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Company Overview and News
Discussion: Development partners Regeneron Pharmaceuticals (REGN) and Teva Pharmaceutical Industries (TEVA) reported topline results of a Phase 3 clinical trial. The trial was evaluating fasinumab in patients with chronic pain from osteoarthritis of the knee or hip. This is a smaller sub-set involving 3565 patients out of the larger planned trial that involves upto 7000 patients. The main study has a time frame of baseline to 72nd week an during this period the incidence of severe destructive arthropathy (‘DA) will be the primary safety endpoint.
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2018-08-19 seekingalpha - 1
Discussion: Bristol-Myers Squibb's (BMY) OPDIVO (nivolumab) is now FDA approved for patients with metastatic small cell lung cancer (‘SCLC) that has progressed after platinum-based chemo and at least one prior line of therapy. This is the first and till date only FDA-approved Immuno-Oncology treatment option for this patient category. Also because this is the first successful checkpoint inhibitor to be approved for these indications, the researchers consider approval of nivolumab to be “particularly exciting.
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2018-08-17 investorplace - 2
Sometimes identifying the best stocks to buy can be difficult, but you could do a lot worse than checking out the stocks selected by one of the world’s savviest hedge fund managers — Warren Buffett.
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Mylan (MYL - Free Report) suffered a setback as rival Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) recently won FDA approval for the first generic version of the former’s EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients.
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2018-08-16 globenewswire - 2
EWING, N.J., Aug. 16, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“Antares”) today announced that the U.S. Food and Drug Administration (FDA) has approved Teva Pharmaceutical Industries, Ltd.’s (“Teva”) epinephrine auto injector drug-device combination product indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients.
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REUTERS: The U.S. Food and Drug Administration on Thursday approved Teva Pharmaceutical Industries Ltd's generic version of Mylan NV's life-saving allergy injection, EpiPen, at a time when regulators are looking to lower healthcare costs.
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Mylan N.V. (NASDAQ: MYL) has had a stranglehold on the market for EpiPen, but this is all changing after the U.S. Food and Drug Administration (FDA) approved Teva Pharmaceutical Ltd. (NYSE: TEVA) for a generic version of it.
2018-08-16 marketwatch - 3
Shares of the U.S.-listed Teva Pharmaceutical Industries Ltd. TEVA, +6.07% surged 6.2% in extremely heavy Thursday afternoon trade after the company's generic version of the EpiPen allergic reaction treatment was approved by the Food and Drug Administration, making it the product's first true generic rival. Teva secured approval for both adult and child-appropriate dose levels of its generic epinephrine autoinjector.
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REUTERS: The U.S. Food and Drug Administration on Thursday approved Teva Pharmaceutical Industries Ltd's generic version of Mylan NV's EpiPen for the emergency treatment of allergic reactions.
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(Reuters) - The U.S. Food and Drug Administration on Thursday approved Teva Pharmaceutical Industries Ltd’s generic version of Mylan NV’s EpiPen for the emergency treatment of allergic reactions.
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Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) both saw handy gains on Thursday after the companies posted positive topline results from their late-stage trial of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip.
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2018-08-15 investorplace - 2
Investors still waiting for Heat Biologics (NASDAQ:HTBX) to trade at a market cap of $100 million will have to wait longer. The stock surged to above $4 a share in May, but that proved temporary.
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2017-10-24 - Asif
Teva Pharmaceutical Industries is global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic medicines and a focused portfolio of specialty medicines. The company operate worldwide, with a significant presence in the United States, Europe and many other markets around the world. Its key strengths include itsworld-leading generics expertise and portfolio, focused specialty portfolio, robust R&D capabilities, global infrastructure and scale and dedicated leadership and employees. Teva Pharmaceutical believe company is strategically positioned to benefit from market, economic and regulatory trends in global healthcare. These trends include aging populations, the increasing prevalence of chronic diseases, economic pressure on governments and private payors to provide affordable healthcare solutions, legislative and regulatory reforms, scientific and technological advances, increased patient awareness...
2018-08-20 - Asif
Overview Recro Pharma is a specialty pharmaceutical company that operates through two business divisions: an Acute Care division and a revenue-generating CDMO division. Each of these divisions are deemed to be reportable segments for financial reporting purposes. The company's Acute Care segment is primarily focused on developing and commercializing innovative products for hospital and related acute care settings. The company's lead product candidate is a proprietary injectable form of meloxicam, a long-acting preferential COX-2 inhibitor. IV meloxicam has successfully completed three Phase III clinical trials for the management of moderate to severe pain, consisting of two pivotal efficacy trials and a large double-blind Phase III safety trial, as well as other safety studies. Overall, the total new drug application, or NDA, program included over 1,400 patients. In late July 2017, the company submitted a NDA to the U.S. Food and Drug Administration, or FDA, for IV meloxicam...
2018-08-20 - Asif
Overview Achillion Pharmaceuticals is a clinical-stage biopharmaceutical company focused on advancing its oral factor D inhibitors into late-stage development and commercialization. Each of the drug candidates in its oral factor D portfolio was discovered in its laboratories and is wholly owned by it. Achillion Pharmaceuticals is focusing its drug development activities on alternative pathway-mediated, rare diseases where there are no approved therapies or where existing therapies are inadequate for patients. To advance its investigational drugs into phase III and commercialization, the company plan to work closely with key stakeholders including patients, payors, regulators and healthcare professionals. The company's first-generation factor D inhibitor, ACH-4471, has demonstrated preliminary clinical proof-of-concept in patients with C3 glomerulopathy, or C3G, a disease affecting the kidney, and paroxysmal nocturnal hemoglobinuria, or PNH, a blood disorder, and has advanced...
2018-08-20 - Asif
General Baytex Energy Corp. was incorporated on October 22, 2010 pursuant to the provisions of the ABCA. Baytex is the successor to the business of Baytex Energy Trust, which was transitioned to Baytex on December 31, 2010. Inter-Corporate Relationships The following table provides the name, the percentage of voting securities owned by it and the jurisdiction of incorporation, continuance, formation or organization of its material subsidiaries either, direct and indirect, as at the date hereof. ||Percentage of voting securities (directly or indirectly)|Jurisdiction of Incorporation/Formation| | ------------ | ------------: | :------------: | |Baytex Energy Ltd.|100%|Alberta| |Baytex Energy USA, Inc.|100%|Delaware| |Baytex Energy Partnership|100%|Alberta| Organizational Structure The following simplified diagram shows the inter-corporate relationships among it and its material subsidiaries as of the date hereof. <img src="https://www.sec.gov/A...
as of ET