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posted by Fnord666 on Thursday January 04 2018, @02:21AM   Printer-friendly
from the what-long-term-side-effects dept.

New drug approvals hit 21-year high in 2017

U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light -- more than double the previous year -- while the figure also rose in the European Union.

The EU recommended 92 new drugs including generics, up from 81, and China laid out plans to speed up approvals in what is now the world's second biggest market behind the United States.

Yet the world's biggest drugmakers saw average returns on their research and development spending fall, reflecting more competitive pressures and the growing share of new products now coming from younger biotech companies. Consultancy Deloitte said last month that projected returns at 12 of the world's top drugmakers were at an eight-year low of only 3.2 percent.

Many of the drugs receiving a green light in 2017 were for rare diseases and sub-types of cancer, which often target very small populations, although they can cost hundreds of thousands of dollars. Significantly, the U.S. drug tally of 46 does not include the first of a new wave of cell and gene therapies from Novartis, Gilead Sciences and Spark Therapeutics that were approved in 2017 under a separate category.

Food and Drug Administration Commissioner Scott Gottlieb has indicated that it might be time to revise the Orphan Drug Act of 1983.


Original Submission

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Politics: Koch-Backed Groups Urge Congress to Pass "Right to Try" Legislation 56 comments

Groups funded by Charles and David Koch have launched ad campaigns aimed at urging Congress to pass legislation that would make it easier for terminally ill patients to try experimental treatments. The bill passed the Senate unanimously, but FDA Commissioner Scott Gottlieb told the House in October (archive) that the FDA already approves 99% of requests for expanded access/compassionate use, and that the primary roadblock is not the FDA, but drug supply constraints. He said that pharmaceutical companies do not continuously manufacture a drug undergoing clinical trials, but instead produce "discontinuous batches":

Several deep-pocketed political advocacy groups founded by Charles and David Koch are ramping up their advocacy before Congress on a niche issue: access to experimental drugs.

On Monday, several Koch-backed groups, including Freedom Partners and Americans for Prosperity, launched an ad campaign urging Congress to pass so-called "right-to-try" legislation, which aims to help terminally ill patients access experimental treatments that haven't yet been approved by the Food and Drug Administration. The Senate unanimously passed a right-to-try bill from Sen. Ron Johnson (R-Wis.) last August, but it has since stalled in the House. Supporters, including lawmakers on Capitol Hill and other off-the-Hill advocates, are focusing their efforts this month on the Energy and Commerce Committee, which would likely have to clear the legislation before the full House could vote on it.

The new ad campaign — also sponsored by Generation Opportunity and The LIBRE Initiative — directly addresses Congress, saying at the end of one commercial, "Congress, give patients a chance. Pass right to try." In addition to a series of digital ads focused on D.C. and key congressional districts, the campaign will include lobbying efforts by the groups, according to a press release. In a letter sent Monday to Committee Chairman Greg Walden (R-Ore.), executives wrote, "We strongly urge your committee to act expeditiously to approve Right to Try legislation and send the bill to the House Floor for a full vote."

Johnson told STAT he's doing everything he can this month to get the legislation passed, and suggested the vice president might become even more engaged. Vice President Mike Pence has supported right-to-try efforts since he signed a similar law as governor of Indiana.

S.204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

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"Black Hole" of Accountability for Drug Trials Flouting FDA Oversight?
Drug Approvals Sped Up in 2017


Original Submission

President Trump Signs "Right to Try" Bill 36 comments

Trump signs 'right to try' drug bill

President Trump signed a bill Wednesday allowing terminally ill patients access to experimental medical treatments not yet approved by the Food and Drug Administration (FDA). Dubbed "right to try," the law's passage was a major priority of Trump and Vice President Pence, as well as congressional Republicans.

"Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it's going to better than a chance, that they will be cured, they will be helped, and be able to be with their families for a long time, or maybe just for a longer time," Trump said at a bill signing ceremony at the White House, surrounded by terminally ill patients and their families.

Trump thanked lawmakers sitting in the audience who sponsored the bill, including Sen. Joe Donnelly, a vulnerable Democrat up for reelection in Indiana.

Also at CNN.

Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
Texas Sanctions FDA-Unapproved Stem Cell Therapies
Drug Approvals Sped Up in 2017

Also submitted by mrpg


Original Submission

Former FDA Commissioner Scott Gottlieb Joins Pfizer Board of Directors 14 comments

Scott Gottlieb walks through the revolving door to the Pfizer board

The revolving door turns again. After a two-year stint running the Food and Drug Administration, Scott Gottlieb has joined the board of directors at Pfizer, giving the world's largest drug maker crucial insights into the inner workings of the Trump administration as it attempts to contain national angst over the rising cost of medicines.

And in doing so, Gottlieb is also picking up where he left before joining the agency, since he had been on the board of several smaller pharmaceutical companies and was also a partner at a venture capital firm that invests in life sciences companies.

"This is classic and it's not surprising," said Sidney Wolfe, a founder of Public Citizen Health Research Group and a long-time FDA watchdog, who had expressed concern about Gottlieb's ties to industry before joining the agency. "Philosophically, he's returning to the ecosystem where he's most comfortable. And he'll get paid very well for it, too."

Also at Financial Times.

Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
FDA Nominee is a Proponent of "Adaptive Trials"
Drug Approvals Sped Up in 2017
Koch-Backed Groups Urge Congress to Pass "Right to Try" Legislation
FDA Labels Kratom an Opioid
FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated] (including Pfizer)
U.S. to Make More Drugs Easily Available, Cutting Role Docs Play


Original Submission

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  • (Score: -1, Flamebait) by Anonymous Coward on Thursday January 04 2018, @05:03AM (3 children)

    by Anonymous Coward on Thursday January 04 2018, @05:03AM (#617522)

    I just want to express my appreciation for the editors in driving away all the lefty commentors and submittors to this sight, so we can have Fine Articles like this with no comments. It just seems much more, clean, like, whiter, if you know what I mean. No comments on science, because it is so far beyond the comprehension of anyone still reading SoylentNews.

    • (Score: 1, Interesting) by Anonymous Coward on Thursday January 04 2018, @05:17AM

      by Anonymous Coward on Thursday January 04 2018, @05:17AM (#617531)

      What you mean, boy? Jus caus al the white crackers can't spell. I mean...sped??

    • (Score: 0) by Anonymous Coward on Thursday January 04 2018, @06:03PM (1 child)

      by Anonymous Coward on Thursday January 04 2018, @06:03PM (#617840)

      I mean, this isn't exactly a controversial article. If we wanted more comments, we should have said something like, "Trump's FDA breaks record for drug approval, scientists concerned about safety!"

      THAT would have created a nice little flame-war to keep us all warm and cozy. As it stands, we're stuck with the silly "not enough women in Bitcoin" article above.

      • (Score: 0) by Anonymous Coward on Friday January 05 2018, @12:22AM

        by Anonymous Coward on Friday January 05 2018, @12:22AM (#618110)

        I had something to say, but whatever, and ignored this. People who know the scam already know, those who don't are pointless to attempt convincing. Its the same old choose a pointless threshold of a meaningless number to indicate progress thing. What more is there to say?

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