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March 27, 2013
06:25 EDTHSP, NVS, BDX, TEVAInjectable drug shortages may ease with rising interest, WSJ reports
The shortage of injectable drugs used by hospitals could ease as more healthcare companies look to become new manufacturers, Wall Street Journal reports. Becton Dickinson (BDX) became the latest player in the $7B market with yesterday's approval for an antihistamine, the paper adds. Reference Link
News For BDX;HSP;TEVA;NVS From The Last 14 Days
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September 28, 2015
05:26 EDTTEVATeva announces approval of Copaxone in Japan
Teva announced the approval by the Japanese Ministry of Health, Labour and Welfare of once-daily COPAXONE 20mg injection for the prevention of relapse of multiple sclerosis . The product will be commercialized in Japan by Takeda Pharmaceutical Company Limited. In Japan, glatiramer acetate was developed as an Unapproved New Drug by Teva Pharmaceutical K.K., a wholly owned subsidiary of Teva, at the request of the MHLW. In March, 2013, Takeda and Teva signed an agreement in which Teva granted Takeda the right to commercialize COPAXONE in Japan. The Japanese approval for COPAXONE is based on the safety and efficacy results of an open-label, 52-week clinical trial conducted by Teva Pharmaceutical K.K. in patients with relapsing-remitting multiple sclerosis in Japan as well as the pivotal trial data sets used for approvals in other countries.
September 27, 2015
18:48 EDTNVSNovartis reports updated Phase 3 data on Tafinlar-Mekinist for melanoma
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16:53 EDTTEVATeva reports Phase 3 data on reslizumab for asthma exacerbations
Teva Pharmaceutical presented results from a post hoc analysis of two pivotal Phase 3 clinical trials showing that treatment with reslizumab reduced clinical asthma exacerbations by 75% versus placebo in a subgroup of patients with late onset asthma with elevated blood eosinophils, who were inadequately controlled on inhaled corticosteroids. Reslizumab is a humanized anti-interleukin-5 monoclonal antibody. Results were pooled from two Phase 3 clinical trials that investigated reslizumab IV 3mg/kg in patients who had at least one asthma exacerbation within the previous year. In the subgroup with late onset asthma, reslizumab showed a 75% reduction in asthma exacerbations and improvement in lung function as measured by forced expiratory volume in one second. In the overall pooled patient population, asthma exacerbations were reduced by 54%, and in the subgroup of subjects diagnosed with asthma at less than 40 years of age, exacerbations were reduced by 42%. Common adverse events in the reslizumab treatment group were comparable to placebo.
16:16 EDTNVSNovartis reports Phase 3 reults on Afinitor for neuroendocrine tumors
Novartis announced results of a Phase 3 pivotal study showing Afinitor, or everolimus, tablets reduced the risk of progression by 52% versus placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin. Additionally, the data show everolimus, a mammalian target of rapamycin inhibitor, extended median progression free survival by 7.1 months. Median PFS by central review was 11 months in the everolimus arm and 3.9 months in the placebo arm. Overall survival was a key secondary endpoint of the trial. While the OS data are not mature, the first interim analysis showed a trend favoring the everolimus arm, according to Novartis. Additional analyses are planned. Another secondary endpoint was best overall response rate. The study found that 64% of patients receiving everolimus experienced at least some degree of tumor shrinkage compared to 26% of those on placebo. Adverse events were consistent with the known safety profile of everolimus. The results of the RADIANT-4 study will serve as the basis of worldwide regulatory submissions for Afinitor for the treatment of advanced, progressive, nonfunctional GI and lung NET, Novartis said.
September 25, 2015
09:02 EDTTEVATeva acquires Gecko Health Innovations, terms not disclosed
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08:37 EDTTEVAAntares Pharma could benefit from drug pricing controversy, says Oppenheimer
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07:22 EDTNVS, TEVAEuropean Society for Medical Oncology to hold a conference
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05:15 EDTNVSNovartis announces CHMP adopted positive opinion for Entresto
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September 24, 2015
18:38 EDTNVSNovartis CEO discusses drug pricing, paying doctors, Washington Post reports
Novartis CEO Joseph Jimenez said in an interview with the Washington Post, "Drug pricing is a very complicated topic because we invest in high-risk activity... So when we price a drug, we price it based on the value it will bring into that marketplace, and also how its price compares to the other therapies currently on the market. There's been a lot of discussion about drug pricing. What we have to do is we have to shift that conversation away from the price toward the value. Like, what exactly is the value of this drug that is going to result in a positive outcome? And is society willing to pay for that drug? At Novartis, we take a little bit of a different approach than our peers. Not only are we a large, innovative drug manufacturer, but we also are the second largest generics manufacturer... I also believe at Novartis that the day that patents expire, it's our obligation to offer a low-cost version in a generic form." Discussing the practice of drug companies paying doctors to prescribe particular drugs, Jiminez said, "It's unfortunate, because that's a situation where society's expectations have changed to the point where even doing what's legal is not doing what's right. What we have to do is, we have to find new ways to educate physicians about our new drugs... We're looking at ways digitally to communicate with physicians and at some new tools, so we can stay ahead of the curve. So rather than wait for regulations to change, Novartis can step back and say, 'We're going to do what society would expect us to do, not just do what's legal.'" Reference Link
09:07 EDTNVSUnilife ammends clinical supply agreement with Novartis
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08:36 EDTBDXBecton Dickinson's Enteric Parasite Panel cleared by FDA
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07:26 EDTTEVATeva stock performance can improve into year-end, says Deutsche Bank
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07:12 EDTTEVATeva added to short-term buy list at Deutsche Bank
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September 22, 2015
08:23 EDTTEVAWith Pharma in 'hot seat,' Citi still likes Allergan, Teva
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07:43 EDTNVS, TEVADrug stocks could be hurt by focus on pricing, says Oppenheimer
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06:20 EDTTEVALeerink reiterates Outperform on Neurocrine after call with neurologists
Leerink analyst Paul Matteis reiterates an Outperform rating on Neurocrine (NBIX) after speaking with two neurologists on the clinical potential of the company's NBI-98854 and Teva's (TEVA) SD-809 for the treatment of Tardive Dyskinesia, Tourette's Syndrome and Huntington's Chorea. Matteis left the call "increasingly optimistic" on the likelihood of NBI-98854 showing Phase III success for Tardive Dyskinesia. The analyst has a $67 price target for shares.
06:19 EDTNVS, HSPClinton to roll out plan to rein in prescription drug costs, USA Today reports
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September 21, 2015
14:28 EDTNVSTuring CEO says will not change Daraprim price despite criticism
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14:04 EDTHSPClinton vow to end drug price gouging sinks biotechs
Biotech stocks have declined across the board in afternoon trading following a tweet by Presidential candidate Hillary Clinton criticizing the "outrageous" prices of specialty drugs. TURING STEPS UP PRICING: Clinton's tweet directly referenced Turing Pharmaceuticals' Daraprim treatment for toxoplasmosis, which recently had its price hiked from just $13.50 per pill to $750 after the privately-held company acquired the drug from Impax Laboratories (IPXL). Importantly, Daraprim was first approved by the FDA in 1953 and its patents have long since expired. No generic versions of the drug currently exist, perhaps in part due to Turing executive chairman Martin Shkreli's strategy of tightly controlling distribution, according to a New York Post article on the issue. In a Bloomberg TV interview this morning, Shkreli claimed that the drug remains underpriced compared to what he called its peers in the rare disease space. However, note that a World Health Organization analysis from 2013 reported that over 190,000 cases of toxoplasmosis occur globally every year and Daraprim continues to be listed on the organization's list of essential medicines for a basic health-care system. INDUSTRY CRITICISM: Turing's Daraprim pricing prompted a response from the Infectious Diseases Society of America and the HIV Medicine Association, which criticized the "unjustifiable" new cost of the drug and urged a "rational" pricing strategy. The news surrounding Daraprim also comes on the heels of Presidential candidate Bernie Sanders issuing a letter in August to Valeant (VRX) and Hospira (HSP), in which he requested information on the "enormous" price increases of two drugs Valeant acquired earlier in the year. REPUBLICAN CONGRESS: In a research note released this afternoon, RBC Capital analyst Michael Yee reminded investors that Republicans still control Congress, offering a sobering reminder that campaign trail promises often fall by the wayside once the candidate steps into office. Yee explained that, though drug pricing debates during next year's election will probably generate headline risk for the biotech space, the Republican-controlled Congress is unlikely to sign into law any material changes on the issue. BIOTECH STOCK ACTION: Hillary Clinton's promise to "lay out a plan" tomorrow to tackle "price gouging" in the specialty drug market sent numerous biotech stocks plunging. Aerie Pharmaceuticals (AERI) has crashed 12.6% at time of writing, while Retrophin (RTRX), Ultragenyx (RARE), and PTC Therapeutics (PTCT) are down 14.7%, 13.4%, and 11%, respectively. Biotech giants AbbVie (ABBV), Gilead (GILD), Bristol-Myers Squibb (BMY) and Biogen (BIIB) have also slipped in intraday trading, while the NASDAQ Biotechnology index is down roughly 4%.
11:24 EDTNVSHillary Clinton vows to take on 'outrageous' specialty drug pricing
Hillary Clinton, on the heels of a Wall Street Journal report detailing Turing Pharmaceuticals' price hike to $750 from $13.50 per pill of a drug called Daraprim which treats a life-threatening parasitic infection, vowed to lay out a plan tomorrow to take on what she calls "price gouging" of specialty drugs. The presidential nominee stated in a tweet, "Price gouging like this in the specialty drug market is outrageous. Tomorrow I'll lay out a plan to take it on." The iShares Nasdaq Biotechnology Index (IBB) moved lower following Clinton's tweet.
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