Valeant Pharmaceuticals Gets Boost From FDA Update [0.14]

Posted on Aug. 17, 2017, 4:15 p.m. by 24/7 Wall St. @ [source]

Shares of Valeant Pharmaceuticals International Inc. (NYSE: VRX) saw a handy gain on Thursday after the company provided an update from the U.S. Food and Drug Administration (FDA).

This pharma giant has been under fire for over a year now, with shares practically falling off a cliff in that time.

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What’s New this Summer? [0.10]

Posted on Aug. 17, 2017, 2:28 p.m. by Stock Gumshoe @ [source]

There’s nothing like a report about a prominent person coming down with a serious illness to prompt the media to zero in on news about potential treatments for that particular condition. Pharmaceutical outfits may not like to cough up the money, but they very much like having an approval date on the calendar, so setting a PDUFA date for a drug is definitely Good News.

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SGMO is initiating its execution of commercially viable ZFN drugs, facilitating future pharmaceutical solutions and a financial instrument with which to hedge CRISPR.

With an undervalued stock, a critically-acclaimed drug leading in its space and a barrage of financial and expertise-based backing, Sangamo Therapeutics (NASDAQ:SGMO) is the ideal vehicle for exposure to a market with high growth potential and a hedge against the antiquated methods (CRISPR/Cas9) of treating hemophilia.

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Citi Research upgraded Mylan shares, saying the generic drug manufacturer is "the best positioned" after a disappointing earnings season for the industry.

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Gilead Sciences Inc. (NASDAQ:GILD) stock lagged behind benchmark indices this year but shows signs of reversal lately. The stock's robust positive momentum should continue on the back of Gilead's revived fortune in HCV market and encouraging developments in HIV.

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If Novartis succeeds in having a branded drug overtake generics, it may position them to reconsider their R&D strategy.

After careful consideration, I have rated Novartis (NYSE:NVS) as a buy for the long term.

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Zai Lab Files for IPO [0.10]

Posted on Aug. 16, 2017, 1:40 p.m. by 24/7 Wall St. @ [source]

Zai Lab has registered an F-1 form with the U.S. Securities and Exchange Commission (SEC) regarding its initial public offering (IPO). As part of that effort, Zai Lab has assembled a management team with global experience and an extensive track record in navigating the regulatory process to develop and commercialize innovative drugs in China.

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Goldman Sachs added Biogen to its Americas Conviction List, highlighting the biotech's lead pipeline Alzheimer's drug as possibly one of the first to successfully prevent or slow the progression of the disease.

Goldman projects that one of the two drugs, known as Aducanumab, could reach peak sales of $12 billion.

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Progenics: Dynavax 2.0? [0.11]

Posted on Aug. 15, 2017, 4:55 p.m. by Long Investing Ideas from Seeking Alpha @ [source]

Small- and mid-cap biotech investing is not for the faint of heart, even in companies with approved drugs on the market, or de-risked prospects.

When Dynavax received a CRL in November 2016 citing safety concerns about Heplisav-B, the company’s much anticipated Hepatitis B vaccine, the market reacted as if it was the end of the road for the small biotech.

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We take a deeper look at Alexion, its new management, and its pipeline below.

Today, we take a deeper look at a mid-cap biotech concern with significant management turnover, a possible new strategic direction and substantial recent insider buying in an exclusive ‘first look’ analysis here on the Insiders Forum.

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This past week has been gloomy for Bristol-Myers Squibb (BMY), which announced that it will be slashing marketing jobs as its HIV drugs near a patent cliff. I feel that the true value for Bristol-Myers Squibb was never the HIV franchise.

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The company has many ways to grow its revenues and earnings again, and thus looks inexpensive at the current valuation. If Gilead's growth plans succeed, the company is attractive at the current level.

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The possibilities are discussed that these patents that Gilead has listed in the FDA's Orange Book on all four of its TAF-containing drugs could benefit the company in different ways. The ideas and possibilities presented here are my own and could be incorrect, possibly materially so.

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With efforts to repeal the Affordable Care Act indefinitely sidelined, the dark cloud of uncertainty hanging over the healthcare sector looks much less threatening. In response, American healthcare stocks are booming.

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Foamix Pharmaceuticals (FOMX) is a clinical stage pharmaceutical company focused on the development topical drugs for dermatological conditions. FOMX’s lead drug is FMX-101 — a topical formulation of the antibiotic minocycline — and is in Phase 3 development for the treatment of moderate-to-severe acne.

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Joaquin Guzman, the Mexican drug lord known as "El Chapo" who is jailed awaiting trial in the United States, may meet with a relative to discuss ways to pay for his defense, a lawyer for Guzman said on Monday.

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After reporting second-quarter results, Teva Pharmaceuticals (TEVA) devastated its shareholders by announcing a dividend cut, writing down part of its Actavis acquisition and issuing a weak outlook.

Markets punished Endo International plc (ENDP) despite the company reporting a mild revenue decline of 4.9%, to $875.9 million.

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We picked Adamas Pharmaceuticals (ADMS) stock in our portfolio last year (see initiation article with full details).

We are reiterating Buy on Adamas stock ahead of PDUFA.

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The billionaire founder of Sun Pharmaceutical Industries Ltd. pledged that the drugmaker would do better after reporting its first loss in at least 12 years amid regulatory headaches and a weakening market for generic drugs.“The reason why we are suffering is our inability to execute,” Dilip Shanghvi said on a conference call with analysts after the results were released. Sun Pharma’s Israel-based unit Taro Pharmaceutical Industries Ltd. said it expects pricing pressure to continue.India’s pharma companies started reporting quarterly results two weeks ago, with many showing double-digit declines in revenue or profit.

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Recently, Galapagos (GLPG) announced positive results for its phase 2a trial treating patients with idiopathic pulmonary fibrosis (IPF). Not only was there a halt in disease progression, but Galapagos noted that its drug was the first of its class (autotaxin inhibitor) to have ever seen positive clinical data in patients with IPF.

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