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Vertex Pharmaceuticals
24 мая, 15:37

Biotech Stock Roundup: FDA Nod for Regeneron RA Drug, Amgen Hit by Study Data

Key highlights in the biotech sector include FDA approval for Regeneron's (REGN) Kevzara and data from Amgen and Celgene.

18 мая, 17:21

Concert Pharma Falls After Clinical Hold on Hair Loss Drug

Concert Pharmaceuticals, Inc. (CNCE) shares were down almost 8% on Wednesday after the company announced that the FDA has placed a clinical hold on a mid-stage study evaluating its pipeline candidate CTP-543 for the treatment of alopecia areata.

18 мая, 16:53

Vertex Ups Kalydeco Sales View as FDA Okays Label Expansion

Vertex Pharmaceuticals Incorporated???s (VRTX) announced that the FDA has approved its lead marketed drug, Kalydeco (ivacaftor) for expanded use.

18 мая, 16:30

Zacks.com featured highlights: Covanta Holding, PTC, Etsy, Vertex Pharmaceuticals and Live Nation Entertainment

Zacks.com featured highlights: Covanta Holding, PTC, Etsy, Vertex Pharmaceuticals and Live Nation Entertainment

17 мая, 14:58

5 Toxic Stocks to Steer Clear Of or Play Short Right Now

High price of the toxic stocks can be ascribed to an irrational exuberance associated with them or some serious fundamental lacunae. Presence of such stocks in your portfolio may result loss of wealth.

17 мая, 14:53

Biotech Stock Roundup: Biogen Inks Deal to Boost Pipeline, Sangamo Soars on Pfizer Deal

Quite a few deals were announced this week including by companies like Biogen (BIIB).

16 мая, 22:31

Why Is Vertex Pharma (VRTX) Stock Soaring This Year?

Vertex Pharmaceuticals, Inc.'s (VRTX) shares have risen 57.8% this year so far, outperforming the increase of 1.3% for the Zacks classified Large-Cap Pharma industry.

10 мая, 00:31

Gottlieb confirmed as FDA chief

The Senate confirmed Scott Gottlieb as FDA commissioner Tuesday, thrusting the conservative drug industry insider into the heated debate over rising drug costs that President Donald Trump has pledged to address. Gottlieb, a former FDA and CMS official in the George W. Bush administration, sailed through confirmation on a 57-42 vote. He'll lead a 15,000 person, $5 billion agency that approves drugs, vaccines, medical devices and regulates tobacco, cosmetics and food. The perch will make Gottlieb an important player in the Trump administration’s plans to speed up the drug approval process and cut back on regulations and red tape, which the president has argued will bring down drug prices.Gottlieb’s nomination raised concerns among Democrats who worry his deep ties to the pharmaceutical industry could compromise his oversight of the companies' products.Gottlieb is a far more traditional candidate than others Trump initially considered for the job, including associates of activist financier Peter Thiel, who pledged to blow up the entire approval process by no longer mandating drugs demonstrate effectiveness before they can be sold. However, Gottlieb is still expected to push the boundaries of FDA reviews and using new authority under the 21st Century Cures Act to speed up evaluations. “While the conventional wisdom is that Gottlieb represents a safe, conventional choice, this is only true if you compare him to two of the other known candidates,” Mark Mansour, who specializes in FDA law at Mayer Brown, wrote in a note to clients.Mansour said Gottlieb will likely be a more “nuanced reformer” than other candidates Trump considered. He “won’t eviscerate the FDA,” but he could push the agency to speed up product approvals by relying more on anecdotal or real-world evidence and on data collected after a product is already on the market, Mansour said. Gottlieb has remained mum on drug pricing ideas that Trump pushed on the campaign trail -- including direct government negotiations of drug prices in Medicare -- arguing such decisions are outside the FDA’s purview. He could still be dragged into HHS Secretary Tom Price's efforts to address drug pricing through regulation. Price kicked off a listening tour last week as part of an HHS initiative to address drug pricing expected in the next few months. Price will meet with the main drug lobbies, PhRMA, BIO and the Association for Accessible Medicines on Friday.Gottlieb in the past opposed ideas similar to those put forth by Trump. However, some of Gottlieb’s other ideas on pricing wouldn’t be as well received by industry groups. He’s suggested changing the way Medicare pays for costly physician-administered drugs to try to bring down prices through private-sector bidding. He’s also been in favor of more transparency around drug pricing — and ending the current system in which drug companies set high list prices but then give rebates to payers. Gottlieb’s nomination raised concerns among Democrats who worry his deep ties to the pharmaceutical industry could compromise his oversight of the companies' products. Before being nominated, Gottlieb, served as a partner at a venture capital firm that worked with a number of leading drug companies. He also served on the boards or held advisory positions at companies including GlaxoSmithKline, Bristol Myers Squibb and Vertex Pharmaceuticals. He has pledged to recuse himself for one year from agency decisions involving more than 20 companies.Republicans view his industry experience as a plus and pointed out that President Barack Obama’s second FDA commissioner, Robert Califf, also had close ties with the drug industry. “It’s a good idea to have people serving in government that have the type of experience in the industries,” they will work with Sen. Lamar Alexander (R-Tenn.), chairman of the Senate HELP Committee, which oversees FDA. Some of lawmakers who criticized Gottlieb for having worked with the drug industry also criticized Trump’s education secretary for not having enough experience in that field, Alexander added.“You can’t have it both ways.” Some Democrats also questioned whether Gottlieb would fail to adequately address the opioid epidemic. "At this time of crisis, we need a leader at the FDA who recognizes the dangers of prescription painkillers, who will stand up to big pharma and reform the FDA to prevent addiction before it takes hold,” Sen. Ed Markey (D-Mass.) said before the vote. “Dr. Scott Gottlieb is not that individual. Dr. Gottlieb's nomination signals a continuation of FDA policies that have cultivated and fueled the opioid epidemic."During his confirmation hearing, Gottlieb suggested that fighting opioid abuse would be a priority for the agency.Republicans agreed. Majority Leader Mitch McConnell ahead of the vote suggested Gottlieb will be an asset to the cause. “I’m sure he’ll be an ally to states that continue to struggle with the opioid crisis because the FDA has a critical role to play,” McConnell said in remarks on the floor before the vote.

03 мая, 15:22

Drug Stock Q1 Earnings Releases on May 4: ZTS, REGN & More

Here we have four pharma companies that are set to report first-quarter results on May 4. Let's see how things are shaping up for them.

01 мая, 16:40

Drug Stocks Q1 Earnings Slated for May 2: MRK, PFE & GILD

The Q1 earnings season is in full swing with financial results from 288 S&P 500 members or 63.8% of the index already out as of Apr 28, 2017.

28 апреля, 16:15

Vertex (VRTX) Q1 Earnings Top, CF Products Sales Strong

Vertex Pharmaceuticals Incorporated (VRTX) reported first-quarter 2017 earnings per share of 13 cents (including the impact of stock-based compensation expense), which beat the Zacks Consensus Estimate of 4 cents.

Выбор редакции
26 апреля, 17:30

What's in Store for Nivalis (NVLS) this Earnings Season?

Nivalis Therapeutics, Inc. (NVLS) is expected to report first-quarter 2017 results early next month. Last quarter, the company had a positive surprise of 9.09%.

26 апреля, 15:18

Biotech Stock Roundup: Biogen Gains on Strong Q1, NASH Data on Gilead Drug

Focus this week remained on Biogen's (BIIB) first quarter results which surpassed expectations.

24 апреля, 17:34

What's in Store for Vertex (VRTX) this Earnings Season?

Vertex Pharmaceuticals, Inc. (VRTX) is scheduled to report first-quarter 2017 results on Apr 27, after the market closes.

18 апреля, 16:30

Zacks.com featured highlights: PTC, Covanta Holding, Live Nation Entertainment, Incyte and Vertex Pharmaceuticals

Zacks.com featured highlights: PTC, Covanta Holding, Live Nation Entertainment, Incyte and Vertex Pharmaceuticals

17 апреля, 16:03

5 Toxic Stocks to Shun or Play Short Right Now

Just like picking up stocks with strong growth potential, pinpointing toxic stocks and abandoning them at the right time is the key to protect your portfolio from big losses or make profits by short selling them.

Выбор редакции
17 апреля, 13:47

Vertex Pharmaceuticals stock price target to $128 from $115 at Leerink Partners

This is a Real-time headline. These are breaking news, delivered the minute it happens, delivered ticker-tape style. Visit www.marketwatch.com or the quote page for more information about this breaking news.

13 апреля, 21:49

Top Research Reports for Today: MSFT, BLK, NOC

Top Research Reports for Today: MSFT, BLK, NOC

12 апреля, 15:36

TherapeuticsMD Falls on Likely Delay in TX-004HR Approval

Shares of TherapeuticsMD, Inc. (TXMD) have declined almost 25% since Monday when it received a letter from the FDA identifying deficiencies in the new drug application (NDA) for its dyspareunia drug, TX-400HR filed last July