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June 25, 2014
05:32 EDTACT, NVS, SHPG, MYLShire says New Jersey court found Vyvanse patents infringed
Shire announces that Judge Stanley Chesler of the U.S. District Court for the District of New Jersey granted Shire's summary judgment motion in a patent infringement lawsuit, holding that certain claims of the patents protecting Vyvanse were both infringed and valid. The ruling prevents the five pharmaceutical manufacturers who have filed Abbreviated New Drug Applications from launching generic versions of Vyvanse until the earlier of either a successful appeal to the U.S. Court of Appeals for the Federal Circuit, or the expiration of these patents in 2023. To appeal successfully, the ANDA Defendants must overturn the court's rulings for each of the 18 patent claims, Shire said. The court's summary judgment ruling concerning Shire's motion included 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse, which cover Vyvanse's active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD. Shire's lawsuit is against the five ANDA defendants that filed ANDAs with the FDA seeking to market generic versions of Vyvanse. The defendants are Actavis (ACT), Amneal Pharmaceuticals, Mylan (MYL), Roxane Laboratories and Novartis' (NVS) Sandoz.
News For SHPG;ACT;MYL;NVS From The Last 14 Days
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September 27, 2015
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
13:51 EDTMYLBMO's pharma predictions for rest of year include take on Mylan, Perrigo
BMO Capital analyst David Maris rolled out his rest of year predictions for the Specialty Pharmaceuticals space. Among them is his belief that Mylan (MYL) will be unsuccessful in acquiring Perrigo (PRGO). Perrigo will either be acquired by another company or make an acquisition itself, Maris tells investors in a research note. His other predictions include Jazz Pharmaceuticals (JAZZ) proving to be a good buying opportunity amidst the current negative sentiment and ZS Pharma (ZSPH) offering upside following the recent pullback given the potential for a near-term buyout and prospects for its "best in class drug for hyperkalemia" winning approval in 2016.
07:22 EDTNVSEuropean 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
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 EDTMYL, SHPGAppeals court affirms Shire Vyvanse patents valid until 2023
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14:13 EDTSHPGAppeals court affirms Shire Vyvanse patents valid until 2023
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09:07 EDTNVSUnilife ammends clinical supply agreement with Novartis
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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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September 22, 2015
07:43 EDTNVSDrug 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.
06:19 EDTNVSClinton 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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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.
10:00 EDTSHPGOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: AerCap (AER) upgraded to Buy from Neutral at BofA/Merrill... Allstate (ALL) upgraded to Buy from Hold at Sandler O'Neill... Central Pacific (CPF) upgraded to Buy from Hold at Sandler ONeill... Cesca Therapeutics (KOOL) upgraded to Buy from Neutral at H.C. Wainwright... CyberArk (CYBR) upgraded to Buy from Hold at Deutsche Bank... DENTSPLY (XRAY) upgraded to Outperform from Market Perform at William Blair... DeVry (DV) upgraded to Outperform from Market Perform at Barrington... Douglas Emmett (DEI) upgraded to Buy from Neutral at Mizuho... Fly Leasing (FLY) upgraded to Neutral from Underperform at BofA/Merrill... Goldman Sachs (GS) upgraded to Outperform from Perform at Oppenheimer... Integra LifeSciences (IART) upgraded to Buy from Neutral at BofA/Merrill... Invesco (IVZ) upgraded to Overweight from Equal Weight at Morgan Stanley... LTC Properties (LTC) upgraded to Buy from Neutral at Mizuho... Molson Coors (TAP) upgraded to Buy from Hold at Societe Generale... Nokia (NOK) upgraded to Buy ahead of Samsung arbitration at Deutsche Bank... PayPal (PYPL) upgraded to Buy from Hold at Stifel... Shire (SHPG) upgraded to Overweight from Equal Weight at Barclays... Sirona Dental (SIRO) upgraded to Outperform from Market Perform at William Blair... Sonic (SONC) upgraded to Buy from Neutral at Longbow... Sun Life Financial (SLF) upgraded to Buy from Neutral at BofA/Merrill... Taylor Morrison (TMHC) upgraded to Buy from Hold at Deutsche Bank... Telecom Argentina (TEO) upgraded to Neutral from Underperform at BofA/Merrill... Vascular Biogenics (VBLT) upgraded to Outperform from Market Perform at JMP Securities... Yamana Gold (AUY) upgraded to Outperform from Neutral at Credit Suisse... lululemon (LULU) upgraded to Overweight from Equal Weight at Morgan Stanley.
06:56 EDTSHPGShire upgraded to Overweight from Equal Weight at Barclays
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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.
05:09 EDTSHPGShire receives European approval for INTUNIV as ADHD treatment
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