Gottlieb is a resident fellow at the American Enterprise Institute and venture partner at New Enterprise Associates. He previously served as former deputy commissioner of the FDA during George W. Bush’s presidency.
Category: Food and Drug Administration
Trump Is Said to Pick Scott Gottlieb as Food and Drug Chief
Scott Gottlieb, a former deputy commissioner of the U.S. Food and Drug Administration, is President Donald Trump’s choice to lead the agency, according to people familiar with the matter. Gottlieb, 44, served in several senior positions at the FDA during the George W. Bush administration.
2 Billion-Dollar Marijuana Stocks That Could Soar Even Higher
You could have made plenty of money investing in the right marijuana stocks last year. Most, however, are small companies without much of a track record.
Why Intercept Pharmaceuticals’ Latest News Caused the Stock to Jump
So when the companyannounced on Friday morning that it was making a significant change to its late-stage clinical study of obeticholic acid in treating NASH, investors were eager to find out what’s going on. Intercept’s phase 3 REGENERATE clinical trial initially had two co-primary endpoints: fibrosis improvement with no worsening of NASH and NASH resolution with no worsening of fibrosis.
Why Ocular Therapeutix Inc Jumped Higher Today
Analyst Elemer Piros is excited about Ocular Therapeutix’s near-term potential to get Dextenza approved to treat post-surgical pain. Last month, Ocular Therapeutix resubmitted its application for Dextenza to the Food and Drug Administration after being issued a complete response letter — the FDA’s euphemism for a rejection — last July.
Organovo Holdings’ Unpleasant Q3 Surprise: Still Plenty of Skepticism About 3D Tissues
The good news was that Organovo continue to grow sales by leaps and bounds in the quarter. Also, the consensus estimate among analysts was that the company would lose $0.10 per share.
Why Aratana Therapeutics Inc. Is Tumbling Today
The pet therapeutics company disclosed in a Securities and Exchange Commission filing on Monday that the Food and Drug Administration’s Center for Veterinary Medicine has requested more information about its appetite stimulant Entyce. Specifically, the CVM is looking for additional data related to the company’s plans to transfer the manufacturing of Entyce to a new vendor.
3 Reasons TransEnterix Inc Stock Could Fall
Investors were hoping the company would win regulatory approval for its low-cost SurgiBot system, but those hopes were dashed after the U.S. Food and Drug Administration In response, TransEnterix has shifted all of its resources to the launch of itsSenhance Surgery system, which was formerly called the ALF-X. While it is possible that the Senhance system could go on to become a smashing success, here’s a look at three reasons why TransEnterix’s stock could continue to disappoint investors.
Side effect kills cancer patient in Stemline drug trial — Feuerstein
Stemline’s SL-401 has demonstrated robust overall tumor response rates in its clinical trial but the drug is also now tied to three patient deaths from capillary leak syndrome. Investors who bought into a $45 million Stemline Therapeutics stock offering on Jan. 19 were not told that one day prior to the financing, a cancer patient in a clinical trial died from a severe side effect, a type of low blood pressure, tied to the company’s drug SL-401.
Better Buy: Inovio Pharmaceuticals vs. Incyte Corp.
Over the same period, shares of Incyte Corp. have risen a healthy 49.6% on the back of several intriguing developments. Both companies have catalysts to look forward to.
Here’s How to Play the Biotech Rebound
Hillary Clinton and Donald Trump shared at least one thing in common. They both publicly railed against high prices for prescription drugs.
Philips Falls Under FDA Scrutiny Over Heart Defibrillators
Royal Philips NV’s health-equipment business in the U.S. has come under renewed scrutiny after the Dutch company disclosed a conflict with authorities over its heart defibrillators more than three years after the Food and Drug Administration warned about their reliability. Philips is in talks with the Department of Justice, representing the FDA, on a civil matter related to inspections of the devices leading up to 2015, the Amsterdam-based company said in a statement Tuesday.
3 Biotechs Likely to Be Acquired in 2017
The year is still young, but we’ve already seen acquisitions of Ariad and CoLucid . Which biotechs could be scooped up next in 2017? Here’s why Clovis Oncology The number of big companies battling to acquire Medivationin 2016 shows that the oncology space is hot.
Art credit: Dave Malan
President Trump may not be a full-spectrum deregulator in the Ronald Reagan tradition. He hasn’t had much to say about the Food and Drug Administration or Federal Communications Commission-two favorite targets of regulatory reformers-and he sometimes sounds like an antitrust activist.
Art credit: Dave Malan
President Trump may not be a full-spectrum deregulator in the Ronald Reagan tradition. He hasn’t had much to say about the Food and Drug Administration or Federal Communications Commission-two favorite targets of regulatory reformers-and he sometimes sounds like an antitrust activist.
New FDA Chief Should Have Medical Experience, Drugmakers Say
President-elect Donald Trump’s pick to lead the U.S. Food and Drug Administration should have a medical background, and the agency should continue evaluating new medications’ effectiveness, drugmaker executives said in comments indicating opposition to two candidates for the regulator’s top post. Trump’s FDA chief should be a doctor or physician-scientist with experience in clinical care and medical research, said Roger Perlmutter, head of research and development for Merck & Co.
5 Ways Vertex Pharmaceuticals Plans to Grow in 2017 and Beyond
However, Vertex CEO Jeff Leiden said on Monday at the J.P. Morgan Healthcare Conference that “business has never been stronger.” He also emphasized that the company has a clear pathway to growth in 2017 and beyond.
Merrimack Soars on $1 Billion Sale of Cancer Drugs to Ipsen
The Nasdaq-listed cancer drugs developer is up 43% in pre-market trading after promising shareholders special dividends worth more than its closing share price on Friday. Nasdaq-listed Merrimack Pharmaceuticals agreed to sell oncology treatments, including its pancreatic-cancer treatment Onivyde, to French drugmaker Ipsen for as much as $1.05 billion, including benchmark payments.
Will 2017 Be Philip Morris International, Inc.’s Worst Year Yet?
It’s no secret that the tobacco industry has gone through dramatic upheavals over the years, and that’s been especially true recently in locations outside the U.S. market. Globally, Philip Morris International has to deal with dozens of different regulators in order to make the most of its market opportunities in the countries it serves, and the financial complexities that a multinational has to deal with also leave the tobacco giant exposed to additional risk.
Silicon Valley Cash Is Still Chasing Blood Despite Theranos Bust
Amid the collapse of Theranos Inc. last year, investors are betting that some of the disgraced blood-testing startup’s lofty medical goals might still have a kernel of promise — at other companies. Grail, a company backed by Bill Gates and Jeff Bezos, said on Thursday that it’s expecting to raise a record $1 billion on the promise of a blood test to detect early-stage cancer.
3 Under-the-Radar Biotech Stocks to Watch in 2017
You read plenty about the biggest biotechs on the market. But what about smaller biotechs that have a lot of potential? Akebia Therapeutics might not have huge market caps yet, but they have a lot going for them.
What Happened in the Stock Market Today
Cempra, a biotech focused on bacterial infectious diseases, slumped 58% after the Food and Drug Administration rejected two drug applications related to its lead product, solithromycin. The applications applied to oral and intravenous versions of the drug aimed at treating community-acquired bacterial pneumonia, or CABP.
What Happened in the Stock Market Today
Fitbit shares spiked 7% following a rare piece of encouraging news about the fitness device maker’s holiday sales trends. Its activity tracking software was the second most-popular download among free apps on Apple ‘s iTunes this past week, beating such heavyweights as Snapchat, YouTube, and Instagram.
Seattle Genetics Plunges After Drug Studies Halted on Deaths
Seattle Genetics Inc. plunged the most in five years after U.S. regulators halted several early-stage blood cancer studies following the deaths of four patients who suffered from liver damage. The Food and Drug Administration halted the trials testing Seattle Genetics’s acute myeloid leukemia, or AML, therapy, called SGN-CD33A.
3 Precision Medicine Stocks to Buy in January
The National Institutes of Health defines precision medicine as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.” For several companies, this approach is already a reality — and it has created opportunities for investors.
How Risky Will 2017 Be for Philip Morris International?
Tobacco has been a long-term winner for investors, and although it has been a separate publicly traded company for less than a decade, Philip Morris International has done just as well as many of its longer-tenured peers in the industry. However, Philip Morris faces several different types of risks, and each of them has caused investors some concern in the past year.
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This week has proven to be a disappointment for bullish investors who were hoping to see the Dow Jones Industrials reach a historic 20,000 milestone. Friday brought slight gains to the overall stock market, but they weren’t enough to push the Dow into uncharted territory, and advances for most major market benchmarks were limited to less than a quarter of one percent.
Congressman wants FDA to take action against ‘fake milk’
In this Feb. 11, 2009, file photo, a shopper looks over the milk aisle at the Hunger Mountain Co-op in Montpelier, Vt. U.S. Reps.
The Most Expensive Drugs of 2016
Prescription drug prices have gotten out of control for many Americans and many insurers. Some drugs cost as much as premium sports cars.
Senator: Exploding e-cigarette recalls need to be considered
In this April 23, 2014 file photo, E-cigarettes appear on display at Vape store in Chicago. U.S. Sen. Charles Schumer is increasing the heat on the federal government to consider recalling e-cigarette batteries and devices that explode and … catch fire, injuring users.