News and Press Releases
Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma
Approval based on positive pivotal ICARIA-MM phase 3 study using the China-based IsaFiRsT real-world study as bridging data, which demonstrated Sarclisa and the standard treatment Pd, improved responses and long-term...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 13, 2025
PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid Leukemia (AML)
Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of LYT-200 to serve broad range of patients across various lines of treatment LYT-200...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 9, 2025
Santhera Announces Approval from China’s NMPA for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy
China’s National Medical Products Administration (NMPA) approved AGAMREE® for the treatment of Duchenne muscular dystrophy in patients aged 4 years and older This approval makes AGAMREE the first and only...
Category: Other, Pharmaceutical
Posted: December 11, 2024
Santhera Pharmaceuticals Headquarters Hohenrainstrasse 24 | 4133 Pratteln | Switzerland
PTC Therapeutics to Participate at Upcoming Investor Conferences
4 November 2024 -- New Jersey, US -- PTC Therapeutics, Inc today announced that the company will present a company overview at the following conferences: UBS Global Healthcare ConferenceWednesday, Nov....
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: November 4, 2024
PTC Therapeutics Inc. 100 Corporate Court South Plainfield, NJ 07080-2449
HUTCHMED Announces that TAGRISSO plus ORPATHYS demonstrated high,clinically meaningful response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trial
New data demonstrate efficacy for the oral treatment combination to address MET-driven resistance in EGFR-mutated lung cancer MET is a common biomarker in this setting for patients who develop resistance...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 16, 2024
Scotland first in the UK to recommend a new treatment option for lung cancer, which could help lower the risk of cancer returning
7 October 2024 -- Scotland, UK -- the Scottish Medicines Consortium has recommended MSD's KEYTRUDA® (pembrolizumab) as monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma (NSCLC)...
Category: Other, Pharmaceutical
Posted: October 7, 2024
Sterling Pharma Solutions Announces Partnership with Soligenix for the Manufacture of Oncology-Targeted API
3 October 2024 -- Cramlington, UK -- Sterling Pharma Solutions, a global contract development and manufacturing organisation, and Soligenix, a late-stage biopharmaceutical company focused on developing and commercialisation of products...
Category: BioManufacturing, Clinical Trials, Pharmaceutical
Posted: October 3, 2024
Sterling Place, Dudley Cramlington, Northumberland, NE23 7QG, United Kingdom
PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients
1 October 2024 -- New Jersey, US -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the FDA has accepted for filing the New Drug Application (NDA) of sepiapterin for the treatment of...
Category: Biotechnology, Drug Discovery, Pharmaceutical
Posted: October 1, 2024
PTC Therapeutics Inc. 100 Corporate Court South Plainfield, NJ 07080-2449
AzurBio Pharma Launches to Fast-Track European Market Entry for Biopharma Companies with Breakthrough Treatments
1 October 2024 -- Paris, France -- AzurBio Pharma, specializing in bringing innovative pharmaceutical products to European markets and focusing on rare and serious diseases with unmet medical needs, is...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 1, 2024
Sarepta Therapeutics Announces Recipients of LGMD Grant Awards for 2024; Program Supports Early Genetic Testing and Awareness
Recipients awarded a total of more than $100,000 in grants Funding will support education and activities to shorten diagnostic journey. 30 September 2024 -- Massachusetts, US -- Sarepta Therapeutics, Inc, the...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: September 30, 2024
Hill House, 1 Little New Street London, EC4A 3TR United Kingdom
PureTech-Invented KarXT Receives U.S. Food and Drug Administration Approval for the Treatment of Schizophrenia in Adults
Milestone triggers payments to PureTech totaling $29 million under agreements with Royalty Pharma and PureTech’s Founded Entity, Karuna Therapeutics, which was acquired by Bristol Myers Squibb in March 2024, and...
Category: Other, Pharmaceutical
Posted: September 27, 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
DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma
Recommendation supported by findings from quadruplet therapy PERSEUS study with daratumumab subcutaneous (SC) formulation in the frontline setting Findings showed 60 percent reduction in risk of disease progression or death...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 20, 2024
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
CARBOGEN AMCIS Announces Two Successful FDA Inspections at its Manufacturing Sites in Neuland and Aarau, Switzerland
23 July 2024 -- Bubendorf, Switzerland -- Switzerland-based CARBOGEN AMCIS, a leading pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, is pleased to announce the successful completion of...
Category: BioManufacturing, Other, Pharmaceutical
Posted: July 23, 2024
Certa Therapeutics Receives EU Orphan Designation for FT011, a GPR68 Inhibitor Being Developed as an Anti-Fibrotic Treatment for Systemic Sclerosis
22 July 2024 -- Melbourne, Australia -- Certa Therapeutics, a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the European Medicines Agency...
Category: Biotechnology, Drug Discovery, Pharmaceutical
Posted: July 22, 2024
