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May 30, 2014
09:17 EDTPFE, MYL, TEVATeva receives favorable court decision regarding generic Celebrex capsules
Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. District Court for the Northern District of West Virginia denied a motion filed by Mylan (MYL) and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex 100, 200 and 400 mg capsules. On April 17, Teva entered into a settlement agreement with Pfizer (PFE) related to Teva’s generic version of Celebrex 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December, 2014, or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
News For TEVA;MYL;PFE From The Last 14 Days
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September 24, 2015
15:24 EDTMYLMylan says Perrigo lawsuit 'without merit'
Mylan (MYL) believes that the Perrigo (PRGO) suit filed in Israel is entirely without merit and that Mylan's offer in Israel is valid and proper in all respects. With that said, Perrigo's efforts are entirely futile, as all Perrigo shareholders-institutional and retail, including those in Israel-have always been free to switch their holdings at any time from the Tel Aviv Stock Exchange to the New York Stock Exchange, through a simple, fully automated, well-established system by notifying their broker. As a result, shareholders can participate fully in Mylan's compelling offer without regard to any lawsuits in Israel or any other frustrating actions pursued by Perrigo in Israel. Further, as Mylan has previously stated publicly, it has been its intent and desire to list Mylan's shares on the TASE to maintain liquidity in Israel for the convenience of those shareholders in Israel who prefer to trade on the TASE, and Mylan is already well-advanced in the process of submitting its application to the TASE and the Israel Securities Authority, and is committed to continuing to work closely with these parties to complete this process.
14:17 EDTMYLAppeals court affirms Shire Vyvanse patents valid until 2023
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07:33 EDTPFEBIND says Pfizer exercises option to obtain license for Accurin drug candidate
BIND Therapeutics (BIND) announced that Pfizer (PFE) exercised its option to obtain an exclusive license to develop and commercialize an Accurin drug candidate for the treatment of solid tumors under the companies' global collaboration agreement. The actively targeted Accurin is designed to impart cellular targeting capability and was engineered by BIND using one of Pfizer's proprietary kinase inhibitors and one of BIND's proprietary ligands. As a result of the option exercise, BIND will receive a $2.5 million option exercise fee from Pfizer. In parallel with exercising its first option, Pfizer informed BIND that it will not exercise its option for the second compound in the collaboration. Under terms of the original collaboration agreement, which was established in April 2013, Pfizer was granted options to obtain exclusive licenses to pursue development and commercialization of two Accurins that incorporate specified Pfizer small molecular targeted therapies. For the Accurin that has been selected, both companies will work together on preclinical research; Pfizer will have responsibility for development and commercialization, and BIND will conduct chemistry, manufacturing and control activities. In addition to the $2.5 million option exercise fee, BIND received an upfront payment of $4.0 million in 2013 and achieved a $1.0 million preclinical development milestone for the selected Accurin in December 2014. BIND has the potential to receive additional milestone payments for the selected Accurin of up to $86.0 million in aggregate upon the achievement of additional specified development and regulatory events under the Pfizer collaboration agreement. BIND may also receive additional milestone payments for the selected Accurin of up to $110 million in aggregate for specified commercial events as well as royalties in the low single to high single digit percentages on potential future sales of the selected Accurin, if any.
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 23, 2015
08:24 EDTMYLWeakness in drug stocks creates buying opportunities, says RBC Capital
After Hillary Clinton unveiled a plan to lower drug prices, RBC Capital does not expect the plan to be passed by Congress. The firm adds that the plan is positive for generic drug makers and could pressure the FDA to more quickly approve generic drug applications. RBC identifies Insys Therapeutics (IINSY), Endo (ENDP), and Sagent Pharma (SGNT) as three stocks it likes that have suffered "disproportionate selloffs over the last two days." The firm identifies Sagent, Emdo and Mylan (MYL) as three companies with high generic exposure that have sold off.
06:16 EDTMYLMylan countersues Perrigo, cites tender offer 'misstatements,' Reuters reports
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05:32 EDTPFEViiV Healthcare announces Triumeq Phase IIIb study met primary endpoint
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September 22, 2015
20:02 EDTPFEClinton 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 EDTPFEHillary 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
08:23 EDTTEVAWith Pharma in 'hot seat,' Citi still likes Allergan, Teva
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08:23 EDTPFEAnalysts 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 EDTTEVA, PFEDrug stocks could be hurt by focus on pricing, says Oppenheimer
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06:35 EDTMYLMylan to cancel 'stichting' takeover defense
Mylan N.V. yesterday confirmed that on September 19, 2015 the Stichting Preferred Shares Mylan, an independent foundation incorporated under the laws of the Netherlands, requested cancellation of the preferred Mylan shares issued to the Foundation on July 23, 2015. The Foundation informed Mylan it was satisfied that influences that might adversely affect the strategy, mission and other interests of Mylan, its business and its stakeholders to be protected by the Foundation as described in the Foundation's articles of association have been sufficiently addressed. Cancellation of the preferred shares requires Mylan shareholder approval. The Mylan Board of Directors will announce the shareholders meeting to approve the cancellation of the preferred shares in due course.
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 EDTPFEClinton to roll out plan to rein in prescription drug costs, USA Today reports
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September 21, 2015
14:28 EDTPFETuring CEO says will not change Daraprim price despite criticism
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11:24 EDTPFEHillary 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.
08:03 EDTPFEPfizer says two Phase 3 tofacitinib 10mg trials met primary endpoints
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05:46 EDTMYLMylan reinstated with an Equal Weight at Barclays
Barclays analyst Douglas Tsao reinstated Mylan (MYL) with an Equal Weight rating and $57 price target. The analyst expects uncertainty around the company's tender offer for Perrigo (PRGO) to weigh on the shares over the near term.
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