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Uitbraak “Wuhan” virus

In miljoenenstad Wuhan in China is een nieuw coronavirus opgedoken. Woensdag vergadert de World Health Organization (WHO) over de uitbraak, die sinds halverwege december al tot 291 bevestigde ziektegevallen en 4 sterfgevallen leidde. Inmiddels is officieel bevestigd dat het virus zich ook van mens op mens kan verspreiden, zij het in beperkte mate. Ook zijn de eerste gevallen buiten China gemeld in Taiwan, Thailand, Japan en Zuid-Korea. Volgens het European Centre for Disease Control en het RIVM is de kans dat het virus Europa bereikt erg klein. Controle en preventie van verdere besmettingen krijgen nu de hoogste prioriteit.

Meer lezen? Zie:

https://edition.cnn.com/2020/01/21/asia/china-china-coronavirus-sars-intl-hnk/index.html

https://nos.nl/artikel/2319112-china-meldt-nieuwe-ziektegevallen-door-coronavirus.html

https://www.rivm.nl/coronavirus/nieuw-coronavirus-in-China

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Signs of progress against the superbugs, but not yet at the scale needed

A core group of pharmaceutical companies are making progress in tackling the spread of antimicrobial resistance, new findings from the 2020 Antimicrobial Resistance Benchmark indicate. However, although a few companies are expanding their efforts, change is not happening at the scale needed to radically impact the threat from drug resistance. 

The 2020 Antimicrobial Resistance Benchmark, published today, finds that more companies are moving to discourage the overselling of their antibiotics and antifungal medicines to doctors and other healthcare professionals. Most companies have a strategy to prevent antibacterial residue being released in factory wastewaters. Furthermore, pharmaceutical companies are sharing more data on where drug resistance is emerging.

Curious about the AMR Benchmark 2020? You can find the full report here.

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Claim your I4H discount before 5 February

Innovation for health brings together over 800 key players in Health & Life Sciences to collaborate on future innovations for healthcare. HollandBio members can get €50 discount on the registration fee of Innovation for Health or I4H Global Investor Forum if the ticket is booked online using the voucher code I4H2020HollandBio upon registration fee.

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GenDx completes CE marking of NGS HLA typing products

GenDx has successfully completed the CE marking of their In Vitro Diagnostics (IVD) HLA typing products NGSgo-MX6-1 and NGSgo-AmpX v2.

NGSgo-AmpX v2
NGSgo-AmpX v2 is the successor of the also CE-marked original version NGSgo-AmpX, which is being successfully sold globally. The v2 product uses the same primer design, however, the oligonucleotides are aliquoted using a new matrix that enhances the stability of product, and a visible orange color facilitates easier handling. The kit now includes the accessory mastermix enzyme GenDx-LongMix, which significantly reduces the time of the amplification procedure.

NGSgo-MX6-1
NGSgo-MX6-1 is a newly developed multiplex amplification strategy, that combines amplification primers of six HLA genes (HLA-A, B, C, DRB1, DQB1 and DPB1) in a single tube. The primer design is very similar to the robust NGSgo-AmpX approach, resulting in a product that is high in quality, while the number of pipetting steps and hands-on time are greatly reduced.

GenDx is currently finishing the early access program (EAP) of the new NGSgo-MX11-3 amplification strategy that combines eleven HLA genes, in three separate tubes. The product will include new amplification strategies that largely provide whole-gene coverage of the relevant HLA genes. The product is scheduled to be available as CE-marked IVD in Q3 of 2020.

About High-Resolution HLA Typing
The HLA system consists of a large family of highly variable genes and allelic variants which form the basis of the human immunological defense system. In stem cell transplantation, matching patient and donor is vital as small differences between HLA alleles may have serious effects on the outcome of transplantation. High-resolution typing is a technology which enables determination of variations in nucleotides, making it ideal for stem cell transplantation purposes.
GenDx offers the NGSgo® reagent line and the NGSengine software package for NGS-based HLA typing.

Source: GenDx (press release)

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DSM names Feike Sijbesma Honorary Chairman

DSM, a global science-based company in Nutrition, Health and Sustainable Living, today announces CEO Feike Sijbesma will be appointed as Honorary Chairman of the company. In this role, Feike Sijbesma will continue to act as an ambassador to DSM.

Feike Sijbesma (60) is DSM’s longest serving CEO since the post-war period and was a member of the Managing Board for 20 years, of which almost 13 years as CEO. He is being named Honorary Chairman after the handover of his role as CEO to his successors in the first quarter of 2020. This nomination is a tribute to Feike’s contribution to DSM over the years, maintaining a connection between him and the company, as Feike will -when requested- continue representing DSM externally, especially in areas such as (mal)nutrition and climate.

“His appointment as Honorary Chairman is a sign of high esteem and an acknowledgment of his tremendous achievements for the company, enabling the connection between the company and Feike to endure. DSM will continue to benefit from Feike’s tremendous network and knowledge in the area of sustainability,” explained Chairman of the Supervisory Board, Rob Routs.

Source: DSM (press release)

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Doe mee, deel je expertise en inspireer jongeren!

Scholieren in aanraking brengen met actueel onderzoek rondom duurzaamheid?

Imagination at Work is een programma van C3 dat middelbare scholieren laat kennismaken met actueel onderzoek rondom duurzaamheid en ze laat reflecteren op mogelijkheden om hierin verder te leren. Een project waarin jongeren samen met experts uit het bedrijfsleven en wetenschap nadenken over en aan de slag gaan met vraagstukken rond bijvoorbeeld voedsel, klimaat, water of grondstoffen. C3 zorgt voor ondersteuning van de experts met een cursus, voor een gestroomlijnd proces en een spannende landelijke finale, waar de beste havo-, en vwo-leerlingen strijden om de hoofdprijs in hun categorie.

Doe mee en begeleid jongeren!
C3 is op zoek naar experts die zich hiervoor in willen zetten. Deelname biedt een unieke kans om jongeren te enthousiasmeren voor de sector en jouw bedrijf. Vanuit C3 bieden we je de ondersteuning die je nodig hebt om de leerlingen op de juiste manier te begeleiden. Op de website vind je een overzicht en de tijdsinvestering in de competitie.

Het project loopt van september 2020 – februari 2021. Leerlingen schrijven zich in op onderwerp vanaf 1 mei 2020, de inschrijving voor experts is open tot 3 april 2020.

Meer informatie en inschrijven via www.imaginationatwork.nl

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TU Delft, Erasmus MC en Erasmus Universiteit zetten in op innovatieve samenwerking

TU Delft, Erasmus MC en de Erasmus Universiteit slaan de handen ineen om in te spelen op maatschappelijke uitdagingen op het gebied van gezondheid, duurzaamheid en digitalisering. Zo willen zij innovaties op multidisciplinair niveau integreren. De Universiteit Leiden en het Leids Universitair Medisch Centrum sluiten zich aan om samen te werken op het gebied van kunstmatige intelligentie.

„De samenleving vraagt om méér dan samenwerking van ons”, zegt Van der Hagen van de TU Delft. „We kunnen de grote maatschappelijke opgaven alleen oppakken als we versmelten. We gaan de muren slechten tussen alles wat bèta is, gamma, alfa, medisch en techniek.”

Kuipers: „Ontwikkelingen in de gezondheidszorg kwamen de afgelopen veertig jaar vooral uit biologie, genetica en farmacologie. Nu komen kennis en kunde ook uit wiskunde, kunstmatige intelligentie, robotica, optica (licht- en lenstechnieken) en domotica (smart homes).”

De samenwerking wordt tastbaar met de bouw van de toekomstige HealthTech campus in Rotterdam. Deze campus zal meer dan alleen een multidisciplinair onderzoekscentrum behelzen. De campus creëert juist ook mogelijkheden voor het MKB en multinationals om zich hier te vestigen. Daarnaast komt er een sterke focus op het stimuleren van multidisciplinaire spin-offs. De ambitie is om met deze combinatie van ijzersterke innovaties en multidisciplinaire technologieën sterk bij te dragen aan het zowel het Nederlandse innovatieklimaat als de maatschappij. 

Lees hier het artikel van het NRC.

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NorthSea Therapeutics $40 Million Series B Financing

NorthSea Therapeutics, (‘NST’) a Dutch biotech company developing novel and innovative strategies for the treatment of NASH (Non-alcoholic Steatohepatitis) and other metabolic, inflammatory and fibrotic diseases, today announced the closing of a US $40 million (€36 million) Series B financing round.

NST welcomes new US investors venBio Partners, which led the Series B round, and Sofinnova Investments. Existing investors, Forbion, Novo Seeds, New Science Ventures (NSV) and BioGeneration Ventures (BGV) all participated.

Richard Gaster, M.D., Ph.D., Principal at venBio Partners and Maha Katabi, Ph.D., CFA, Partner at Sofinnova Investments, will join NST’s board of directors.

The proceeds of this fundraising will be used by NST to drive the development of its pipeline of SEFA (Structural Engineered Fatty Acids) programs. The Company will develop two additional SEFAs within its clinical pipeline in addition to completing the Phase 2b with its lead candidate Icosabutate.

Icosabutate, NST’s lead product, is a structurally designed fatty acid that regulates pivotal pathways involved in hepatic lipids, inflammation and fibrosis. In September 2019, NST announced that it had dosed the first patient in its Phase 2b dose ranging ICONA study (ICOsabutate in NASH) and that around thirty clinical trial sites have been initiated in the US.

NST’s second SEFA program is SEFA-1024 for dyslipidaemia, a condition where there is an abnormal amount of triglycerides and/or atherogenic cholesterol in the blood. Severe or untreated dyslipidaemia can lead to a variety of serious health conditions including coronary artery disease (CAD) and peripheral artery disease (PAD). The Company aims to initiate a Phase 1 study in the second half of 2020.

The third SEFA program is SEFA-6179 for the orphan indication, PNALD (Parenteral Nutrition-Associated Liver Disease). PNALD is a liver disease that affects patients with intestinal failure who are dependent on total parenteral nutrition; this is where nutrition is administered to the patient via alternative routes to the mouth or alimentary canal. The disease represents a high unmet medical need as there are currently no approved treatments available. NST’s aim is to initiate a Phase 1 study in the first half of 2021.

Rob de Ree, NST’s CEO, commented: “We are delighted to start the year with a successful Series B financing, which brings both US investment and expertise to our shareholder syndicate and to our Board. The great support from both new and existing shareholders will enable us to leverage our SEFA technology and to enter the clinic with two new clinical programs within the next 18 months. Both new programs have the potential to have a significant impact on patient care.”

Sander Slootweg, NST’s Chairman of the Board and Managing Partner of Forbion, said: “We are very pleased to have added venBio and Sofinnova to our shareholder’s base. As both parties only selectively invest in Europe, we see this as a true testimony to the excitement of our most advanced drug candidate Icosabutate and our SEFA platform. With the proceeds of this round we expect to show both the breadth and strength of our technology in patients and establish SEFAs as a new and exciting therapeutic modality.”

Richard Gaster, Principal at venBio Partners, added: “NorthSea Therapeutics’ structurally designed fatty acid platform has generated compounds with the potential to address a diverse set of metabolic disorders. The Company will initially focus on NASH, which we believe is an area of large unmet medical need and where we are confident there is room for multiple successful approaches with the right cardiometabolic profile. We are excited about Icosabutate based on its impressive clinical data in patients with dyslipidaemia, and robust pre-clinical data in a number of models of NASH. This financing will enable NST to complete its ongoing Phase 2b trial in NASH before the vast majority of NASH assets currently in clinical development. Given the management team’s stellar track record, we are very optimistic and confident about the future.”

Source: NorthSea Therapeutics (Press release)

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Human medicines: highlights of 2019

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EMA has published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use.

Innovative medicines are essential to advancing public health as they bring new opportunities to treat certain diseases. In 2019, EMA recommended 66 medicines for marketing authorisation. Of these, 30 had a new active substance which had never been authorised in the EU before. The infographic includes a selection of medicines that represent significant progress in their therapeutic areas. 

Once a medicine is authorised by the European Commission and prescribed to patients, EMA and the EU Member States continuously monitor its quality and benefit-risk balance and take regulatory action when needed. Measures can include a change to the product information, the suspension or withdrawal of a medicine, or a recall of a limited number of batches. An overview of some of the most notable recommendations is also included in the document.

Source: EMA

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Wat is er mis met genetische aanpassing van voedsel?

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Dat is het onderwerp van een speciale avond op 15 januari in Enkhuizen. Op de avond is de film ‘Well Fed’ van Filmmaker Hidde Boersma te zien en reflecteert Peter van der Toorn van zaadveredelingsbedrijf Syngenta op de rol van genetische modificatie van voedsel. Met de bijeenkomst willen Boersma en Van der Toorn het bredere publiek meenemen in wat genetische modificatie inhoudt. Wat HollandBIO betreft een zeer prijzenswaardig initiatief!

Tijdens de bijeenkomst staat de vraag centraal wat genetische modificatie vandaag de dag precies betekent. Vrijwel alles wat wij eten is namelijk door de mens gemaakt. Zo legt Van der Toorn uit dat de kool die nu van het land komt, er heel anders uitziet en soms zelfs smaakt dan vroeger het geval was. Om tegemoet te komen aan klimaatverandering en de ambitie om tot een duurzame landbouw te komen, zou genetische modificatie van gewassen een deel van de oplossing kunnen bieden. Voor het lezen van het hele artikel is inloggen verplicht.