Entries by https://www.sandoz.com/rss/feeds/news/media-releases.xml

Applications for proposed first-of-a-kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA

Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple sclerosis in US and EU Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease that can drastically a…

Sandoz Supplemental Biologics License Application accepted by US FDA for biosimilar Hyrimoz® (adalimumab-adaz) high concentration formulation (HCF)

Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study Proposed Hyrimoz® HCF would help expand access to medicine for patients with chronic immune-mediated inflammatory diseases Sandoz is comm…

Novartis delivers continued strong momentum of key growth brands, progress on strategic initiatives and confirms FY’22 Group guidance

Ad hoc announcement pursuant to Art. 53 LRQ2 sales grew +5% cc1 (-1% USD)Innovative Medicines (IM) sales grew +5% cc (-1% USD); strong performance of key growth brands including Entresto (+33% cc), Kesimpta (+270% cc), Cosentyx (+12% cc), Kisqali (+43%…

Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics studyAdalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patientsSubmission builds o…

HEXAL launches Dimethyl fumarate HEXAL® a generic drug for Tecfidera®, in Germany, offering an economically efficient treatment option for the care of adult patients with multiple sclerosis*

Dimethyl fumarate HEXAL® is bioequivalent to the originator product 1,2,3Additional 196 pack size reduces co-payment burden for patientsBasel, June 10, 2022 — Sandoz expands its portfolio and today announces the launch of the generic drug Dimethyl fuma…

Sandoz announces new global ‘Act4Biosimilars’ initiative, to improve patient access and increase adoption by at least 30% in 30+ countries by 2030

Multidisciplinary Steering Committee established to drive action includes patient advocacy leaders, healthcare professionals, biosimilar experts and industry leaders Action Plan will provide roadmap and tools to improve approvability, accessibility, ac…

Sandoz appoints new Board representative to global AMR Industry Alliance

Dr. Boumediene Soufi, global head of Sandoz AMR (antimicrobial resistance) program, to represent Sandoz as Board member of AMR Industry Alliance (AMRIA)The Alliance brings together about 100 life science companies / associations in search of sustainabl…

Sandoz launches first generic pirfenidone in US for patients with idiopathic pulmonary fibrosis, growing its respiratory portfolio

Pirfenidone is used to treat idiopathic pulmonary fibrosis (IPF),1 a progressive disease that causes irreversible lung scarring and makes it difficult to breathe2Approximately 140,000 Americans live with IPF, a rare disease with no cure, and 50,000 new…

Novartis delivers solid sales and profit growth. Strong performance of in-market brands supports confidence in mid-term growth outlook

Ad hoc announcement pursuant to Art. 53 LRQ1 sales grew +5% (cc1, +1% USD), core operating income grew +9% (cc, +3% USD)Innovative Medicines (IM) sales grew +4% (cc, +1% USD) and core operating income +5% (cc, 0% USD)Strong performance of key growth br…

Sandoz launches generic brimonidine tartrate/timolol maleate eyedrop in US for patients with ocular hypertension, expanding leading ophthalmic portfolio

Brimonidine tartrate/timolol maleate combination eyedrop is used to treat elevated eye pressure in patients with ocular hypertension1Ocular hypertension affects over 5% of all adults2; the eye does not properly drain fluid, causing eye pressure to buil…