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Archive by category Global Health & Biotech

Teva and Alvotech Announce SELARSDI™ (ustekinumab-aekn) Injection Now Available in the U.S.

In October 2024, the U.S. Food and Drug Administration (FDA) approved SELARSDI™ for all indications matching the reference product Stelara® (ustekinumab) and has granted a provisional determination of interchangeability for SELARSDI SELARSDI is the second biosimilar to launch in the U.S. under the Teva and Alvotech strategic partnership, which includes nine products SELARSDI is approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients 6 years and [...]

Philips and Mass General Brigham announce collaboration to improve patient care with live AI-powered insights

February 21, 2025 Integrating advanced data analytics into clinical practice to improve patient care Amsterdam, The Netherlands and Cambridge, MA – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and Mass General Brigham (MGB), home to one of the largest hospital system-based research enterprises in the US, today announced a new collaboration to [...]

Boehringer Ingelheim and partners start clinical development of a first-in-class, inhaled gene therapy for people with cystic fibrosis

Ingelheim, Germany, 20 February 2025 – Boehringer Ingelheim, IP Group, the UK Respiratory Gene Therapy Consortium (GTC)1 and OXB,1 today announce the start of LENTICLAIRTM 1, a Phase I/II trial of BI 3720931, a novel, first-in-class, gene therapy aiming to improve disease outcomes in people with cystic fibrosis (CF), regardless of gene mutations that are causing the disease. The [...]

Society for Clinical Research Sites (SCRS) and Fortrea Partner to Advance Collaboration in Clinical Research

Fortrea to Sponsor SCRS’ Collaborate Forward Working Group, Encouraging Collaboration for More Efficient Clinical Trials DURHAM, N.C., Feb. 20, 2025 (Korea Bizwire) – The Society for Clinical Research Sites (SCRS) and Fortrea (Nasdaq: FTRE), a leading global contract research organization (CRO), are pleased to announce Fortrea’s sponsorship of the SCRS Collaborate Forward working group. Comprising [...]

Boehringer’s zongertinib receives Priority Review from U.S. FDA for the treatment of HER2 (ERBB2)-mutant advanced non-small cell lung cancer

Ridgefield, Conn., U.S., and Ingelheim, Germany Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved The application for this investigational treatment is based on positive results from the Phase Ib Beamion LUNG-1, Cohort 1 trial that demonstrated an objective response [...]

Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Middle East

Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Middle East First patient implanted with Genio at Saudi German Hospital in Dubai, United Arab Emirates Mont-Saint-Guibert, Belgium – February 19, 2025, 7:05am CET / 1:05am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for [...]

Philips proposes new Supervisory Board appointments and reappointments, and Board of Management reappointment

Mr David Pyott to retire from Philips’ Supervisory Board after his third consecutive term. Mr Bob White proposed as new member of the Supervisory Board. Ms Indra Nooyi and Ms Chua Sock Koong proposed for reappointment as members of the Supervisory Board. Mr Marnix van Ginneken proposed for reappointment as member of Philips’ Board of [...]

Philips delivers growth, improved profitability, and strong cash flow in Q4 and 2024; continues solid execution of its three-year plan

February 19, 2025 Full Year and Q4 Group performance highlights Sales of EUR 18.0 billion in 2024, comparable sales growth 1%; EUR 5.0 billion in Q4, comparable sales growth 1%, despite double-digit decline in China Comparable order intake increased 1% in 2024; up 2% in Q4, despite double-digit decline in China Income from operations was [...]

Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)

REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 18, 2025 (Korea Bizwire) – Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) [...]

Bahrain Makes History with First Successful CRISPR-Based Sickle Cell Treatment Outside the US

MANAMA, Kingdom of Bahrain, Feb. 16, 2025 (Korea Bizwire) – The Bahrain Oncology Centre (BOC) has made medical history by successfully treating a sickle cell disease (SCD) patient using CRISPR-based gene-editing therapy, Casgevy (exagamglogene autotemcel). This marks the first successful treatment of its kind outside the United States, positioning Bahrain as a global leader in [...]