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Tag: United States

European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)

REYKJAVIK, Iceland and LONDON, June 23, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept 2 mg). Based on a positive recommendation by CHMP, biosimilar medicines can be approved by the European Commission for marketing in the European Economic Area, that includes the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.

European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)

REYKJAVIK, ICELAND and LONDON, UK (June 23, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept 2 mg). Based on a positive recommendation by CHMP, biosimilar medicines can be approved by the European Commission for marketing in the European Economic Area, that includes the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.

Navamedic ASA expands into addiction treatment through the acquisition of the business of dne pharma and announces a partially underwritten rights issue

NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA, THE HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE...

AI Query Processing: Quantifying Carbon Footprint in Algorithmic Models

Artificial intelligence, particularly generative AI, is becoming integral to various aspects of daily life, from search engine optimization to automated email composition. However, the...

IASO Bio presents promising efficacy of Equecabtagene Autoleucel in patients with Multiple Sclerosis in IIT study at the 11th Congress of the European Academy...

SHANGHAI and NANJING, China and SAN FRANCISCO, June 22, 2025 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development,...

Shareholders who own 3D Systems (NYSE: DDD) Should Contact Wolf Haldenstein

NEW YORK, June 22, 2025 (GLOBE NEWSWIRE) -- Wolf Haldenstein Adler Freeman & Herz LLP announces that securities class action lawsuit has been filed in the United States District Court for the District of Delaware on behalf of all persons or entities who purchased or otherwise acquired 3D Systems Corporation (3D Systems or the Company) (NYSE: DDD) securities between August 13, 2024 and May 12, 2025, inclusive (the Class Period).

Lilly’s once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials

Results from the fixed-dose QWINT-1 study, along with the QWINT-3 and QWINT-4 studies, reinforce efsitora's potential to simplify insulin management with weekly dosing Lilly plans...

Pomerantz Law Firm Announces the Filing of a Class Action Against PepGen Inc. and Certain Officers – PEPG

NEW YORK, June 22, 2025 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against PepGen Inc. ("PepGen" or the "Company")...

Pomerantz Law Firm Announces the Filing of a Class Action Against Fortrea Holdings, Inc. and Certain Officers – FTRE

NEW YORK, June 22, 2025 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Fortrea Holdings, Inc. ("Fortrea" or the...

CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in NEJM

Data presented simultaneously at the American Diabetes Association's® 85th Scientific Sessions, showed mean weight reduction in the highest range of efficacy observed with existing...

HD Hyundai Joins Forces with U.S. Shipbuilder for Vessel Construction

An exclusive Memorandum of Understanding (MOU) between HD Hyundai and Tampa Ship, part of the Edison Chouest Offshore family of affiliated companies, was executed...

Celebrity Stylist Axel Rojas Opens Hair Salon in Dallas

From LA studios and salons, he brings his artistry and vision home DALLAS, June 21, 2025 /PRNewswire/ -- After styling icons like Madonna and the...

BexBack Launches $50 Welcome Bonus and 100% Deposit Match to Empower Crypto Traders with 100x Leverage

SINGAPORE, June 21, 2025 (GLOBE NEWSWIRE) -- BexBack Exchange has launched an aggressive new promotion to empower both new and seasoned crypto traders: a $50 welcome bonus and a 100% deposit match for all new users. As the crypto market braces for another period of high volatility, BexBack is making futures trading more accessible and profitable than ever. With up to 100x leverage, zero KYC requirements, and support for over 50 digital assets, the platform provides an ideal environment for those seeking to capitalize on market swings without large upfront capital.

Lilly’s oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results published in The...

The investigational once-daily pill lowered A1C by an average of 1.3% to 1.6% across doses, with improvements seen as early as four weeks, in adults...

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