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February 4, 2013
08:55 EDTGSK, GSK, CBST, CBST, FOLD, FOLDFDA to hold a public hearing
Public hearing entitled, "Drug Development to Address Unmet Medical Needs" is being held at FDA Silver Spring, Maryland offices with participants to include Paul Huckle from GlaxoSmithKline, Jennifer Jackson from Cubist Pharmaceuticals and John Crowley from Amicus Therapeutics on February 4 at 9 am. Webcast Link
News For GSK;CBST;FOLD From The Last 14 Days
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October 2, 2015
10:50 EDTFOLDAmicus plunges after saying unlikely to submit migalastat NDA by year end
Shares of Amicus Therapeutics (FOLD) fell dramatically in morning trading after the company said it is unlikely to submit a New Drug Application for its Fabry disease treatment to the U.S. Food and Drug Administration by the end of the year. WHAT'S NEW: Amicus said this morning that it does not expect to be in the position to submit a New Drug Application for migalastat monotherapy, a treatment of Fabry disease, in the United States by the end of 2015 as a result of additional regulatory guidance from the FDA. The company said it received final FDA minutes from its September pre-NDA meeting and has had more follow-up meetings with the agency this week. Amicus said it plans to further evaluate several U.S. pathways to support submission requesting full approval, including gathering additional data. The FDA requested further integration of extant clinical data across studies, which requires more time to complete, the company said. WHAT'S NOTABLE: On September 15, Amicus Therapeutics said that, following a pre-NDA meeting with the FDA, it was still on track to submit an NDA for migalastat in the fourth quarter of 2015 under Accelerated Approval, which is only available to therapies for severe and life-threatening conditions that address "significant" unmet medical needs. In addition to the NDA submission, Amicus said it would submit for review the protocol for the Phase 4 study confirming "positive" effects of migalastat on gastrointestinal symptoms in patients. ANALYST OPINION: On September 16, Chardan analyst Gbola Amusa downgraded Amicus to Neutral from Buy, citing valuation and the stock's outperformance relative to the NASDAQ Biotechnology Index. At the time, Amusa said that Amicus' shares were near all-time highs and that he saw less scope for outperformance in the near-term. Amusa noted that, ahead of the Committee for Medicinal Products for Human Use's opinion on Amicus' Galafold, he thinks Amicus would be an "interesting" M&A target for Sanofi (SNY) and Shire (SHPG). Amusa said he sees a positive CHMP on Galafold by November or December, at which time the chances of Amicus getting acquired could increase. PRICE ACTION: Amicus Therapeutics dropped 32.07% to $9.28 in morning trading.
10:10 EDTFOLDOptions with increasing implied volatility
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09:15 EDTFOLDAmicus drops 47% after saying unlikely to submit migalastat NDA by year end
09:03 EDTFOLDAmicus Therapeutics provides regulatory update for migalastat monotherapy
Amicus Therapeutics announced additional regulatory guidance from the U.S. Food and Drug Administration on the oral small molecule pharmacological chaperone migalastat for the treatment of Fabry disease. Amicus has received final FDA minutes from the September pre-NDA meeting and has conducted additional follow-up interactions with the Agency this week. In conjunction with the Agency, Amicus is further evaluating several U.S. pathways including potentially generating additional data on migalastat's effect on gastrointestinal symptoms in Fabry disease to support submission requesting full approval as well as a Subpart H strategy. In addition, the Agency has requested further integration of existing clinical data across studies which will require more time to complete. Based on this guidance from the FDA, Amicus does not anticipate being in a position to submit the NDA for migalastat monotherapy in the United States by the end of this year. The timing of an NDA submission will be based on the determination of the optimal regulatory pathway.
October 1, 2015
08:04 EDTGSKPfizer completes acquisition of Nimerix, Mencevax from GSK
Pfizer (PFE) announced that it has completed the acquisition of GlaxoSmithKline's (GSK) quadrivalent meningococcal ACWY vaccines Nimenrix and Mencevax.
September 30, 2015
19:12 EDTFOLDOn The Fly: After Hours Movers
UP AFTER EARNINGS: 8Point3 Energy (CAFD), up 3.2%. ALSO HIGHER: PBF Energy (PBF), up 4.3% after announcing that it will acquire a Torrance, CA refinery from ExxonMobil (XOM)... Verisk Analytics (VRSK), up 5.2% after being added to the S&P 500. LOWER: Medgenics (MDGN), down 11.1% after filing to sell common stock... Concho Resources (CXO), down 4.4% after filing to sell 7M shares of common stock... Joy Global (JOY), down 2.2% after Verisk Analytics replaced the company in the S&P 500... Amicus Therapeutics (FOLD), down 1.7% after filing to sell 5.92M shares of common stock for holders.
17:04 EDTFOLDAmicus files to sell 5.92M shares of common stock for holders
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12:41 EDTGSKGlaxoSmithKline exercises option for Liquidia Technologies' inhaled therapeutics
Liquidia Technologies announced that GlaxoSmithKline has exercised its option under a Collaboration and Option Agreement signed in 2012 to exclusively license the right to research, develop, and commercialize inhaled therapeutics derived from the company's proprietary PRINT technology. Through this collaboration, Liquidia and GSK will continue to work together with the goal of advancing inhaled therapeutics into clinical studies. According to the agreement signed in June 2012, Liquidia was granted an upfront payment comprised of cash and equity, R&D funding, and potential development milestones and royalties. As a result of the GSK decision to exercise the option, Liquidia will receive an option fee, continued R&D funding, and potential product-based development and regulatory milestone payments. Liquidia has also retained the ability to independently develop an inhaled treatment for a particular disease field.
07:11 EDTFOLDLeerink to hold a roundtable
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September 28, 2015
07:52 EDTGSKIIR Holdings to hold a conference
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September 27, 2015
16:58 EDTGSKGlaxoSmithKline, Theravance report Phase 3 data on Anoro Ellipta for COPD
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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
07:43 EDTGSKDrug stocks could be hurt by focus on pricing, says Oppenheimer
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06:19 EDTGSKClinton to roll out plan to rein in prescription drug costs, USA Today reports
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September 21, 2015
14:28 EDTGSKTuring CEO says will not change Daraprim price despite criticism
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13:17 EDTFOLDRBC 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 EDTGSKHillary 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.
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