries or traumatic injuries to bind or hold the external and internal tissues. Some of the major surgical sealants based on their composition are collagen-based compounds, fibrin sealants, synthetic sealants such as cyanoacrylates, and tissue adhesive glues such as hydogels and glutaraldehyde glues. Fibrin sealants, also known as fibrin glue, are a hemostatic agent. Fibrin glue is a unique adhesion material used in surgeries for closure of wounds. Fibrin glues are mainly extracted from collective plasma and contain different amounts of purified and virally-inactivated human proteins. Fibrin glue is composed of two components, including fibrinogen and factor XIII. These concentrated ingredients interact with a solution of thrombin and calcium to form coagulum. As the thrombin and fibrinogen/factor XIII solution combine, a clot of a blood protein called fibrin develops in a few seconds, depending on the dilute form of thrombin is used. Some of the characteristics of fibrin glue include high internal bond strength, high surface adherence strength, and ability to enhance tissue regeneration and clot formation. Fibrin glue is mainly used in cardiac, vascular, and pulmonary surgeries, burn bleeding, and lacerations of liver and spleen. It is also used in other surgeries such as neurosurgeries, plastic surgeries, wound management, and general and orthopedic surgeries. Fibrin glue lowers the risk of infection, provides early hemostasis on the treated area, and improves cosmesis. It also promotes natural tissue healing. However, one of the disadvantages of fibrin glue is the risk of transmission of infectious organisms from human bodies to the glue. Tisseel, biocol, and beriplast are some of the commercially-prepared fibrin sealants. Request Full TOC: www.persistencemarketresearch.com/toc... North America dominates the global market for fibrin glue due to a large aging population and increasing number of surgical procedures. Asia is expected to witness high growth rates in the next five years in the global fibrin glue market. China and India are expected to be the fastest-growing fibrin glue markets in Asia Pacific. Some of the key driving factors of the fibrin glue market in emerging countries are a large pool of patients, increasing healthcare expenditure, and rising government funding. In the recent years, the use of fibrin glue has increased due to increasing number of surgical procedures. Increasing aging population, rise in incidences of chronic wounds, venous ulcers, diabetic ulcers, and pressure sores, and the relatively-low chances of complication associated with these products are some of the key factors driving the growth of the global fibrin glue market. In addition, increasing healthcare awareness is also fueling the growth of the global fibrin glue market. However, economic slowdown and minimal invasive procedures, such as laparoscopic and endoscopic surgeries, are some of the major factors restraining the growth of the global fibrin glue market. In addition, unfavorable reimbursement policies would also restrain growth of the global fibrin glue market. Technological advancements would create opportunities for the global fibrin glue market. However, alternative components for wound closure could pose a challenge for the global fibrin glue market. Some of the major companies operating in this market are Cryolife, Inc., Baxter International, Inc., Omrix Biopharmaceutical, Inc., Haemacure, Vivostat A/S, Harvest Technologies, Interpore Cross, and CSL Behring.www.medgadget.com/2015/09/global-fibr...
Amgen neemt Nederlands biotechbedrijf Dezima over AMSTERDAM (Dow Jones)--Amgen inc (AMGN) neemt biotechbedrijf Dezima Pharma uit Naarden over voor een bedrag dat op kan lopen tot $1,55 miljard. Dit meldde e e n van de voornaamste investeerders in Dezima, Forbion Capital Partners, woensdag. Dezima, dat in 2012 werd opgericht, ontwikkelt medicijnen voor patienten met dyslipidemie, oftewel stoornissen in de vetstofwisseling, die ook aan hart-en vaatziekten lijden. Amgen betaalt een voorschot van $300 miljoen voor Dezima. Dit bedrag kan met $1,25 miljard oplopen, plus lage enkelcijferige royalty's op de netto-verkopen. De overname is onderhevig aan goedkeuring van de US Federal Trade Commission. "Dezima is het ultieme voorbeeld van een modern start-up bedrijf", zegt bestuursvoorzitter Sander Slootweg in een toelichting. "De overname en de waarde die Amgen aan het bedrijf heeft toegekend, bevestigt ons geloof in het team en de wetenschap." Kleine Nederlandse biofarmaceutische bedrijven zijn vaker een prooi voor grote Amerikaanse farmaceuten. Zo nam Pfizer inc (PFE) eerder dit jaar een minderheidsbelang in AM-Pharma uit Bunnik ter waarde van $87,5 miljoen, met de exclusieve optie tot overname. Door Marleen Groen; Dow Jones Nieuwsdienst; +31 20 5715 200; marleen.groen@wsj.com
Perrigo roept aandeelhouders op vijandig bod Mylan af te wijzen AMSTERDAM (Dow Jones)--Perrigo Co plc (PRGO) roept zijn aandeelhouders op om het vijandige bod dat Mylan nv (MYL) eerder deze week uitbracht, af te wijzen. "Ik roep u sterk op om uw investering in Perrigo te beschermen en uw aandelen niet aan te bieden onder Mylans ontoereikende bod", schreef Perrigo chief executive Joseph Papa donderdag in een brief aan aandeelhouders. Volgens Papa houdt het bod van Mylan, van $75 per aandeel in contanten en 2,3 Mylan-aandeel voor elk Perrigo-aandeel, te weinig rekening met de groeivooruitzichten van Perrigo en zou een fusie de aandeelhouders van het Ierse bedrijf teveel blootstellen aan financiele risico's, omdat tweederde van het bod uit aandelen van Mylan bestaat. Mylan-bestuursvoorzitter Robert Coury heeft uiteraard wel vertrouwen in het bod en zei maandag bij de lancering: "We hebben er zeer veel vertrouwen in dat een meerderheid van de Perrigo-aandeelhouders dit volledige en aantrekkelijke bod zullen steunen, zeker gezien het feit dat er geen interesse is van concurrenten, maar ook vanwege de aanzienlijke onzekerheid over en het risico en het tijdspad van het uitvoeren van Perrigo's zelfstandigheidsstrategie." Het Britse Mylan, dat zijn hoofdkantoor in Nederland heeft, bracht in april voor het eerst een bod uit op zijn sectorgenoot. Tot nu toe wees Perrigo elk bod van Mylan echter af. Beide ondernemingen maken generieke geneesmiddelen. Waar Perrigo onder meer medicijnen tegen verkoudheid ontwikkelt, en flesvoeding voor baby's, staat Mylan bekend om zijn EpiPen; een wegwerpinjectie met adrenaline die wordt gebruikt bij levensbedreigende allergische reacties. Mylan richt zich daarnaast ook op de ontwikkeling van nieuwe producten, zoals behandelingen tegen hart- en vaatziekten. Mocht de fusie doorgaan, dan krijgt Perrigo 40% van het nieuwe bedrijf in handen. Het bod geldt tot 13 november. Mylan was zelf eerder dit jaar nog in beeld als overnameprooi voor het Israelische Teva Pharmaceuticals. Dat bedrijf deed nooit een daadwerkelijk bod en liet de interesse in Mylan in juli varen, toen het koos om de generieke medicijnentak van Allergan plc voor meer dan $40 miljard over te nemen. Door Lisa Beilfuss; vertaald en bewerkt door Marleen Groen; Dow Jones Nieuwsdienst; +31 20 5715 200; marleen.groen@wsj.com
Galapagos 'perfect fit' voor AbbVie Gepubliceerd op 21 sep 2015 om 17:56 | Views: 1.482 17:39 58,32 +4,91 (+9,19%) AMSTERDAM (AFN/BLOOMBERG) - De Amerikaanse farmaceut AbbVie lijkt naar kleinere overnames in de sector. Dat zei de financieel topman van het bedrijf vrijdag volgens analisten van Bryan Garnier, tijdens een beleggersbijeenkomst. Het bedrijf ziet daarbij Galapagos als een 'perfect fit', zo zou de bestuurder hebben aangegeven. Galapagos en AbbVie zijn al samenwerkingspartners. AbbVie moet binnenkort een besluit geven over het nemen van een licentie op het Galapagos-middel filgotinib. De piekverkopen van dat product worden geschat op 2 miljard euro. Galapagos sloot maandag 9,2 procent hoger op 58,32 euro.
Galapagos presenteert Fase 1 resultaten AMSTERDAM (Dow Jones)--Galapagos nv (GLPG.AE) presenteert dinsdag preklinische en Fase 1 resultaten voor autotaxin remmer GLPG1690 op het longziektencongres van de European Respiratory Society in Amsterdam. Het biotechbedrijf meldt voorafgaand aan het congres dat de presentatie zal laten zien dat GLPG1690 mogelijk ook kan worden toegepast voor andere longziektes zoals COPD. Het kandidaatmedicijn is een remmer van autotaxin in muizen en mensen en vermindert ook ontstekingen bij een muis tot hetzelfde niveau als bij de standaardtherapie voor COPD, meldt Galapagos. Ook maakt het biotechbedrijf de resultaten bekend van een Fase 1 studie met het middel bij gezonde vrijwilligers. Hieruit blijkt dat GLP1690 alle gewenste eigenschappen heeft voor een oraal medicijn, zoals goede veiligheid en 60% remming van de relevante biomarker. - Door Levien de Feijter; Dow Jones Nieuwsdienst; +31 20 571 52 00; levien.defeijter@wsj.com
Valeant chief Pearson tries to stem the bleeding of share price with letter addressing growth prospects Sep 28 2015, In an effort to stop the slide in its share price, Valeant Pharmaceuticals (VRX -1.7%) CEO Mike Pearson pens a letter outlining the company's business prospects. Shares have slumped over 20% since last week as investors head for the exits over concerns about the company's reliance on its U.S. business and its exposure to U.S. government drug price reimbursement. Mr. Pearson says both perceptions are incorrect.In 2016, the company expects to generate ~30% of its revenues outside the U.S. where it has historically realized little or no net price increases. Emerging market top-line growth will be high single-digit to low double-digit while ex-U.S. developed markets should deliver 3 - 5% sales growth.A fifth of 2016's revenues will come from U.S. businesses, including Contact Lenses, Consumer, Surgical Devices and Generics. The company expects double-digit sales growth overall.Another fifth of 2016's revenues will come from Dermatology, Ophthalmology RX and Dentistry RX. The company expects double-digit sales growth for the foreseeable future.Another fifth will come from Salix, which should deliver double-digit script growth and revenue growth in line with current trends.The remaining 10% of revenues will come from its Neuro and Other portfolio which should generate mid-single-digit top-line growth in 2016.Valeant's exposure to U.S. government reimbursement represents ~15% of total revenues. Of this, ~5% is Medicaid and 10% is Medicare.
Het gaat nog eens fout met Valeant... Het zijn regelrechte woekeraars die nu teveel in de gaten beginnen te lopen in de States. Niet ervan opkijken als er over een tijdje reorganisaties gaan plaatsvinden daar met hopelijk dan geen konsekwenties voor het dealerschap van Salix/Valeant voor Ruc USA!
Ja ja...vandaar weinig postings over de Valeant koers.Pharming móet wel scoren in deze situatie.
De politiek gaat zich ermee bemoeien. Dit gaat niet goed voor Valeant.... Valeant takes another hit after House Dems request subpoena for docs on drug pricing; shares off 12% Sep 28 2015, 13:35 ET | About: Valeant Pharmaceutical... (VRX) | Valeant Pharmaceuticals (VRX -11.9%) gets some rude treatment today. Shares are down on a 4x surge in volume in response to the news that Democrats in the U.S. House of Representatives have made a request to subpoena the company for documents related to its increases in drug pricing.In a letter to Jason Chaffetz, Chairman of House's Committee on Oversight and Government Reform, 18 Democratic representative stated, "We believe it is critical to hold drug companies to account when they engage in "a business of buying old neglected drugs and turning them into high-priced specialty drugs."Valeant may have some explaining to do. It increased the prices of Nitropress and Isuprel 212% and 525%, respectively, the day it bought them.
Dear Colleagues: A number of you have asked me and other senior members of our management team about the significant drop in our stock price – especially over the past 5 trading days. While the entire pharmaceutical and biotech sector has been impacted by market volatility and numerous press articles about pharmaceutical pricing, we have been hit particularly hard. After talking with a number of investors and observing the concerns and assertions in the media, I thought it would be helpful to give you my perspective on the two main issues worrying investors: 1) Concern that our business model and strategy is dependent upon large price increases in our U.S. pharmaceutical business, 2) Concern around our exposure to U.S. government drug price reimbursement I can assure you that this bear thesis is incorrect on both accounts. Valeant is well-positioned for strong organic growth, even assuming little to no price increases. As we have stated many times, Valeant’s core operating principles include a focus on volume growth and a concentration on private and cash pay markets that avoid government reimbursement in the U.S. and across the world. We have consistently pursued profitable growth through diversification, strong execution and financial discipline while minimizing exposure to governmental policy changes and volatility. Our strategy is quite different from traditional pharmaceutical companies in this regard, and is still not always well understood. We have - and will continue to - work diligently to upgrade the quality of our assets through a strong track record of developing high quality products internally (e.g., Jublia, ULTRA Contact Lenses) and through acquisitions (e.g., Bausch + Lomb, Salix). By focusing on organic growth and execution, we will continue to demonstrate our strong business performance to the market. Needless to say, I thank all of you for your continued hard work to deliver these results. Turning to the first concern about our business model, the majority of our portfolio will continue to deliver strong volume-based organic growth and is not dependent on price increases. To put this in context, let me lay out the facts. • In 2016, we expect to generate approximately 30% of our revenue outside the U.S., where we have historically realized little to no net price increases and in fact, during some quarters, our net price has actually decreased. We expect continued high single-digit/low double-digit growth in our emerging markets and 3-5% growth in ex-U.S. developed markets going forward. • We expect approximately 20% of our 2016 revenue to come from U.S. businesses including Contact Lenses, Consumer, Surgical Devices and Generics. These businesses realize, on average, small price increases in line with the Consumer Price Index, or no price increases at all. We expect continued double-digit growth overall for these businesses. • Dermatology, Ophthalmology RX and Dentistry Rx 2016 revenue is expected to represent approximately 20% of revenue and, across these businesses, our teams have delivered over 30% script growth year to date. We expect continued double-digit growth for the foreseeable future given the strength of our brands (e.g., Jublia, Prolensa, Retin-A Micro franchise, Solodyn) and a strong, late stage pipeline (Addyi, brodalumab, IDP-118 and Vesneo). • We expect the Salix business to represent approximately 20% of our 2016 revenue and expect double-digit script growth and corresponding revenue growth trends to continue. • Finally, we expect the remaining approximately 10% of our business in 2016 to come from our Neuro and Other portfolio, where we have historically taken price increases. This business is becoming a smaller part of our portfolio over time, and is one area whose growth is not driven by volume. With the recent genericization of Xenazine, this portfolio is composed primarily of off-patent, legacy products that are competing against low-priced generics. This segment also includes Isuprel and Nitropress, which have been the focus of much of the U.S. press. We purchased these two assets earlier this year and we thought the best long-term commercial strategy was to reprice these brands. However, it is worth mentioning that neither product’s revenue is part of our organic same-store sales growth calculation since we have owned them for less than a year. On average, we have budgeted a mid-single digit revenue growth rate for this segment in 2016. Turning to the second concern about proposed changes to government reimbursed products in the U.S., our exposure to U.S. government reimbursement currently represents approximately 15% of our total revenue. Of this, about one third, or ~5%, represents sales to Medicaid, the Department of Veterans Affairs, the Department of Defense, and other government entities, where the business is at best marginally profitable. Despite this, we continue to offer our products through these programs to ensure these patients continue to have access to needed medications. The remaining 10% of our government exposure is related to Medicare. As I stated above, our overall strategy is to focus on private and cash pay markets and to minimize government reimbursement. I believe our exposure to government reimbursement is lower than any other major pharmaceutical company. As we approach the end of the third quarter, I want to thank all of you for delivering what we expect will be another quarter of double-digit organic growth and strong financial performance, despite the genericization of two of our largest products, Targretin and Xenazine. Our fundamentals remain strong for the rest of 2015 and we expect double-digit organic growth in 2016 and beyond as we prepare for the launch of Addyi and anticipate other potential product approvals such as Veseno, Relistor Oral, and brudalumab. This is not the first time we have faced questions about our business model and strategy in the market, and it likely won’t be the last. By continuing to focus on organic growth and execution, I am convinced we will continue to generate the best outcomes for our shareholders and the healthcare community. I want to once again thank all of you for your hard work and I know that together we will demonstrate the strength of our operating model. Mike
'Kiadis voldoet aan verwachtingen' Gepubliceerd op 30 sep 2015 om 09:43 AMSTERDAM (AFN) - Biotechnologiebedrijf Kiadis Pharma voldoet aan zijn eigen doelstellingen in het onderzoek rond zijn belangrijkste product. Dat stelde analist Jan De Kerpel van KBC Securities woensdag. Het in Amsterdam genoteerde Kiadis gaf eerder op de dag aan wettelijke goedkeuring te hebben gekregen van de autoriteiten in Canada en België voor het verdere zogeheten fase-2 klinisch onderzoek met zijn belangrijkste product ATIR101. Volgens De Kerpel mogen de resultaten daarvan in de tweede helft van volgend jaar worden verwacht. KBC handhaafde zijn koopadvies voor het aandeel Kiadis, dat door beursbedrijf Euronext onlangs werd opgenomen in de index voor kleine bedrijven, de AScX. De Belgische bank hanteert een koersdoel van 14,50 euro. Beleggers reageerden woensdagochtend enthousiast op het bericht van Kiadis, dat bij de opening een koerswinst van bijna 10 procent boekte. Na ruim twintig minuten handel resteerde een plus van 5,7 procent, tot 12 euro.
Pfizer verhoogt outlook AMSTERDAM (Dow Jones)--Pfizer inc (PFE) heeft woensdag zijn outlook voor de rest van het jaar verhoogd, om de recent afgeronde overname van Hospira inc mee te nemen in zijn verwachtingen. De farmaceut uit New York verwacht een omzet in 2015 in een bandbreedte van $46,5-47,5 miljard (van $45-46 miljard) en een aangepaste winst per aandeel van tussen de $2,04-2,10. Deze range lag eerder tussen de $2,01-2,07. De verwachte winst per aandeel is wel iets verlaagd; naar $1,29-1,38, van $1,38-1,47. Eerder deze maand rondde Pfizer de overname af van zijn kleinere rivaal Hospira voor $16 miljard. Hiermee ontstaat een marktleider in de opkomende markten op het gebied van goedkopere varianten van dure biotech-medicijnen. Toezichthouders hadden bezwaren tegen de fusie, omdat de twee bedrijven samen een hoog marktaandeel zouden krijgen in de markt voor bepaalde steriele injecteerbare geneesmiddelen. Daarom heeft Pfizer beloofd activiteiten op dat gebied te desinvesteren. Ook stopt het Amerikaanse concern met de ontwikkeling van een goedkopere variant van Infliximab, een middel dat wordt gebruikt tegen bij auto-immuunziekten als reuma. Wel houdt het van dit middel, mits het op de markt komt, de marketingrechten buiten Europa. Door Ezequiel Minaya; vertaald en bewerkt door Marleen Groen; Dow Jones Nieuwsdienst; +31 20 5715 200; marleen.groen@wsj.com
30 September 2015, BURLINGTON, Mass.--(BUSINESS WIRE) Dyax Corp. (NASDAQ:DYAX) today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending DX-2930 for designation as an orphan medicinal product for the treatment of hereditary angioedema (HAE). Dyax is developing DX-2930, an investigational fully human monoclonal antibody inhibitor of plasma kallikrein (pKal), as a subcutaneous injection for prevention of HAE attacks. “There is a significant unmet medical need for a prophylactic treatment option for HAE , a potentially life-threatening condition,” said Burt Adelman, M.D., Executive Vice President of Research and Development and Chief Medical Officer at Dyax. “Our regulatory strategy supports our global development plan for DX-2930 and our goal for providing an improved therapy for patients with HAE around the world. We look forward to initiating a Phase 3 clinical trial for DX-2930 for HAE prophylaxis by year-end 2015.” Under the EMA guidelines, the COMP adopts an opinion on the granting of orphan drug designation, after which the opinion is submitted to the European Commission (EC) for the endorsement of the opinion. Orphan drug designation by the EC provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the EU, and where no satisfactory treatment exists, or where a treatment exists, a new treatment may provide a significant benefit to patients affected by the condition. Additionally, this designation provides up to 10 years of market exclusivity if the product candidate is approved for marketing in the European Union and the orphan designation is maintained. Orphan status also permits EMA assistance in optimizing the candidate’s clinical development through participation in clinical trial design and preparation of the product marketing application. Orphan Medicinal Product designation does not change the standards for approval.
De FDA wil meer gegevens over de trials van Amicus m.b.t. haar produkt voor de ziekte van Fabry. Op zijn minst loopt Amicus vertraging op voor goedkeuring in de USA. Het is afwachten wat de EMA besluit volgend jaar voor wat betreft goedkeuring voor de EU. Dit kan gunstig zijn voor Pharming dat immers ook een produkt voor de ziekte van Fabry in ontwikkeling heeft. Vaart maken Sijmen! Why a Big Delay From the FDA Has Amicus Therapeutics Shares Crashing A delay in filing for U.S. approval of its therapy for Fabry disease is causing Amicus Therapeutics to tumble. What: After reviewing minutes associated with its discussion with the FDA regarding filing its Fabry disease drug Galafold for U.S. approval, Amicus Therapeutics (NASDAQ:FOLD) will need to push back its previously reported timeline and as a result, its shares are falling by over 30% today. So what: Previously, Amicus Therapeutics reported that its meeting with the FDA suggested it could file Galafold for approval by the end of this year. However, after reviewing the minutes of their discussion with regulators and communicating with the agency, Amicus Therapeutics is now unsure of when it will be able to file Galafold for approval. The news is a blow to the clinical stage rare disease drugmaker because the market for Fabry disease treatment is worth hundreds of millions of dollars annually and every month that a filing is delayed is another month without sales in the important U.S. market. Amicus Therapeutics is considering its alternatives, including getting additional data related to Galafold's impact on the gastrointestinal tract that could support a filing and address safety concerns. The company is also consolidating additional data from prior trials, which will take some time, too. Because Amicus Therapeutics hasn't decided on the appropriate next step, it no longer anticipates a U.S. filing this year and it isn't certain when a filing could occur. Take Long View Now what: Amicus Therapeutics Galafold application has already been filed for approval in Europe and a decision from EU regulators is expected in the first half of 2016. It's unclear whether or not the FDA's desire for more information suggests the EU will similarly press the pause button, but if EU regulators are satisfied, then Galafold could become available in European markets by the end of next year. Assuming Amicus gets its ducks in a row and completes a filing in the U.S. in 2016, then it could receive a go-no-go decision on Galafold at some point in 2017. Obviously, winning approval for Galafold in both markets is ideal; however, if Galafold doesn't get approval in the U.S., but does get approval in the EU, then it could still become a top seller for the company. In 2012, pushback from the FDA led to Shire yanking its application for the Fabry disease drug Replagel and although Replagel is only approved in Europe, its sales are still running at an annualized pace of $468 million exiting the second quarter. Regardless, this FDA delay is a blow to investors hoping for a quicker path to profitability; especially following the company's recent spending to acquire Scioderm in order to get its hands on the late stage drug Zorblisa, a therapy for a rare pediatric condition. Overall, a delay in an FDA filing is concerning, but the potential for an EU approval next year, an opportunity to file for approval of Zorblisa by 2017, and a solid balance sheet makes Amicus Therapeutics a company that risk-tolerant investors may want to consider buying on sale.
De FDA wil meer gegevens over de trials van Amicus m.b.t. haar produkt voor de ziekte van Fabry. De koers van de aandelen Amicus werd afgelopen vrijdag gehalveerd. Op zijn minst loopt Amicus vertraging op voor goedkeuring in de USA. Het is afwachten wat de EMA besluit volgend jaar voor wat betreft goedkeuring voor de EU. Dit kan gunstig zijn voor Pharming dat immers ook een produkt voor de ziekte van Fabry in ontwikkeling heeft. Vaart maken Sijmen!www.fool.com/investing/general/2015/1... Why a Big Delay From the FDA Has Amicus Therapeutics Shares Crashing A delay in filing for U.S. approval of its therapy for Fabry disease is causing Amicus Therapeutics to tumble. What: After reviewing minutes associated with its discussion with the FDA regarding filing its Fabry disease drug Galafold for U.S. approval, Amicus Therapeutics (NASDAQ:FOLD) will need to push back its previously reported timeline and as a result, its shares are falling by over 30% today. So what: Previously, Amicus Therapeutics reported that its meeting with the FDA suggested it could file Galafold for approval by the end of this year. However, after reviewing the minutes of their discussion with regulators and communicating with the agency, Amicus Therapeutics is now unsure of when it will be able to file Galafold for approval. The news is a blow to the clinical stage rare disease drugmaker because the market for Fabry disease treatment is worth hundreds of millions of dollars annually and every month that a filing is delayed is another month without sales in the important U.S. market. Amicus Therapeutics is considering its alternatives, including getting additional data related to Galafold's impact on the gastrointestinal tract that could support a filing and address safety concerns. The company is also consolidating additional data from prior trials, which will take some time, too. Because Amicus Therapeutics hasn't decided on the appropriate next step, it no longer anticipates a U.S. filing this year and it isn't certain when a filing could occur. Take Long View Now what: Amicus Therapeutics Galafold application has already been filed for approval in Europe and a decision from EU regulators is expected in the first half of 2016. It's unclear whether or not the FDA's desire for more information suggests the EU will similarly press the pause button, but if EU regulators are satisfied, then Galafold could become available in European markets by the end of next year. Assuming Amicus gets its ducks in a row and completes a filing in the U.S. in 2016, then it could receive a go-no-go decision on Galafold at some point in 2017. Obviously, winning approval for Galafold in both markets is ideal; however, if Galafold doesn't get approval in the U.S., but does get approval in the EU, then it could still become a top seller for the company. In 2012, pushback from the FDA led to Shire yanking its application for the Fabry disease drug Replagel and although Replagel is only approved in Europe, its sales are still running at an annualized pace of $468 million exiting the second quarter. Regardless, this FDA delay is a blow to investors hoping for a quicker path to profitability; especially following the company's recent spending to acquire Scioderm in order to get its hands on the late stage drug Zorblisa, a therapy for a rare pediatric condition. Overall, a delay in an FDA filing is concerning, but the potential for an EU approval next year, an opportunity to file for approval of Zorblisa by 2017, and a solid balance sheet makes Amicus Therapeutics a company that risk-tolerant investors may want to consider buying on sale.
Valeant verder in het nauw NY Times article on Valeant's aggressive price-spiking adds to its pain; shares slump 11% The biotech sell-off has not been kind to Valeant Pharmaceuticals (VRX -10.8%). Shares have retreated almost 40% since peaking in early August. The company has recently drawn additional scrutiny from Washington, D.C. over its tactics of aggressively raising the prices of existing drugs that it acquires. According to one analyst, these increases account for 14% of the company's top-line growth.The NY Times adds to the company's pain with an article published today titled, "Valeant's Drug Price Strategy Enriches It, but Infuriates Patients and Lawmakers." The piece describes the impact the company's price spike of Cuprimine has had on a retired carpenter in Michigan who has been taking the drug for an inherited disorder called Wilson's disease for 55 years. His monthly out-of-pocket costs increased almost five-fold to $1,800 after the company spiked the price more than four-fold overnight.House Democrats intend to subpoena the company for pricing-related documents. The pressure on the company to explain/justify its actions will most certainly continue to rise since it has become a Presidential campaign issue. In any event, it should be good theater watching how Valeant handles the situation.
Bedankt voor aanreiken info Beur. Als je zelf geen tijd en energie hebt om te zoeken is fijn. En tja Biotech... interessant maar risky. groetjip.
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