News and Press Releases
Exclusive UniSafe® distribution agreement between Owen Mumford and NIPRO exceeds expectations in Japan with new biosimilar launch
6 December 2024 - Oxford, UK – Owen Mumford, a global leader in medical devices, is pleased to announce that its exclusive agreement with Osaka-based NIPRO CORPORATION (NIPRO) to distribute...
Category: Drug Delivery, Manufacturing and Packing
Posted: December 6, 2024
Outlook Therapeutics Announces NICE Recommendation of LYTENAV (bevacizumab gamma) for the Treatment of Wet AMD
First positive reimbursement decision worldwide for LYTENAVA™; First launch anticipated in H1 2025 LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD...
Category:
Posted: December 6, 2024
Outlook Therapeutics, Inc. 111 S. Wood Ave Unit,100 Iselin, NJ 08830
CHMP recommends RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
The amivantamab plus lazertinib combination regimen offers potential to provide new standard of care as first-line option for adult patients with advanced NSCLC with EGFR ex19del or L858R substitution mutations...
Category: Clinical Trials
Posted: November 20, 2024
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
OKYO Pharma Announces Start of Phase 2 Clinical Trial to Treat Patients with Neuropathic Corneal Pain
Neuropathic corneal pain (NCP) is listed in the National Organization for Rare Disorders (NORD) as an orphan disease OKYO is the first company to have an IND application granted by...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 16, 2024
Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old
Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in adults and adolescents...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 20, 2024
The Charter Building, Vine Street, Uxbridge, Middlesex, United Kingdom, UB8 1JG
Professor V. A. Bumelis opens the Lithuanian Museum of Biotechnology
20 September 2024 – Savaitiskes, Lithuania –The 40th anniversary of the Lithuanian biopharmaceutical industry and science was marked on Monday with the opening of the Lithuanian Biotechnology Museum in the...
Category: Biotechnology, Other
Posted: September 20, 2024
Merck Receives European Commission Approval for WINREVAIR™ (sotatercept) in Combination With Other Pulmonary Arterial Hypertension (PAH) Therapies, for the Treatment of PAH in Adult Patients With Functional Class II-III
26 August, 2024 – New Jersey, US – Merck, known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved WINREVAIR™ (sotatercept), in...
Category: Pharmaceutical
Posted: August 28, 2024
1 rue Jacques Monod, Site Montesquieu, 33650 Martillac, France
European Commission Approves Astellas’ PADCEVTM (enfortumab vedotin) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer
First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years European Marketing Authorization based on positive overall survival and...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: August 28, 2024
CHMP recommends RYBREVANT®▼ (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) after failure of prior therapy
Patients with EGFR ex19del or EGFR L858R mutations, the most common EGFR mutations in NSCLC, currently face a poor prognosis and limited treatment options after disease progression on osimertinib1,2,3,4 ...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: July 26, 2024
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Johnson & Johnson Receives Positive CHMP Opinion for Yuvanci® (Single Tablet Combination Therapy [STCT] of Macitentan and Tadalafil) for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
If approved, Yuvanci® would become the only single tablet combination for treatment for patients with PAH Johnson & Johnson’s comprehensive PAH portfolio has the potential to cover all guideline-recommended treatment...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: July 26, 2024
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Signant Health Appoints 20-Year Life Sciences Veteran Paul Richmond to executive leadership team as chief commercial officer
15 July 2024 – Pennsylvania, US – Signant Health, the leader in evidence generation for modern clinical trials, announced today the appointment of Paul Richmond as chief commercial officer. A...
Category: Clinical Trials, Other, Pharmaceutical
Posted: July 16, 2024
Just – Evotec Biologics expands tech partnership for biosimilars with Sandoz
Just – Evotec Biologics expands partnership with Sandoz for development and commercial manufacturing of biosimilars Additional biosimilars potentially to be added to Sandoz development pipeline Further guarantees for Sandoz long-term...
Category: BioManufacturing, Biotechnology
Posted: July 10, 2024
Just – Evotec Biologics, Inc. 401 Terry Avenue North Seattle, WA 98109, US
Formycon receives FDA approval for FYB203/ AHZANTIVE) (aflibercept-mrbb), a biosimilar to Eylea
1 July 2024, Planegg-Martinsried, Germany - Formycon AG (FSE: FYB, “Formycon”) and its licencing partnerKlinge Biopharma GmbH ("Klinge") jointly announce that the U.S. Food and Drug Administration ("FDA")approved FYB203/AHZANTIVE (aflibercept-mrbb),...
Category: Pharmaceutical
Posted: July 1, 2024
CHMP adopts positive opinion for BALVERSA (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
Pending approval, erdafitinib would become the first therapy targeting FGFR3 alterations in patients with metastatic urothelial carcinoma, one of Europe’s most common cancers The CHMP’s recommendation is based on results...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: June 28, 2024
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Formycon reports on the results of the annual general meeting
Management provides detailed report on financial year 2023 and current company performance. Shareholders approve all agenda items and formally approve the acts of the members of the management board and...
Category: BioManufacturing
Posted: June 13, 2024
