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April 10, 2014
11:42 EDTGILD, GSK, RHHBYReport claims Tamiflu, Relenza do little to prevent the spread of flu
The Cochrane Collaboration, an independent nonprofit organization that aims to help health professionals, patients, and policy makers access evidence-based medicine to guide their decisions, concluded in a newly published report that neuraminidase inhibitors Tamiflu and Relenza are stockpiled and recommended by public health agencies but have not been proven to prevent the spread of flu or reduce dangerous complications. Tamiflu was co-developed by and is marketed by Gilead Sciences (GILD) and Roche (RHHBY), while Relenza is marketed by GlaxoSmithKline (GSK). Roche said "we disagree with the overall conclusions" and warned they could "potentially have serious public health implications," according to a company statement quoted by BBC News. Reference Link
News For GILD;RHHBY;GSK From The Last 14 Days
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September 25, 2015
07:42 EDTRHHBYExelixis: CHMP adopts positive opinion for cobimetinib, vemurafenib combination
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07:34 EDTGILDGilead says CHMP adopts poistive opinion for single tablet regimen Genvoya
Gilead Sciences announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion on the company's Marketing Authorization Application for the investigational, once-daily single tablet regimen Genvoya for the treatment of HIV-1 infection. The data submitted in the MAA support the use of the regimen among adult and adolescent treatment-naive individuals, virologically suppressed adults who switch regimens and adults with mild-to-moderate renal impairment. The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union. If authorized, Genvoya would be Gilead's first single tablet regimen to contain TAF. The MAA for Genvoya is supported by 48-week data from two pivotal Phase 3 studies in which the regimen met its primary objective of non-inferiority compared to Gilead's Stribild among treatment-naive adult patients. In the studies, Genvoya demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to Stribild. The MAA is also supported by data from additional Phase 3 studies evaluating the TAF-based regimen among adolescents, virologically suppressed adult patients who switched to Genvoya and adult patients with mild-to-moderate renal impairment.
07:22 EDTRHHBYEuropean Society for Medical Oncology to hold a conference
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06:23 EDTRHHBYRoche CEO: Will see growth regardless of setbacks, Reuters reports
Roche Holding's product lineup is so good that the company will see growth regardless of setbacks, Reuters reports, citing an interview with CEO Severn Schwan with Finanz und Wirtschaft. "Roche could have six new active pharmaceutical ingredients approved within two years. We never had this before," Schwan said. Reference Link
September 24, 2015
11:24 EDTGSKGlaxoSmithKline receives positive CHMP opinion in Europe for Nucala
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05:24 EDTGSKGlaxoSmithKline and Theravance intend to file Relvar Ellipta for COPD in Japan
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September 23, 2015
13:09 EDTGSKEU could green light GlaxoSmithKline's new asthma drug this week, Reuters says
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05:32 EDTGSKViiV Healthcare announces Triumeq Phase IIIb study met primary endpoint
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September 22, 2015
20:02 EDTGILDClinton vows $250 cap on monthly drug costs in blast against biotechs, insurers
Democratic presidential candidate Hillary Clinton railed against biotech companies as well as health insurers at a community health care forum in Iowa on Tuesday. Clinton began her speech by praising the Affordable Care Act, but quickly noted that she wants to strengthen it due to what she called the rising cost of prescription drugs. She explained, "Our pharmaceutical and biotechnology industries deserve credit... [But] too often, these drugs cost a fortune. Now, sometimes there is a good reason for that. Scientific breakthroughs are often the result of major investment... so it may makes sense, for a short period of time, to have to charge a lot of money for a drug. But when a drug has no competition, when there aren't any other treatments that can do what it does, pharmaceutical companies can charge astronomical fees far beyond anything that it would take to recoup their investment, and far beyond what they charge consumers anywhere else in the world outside of America." Referencing the recent criticism against Turing Pharmaceuticals, Clinton went on to say that "pharmaceutical companies that acquire an existing affordable drug that people rely on, and then turn around and charge a fortune for it, [are just betting] on the fact that desperate people will find some way to pay for it." Preemptively responding to questions of whether greater regulation will dampen investment, Clinton commented that "some people worry that my proposals will threaten innovation, but I have designed a plan that will do exactly the opposite... Under my plan, drug companies that want to keep getting federal support will have to redirect more of their profits into meaningful investments in research and development." Clinton also criticized incremental drug improvements, saying that "too often, so-called new drugs are really old drugs that have just been tweaked a little bit, but then they're marketed as breakthrough drugs and they're sold for high prices." The Democratic candidate went on to condemn advertising in the drug industry, remarking that "I also want to tackle direct to consumer advertising... Other countries ban these ads because they are so often misleading. But at the very least, we shouldn't be encouraging them with corporate write-offs... Under my plan, we will instead use that taxpayer money to fund innovation... I would also like to make sure any ads the drug industry does run are approved by the FDA." Moving more broadly onto Medicaid and health insurers, Clinton stated, "I believe Medicare should be able to negotiate for lower prices for its members... I will require drug companies to provide higher rebates for prescription drugs to low income Medicare patients, just like they have to do for Medicaid patients... I think the insurance companies need to be put on notice." Providing more concrete details of her plan, Clinton concluded, "I will cap out of pocket drug costs for working families. You won't have to pay more than $250 a month for covered medications... Particularly for people who have a chronic illness. Also under my plan, you will be able to import cheaper drugs from other countries legally. If the medicine you need costs less in Canada, you should be able to buy it from Canada or any other country that meets our safety standards... I will also make sure we have more generics on the market [by boosting funding for] the FDA's office of generic drugs."
17:35 EDTGILDHillary Clinton vows to cap out-of-pocket drug costs at $250 per month
Presidential candidate Hillary Clinton said in a tweet that, "Under my plan, I'll cap out-of-pocket drug costs for families. You won't have to pay more than $250/month for covered medications." Reference Link
09:33 EDTGILDActive equity options trading on open
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08:23 EDTGILDAnalysts say buy select biotech stocks ahead of Clinton drug plan
Ahead of Presidential candidate Hillary Clinton laying out her plan to tackle "price gouging" in the specialty drug market at an event in Iowa later today, analysts at research firms Jefferies and Piper Jaffray are recommending select biotech stocks that they view as buys amid the weakness in the space. DEBATE: Biotech stocks broadly declined yesterday, with the NASDAQ Biotechnology index (IBB) sliding roughly 4.4%, after privately-held Turing Pharmaceuticals made headlines by enacting a 5,000% price increase on a 62-year-old drug that fights complication of AIDS and cancer. Furor around the sudden price hike for Turing's Daraprim reignited a debate around drug prices that previously embroiled costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni. The news also follows Presidential candidate Bernie Sanders issuing a letter in August to Valeant (VRX) and Pfizer's (PFE) Hospira, in which he requested information on the "enormous" price increases of two drugs Valeant acquired earlier in the year. Presidential candidate Hillary Clinton sent the debate to center stage yesterday by criticizing the "outrageous" prices of specialty drugs and promising to lay out a plan today to tackle "price gouging" in the specialty drug market. Clinton's proposal, which she'll outline in a speech in Iowa later today, would force pharmaceutical companies to reinvest their profits into research, allow for more generic and imported drugs and allow Medicare to negotiate lower drug costs and cap out-of-pocket expenses, according to details of the plan shared with USA Today. Zeke Emanuel, chair of medical ethics and health policy at the University of Pennsylvania, appeared on Nightly Business Report to discuss the problem of high drug prices and his suggested solutions. During his interview, Emanuel contended that giving Medicare the ability to negotiate drug prices may drive up prices for everyone else. DEFENSES: The Jefferies Biotechnology research team, led by Brian Abrahams, Eun Yang and Biren Amin, say their Washington D.C. consultants indicate the recent political rhetoric around drug pricing is unlikely to result in any substantive future policy changes that would impact biotech sector fundamentals. As such, they recommend using yesterday's selloff to buy select companies including Celgene (CELG), BioMarin (BMRN) and Alkermes (ALKS). Pricing concerns are nothing new, and will likely continue to be a headwind for the sector, the analysts tell investors in a research note. Hillary Clinton's proposal to combat drug pricing is likely to include "some combination of old and tried policies that have been out there for a few years," they write. The analysts also like shares of AMAG Pharmaceuticals (AMAG), Alder Biopharmaceuticals (ALDR) and Cempra (CEMP). Meanwhile, Piper Jaffray analyst Edward Tenthoff recommends buying shares of Vertex Pharmaceuticals (VRTX) following yesterday's selloff. Tenthoff believes that drugs like Vertex's Orkambi will maintain premium pricing because of the disease modifying value to patients and payors. Orkambi is approved to treat cystic fibrosis in patients 12 years and older. The analyst reiterates an Overweight rating on Vertex with a $163 price target. DOWNGRADE: Brean Capital analyst Difei Yang downgraded Horizon Pharma (HZNP) to Hold saying "unsettling recent developments" make the stock's premium valuation no longer justified. The public discussion on high drug prices is a negative for the company while its attempt to acquire Depomed (DEPO) is unlikely to result in a completed deal, Yang tells investors in a research note. Further, Horizon's prescription trends are showing weakness, said Yang, who views the stock as more risky than in the past. PRICE ACTION: Horizon closed yesterday down $2.93, or 9.2%, at $28.99, while Vertex dropped $5.97, or 4.8%, to $118.19. A number of the biggest stocks in biotechnology were also weak yesterday, with Gilead sliding about 2.5%, Amgen (AMGN) dropping 2.3%, Celgene declining 2.8% and Biogen (BIIB) falling more than 5.5%.
07:43 EDTRHHBY, GSKDrug stocks could be hurt by focus on pricing, says Oppenheimer
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06:19 EDTGILD, RHHBY, GSKClinton to roll out plan to rein in prescription drug costs, USA Today reports
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September 21, 2015
16:53 EDTGILDOn The Fly: Top stock stories for Monday
Stocks on Wall Street began the session in positive territory and remained there for most of the morning. The Nasdaq was the first index to show signs of weakness after Hillary Clinton pledged to address the high cost of specialty drugs, sinking multiple biotech stocks. The averages later recovered from their afternoon lows, with both the Dow and S&P posting gains and the Nasdaq narrowly finishing in the green after Monday's drug pricing debate. ECONOMIC EVENTS: In the U.S., existing home sales fell 4.8% to a 5.31M rate in August, versus expectations for them to be down 1.6% to a rate of 5.5M. Over the weekend, three Federal Reserve officials, namely San Francisco Fed President John Williams, St. Louis Fed President James Bullard and Richmond Fed President Jeffrey Lacker, all argued that an interest-rate increase is still warranted this year. COMPANY NEWS: Biotech stocks declined after privately-held Turing Pharmaceuticals made headlines by enacting a 5,000% price increase on its treatment for toxoplasmosis, reigniting a debate around drug prices that previously embroiled costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni. Presidential candidate Hillary Clinton sent the debate to center stage by criticizing the "outrageous" prices of specialty drugs and promising to lay out a plan tomorrow to tackle "price gouging" in the specialty drug market. The NASDAQ Biotechnology index fell roughly 4.4% following the attention paid to Turing's drug and Clinton's response... Shares of Volkswagen (VLKAY) trading in New York dropped 17.1% to $30.10 after the EPA and California Air Resources Board detected manipulations that violate U.S. environmental standards while testing certain Volkswagen diesel cars. The EPA said Volkswagen may face civil penalties of $37,500 for each vehicle not in compliance with federal clean air rules, which could total as much as $18B, according to Reuters... Apple (AAPL), which has previously been reported to be working on an electric car via its "Project Titan," is speeding up those efforts and setting 2019 as a target to ship its first vehicle, according to The Wall Street Journal. Shares of Tesla Motors (TSLA) were volatile following the Journal's report, but closed the day up 1.37% at $264.20. MAJOR MOVERS: Among the notable gainers was Atmel (ATML), which surged 12.65%, to $8.19 after agreeing to be acquired by German chipmaker Dialog Semiconductor in a deal valued at roughly $4.6B. Also higher was Starwood Waypoint (SWAY), which gained $2.89, or 12.70%, to $25.64 after announcing a stock-for-stock merger agreement with Colony American Homes. Additionally, Pandora (P) rose 8.17% to $21.31 after receiving an interim opinion from the Register of Copyrights regarding the company's agreements with Merlin and Naxos. Among the noteworthy losers was GoPro (GPRO), which fell $2.88, or 8.19%, to $32.27 after Barron's contended that the company's stock could plunge another 30% to $25 as Apple, Sony (SNE), and others pressure the company's "one-hit wonder" products. Also lower was Mallinckrodt (MNK), which lost $8.23, or 10.02%, to $73.87 after ANI Pharma (ANIP) announced plans to acquire two new drug applications from Merck (MRK) that could compete with Acthar, Mallinckrodt's largest product. Separately, D.R. Horton (DHI) dipped 2.91% after the August U.S. existing home sales report showed a 4.8% drop for the month. Note also that Lennar (LEN) slipped 0.27% after its quarterly earnings report beat analyst estimates. INDEXES: The Dow rose 125.61, or 0.77%, to 16,510.19, the Nasdaq added 1.73, or 0.04%, to 4,828.96, and the S&P 500 gained 8.94, or 0.46%, to 1,966.97.
14:28 EDTGSK, RHHBYTuring CEO says will not change Daraprim price despite criticism
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14:04 EDTGILDClinton 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%.
13:17 EDTGILDRBC reminds biotech investors that Republicans still control Congress
RBC Capital analyst Michael Yee notes that biotech indices are under pressure after Hillary Clinton tweeted about an upcoming plan to fight specialty drug pricing. The news follows a Wall Street Journal story about a private company dramatically increasing the price of their drug and another confirmed progressive multifocal leukoencephalopathy case for Biogen (BIIB), Yee tells investors in an intraday research note. Next year's election is likely to turn up the noise around drug pricing, creating headline risk for the biotech space, the analyst cautions. However, he reminds investors that Republicans control Congress, making it unlikely that "anything material" will get signed into law. Biotech names moving lower in today's trading include Biogen, AbbVie (ABBV), Gilead (GILD), Alkermes (ALKS), BioMarin (BMRN), Amicus (FOLD) and PTC Therapeutics (PTCT).
11:24 EDTRHHBY, GSKHillary 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.
08:34 EDTGILDGilead reports results from four international Phase 3 ASTRAL studies
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