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June 4, 2014
04:55 EDTZIOP, ZIOP, PFE, PFE, ALKS, ALKS, TEVA, TEVA, SNY, SNY, GSK, GSK, MRK, MRK, RHHBY, RHHBY, BAYRY, BAYRY, DRNA, DRNA, KBIO, KBIO, ABBV, ABBVBoston Biotech Conference to hold a conference
Boston CEO Conference to be held in Boston on June 4-5.
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July 16, 2014
07:04 EDTPFEPfizer says primary endpoint met in Phase 3 study of BeneFIX
Pfizer announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX showed a statistically significant reduction in the annualized bleeding rate relative to on-demand treatment with BeneFIX. In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%. Study results also showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. In addition to meeting the primary endpoint, the secondary study endpoints showed that none of the 1,254 prophylaxis infusions administered during the study were associated with a less than expected therapeutic effect occurrence, which was defined as a spontaneous bleed occurring within 48 hours of a prophylaxis infusion. These results are preliminary, top-line data and are subject to additional analyses. Complete results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
06:26 EDTMRK, RHHBYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
05:38 EDTGSKGSK, Theravance initiate Phase III IMPACT study
GlaxoSmithKline (GSK) and Theravance (THRX) announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the 'closed' triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease, or COPD. IMPACT is the first pivotal phase III study in a programme to evaluate a once-daily closed triple combination treatment of an inhaled corticosteroid, or ICS; a long-acting muscarinic antagonist, or LAMA; and a long-acting beta2-adrenergic agonist, or LABA, in patients with COPD. The IMPACT study will enrol approximately 10,000 patients and assess whether the combination of FF, or fluticasone furoate, an ICS, UMEC, or umeclidinium, a LAMA, and VI, or vilanterol, a LABA, all delivered in GSK's Ellipta inhaler, can reduce the annual rate of moderate and severe exacerbations compared with two approved once daily COPD treatments, Relvar/Breo Ellipta, FF/VI, which is an ICS/LABA combination, and Anoro Ellipta, UMEC/VI, which is a LAMA/LABA combination.
July 15, 2014
12:21 EDTGSKOn The Fly: Midday Wrap
Stocks on Wall Street were lower at midday despite better than expected quarterly reports from two of the nation's largest financial institutions. Stock futures improved during the pre-market trading session, leading to a higher open for the broader market, following better than expected earnings reports from JP Morgan (JPM) and Goldman Sachs (GS). The earnings news also came alongside another huge M&A deal, as tobacco giants Reynolds American (RAI) and Lorillard (LO) confirmed plans to merge. However, the major averages weakened throughout the morning and fell into negative ground against the backdrop of Fed Chair Janet Yellen giving testimony on Capital Hill. In the Board of Governors' Monetary Policy Report, the central bank said valuation metrics in "some sectors" appear substantially stretched, "particularly those for smaller firms in the social media and biotechnology industries." ECONOMIC EVENTS: In the U.S., retail sales increased 0.2% in June compared to the month prior, making for the weakest reading since January and missing the consensus forecast for an increase of 0.6%. The Empire State manufacturing index climbed to a four-year high of 25.6 in July, beating expectations for a reading of 16.5. Import prices rose 0.1% in June, with export prices slipping 0.4%. Business inventories grew 0.5% in May, which was just below the 0.6% consensus growth expectation. In Europe, Germany's ZEW survey missed expectations, as both its Current Situation and Expectations reading were lower than forecast. COMPANY NEWS: Shares of JPMorgan advanced nearly 4% after the bank reported a profit of $1.46 a share, which included a legal expense of 13c a share, beating analysts' consensus forecast of $1.29. The earnings report comes after CEO Jamie Dimon recently disclosed that he has throat cancer. During the company's conference call, Dimon said he was "feeling great," that doctors had found no evidence of cancer anywhere except in the location where it had originally been detected, and that his prognosis for recovery is "excellent"... Also in the large-cap bank sector, Goldman Sachs' headline earnings and revenue similarly beat expectations. The firm, which said it ranks first in worldwide announced and completed mergers and acquisitions for the year-to-date, advanced about 1% following its report... Along with JPMorgan in the Dow Jones Industrial Average, Johnson & Johnson (JNJ) reported quarterly sales and profits that beat expectations and the healthcare conglomerate raised its fiscal year EPS view to $5.85-$5.92 from $5.75-$5.85. However, its increased outlook range still fell short of the $5.90 per share consensus forecast that analysts had prior to its report... Reynolds American confirmed news that has been speculated for many weeks, announcing that it will acquire peer Lorillard in a cash-and-stock transaction currently valued at $68.88 per Lorillard share, or a total of $27.4B, including the assumption of net debt. Shares of both fell afterward, with Lorillard down 8% to trade near $61.75 at midday and Reynolds slipping 5%. MAJOR MOVERS: Among the notable gainers was small-cap pharma biotechnology research company Codexis (CDXS), which surged nearly 50% after announcing a collaboration and license agreement with GlaxoSmithKline (GSK). Among the noteworthy losers was Aaron's (AAN), which is engaged in the lease ownership and retail sale of a variety of consumer products. Its stock fell over 6% after the company lowered its second quarter outlook, citing lower than expected performance of its core business as the reason for the revision. INDEXES: Near midday, the Dow was down 33.45, or 0.2%, to 17,021.97, the Nasdaq was down 40.48, or 0.91%, to 4,399.94, and the S&P 500 was down 9.24, or 0.47%, to 1,967.86.
11:13 EDTTEVA, MRKPerrigo retreats after analyst sees limited potential buyers
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09:21 EDTGSKOn The Fly: Pre-market Movers
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08:11 EDTMRKMerck looks to revive livestock drug Zilmax, WSJ says
Merck has been preparing to conduct a large-scale study this summer to evaluate the safety of its Zilmax feed additive, which the company pulled from the U.S. market last year over concerns in the beef industry that the drug made it difficult for some animals to walk, reported The Wall Street Journal. Reference Link
07:35 EDTMRKPerrigo potential buyers list could be limited, says Jefferies
After Globes reported that Perrigo retained an investment bank to assist with a potential merger, Jefferies says the list of potential buyers could be limited since the store brand business is fundamentally a high volume, lower margin model. The firm notes U.S. companies that currently do not have large over-the-counter divisions include Bristol-Myers (BMY), Eli Lilly (LLY) and Merck (MRK). Jefferies views the merger speculation surrounding Perrigo as not surprising given the company's strong long-term fundamentals and attractive Irish domicile. It has a Buy rating on the stock with a $160 price target.
06:28 EDTTEVAActivist shareholder says Teva to appoint new chairman, Reuters says
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05:37 EDTRHHBYGenentech Avastin granted priority review by FDA
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July 14, 2014
21:08 EDTGSKCodexis to host conference call
Conference call to discuss the strategic collaboration and license agreement with GSK will be held on July 15 at 8:30 am. Webcast Link
16:30 EDTABBVOn The Fly: Closing Wrap
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16:18 EDTABBVShire shareholders should support latest AbbVie offer, Telegraph says
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16:06 EDTGSKCodexis announces $25M collaboration, license agreement with GlaxoSmithKline
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11:20 EDTRHHBYExelixis seen as potential target for Roche, TheStreet says
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09:34 EDTABBVAbbVie falls after revised Shire acquisition proposal, levels to watch
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09:16 EDTABBVOn The Fly: Pre-market Movers
HIGHER: Citigroup (C), up 3.6% after reporting better than expected Q2 results, announcing $7B settlement with DOJ and FDIC... Apple (AAPL), up 0.7% after Barclays upgrades stock to Overweight, Morgan Stanley raises Apple estimates above consensus... Shire (SHPG), up 1.6% after receiving revised proposal from AbbVie (ABBV) of GPB 53.20 per share, which it says it would be willing to recommend to Shire shareholders. AbbVie is down 2.8% after the news... Mylan (MYL), up 4% after acquiring Abbott's (ABT) non-U.S. developed markets specialty and branded generics business in all-stock transaction valued at about $5.3B. Abbott up 1.6% after the news... Progenics (PGNX), up 13% after FDA says RELISTOR can be approved on data submitted in sNDA... Exelixis (EXEL), up 13% after announcing coBRIM Phase 3 trial met primary endpoint... URS (URS) up 8% after acquired by AECOM Technology (ACM) for $56.31 per share. AECOM shares alos up 2% after deal announcement... Whiting Petroleum (WLL), up 4.5% after agreeing to acquire Kodiak Oil & Gas (KOG) in a $6B transaction. Kodiak Oil & Gas up 3%... Kandi Technologies (KNDI), up 11% after announcing JV's sale of 4,114 EVs in Q2. LOWER: Riverbed (RVBD), down 4.5% after saying it sees its Q2 adjusted EPS at low end of 26c-28c range... Harmonic (HLIT), down 13% after reporting preliminary Q2 earnings results.. EBay (EBAY), down 0.5% after downgraded at Pacific Crest, confirming partnership plans with Sotheby's (BID).
08:04 EDTTEVATeva announces FDA acceptance of NDA filing for albuterol MDPI
Teva Pharmaceuticals Industries announced that the U.S. Food and Drug Administration has accepted for review the company’s new drug application for albuterol multi-dose dry-powder inhaler, an investigational breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm in patients 12 years of age and older. The NDA filing includes data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in adults and adolescents with asthma and exercise-induced bronchospasm. The NDA for albuterol MDPI has been accepted by the FDA for standard review, with a FDA Regulatory Action expected in March 2015.
06:17 EDTGSKXinhua: China indicts two GSK foreign investigators, The Guardian reports
Prosecutors in China have indicted two foreign investigators, British national Peter Humphrey and his wife, Yu Yingzeng, linked to GlaxoSmithKline, for illegally obtaining private information on Chinese citizens, reports The Guardian. Citing state media news agency Xinhua, the case is the first indictment by Chinese prosecutors against foreigners for illegal investigation. Reference Link
05:27 EDTABBVShire receives revised proposal from AbbVie of GPB 53.20 per share
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