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Year: 2021

Roche launches the AVENIO Edge System to simplify and automate next-generation sequencing sample preparation, reduce human error and advance precision medicine

Next-generation sequencing (NGS) enables a better understanding of genetic mechanisms linked to specific diseases and is helping drive personalised healthcare Preparing DNA for sequencing libraries is complex and prone to human error, which can interfere with accurate sequencing results The new AVENIO Edge System is a fully-automated solution for the sample preparation workflow, from DNA sample input to the output of sequencing-ready libraries, and supports more comprehensive testing with consistent and high quality results for precision medicine for the futureBasel, 13 December 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the AVENIO Edge System, a core component of Roche’s strategy to advance sequencing technologies. Built on best-in-class foundational capabilities to deliver a fully-automated, integrated...

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Celyad Oncology Presents Updates on shRNA-Based CAR T Programs at the 63rd ASH Annual Meeting and Exposition

Data continues to support the versatile potential of non-gene edited shRNA technology with updates from the CYAD-02 and CYAD-211 clinical programs Management to host conference call today December 13th at 2:30 p.m. CET / 8:30 a.m. ESTMONT-SAINT-GUIBERT, Belgium, Dec. 13, 2021 (GLOBE NEWSWIRE) — Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced that data from the Phase 1 CYCLE-1 trial of CYAD-02 for the treatment of relapsed or refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) and the Phase 1 IMMUNICY-1 trial of CYAD-211 for the treatment of r/r multiple myeloma were presented at the 63rd American Society of Hematology (ASH) Annual Meeting...

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Save the date Fagron Capital Markets Day 2022

Regulated informationNazareth (Belgium)/Rotterdam (The Netherlands), 13 December 2021 – 7:00AM CET Save the date Fagron Capital Markets Day 2022 Fagron is pleased to announce its Capital Markets Day will be held on 15 March 2022. The event will take place at its premises in Capelle aan den IJssel, the Netherlands, and participants will have the opportunity to attend in person or via a webcast facility. At the event, members of Fagron’s Executive Leadership team will provide an update on business activities and strategy and present medium-term objectives. Further details, including the full program and timing, will be provided in advance of the event and registration will be available on Fagron’s website closer to the event. Further informationKaren BergGlobal Investor Relations ManagerTel. +31 6 53 44 91 99karen.berg@fagron.com About FagronFagron...

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Acacia Pharma Announces Successful Completion of BARHEMSYS® Post-approval Requirement Study in Patients with Severe Renal Impairment

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014. Cambridge, UK and Indianapolis, US – 13 December 2021: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or cancer chemotherapy, announces the successful completion of its post-approval requirement clinical trial investigating the effects of BARHEMSYS® (amisulpride injection) in individuals with severe renal impairment. The study showed no clinically relevant difference in the pharmacokinetics, electrocardiogram (ECG) parameters or safety profile of BARHEMSYS between individuals with...

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AMG Advanced Metallurgical Group N.V. Increases Guidance for 2022 and Announces a Consolidation of its Lithium Activities

Amsterdam, 13 December 2021 (Regulated Information) — AMG Advanced Metallurgical Group N.V. (“AMG”, EURONEXT AMSTERDAM) is pleased to increase its earnings guidance for 2022 based on improved market conditions in lithium as well as favorable conditions throughout our portfolio. AMG is increasing its EBITDA guidance for the full year 2022 to a range of between $175 million and $200 million from the previous guidance (“to exceed $150 million”). Organizationally, AMG will bring its lithium value chain under one corporate entity named AMG Lithium. AMG Lithium will comprise both AMG’s Brazilian mining and processing plants as well as the German hydroxide project. The new company will be headed by Mr. Fabiano Costa and Dr. Stefan Scherer as Managing Directors. The mission of AMG Lithium is to further increase the long-term value of AMG’s...

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AF-KLM has redeemed 500 million euros of the outstanding 4 billion euros bank loan guaranteed by the French State (the “PGE”) and negotiated a revision of the redemption profile with a maturity extended from May 2023 to May 2025

Roissy, December 13, 2021 Air France-KLM has redeemed 500 million euros of the outstanding 4 billion euros bank loan guaranteed by the French State (the “PGE”) and negotiated a revision of the redemption profile with a maturity extended from May 6, 2023 to May 6, 2025 Following early signs of a recovery of the worldwide air traffic, combined with an improved access to capital markets, Air France-KLM has agreed with the syndicate of the 9 banks of the PGE and the French State to redeem 500 million euros of the outstanding bank loan notional, bringing it down to 3.5 billion euros and, concomitantly, to amend its redemption profile by substituting the single repayment initially due on May 6, 2023 with a new maturity on May 6, 2025, at the latest, at Air France-KLM’s discretion, as follows: ▪ May 2023: partial redemption of 800 million euros,which...

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Interim data from phase III HAVEN 6 study demonstrate favourable safety and efficacy profile of Roche’s Hemlibra in people with moderate or mild haemophilia A

People with moderate or mild haemophilia A have significant unmet clinical needs, as this population may not use preventative treatments due to missed or delayed diagnoses of bleeding episodes and a lack of treatment guidelines1,2 New data indicate that Hemlibra has a favourable safety profile in people with moderate or mild haemophilia A without factor VIII inhibitors, with no new safety signals identified3 Hemlibra also achieved clinically meaningful bleed control, with 80.3% of participants experiencing no bleeding episodes that required treatment and 90.1% experiencing no joint bleeds that required treatment3 A separate analysis of thrombosis-related events in people taking Hemlibra, including real-world data, further confirmed the safety profile of Hemlibra4Basel, 13 December 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today...

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ObsEva Appoints Will Brown as Chief Financial Officer

 Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange GENEVA, Switzerland – December 13, 2021 – ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced the appointment of Will Brown as Chief Financial Officer and member of the company’s Executive Committee, effective January 1, 2022. “We are thrilled to welcome Will, a highly accomplished biopharmaceutical executive with proven business development and financial acumen, to ObsEva’s executive team,” said Brian O’Callaghan, Chief Executive Officer of ObsEva. “This is an exciting time for ObsEva on the heels of the recent NDA acceptance from the FDA for linzagolix — which if approved, would be the first and only GnRH receptor antagonist with flexible dosing options...

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Outcome of AS Inbank Subordinated Bond Subscription

On Thursday, 9 December 2021, the public offering of subordinated bonds of AS Inbank (hereinafter Inbank) ended. 1166 investors participated in the issue, subscribing to subordinated bonds for a total of 32.8 million euros. This means the initial issue volume was oversubscribed 2.7 times.  As the initial issue volume of 12 million euros was oversubscribed, Inbank used its right to increase the issue volume to 15 million euros. The Management Board of Inbank decided to allocate the subordinated bonds based on the following principles:All subscription orders of the same subscriber were summed up; Subscriptions of Inbank employees up to the value of 10,000 euros were fulfilled; All subscriptions up to the threshold of 3,000 euros were fulfilled; Inbank’s shareholders and institutional investors were allocated 55% of the...

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Positive Phase 3 Dupixent® (dupilumab) data in children 6 months to 5 years with moderate-to-severe atopic dermatitis featured in RAD 2021 late-breaking session

Positive Phase 3 Dupixent® (dupilumab) data in children 6 months to 5 years with moderate-to-severe atopic dermatitis featured in RAD 2021 late-breaking session Dupixent significantly improved skin clearance and reduced overall disease severity and itch in a Pivotal trial that met all primary and secondary endpoints Data reinforce well-established safety profile of Dupixent Global regulatory filings are planned in the coming months starting with the U.S. by the end of 2021PARIS and TARRYTOWN, N.Y. – December 13, 2021 – Positive Phase 3 results show adding Dupixent® (dupilumab) to standard-of-care topical corticosteroids (TCS) significantly improved skin clearance and reduced overall disease severity and itch in infants and children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. These data will be...

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