Dec. 1, 2014, 3:52 PM
- Italy's drug regulator AIFA determines that Novartis' (NVS -0.3%) FLUAD vaccine is safe. Last week, the agency suspended two lots of the product after three people died shortly after being vaccinated.
- Previously: Italian drug regulator suspends two batches of Novartis flu vaccine after deaths
Dec. 1, 2014, 12:26 PM
- Teva Pharmaceutical Industries (TEVA) launches its generic equivalent to Novartis' (NVS -0.1%) high blood pressure med Exforge HCT (Amlodipine, Valsartan, Hydrochlorothiazide) Tablets in the U.S.
- Teva was the first to file so it has marketing exclusivity against other generic firms for 180 days.
- Per IMS Health, Exforge HCT generates annual sales in the U.S. of ~$158M.
Dec. 1, 2014, 7:12 AM
- Novartis' (NYSE:NVS) Gilenya (fingolimod), approved for relapsing multiple sclerosis (MS) in the U.S. and highly active relapsing-remitting MS in Europe, failed to demonstrate a significant difference compared to placebo on a combination of disability measures in a Phase 3 trial evaluating the drug in primary progressive multiple sclerosis (PPMS). PPMS is a disorder of the central nervous system which affects ~10% of the 2.3M MS sufferers worldwide.
- Two other Phase 3 trials assessing Gilenya in pediatric MS and chronic demyelinating polyradiculoneuropathy are ongoing.
Nov. 28, 2014, 8:15 AM
- After three people died shortly after receiving Novartis' (NYSE:NVS) Fluad influenza vaccine, Italy's drug regulator AIFA suspends two lots of the product. In an e-mailed statement, Novartis says, "A review of the two batches confirmed that they conform with all production and quality standards and no casual relationship to the vaccine have been established."
- Fluad was approved in 1997 and has an extensive history of safe use.
- The three deaths, and another serious adverse event, all occurred in the southern regions of Sicily and Molise. One of the deaths was a 68-year-old man who died ten minutes after being vaccinated.
Nov. 28, 2014, 7:28 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) grants accelerated assessment to Novartis' (NYSE:NVS) LCZ696, an investigational drug for the treatment of heart failure with reduced ejection fraction. This is the first time CHMP has extended such a review for a cardiovascular medicine. The designation shortens the committee's review period by 60 days (210 to 150) so a decision should be forthcoming in 2015.
- Novartis expects to submit its Marketing Authorization Application (MAA) in early 2015. The basis for the submission is he Paradigm-HF study where LCZ696 demonstrated superiority compared to ACE-inhibitor enalapril.
- The drug candidate is under Fast Track review in the U.S. The company's rolling submission should be complete by the end of next month.
- Previously: Novartis chief says new heart failure drug will be a winner
- Previously: Novartis heart failure drug candidate beats enalapril
Nov. 26, 2014, 3:48 PM
- The Federal Trade Commission approves GlaxoSmithKline's (GSK +0.4%) proposed acquisition of Novartis' (NVS +0.6%) vaccines business and the proposed creation of a consumer healthcare joint venture between the two firms.
- As a condition of the positive vote, Novartis will divest its private label nicotine replacement therapy transdermal patch, Habitrol, in the U.S. to Dr. Reddy's Laboratories SA (RDY +1.5%).
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
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Nov. 25, 2014, 7:10 AM
- The FDA extends its priority review period by up to three months for Novartis' (NYSE:NVS) panobinostat in combination with bortezomib and dexamethasone for the treatment of patients with previously treated multiple myeloma.
- The company submitted the NDA in March 2014. The FDA granted priority review status in May which reduced the standard 12-month review period to eight months. The extension follows the Oncologic Drugs Advisory Committee meeting earlier this month which voted 5-2 that the the benefits of panobinostat do not outweigh the risks.
- Previously: Ad Comm votes against panobinostat
Nov. 24, 2014, 8:18 AM
- The European Commission approves Novartis' (NYSE:NVS) Signifor (pasireotide) for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadaquately controlled on treatment with a first-generation somatostatin analogue (SSA).
- The once monthly injection directly targets the pituitary tumor and gives patients an alternative treatment option for those who are inadaquately controlled by SSAs.
- Signifor is currently approved in over 60 countries for the treatment of Cushing's disease.
Nov. 24, 2014, 8:02 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Duaklir Genuair (aclidium bromide/formoterol fumarate 340/12 mcg) for the maintenance bronchodilator treatment in adults with chronic obstructive pulmonary disease (COPD).
- The product is a fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action. Aclidium bromide is an anticholinergic or long-acting muscarinic antagonist that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both are currently approved as stand-alone therapies for the maintenance treatment of COPD in the U.S. and Europe.
- Genuair is a multi-dose pre-loaded dry powder inhaler that utilizes optical and acoustic signals to inform the patient that the correct dose has been delivered.
- COPD-related tickers: (NYSE:GSK) (NYSE:NVS) (NASDAQ:THRX) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Nov. 24, 2014, 7:05 AM
- On December 18 GlaxoSmithKline (NYSE:GSK) shareholders will vote on the company's planned acquisition of Novartis' (NYSE:NVS) vaccines business, the latter's acquisition of Glaxo's cancer products and the combination of their consumer healthcare businesses. The total value of the assets involved is ~$20B.
- Previously: Novartis announces billions of dollars in deals with GSK, Eli Lilly
- Previously: Why Glaxo bids adieu to cancer drugs
Nov. 21, 2014, 7:19 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting regulatory approval for Novartis' (NYSE:NVS) secukinumab for the first-line systemic treatment of adult patients with moderate-to-severe plaque psoriasis. A final decision by the European Commission usually takes about 60 days.
- Secukinumab is an interleukin-17A inhibitor and will be sold under the brand name Cosentyx. It will compete with Amgen's (NASDAQ:AMGN) Enbrel (etanercept) which generated $4.6B in sales the past four quarters. In clinical trials, secukinumab demonstrated superiority to etanercept in skin clearance measurements.
- Last month, an FDA advisory committee voted unanimously in favor of approval for secukinumab for the same indication.
- Previously: Ad Comm backs approval of secukinumab
Nov. 18, 2014, 7:47 AM
- At this week's American Heart Association meeting in Chicago, Novartis (NYSE:NVS) presented additional data on its heart failure drug candidate, LCZ696, compared to the ACE inhibitor enalapril.
- LCZ696, an ARNI inhibitor, demonstrated a 20% reduced risk of dying suddenly; reduced first and subsequent HFrEF (heart failure with reduced ejection fraction) hospitalizations by 21% and 23%, respectively; reduced hospitalizations for a cardiovascular reason or by any reason both by 16%; reduced the need for more intense treatment at home by 16% and reduced emergency room visits due to rapid symptom worsening by 30%.
- The hospitalization periods for LCZ696 and enalapril were similar, but patients receiving LCZ696 had 18% fewer stays in intensive care and were 31% less likely to need IV drugs to help their heart pump.
- LCZ696 is a twice a day medicine being investigated for heart failure. Its mode of action enhances the protective neurohormonal systems of the heart while simultaneously suppressing the harmful system ((RAAS)). Current drugs only block the harmful effects so mortality remains high with up to 50% of patients dying within five years of a heart failure diagnosis.
- The company expects to complete its PMA submission to the FDA by the end of 2014 and its MAA to Europe's EMA in early 2015.
Nov. 15, 2014, 5:11 PM
- More than 60% of secukinumab 150mg patients achieved significant improvements in ankylosing spondylitis (AS) symptoms, seen as early as Week 1 and sustained through one year of treatment.
- Primary endpoint measure 1: 60.8% and 59.7% for secukinumab 150mg and 75mg, respectively, vs. 28.7% for placebo.
- Primary endpoint measure 2: 61.1% and 41.1% for secukinumab 150mg and 75mg, respectively, vs. 28.4% for placebo.
- Secukinumab is the first selective IL-17A inhibitor to significantly improve signs and symptoms of AS versus placebo in Phase III studies.
- AS is a common type of spondyloarthritis, a family of long-term, inflammatory diseases impacting joints, which affects up to 1% of the general population.
- Source: press release
Nov. 13, 2014, 11:56 AM
- The FDA's Anesthetic and Analgesic Drug Products Advisory Committee meets on November 24, 25 to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also review the efficacy of ESI and the overall risk benefit profile of injecting steroids in the epidural space to treat pain. Regulatory options will also be discussed which could include changes to product labeling.
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- Related tickers: (MRK +0.7%)(PFE +0.2%)(BMY -1.3%)(NVS +2%)
Nov. 12, 2014, 1:13 PM
- The FDA's Ophthalmic Devices Panel of the Medical Devices Advisory Committee meets tomorrow to discuss Alcon Laboratories' (NVS -0.1%) premarket approval application (PMA) for its AcrySof IQ ReSTOR Multifocal Toric Posterior Chamber Intraocular Lens. The applied-for indication is the visual correction of aphakia and pre-existing astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia.
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