Tag Archives: Sandoz

Sandoz Gains Investment-Grade Rating Post Spin-off, Secures Substantial Financing

(IN BRIEF) Novartis has confirmed its plans for a full Spin-off of its Sandoz business, with trading of new Sandoz Group AG shares and ADRs scheduled to begin on October 4, 2023. This comes after receiving shareholder approval and key … Read the full press release

Sandoz Expands Hospital Offering and Anti-Infectives Portfolio with Mycamine® Brand Rights Acquisition

(IN BRIEF) Sandoz, a global leader in generic and biosimilar medicines, has successfully acquired the worldwide brand rights for the systemic antifungal agent Mycamine® (micafungin sodium) from Astellas. This acquisition bolsters Sandoz’s position in the global hospital sector and enhances … Read the full press release

Sandoz’s distribution and collaboration agreement to bring more affordable treatments to the US

(IN BRIEF) Sandoz to commercialize six products exclusively in the US following distribution and collaboration agreement with Adalvo. The products are aimed at treating disorders that affect millions of people in the US each year, including antifungal/antibiotic, oncology, and pulmonary. … Read the full press release

Sandoz to Invest Over $400 Million in New Biologics Plant in Slovenia

(IN BRIEF) Sandoz, a global leader in generic and biosimilar medicines, has signed a Memorandum of Understanding to build a new biologics production plant in Lendava, Slovenia, in a move expected to be worth at least USD 400 million. The … Read the full press release

El CEO de Firmenich, Gilbert Ghostine, encabezará a Sandoz como presidente designado de la nueva junta directiva

(NOTICIA EN BREVE) Gilbert Ghostine ha sido designado presidente designado de la nueva junta directiva de Sandoz, tras el anuncio de la junta directiva de Novartis. La nueva Junta Directiva de Sandoz se formará en la segunda mitad de 2023, … Read the full press release

Firmenich CEO Gilbert Ghostine to Lead Sandoz as Chairman-Designate of New Board of Directors

(IN BRIEF) Gilbert Ghostine has been appointed as Chairman-designate of the new Board of Directors of Sandoz, following the announcement by Novartis Board of Directors. The new Board of Directors of Sandoz will be formed in the second half of … Read the full press release

Sandoz acquires Mycamine, reinforcing its anti-infectives portfolio

(IN BRIEF) Sandoz, a global leader in off-patent (generic and biosimilar) medicines, has signed an agreement to acquire worldwide product rights for leading systemic antifungal agent Mycamine® (micafungin sodium, Funguard® in Japan) from Astellas. This acquisition will reinforce Sandoz’s hospital … Read the full press release

Sandoz adquiere Mycamine, reforzando su cartera de antiinfecciosos

(NOTICIA EN BREVE) Sandoz, líder mundial en medicamentos sin patente (genéricos y biosimilares), ha firmado un acuerdo para adquirir los derechos de producto a nivel mundial del agente antifúngico sistémico líder Mycamine® (micafungina sódica, Funguard® en Japón) de Astellas. Esta … Read the full press release

La división Sandoz de Novartis amplía su cartera de medicamentos respiratorios con la adquisición de la empresa británica Coalesce Product Development Limited

Sandoz obtiene capacidades y activos significativos en el desarrollo de dispositivos médicos y medicamentos que apuntan a importantes oportunidades de crecimiento en genéricos complejos y respiratorios Las enfermedades respiratorias son la principal causa de muerte y discapacidad e imponen una … Read the full press release

Novartis division Sandoz expands respiratory medicines portfolio with the acquisition of British company Coalesce Product Development Limited

Sandoz gains significant capabilities and assets in medical and drug device development that target major growth opportunities in respiratory and complex generics Respiratory diseases are leading cause of death and disability and impose huge financial burden on patients worldwide Acquisition … Read the full press release

Francesco Balestrieri appointed ad-interim CEO of Sandoz reporting directly to Vas Narasimhan, CEO, Novartis

(PRESS RELEASE) BASEL, 15-Mar-2019 — /EuropaWire/ — Sandoz’s current Region Head Europe Francesco Balestrieri has just been appointed ad-interim CEO of Sandoz reporting directly to Vas Narasimhan, CEO, Novartis. The change is made as the current CEO of Sandoz, a … Read the full press release

Sandoz certified “TOP Employer Asia Pacific 2019” for its exceptional employee offerings in the region

Sandoz has been certified by the Top Employers Institute for its exceptional employee offerings in Asia Pacific (APAC) The annual, international research undertaken by the Top Employers Institute recognizes leading employers around the world This exclusive certification underlines Sandoz´ commitment … Read the full press release

Sandoz announces European Commission approval for Zessly® (infliximab) for use in Europe

European Commission’s (EC) approval based on comprehensive data package confirming that Zessly® matches safety, efficacy and quality of reference medicine Biosimilars such as Zessly enable earlier patient access to important medicines and positively impact healthcare systems Zessly is the third EC … Read the full press release

Novartis division Sandoz receives US FDA complete response letter regarding the Biologics Licensing Application for its proposed biosimilar rituximab

Holzkirchen, Germany, 04-May-2018 — /EuropaWire/ — Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab. Sandoz stands behind … Read the full press release

Sandoz: EMA Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion for marketing authorization of infliximab

Sandoz is seeking approval of biosimilar infliximab for use in all indications of its reference medicine across gastroenterology, rheumatology and dermatology Positive opinion is based on comprehensive clinical and non-clinical data that is expected to confirm that Sandoz biosimilar infliximab … Read the full press release

Sandoz today expands pilot project with leading charity World Child Cancer

Expanded partnership to help “even the odds” of survival for children with cancer in the Philippines, Myanmar, Mexico and Ghana In developed countries, the survival rate for childhood cancer is 80%, while in developing countries it can be as low … Read the full press release

Generic medicines accounted for 62% of all medicines prescribed in Europe in 2016

New data just released in the two largest global pharma markets show the substantial and growing level of savings made possible by increased use of generic medicines. HOLZKIRCHEN, 21-Jun-2017 — /EuropaWire/ — Generic medicines accounted for 62% of all medicines prescribed … Read the full press release

Sandoz: European Commission approves Rixathon for use in Europe

European Commission approves Sandoz Rixathon® to treat blood cancers and immunological diseases. Approval expected to broaden patient access to biologics and enable budget-constrained healthcare systems to reallocate resources to other healthcare priorities. Sandoz now has four biosimilars approved in Europe … Read the full press release

Novartis Reinforces Commitment to Sandoz With Major Investment in Business

Total investment of EUR 105 million in Prevalje site reinforces commitment to largest Sandoz business, Anti-Infectives, and single largest global product, broad-spectrum antibiotic amoxicillin-clavulanic acid. The investment will bring 150 new jobs, more than doubling the number of employees at … Read the full press release

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