Tag Archives: Sandoz

New Sandoz Biosimilar Shows Promising Equivalency Results

Sandoz proposed biosimilar adalimumab (GP2017) shown to have equivalent efficacy and a similar safety profile as reference medicine, Humira®* Comprehensive development program show potential of GP2017 to treat inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis … Read the full press release

Sandoz’s EGALITY trial results: equivalence in Psoriasis Area and Severity Index (PASI) 75 response rates at week 12 met

The EGALITY study met its primary endpoint demonstrating equivalent efficacy of Sandoz biosimilar etanercept candidate to the originator product at week 12 As a first-of-its kind, the confirmatory clinical safety and efficacy study compares originator etanercept to a biosimilar candidate … Read the full press release

European Medicines Agency accepted Sandoz’s Marketing Authorization Application for biosimilar to Roche’s EU-licensed MabThera®

Sandoz advances biosimilar portfolio with sixth major biosimilar file acceptance in less than one year Sandoz is seeking approval for all indications included in the reference product’s label Sandoz’ submission includes data from multiple clinical trials with over 800 patients … Read the full press release

Sandoz and World Child Cancer announce new health initiative in the Philippines

Holzkirchen, Germany, 18-Feb-2016 — /EuropaWire/ — Sandoz, together with leading global charity World Child Cancer (WCC), is pleased to announce a new health initiative in the Philippines, aimed at improving the standard of care for children suffering from cancer. Cancer survival … Read the full press release

Sandoz continues to advance its biosimilars program: US FDA acceptance for its proposed biosimilar pegfilgrastim

Sandoz continues to advance its biosimilars program: Regulatory submission for Sandoz’ proposed biosimilar pegfilgrastim accepted by the FDA Sandoz demonstrates commitment to oncology by seeking approval for its proposed biosimilar pegfilgrastim. Sandoz believes that the totality of evidence in its … Read the full press release

Sandoz announced US market introduction of its generic version of Pulmicort Respules®

Princeton, New Jersey, 30-7-2015 — /EuropaWire/ — Sandoz today announced the US market introduction of its budesonide inhalation suspension, a generic version of Pulmicort Respules® (budesonide) inhalation suspension 1 mg strength by AstraZeneca LP. Sandoz’s budesonide inhalation suspension product is indicated … Read the full press release

Sandoz launches respiratory health program aimed at improving the diagnosis and treatment of asthma – Breathe Africa

Non-communicable diseases like asthma are rising rapidly in sub-Saharan Africa where healthcare systems are ill-prepared to cope1 – Zambia is ranked #1 in the world for mortality due to asthma2 Increasing the medical expertise of local healthcare professionals is a … Read the full press release

Sandoz launches New Life & New Hope program aimed at improving maternal and child health and reduce mortality associated with childbirth in Ethiopia

Approximately 400 mothers and newborns die in Ethiopia each day1,2partly due to health workers’ limited knowledge in the area of obstetrics Enhancing medical knowledge and skills of health workers helps reduce maternal and newborn mortality Sandoz is committed to increasing … Read the full press release

Sandoz: 160,000 – 200,000 children estimated to be diagnosed with childhood cancer each year

Holzkirchen, Germany, 6-2-2015 — /EuropaWire/ — Between 160,000 and 200,000 children are estimated to be diagnosed with childhood cancer and around 100,000 die from it each year. With proper diagnosis, treatment and drugs, most childhood cancers can be cured. In … Read the full press release

Sandoz announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen’s NEUPOGEN®

Pivotal PIONEER study compared safety and efficacy of the two compounds in the prevention of neutropenia in patients with breast cancer PIONEER data supported filing for biosimilar filgrastim in the US The abstract of the study results is published online … Read the full press release

Global generics industry newsletter Generics Bulletin awarded “Biosimilars Initiative of the Year” to Sandoz

Holzkirchen, 16-10-2014 — /EuropaWire/ — Sandoz is pleased to announce that Generics Bulletin, a newsletter covering commercial and regulatory information for the global generics industry, has awarded the company with “Biosimilars Initiative of the Year”, for its file acceptance of G-CSF … Read the full press release

Sandoz appoints Vas Narasimhan as Head of Sandoz Biopharmaceuticals & Oncology Injectables

Munich, Germany, 28-3-2014 — /EuropaWire/ — Sandoz announced today that Vasant (Vas) Narasimhan, MD, MPP, has been appointed Head of Sandoz Biopharmaceuticals & Oncology Injectables effective April 1, 2014. Vas, currently Global Head of Development at Novartis Vaccines, succeeds Ameet Mallik who will … Read the full press release

Sandoz announced it received Romanian marketing authorization for AirFluSal® Forspiro®

Holzkirchen, Germany, 31-1-2014 — /EuropaWire/ — Sandoz announced today it has received Romanian marketing authorization for AirFluSal® Forspiro®, an innovative new inhaler for patients with asthma and COPD. The product was first approved in Denmark on December 18th, 2013. The new product … Read the full press release

US Federal Circuit Court invalidated patents asserted against Sandoz by Teva Pharmaceuticals in litigation over generic version of Copaxone

Princeton, New Jersey, 29-7-2013 — /EuropaWire/ — Sandoz announced today that the US Federal Circuit Court of Appeals has invalidated several patents asserted against the company by Teva Pharmaceuticals in litigation concerning a generic version of Copaxone® – one of the leading … Read the full press release

The global leader in biosimilars Sandoz initiated Phase III clinical trial for biosimilar etanercept

Trial expected to support registration in the U.S. and European Union Sandoz continues to advance biosimilar pipeline with seven Phase III trials across five molecules Global program underscores Sandoz’s leadership in biosimilars Holzkirchen, Germany, 1-7-2013 — /europawire.eu/ — Sandoz, the global … Read the full press release