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March 26, 2013
06:32 EDTBMY, TEVA, ACT, GNK, NVS, PFE, GSK, MYL, JNJSome justices seem skeptical about payments to generic drug firms, NY Times says
Several Supreme Court justices seemed skeptical about the practice of brand name pharmaceutical companies paying generic companies to keep their cheaper drugs off the market for a longer time, according to The New York Times. Some of the justices appeared to be interested in issuing a narrow ruling in the case they are hearing regarding the issue that would not create a precedent, the newspaper added. Reference Link
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September 29, 2015
08:02 EDTTEVAEagle Pharma receives new patent for bendamustine rapid infusion product
Eagle Pharmaceuticals (EGRX) announced that the United States Patent and Trademark Office has granted U.S. Patent No. 9,144,568, which pertains to the use of the bendamustine hydrochloride formulation administered in a 50mL bag within ten minutes. The patent issued today expires on March 15, 2033. This new patent, along with three previously issued Patents, further expands and protects Eagle's bendamustine HCI intellectual property estate. The Prescription Drug User Fee Act goal date for a decision on the NDA by the FDA is December 2015. The NDA requests FDA approval of the rapid infusion bendamustine HCl product for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The NDA for Eagle's rapid infusion bendamustine product is supported by data from a clinical trial completed in November 2014, which demonstrated that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low- volume, 50 mL admixture. The rapid infusion product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. In February 2015, Eagle and Teva Pharmaceutical Industries Ltd. (TEVA) entered into an exclusive license agreement for the rapid infusion bendamustine product. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.
06:31 EDTJNJJohnson & Johnson upgraded to Buy from Hold at Deutsche Bank
Deutsche Bank analyst Kristen Stewart upgraded Johnson & Johnson to Buy calling the company a "diversified safe haven" amid volatile times for the sector. Stewart left a recent meeting with management "feeling more confident" that the company will see growth across all divisions, including pharma despite patent expirations. J&J is "flush with cash," giving management opportunities to enhance growth through deals, she tells investors in a research note. Stewart keeps a $110 price target for J&J shares. The stock closed yesterday up 28c to $91.28.
05:23 EDTBMYBristol-Myers upgraded to Buy from Neutral at UBS
UBS analyst Marc Goodman upgraded Bristol-Myers Squibb to Buy saying Opdivo positions the company as a clear leader in the immuno-oncology space. Goodman raised his 2020 sales estimate for the drug to $10B from $8B citing the "very strong" renal cancer data, a larger lung market and additional smaller new indications. The recent pullback in the Pharma sector is overdone, Goodman tells investors in a research note on Bristol titled "We Like This Opportunity Right Here Right Now." He raised his price target for shares to $75 from $65. Bristol closed yesterday down $2.75 to $57.49.
September 28, 2015
16:40 EDTTEVAAllergan to begin reporting Global Generics business as discontinued ops in Q3
Allergan (AGN) intends to begin reporting its Global Generics business as discontinued operations with its third quarter 2015 results. The transaction with Teva (TEVA) is expected to close in the first quarter of 2016.
16:23 EDTTEVAAllergan sees 10% branded revenue growth after divestiture of generics unit
Following the close of the divestiture of the Generics business to Teva (TEVA), New Allergan (AGN) expects to have a powerful financial profile to drive continued long-term growth: 10% branded revenue growth; Non-GAAP gross margins of 77% to 79% with additional long-term expansion anticipated; Non-GAAP SG&A as a percentage of revenue between 21-24%, declining within that range over time; Non-GAAP tax rate of ~15%; Interest expense for New Allergan will be largely dependent on capital deployment decisions following the close of the transaction; Commitment to investment grade ratings. "New Allergan will have strong double-digit revenue growth and will be a development powerhouse stacked with 70 mid-to-late stage R&D projects to address customer and patient needs," said Brent Saunders, CEO and President. "The New Allergan will be lean and nimble with an expanded margin profile driven by leading brands in seven therapeutic categories, a streamlined operating model with one of the most efficient SG&A as a percentage of sales in the industry, a non-GAAP tax rate of approximately 15 percent, and a simplified manufacturing network globally. The continued robust performance of our overall business and strong mid-to-late stage pipeline puts Allergan in a strong position to meet our growth targets for the remainder of the year and over the long-term."
15:29 EDTJNJJohnson & Johnson volatility at 52-week high
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15:20 EDTBMYBristol-Myers volatility at 52-week high
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15:01 EDTPFEPfizer volatility at high end of one-year range
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12:22 EDTNVSArray says binimetinib-encorafenib combo shows differentiated tolerability
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07:58 EDTNVSNovartis to hold a conference call
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07:52 EDTGSK, TEVA, PFE, BMYIIR Holdings to hold a conference
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07:46 EDTTEVAUBS to hold a field trip
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07:31 EDTMYLMylan launches generic Invega tablets
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07:27 EDTMYL, JNJ, PFEFDA and the Parental Drug Association to co-host a conference
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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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18:28 EDTBMYBristol-Myers reports longer term Phase 3 data on Opdivo for lung cancer
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16:58 EDTGSKGlaxoSmithKline, Theravance report Phase 3 data on Anoro Ellipta for COPD
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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.
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