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Jul. 24, 2015, 1:47 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting the approval of Novartis' (NVS -1.1%) Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. A final decision by the European Commission usually takes ~60 days. The FDA has granted Priority Review for the same patient population.
- The combination has been cleared in the U.S. since January 2014 for the treatment of BRAF V600E/K mutation-positive unresectable or metastatic melanoma.
Jul. 24, 2015, 12:26 PM
- The FDA approves Novartis' (NVS -0.5%) Odomzo (sonidegib) for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy or who are not candidates for surgery or radiation therapy.
- Odomzo is a once-daily pill that inhibits the molecular pathway called Hedgehog. It will compete with Roche's (OTCQX:RHHBY -0.9%) Erivedge (vismodigib), an antagonist of part of the hedgehog signaling pathway called smoothened receptor (SMO), that was cleared in January 2012. It will generate ~$175M in sales this year.
Jul. 24, 2015, 10:10 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of Novatis' (NVS +0.3%) Revolade (eltrombopag) for the treatment of adult patients with acquired severe aplastic anemia who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for hematopoietic stem cell transplantation. A final decision by the European Commission usually takes ~60 days.
- Novartis acquired Revolade, branded as Promacta in the U.S., from GlaxoSmithKline earlier this year. It is currently approved for the treatment of thrombocytopenia (low blood platelets).
- Revolade utilizes Ligand Pharmaceuticals' (LGND +0.2%) Captisol technology which optimizes its solubility and stability.
Jul. 22, 2015, 11:43 AM
- Novartis (NVS -1.4%) submits a supplemental Biologics License Application (sBLA) to the FDA seeking approval for Arzerra (ofatumumab) for the maintenance treatment of patients with relapsed chronic lymphocytic leukemia (CLL). It is currently cleared, in combination with chlorambucil, for treatment-naive CLL patients who are not candidates for fludarabine or who are refractory to fludarabine and alemtuzumab.
- Ofatumumab is a human monoclonal antibody that binds to CD20, an antigen found on the surface of CLL cells and normal B lymphocytes. It was approved by the FDA in April 2014 and by the European Commission in July 2014.
- Novartis is developing ofatumumab for cancer indications as part of its acquisition of GlaxoSmithKline's (GSK -1%) oncology business. GSK will continue to develop and commercialize it for autoimmune indications. The antibody was discovered by Danish biotech Genmab A/S (OTC:GNMSF) (OTCPK:GMXAY).
Jul. 21, 2015, 12:36 PM
- The U.S. Court of Appeals for the Federal Circuit rejects Amgen's (AMGN -0.5%) attempt to block Novartis' (NVS -1.7%) Sandoz unit from launching Zarxio (filgrastim - sndz), a biosimilar to Neupogen (filgrastim), in the U.S. The current injunction will remain in place until September 2.
- A district court rebuffed Amgen in March. The FDA approved Zarxio on March 6.
- Previously: Court rejects Amgen's bid to block Neupogen biosimilar (March 20)
- Previously: FDA clears first biosimilar (March 6)
Jul. 21, 2015, 7:37 AM
- Novartis (NYSE:NVS) Q2 results ($M): Total Revenues: 12,694 (-5.3%); Pharmaceuticals: 7,847 (-4.3%); Alcon: 2,559 (-9.2%); Sandoz: 2,288 (-1.8%).
- Net Income: 1,838 (-28.9%); EPS: 0.75 (-27.2%); CF Ops: 2,910 (-12.9%); Gross Profit: 8,409 (-12.1%).
- Key Product Sales: Gleevec/Glivec: 1,184 (-1.3%); Gilenya: 700 (+15.5%); Lucentis: 537 (-13.2%); Afinitor/Votubia: 423 (+10.2%); Sandostatin: 413 (-1.0%); Diovan/Co-Diovan: 333 (-55.2%); Tasigna: 412 (+10.5%); Galvus: 273; Exforge: 272 (-26.5%).
- 2015 Guidance: Group Net Sales Growth: mid single digit (unch); Core Group Operating Income Growth: high single digit (unch); Pharmaceuticals Sales Growth: mid single digit (unch); Alcon Sales Growth: low single digit from mid-to-high single digit; Sandoz Sales Growth: high single digit from mid single digit.
Jul. 21, 2015, 6:16 AM
- Novartis (NYSE:NVS): Q2 EPS of $1.27 beats by $0.03.
- Revenue of $12.69B (-4.9% Y/Y) beats by $240M.
Jul. 21, 2015, 3:45 AM
- Novartis' (NYSE:NVS) second-quarter profit fell 32% from the same period last year, as the drug giant got hit by a strong dollar and weak results from its eye-care treatment business.
- Net income fell to $1.86B, or $0.77 per share in the quarter ended in June vs. $2.72B a year earlier. Core net income fell 8%.
- Novartis also confirmed its full year outlook, with net sales expected to grow in the mid-single digits and core operating income to grow at a faster, high-single-digit rate.
Jul. 20, 2015, 5:30 PM
Jul. 20, 2015, 9:06 AM
- A Phase 3 clinical trial, called CheckMate-025, comparing Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) to Novartis' (NYSE:NVS) Afinitor (everolimus) in patients with advanced/metastatic renal cell carcinoma (RCC) has been stopped early after an assessment by the independent Data Monitoring Committee concluded that the study met its primary endpoint of demonstrating superior overall survival (OS) in patients receiving Opdivo. Secondary endpoints include objective response rate and progression-free survival.
- BMY will complete a full analysis of the data and will share the results with health authorities in the near future. It plans to present the information at a future medical meeting and submit it for publication.
- Bristol-Myers SVP, Head of Development, Oncology, Michael Giordano says, "The results of CheckMate-025 mark the first time an immuno-oncology agent has demonstrated a survival advantage in advanced RCC, a patient group that currently has limited treatment options. Through our Opdivo clinical development program, we aim to redefine treatment expectations for patients with advanced RCC by providing improved survival."
- Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor, is approved in the U.S. for the treatment of metastatic melanoma and previously treated advanced squamous non-small cell lung cancer.
Jul. 20, 2015, 7:42 AM
- Top-line results from a Phase 3 clinical trial, called METEOR, show Exelixis' (NASDAQ:EXEL) Cometriq (cabozantinib) reduced the risk of disease progression or death by 42% compared to Novartis' (NYSE:NVS) Afinitor (everolimus). The late-stage study compared the two drugs in 658 patients with renal cell carcinoma (RCC) who had experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor.
- The trial met its primary endpoint of a statistically significant increase in progression-free survival (PFS) in the first 375 randomized patients (p<0.0001) as determined by an independent radiology committee.
- Data on Overall Survival (OS) in the population of 658 patients were immature at the data cutoff, although an interim analysis showed a trend in OS favoring cabozantinib. Final analysis of OS is expected around August 2016.
- Exelixis plans to complete regulatory filings in the U.S. and Europe early next year. The FDA designated cabozantinib for Fast Track review for RCC in April. It originally approved it in November 2012 for the treatment of progressive metastatic medullary thyroid cancer.
- The company will host a conference call this morning at 8:30 am ET to discuss the data.
- Shares are up 33% premarket on robust volume.
Jul. 16, 2015, 8:34 AM
- Small cap Radius Health (NASDAQ:RDUS) is up a modest 2% premarket on light volume in response to its announcement that its investigational drug RAD1901, in combination with CDK4/6 inhibitors [Pfizer's (NYSE:PFE) Ibrance (palbociclib)] and mTOR inhibitors [Novartis' (NYSE:NVS) Afinitor (everolimus)] showed anti-tumor activity in preclinical breast cancer models with either wild type or mutant ESR1 (estrogen receptor 1). Tumor shrinkage was much greater when exposed to the combination including RAD1901 compared to the other agents alone.
- RAD1901 is a selective estrogen receptor degrader (SERD) that crosses the blood-brain barrier. If approved, it will be the first ER-targeted therapy to have this capability thereby enabling the treatment of intracranial metastatic breast cancer tumors.
- The company is currently enrolling patients in a Phase 1 dose escalation study of RAD1901 in postmenopausal women with advanced estrogen receptor-positive and HER2-negative breast cancer. The study will determine the recommended dose for a Phase 2 trial.
Jul. 9, 2015, 9:14 AM
- The Medicines Company (NASDAQ:MDCO) announces an agreement with Sandoz (NYSE:NVS) allowing the latter to launch an authorized generic version of Angiomax (bivalirudin) in the U.S.
- Recently, MDCO lost an appeal of a court ruling that found its Angiomax patents were valid but not infringed by Hospira's generic version. The appeals court ruled that the patents were actually invalid. In October of last year, MDCO prevailed in a patent suit against Mylan.
- Previously: The Medicines Company loses appeal of Angiomax patent suit against Hospira (July 2)
- Previously: Medicines Co. prevails in patent challenge from Mylan (Oct. 28, 2014)
Jul. 7, 2015, 4:43 PM
- The FDA approves Novartis' (NYSE:NVS) LCZ696, branded as Entresto (sacubitril/valsartan), for the treatment of heart failure with reduced ejection fraction. The agency's assessment was done under its Priority Review and Fast Track designations.
- Entresto's mechanism of action enhances the protective neurohormonal systems of the heart while simultaneously suppressing the harmful RAAS (renin-angiotensin-aldosterone system). Analysts project peak sales for the blockbuster of almost $4B.
- Heart failure affects over 5M Americans.
Jun. 30, 2015, 3:12 PM
- The U.S. Department of Justice wants Novartis (NVS -0.1%) to cough up $3.35B in civil fines and damages as restitution for its alleged misconduct in promoting Myfortic (to prevent organ rejection in kidney transplant recipients) and Exjade (to treat iron overload from blood transfusions) to federal healthcare programs that resulted in substantial over-payments for the meds. Specifically, the feds accuse the company of using various schemes, such as rebates, to boost sales to specialty pharmacies.
- The Justice Department seeks $1.52B in damages, triple what Medicare and Medicaid paid for the two drugs as a result of the kickbacks between 2004 and 2013, and up to $1.83B in fines.
- The case stems from a whistleblower lawsuit filed in 2011 by a former sales manager.
- Another wrinkle in the situation is the impact the company's Corporate Integrity Agreement, signed in 2010, will have. It requires the firm to establish an internal compliance program and report violations, areas that appear to have been unaddressed.
Jun. 29, 2015, 9:22 AM
- Results from a Phase 3 trial, called FUTURE 2, show that 64% of psoriatic arthritis (PsA) patients treated with subcutaneous injections of Novartis' (NYSE:NVS) Cosentyx (secukinumab) (150 mg or 300 mg) continued to exhibit improvement after one year of treatment as measured by ACR20 (20% improvement of symptoms). In addition, ACR50 (50% improvement in symptoms) rates were maintained as well (39% and 44%, respectively).
- The study met its primary endpoint of ACR20 at week 24 versus placebo. The response rates for 150 mg, 300 mg and placebo were 51%, 54% and 15%, respectively (p<0.0001). The data were published in The Lancet.
- Secukinumab is the first IL-17A (interleukin 17-A) inhibitor to demonstrate efficacy in a late stage PsA study. IL-17A is a pro-inflammatory cytokine produced by activated T cells.
- Regulatory applications for PsA are in process. Consentyx is currently cleared for sale in the U.S. for the treatment of moderate-to-severe plaque psoriasis.
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