Sandoz announced the launch of the generic oncology medicine gefitinib indicated for adult patients with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR-TK, which is recommended by ESMO as first-line treatment. The medicine is expected to become available immediately in 13 countries across Europe on the day the reference medicine loses market exclusivity. Sandoz plans to continue to expand to other countries through a phased rollout.
Novartis announced that it has completed its acquisition of Xiidra (lifitegrast ophthalmic solution) 5%, the first and only prescription treatment approved to treat both signs and symptoms of dry eye by inhibiting inflammation caused by the disease.
Novartis announced that new data from the active treatment phase (ATP) of the STRIVE Phase III clinical study demonstrate Aimovig (erenumab) 70 mg and 140 mg significantly reduced monthly migraine days (MMD) and migraine-specific medication days (MSMD) for episodic migraine patients who have previously struggled to find effective and tolerable preventive therapies specifically designed for migraine prevention. These findings add to the breadth of clinical data which show the sustained efficacy of Aimovig across the spectrum of migraine, including in those who have failed prior preventive treatments.
New analysis of Novartis data confirms that Cosentyx demonstrates durable comprehensive treatment across psoriatic disease. The abstract "Secukinumab provides comprehensive long-term treatment across multiple manifestations of psoriatic disease" (World Congress of Dermatology in June 2019) presented the long-term efficacy and safety of secukinumab in multiple manifestations of psoriatic disease including, moderate-to-severe plaque-type, nail and palmoplantar psoriasis; psoriatic arthritis and ankylosing spondylitis. Data are derived from key Phase III, randomised, double-blind trials of secukinumab (SCULPTURE, ERASURE/FIXTURE, TRANSFIGURE, GESTURE, FUTURE 2 and MEASURE 2) in a total of 1,872 patients.
Sandoz announced data from the Phase III ADMYRA trial demonstrating that the efficacy and safety of biosimilar Hyrimoz (adalimumab) matches that of the reference medicine adalimumab with no clinically meaningful differences in patients with moderate-to-severe rheumatoid arthritis (RA) with inadequate response to disease modifying antirheumatic drugs (DMARDs), including methotrexate (MTX).
Novartis announced new data from the MAXIMISE trial evaluating the efficacy and safety of Cosentyx (secukinumab) in the management of axial manifestations of psoriatic arthritis (PsA). The ongoing 52-week Phase IIIb trial met both its primary and key secondary endpoint with 63.1% of Cosentyx 300 mg and 66.3% of Cosentyx 150 mg patients achieving ASAS20 at Week 12 (versus 31.3% for placebo) respectively. Rapid onset of relief was seen as early as week four, with the trial demonstrating a favorable safety profile consistent with previous clinical trials.
Novartis announced that Marie-France Tschudin, currently President, Advanced Accelerator Applications (AAA), a Novartis company, has been appointed President, Novartis Pharmaceuticals. She reports to Vas Narasimhan, CEO Novartis, and is a member of the Executive Committee with immediate effect. Marie-France Tschudin succeeds Paul Hudson who has left Novartis to take the CEO position of a multinational pharmaceuticals company.
AAA, announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of LysaKare 25g/25g (arginine hydrochloride/lysine hydrochloride) solution for reduction of renal (kidney) radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide (Lutathera) in adults. If approved by the European Commission, LysaKare would be the first commercially registered arginine hydrochloride/lysine hydrochloride amino acid solution of this concentration available in Europe.
Novartis announced results from the landmark COMBI-d and COMBI-v clinical trials, concluding that first-line treatment with Tafinlar (dabrafenib) and Mekinist (trametinib) offers both overall and progression-free long-term survival benefits to patients with unresectable or metastatic BRAF-mutation positive melanoma.
Xolair (omalizumab) significantly reduced nasal polyps and congestion symptoms in adults with chronic rhinosinusitis with nasal polyps in two phase III studies, POLYP 1 and POLYP 2.
Novartis announced statistically significant overall survival (OS) results for Kisqali in combination with endocrine therapy. The Phase III MONALEESA-7 trial evaluated Kisqali plus endocrine therapy (goserelin plus either an aromatase inhibitor or tamoxifen) as initial treatment compared to endocrine therapy alone in pre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
Novartis' phase III QUARTZ study of new investigational inhaled combination treatment QMF149 meets primary and key secondary endpoints in patients with inadequately controlled asthma.
The US Food and Drug Administration (FDA) approved Novartis’ Piqray - the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer.
AveXis receives US FDA approval for Zolgensma, the first and only gene therapy for pediatric patients with spinal muscular atrophy (SMA).
Novartis data at the 2019 American Academy of Neurology Annual Meeting (AAN) show Gilenya is the first and only disease-modifying therapy with proven superiority versus glatiramer acetate in relapsing remitting MS. Full results from the ASSESS study demonstrate patients with relapsing remitting multiple sclerosis (RRMS) taking Gilenya (fingolimod) 0.5mg had significantly fewer relapses than patients taking glatiramer acetate 20mg.
Sandoz announced that it has received regulatory approval from China's National Medical Products Administration (NMPA) for its generic rosuvastatin, under the NMPA's Quality Consistency Evaluation (QCE) system. Sandoz is the first multinational pharmaceutical company to receive such an approval under the recently introduced QCE system, which aims to ensure that all generic medicines marketed (or manufactured) in China meet internationally recognized quality standards.
Novartis announced that it has entered into an agreement with Takeda Pharmaceutical Company Limited to acquire the assets associated with Xiidra® (lifitegrast ophthalmic solution) 5% worldwide. Xiidra® is the first and only prescription treatment approved to treat both signs and symptoms of dry eye by inhibiting inflammation caused by the disease. This transaction closed on July 1, 2019.
Novartis announced a new analysis of the Phase III EXPAND study, demonstrating that treatment with Mayzent (siponimod) had a clinically meaningful positive impact on cognitive processing speed (CPS) in patients with SPMS, an important element in cognitive function.
Sandoz announced that it has entered into an agreement to commercialize a proposed trastuzumab biosimilar. This medicine is currently in Phase III clinical development for treatment of human epidermal growth factor receptor 2 positive (HER2+) breast and specific gastric cancer tumors.
Novartis has appointed Richard Saynor as CEO of Sandoz effective no later than August 1, 2019. He will be a member of the Executive Committee of Novartis and report to Vas Narasimhan, CEO, Novartis.
Novartis announced that the US FDA accepted the company's Biologics License Application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD.
Sandoz announced that it has signed an agreement with Shionogi & Co Ltd for commercialization of Rizmoic® (naldemedine) in the key European markets of Germany, the UK and the Netherlands, plus right of first refusal for certain other European markets.
Novartis completed the spin-off of the Alcon eye care devices business through a dividend-in-kind distribution to holders of Novartis shares and ADRs (American Depositary Receipts), with each holder receiving one Alcon share for every five Novartis shares or ADRs held on April 8, 2019, at the close of business.
Novartis announced that the China Health Authority NMPA approved Cosentyx (secukinumab), the first-in-class interleukin-17A (IL-17A) inhibitor for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
AveXis, a Novartis company, announced it signed an agreement to purchase an advanced biologics therapy manufacturing campus in Longmont, Colorado, further expanding production capacity of AveXis as it prepares to launch Zolgensma (onasemnogene abeparvovec-xioi) a gene therapy approved by the FDA for the treatment of children less than 2 years old with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene, and for future gene therapy treatments in development.
Novartis announced the planned acquisition of IFM Tre, a subsidiary of IFM Therapeutics LLC focused on developing anti-inflammatory medicines targeting the NLRP3 inflammasome. The acquisition will give Novartis full rights to IFM Tre's portfolio of NLRP3 inhibitors.
Novartis received US FDA approval for Mayzent (siponimod), the first oral drug to treat secondary progressive MS with active disease.
Novartis announced that Richard Francis will be stepping down as CEO of the Sandoz Division, and as a member of the Executive Committee of Novartis on March 31, 2019. Francesco Balestrieri, currently Region Head Europe, Sandoz, has been appointed ad-interim CEO Sandoz, reporting to Vas Narasimhan, CEO, Novartis.
Novartis shareholders approved all resolutions proposed by the Board of Directors at the Annual General Meeting.
Novartis announced that it is exercising its option to license the rights to develop and commercialize TQJ230, an investigational agent previously known as AKCEA-APO(a)-LRx, from Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, for targeted cardiovascular therapy. TQJ230 was discovered by Ionis and has been co-developed to date by Akcea and Ionis. Novartis is now responsible for worldwide development and commercialization of this asset.
Novartis announced that the US FDA has granted crizanlizumab (SEG101) Breakthrough Therapy designation for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD).
Sandoz and Pear Therapeutics, Inc. announced the US commercial launch of reSET-O for patients with Opioid Use Disorder (OUD). reSET-O, cleared by the US FDA in December, is immediately available.
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