Month: May 2022

REGULATED INFORMATIONMont-Saint-Guibert, Belgium, 31 May 2022, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics, today announces that it has signed the definitive subscription agreement for a maximum EUR 5 million convertible bonds (CBs) facility arranged by ABO Securities, through its affiliated entity Global Tech Opportunities 15. The proceeds of the financing will contribute to continuing to advance the clinical development of Bone Therapeutics’ lead asset, its allogeneic bone cell therapy, ALLOB. ABO Securities has committed to subscribe to up to EUR 5 million in CBs. The CBs will be issued and subscribed in ten tranches. A first tranche of 10 CBs with an aggregate principal amount of EUR 0.5 million will be subscribed by ABO before notary...

Approval based on interim RAINBOWFISH data which show pre-symptomatic babies treated with Evrysdi for at least one year were able to sit, stand and walk Prescribing information updated with FIREFISH data showing the majority of symptomatic babies treated with Evrysdi for at least two years could sit for at least five seconds Evrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to dateBasel, 31 May 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated...

        Positive scientific opinion under Early Access to Medicines Scheme (EAMS) will make efgartigimod available to eligible generalized myasthenia gravis (gMG) patients in the UK prior to marketing authorization Efgartigimod was granted a Promising Innovative Medicine (PIM) designation by UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in November 2021 Breda, the Netherlands—May 31, 2022—argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that efgartigimod, the Company’s neonatal Fc receptor (FcRn) blocker has been awarded a positive scientific opinion by the MHRA under the EAMS. Within the EAMS, efgartigimod is indicated for the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody...

 FDA accepts Dupixent® (dupilumab) for priority review in adults with prurigo nodularisDupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approvedAcceptance marks another important step in advancing Dupixent for a broad range of diseases with underlying type 2 inflammationParis and Tarrytown, N.Y. May 31, 2022. The U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. The target action date for the FDA decision is September 30, 2022. The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18...

Prosafe is pleased to announce the appointment of Reese McNeel (45) as Chief Financial Officer. Mr McNeel will replace the current DCEO&CFO, Stig H. Christiansen, who, as previously announced, has accepted a position with another company. Mr McNeel will take up his position on 1 August 2022. Mr McNeel has more than 20 years of experience from management and financial positions, including many years of experience from the offshore industry. Most recently, he served as Deputy Chief Executive Officer & Chief Financial Officer at Atlantica Tender Drilling Ltd. Prior to this, he was Chief Executive Officer and Chief Financial Officer of Sevan Marine ASA. Mr McNeel holds a Master of Business Administration from the IESE Business School in Barcelona and a degree in Finance and Economics from Utah State University. “We are very pleased...

WISeKey Announces the Launch of “The Code to The Metaverse” an Interactive Multi-Media Platform at Davos Event TransHuman Code Authors, Carlos Moreira and David Fergusson Introduce ‘The Code to The Metaverse’ at Davos Event Geneva and Zug Switzerland, May 31, 2022 – WISeKey International Holding Ltd (“WISeKey”, SIX: WIHN), a leading cybersecurity, IoT and AI company, announced that its CEO and founder, Carlos Moreira and David Fergusson, Executive Managing Director, M&A at Generational Equity, introduced their latest project, The Code to The Metaverse at Davos event. In the bestselling 2019 book, The transHuman Code, Carlos Moreira and David Fergusson offered a carefully curated take on the essential conversations that will determine if technology will upgrade or undermine our humanity. Born at Davos event, through multiple conversations...

Multidisciplinary Steering Committee established to drive action includes patient advocacy leaders, healthcare professionals, biosimilar experts and industry leadersAction Plan will provide roadmap and tools to improve approvability, accessibility, acceptability and affordability (4As) of biosimilarsSandoz launched initiative to support improved healthcare access, equity and sustainabilityBasel, May 31, 2022 – Sandoz, a global leader in generic and biosimilar medicines, today announced the launch of a new global initiative called ‘Act4Biosimilars’ to help address health inequity and inequality worldwide. Act4Biosimilars aims to increase patient access to advanced medicines by facilitating greater approvability, accessibility, acceptability and affordability (the 4 A’s) of biosimilars. The initiative is supported by a multidisciplinary...