Yesterday, 10:02 AM
Mon, Jul. 25, 10:34 AM
- The FDA lifts its clinical hold on Novartis' (NVS -1%) Phase 1/2 study assessing CGF166 in patients with severe-to-profound hearing loss after the Data Safety and Monitoring Board recommended that the trial continue. The agency stopped the trial in January of this year in accordance with criteria in the study's protocol that required a review of the results. Top-line data should be available in 2017.
- CGF166 is an advanced adenoviral vector engineered to deliver the human atonal gene to sensory cells in the inner ear. Novartis licensed it from GenVec (GNVC -2.4%) in January 2010.
Tue, Jul. 19, 7:16 AM
- Novartis (NYSE:NVS) Q2 results ($M): Total Revenues: 12,470 (-1.8%); Innovative Medicines: 8,387 (-2.8%); Alcon: 1,506 (-1.6%); Sandoz: 2,577 (+1.9%).
- Oncology: 3,319 (-4.6%); Ophthalmology: 1,404 (-11.1%); Established Medicines: 1,240 (-18.1%); Neuroscience: 952 (+1.0%); Immunology & Dermatology: 734 (+52.0%); Respiratory: 397 (+10.0%); Cardio-Metabolic: 341 (+24.9%).
- Net Income: 1,806 (-1.7%); EPS: 0.75 (unch); CF Ops: 3,111 (+6.9%).
- Key Product Sales: Gleevec/Glivec: 891 (-24.7%); Gilenya: 811 (+15.9%); Lucentis: 475 (-11.5%); Tasigna: 458 (+2.7%); Sandostatin: 424 (+4.2%); Afinitor/Votubia: 365 (-5.4%); Galvus: 306 (+12.1%); Cosentyx: 260 (+400.0%).
- 2016 Guidance: Group Net Sales: flat; Core Group Operating Income: flat to low single-digit decline.
Tue, Jul. 19, 5:21 AM
Tue, Jul. 19, 5:04 AM
- Novartis (NYSE:NVS) -1% premarket after lowering its full year earnings guidance on plans to increase spending on its drug Entresto.
- Ericsson (NASDAQ:ERIC) reversed earlier losses as investors digested the firm's plans to cut costs by twice as much as previously thought.
- Rio Tinto (NYSE:RIO) -5% premarket after reporting that Q2 iron-ore production rose a weaker-than-expected 8%.
Mon, Jul. 18, 5:30 PM
Wed, Jul. 13, 7:51 AM
- Spectrum Pharmaceuticals' (NASDAQ:SPPI) Allos Therapeutics and Fresenius Kabi USA have entered into settlement agreement to resolve their patent litigation relating to Folotyn (pralatrexate injection). Under the terms of the settlement, Fresenius will be permitted to market a generic version of Folotyn in the U.S. on November 15, 2022 or earlier under certain circumstances.
- The Company has also settled with Teva Pharmaceuticals USA (NYSE:TEVA), Dr. Reddy’s Laboratories (NYSE:RDY) and Sandoz (NYSE:NVS).
Mon, Jul. 11, 12:09 PM
- The FDA's Arthritis Advisory Committee will meet on Wednesday, July 13 to review and discuss the Biologics License Application (BLA) from Novartis' (NVS +0.5%) Sandoz unit seeking approval of GP2015, a biosimilar to Amgen's (AMGN) Enbrel (etanercept). A positive recommendation appears likely.
- Draft Questions
- FDA Briefing Doc
- Sandoz Briefing Doc
- Update: The committee voted 20-0 backing approval.
Tue, Jul. 5, 11:43 AM
- The FDA approves Abbott Vascular's (ABT -0.3%) Absorb GT1 Bioresorbable Vascular Scaffold System, the first full absorbable stent cleared for sale in the U.S. to treat coronary artery disease.
- The GT1 releases everolimus [Novartis' (NVS -1.1%) Afinitor] which limits the growth of scar tissue. It is gradually absorbed by the body in about three years.
Thu, Jun. 30, 4:18 PM
- Array BioPharma (NASDAQ:ARRY) files a New Drug Application (NDA) with the FDA seeking approval of lead product candidate binimetinib for the treatment NRAS mutation-positive melanoma. The principal data supporting the application was generated in the Phase 3 NEMO study which showed an improvement in progression-free survival versus the chemo agent dacarbazine.
- Binimetinib inhibits a protein kinase enzyme called MEK, which plays a key role in a cellular signaling pathway that is over-activated in certain cancers, especially those that express the mutations BRAF, KRAS and NRAS. Array licensed binimetinib to Novartis (NYSE:NVS) in 2010 but reacquired the rights after Novartis acquired GlaxoSmithKline's (NYSE:GSK) oncology business in early 2015.
- Previously: Array Bio's lead product candidate successful in late-stage melanoma study; shares up 28% premarket (Dec. 16, 2015)
Thu, Jun. 23, 7:57 AM
- The FDA designates Incyte's (NASDAQ:INCY) Jakafi (ruxolitinib) a Breakthrough Therapy for the treatment of acute graft-versus-host disease (GVHD), a condition where the donated tissue, bone marrow or peripheral blood stem cells, view the recipient's body as foreign and attack the body. It is a significant cause of morbidity and mortality in transplant patients. There are no currently approved treatments for the disorder.
- Breakthrough Therapy status allows for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
- Jakafi is a JAK1/JAK2 inhibitor cleared in the U.S. for the treatment of a type of blood cancer called polycythemia vera and a bone marrow disorder called myelofibrosis. Novartis (NYSE:NVS) owns ex-U.S. rights to the product which now includes the GVHD indication. Incyte owns the U.S. rights.
Mon, Jun. 20, 8:21 AM
- Ophthotech (NASDAQ:OPHT) hits its enrollment target in a Phase 3 clinical trial assessing lead product candidate, Fast Track-tagged Fovista (pegleranib), in combination with Regeneron Pharmaceuticals (NASDAQ:REGN) and Bayer's (OTCPK:BAYRY) Eylea (aflibercept) or Roche's (OTCQX:RHHBY) Avastin (bevacizumab) for the treatment of patients with wet age-related macular degeneration (wet AMD). According to ClinicalTrials.gov, the estimated study completion date is July.
- The event triggers a $30M milestone payment from ex-U.S. commercialization partner Novartis Pharma AG (NYSE:NVS). The company has earned $330M in upfront fees and milestones from Novartis to date. Going forward, it can earn an additional $300M in regulatory milestones and up to $400M in sales-base milestones plus royalties on ex-U.S. Fovista sales.
- The Fovista Phase 3 program consists of three clinical trials. Results from the first two, evaluating Fovista with Roche's Lucentis (ranibizumab), are expected in Q4.
- Fovista is an anti-platelet-derived growth factor (anti-PDGF) agent
- Previously: Ophthotech moving ahead with Fovista studies (May 11, 2015)
Mon, Jun. 13, 4:43 PM
- The FDA's Arthritis Advisory Committee will review Amgen's (NASDAQ:AMGN) Biologics License Application (BLA) seeking approval of ABP 501, its biosimilar candidate to AbbVie's (NYSE:ABBV) Humira (adalimumab). The specific date has not been announced, but the FDA's action date (PDUFA) is September 25. Advisory committee meetings are typically three months or less beforehand under standard review and two months beforehand under priority review.
- The Arthritis Committee is scheduled to convene on July 13 to discuss Novartis (NYSE:NVS) unit Sandoz's BLA for its Enbrel (etanercept) biosimilar. No other meeting date is listed on the FDA's website.
Thu, Jun. 9, 7:17 AM
- Spectrum Pharmaceuticals (NASDAQ:SPPI) unit Allos Therapeutics and Novartis (NYSE:NVS) unit Sandoz settle their patent litigation related to lymphoma drug Folotyn (pralatrexate injection). Sandoz will be permitted to sell a generic version in the U.S. on November 15, 2022 or earlier under certain circumstances.
Mon, Jun. 6, 12:30 PM
- A Phase 2 clinical trial evaluating the combination of Novartis' (NVS +0.3%) Tafinlar (dabrafenib) and Mekinist (trametinib) in lung cancer patients with a certain genetic mutation showed an overall response rate of 63%. The data were presented at ASCO16 in Chicago.
- The non-randomized, open-label study enrolled 57 patients with metastatic non-small cell lung cancer (NSCLC) who had the genetic mutation BRAF V600E and had failed at least one prior line of chemo. The primary endpoint was overall response rate (ORR). Secondary endpoints were duration of response (DoR) and progression-free survival (PFS). All were determined by the investigator.
- Median DoR and PFS were 9.0 months and 9.7 months, respectively, while 63.2% (n=36/57) showed a clinical response. Half of the responders (n=18/36) continued to respond to treatment at the time of the data cutoff.
- The most common adverse events (>20%) were pyrexia (fever), nausea, vomiting, diarrhea, asthenia (lack of energy), decreased appetite, dry skin, chills, peripheral edema, cough and rash.
- Tafinlar and Mekinist are currently approved by the treatment of BRAF V600E-positive melanoma.
Sun, Jun. 5, 9:32 PM
- Results from a Phase 3 clinical trial, METEOR, assessing Exelixis' (NASDAQ:EXEL) CABOMETYX (cabozantinib) in patients with advanced renal cell carcinoma (RCC) who have had prior anti-angiogenic therapy showed almost a 30% increase in median overall survival (OS) compared to Novartis' (NYSE:NVS) Afinitor (everolimus). The data were presented today at ASCO16 in Chicago.
- After almost 19 months, median OS for patients treated with CABOMETYX was 21.4 months compared to 16.5 months for everolimus with a 34% reduction in the risk of death (hazard ratio = 0.66).
- The FDA approved CABOMETYX for the treatment of RCC in April.
- Previously: FDA approves Exelixis' lead cancer drug cabozantinib; shares up 9% premarket (April 26)
Novartis AG develops, manufactures, and markets healthcare products. It operates through the following segments: Pharmaceuticals, Alcon, Sandoz, Vaccines & Diagnostics, and Consumer Health. The Pharmaceuticals segment provides patent-protected prescription medicines. The Alcon segment offers... More
Industry: Drug Manufacturers - Major
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