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Farmas USA

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#99339

Re: Farmas USA

Noticias del día

Mylan has received a "preliminary" inquiry from the Federal Trade Commission asking about the company’s commercial practices for its EpiPen. A statement from the company indicated the inquiry included questions about Mylan's (NASDAQ:MYL) efforts to block rival Teva Pharmaceutical (NYSE:TEVA) from gaining approval in the U.S. to sell a generic version of the severe-allergy treatment.

Three of the biggest makers of diabetes treatments, Sanofi (NYSE:SNY), Novo Nordisk (NYSE:NVO) and Eli Lilly (NYSE:LLY), were named in a proposed class action lawsuit by a group of patients alleging price-fixing. The suit accuses the companies of exploiting the U.S. drug pricing system that benefits them and pharmacy benefit managers, and claims they simultaneously hiked the price of insulin by over 150% during the past five years.

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#99341

Re: Farmas USA

DMTX

-25% ahora mismo

Resultados de seguridad de fase I con troblemas de toxicidad. ¿Alguien sabe qué más tiene esta?

Dimension Announces Interim Topline Results from Ongoing Phase 1/2 Clinical Program for DTX101, Dimension’s Lead AAV Product Candidate in Development for Adult Patients with Moderate/Severe to Severe Hemophilia B

http://investors.dimensiontx.com/phoenix.zhtml?c=254192&p=irol-newsArticle&ID=2240877

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#99342

Re: Farmas USA

MCRB

+9,78% en pre

Seres Therapeutics Announces Key Findings from SER-109 Phase 2 Study Analyses

https://finance.yahoo.com/news/seres-therapeutics-announces-key-findings-120000844.html

Seres finally explains 'poop pill' failure, reassuring investors

a misdiagnosis of certain patients in the trial meant that some participants did not actually have the disease, called Clostridium difficile infection, or C. diff. The company also said that some patients may not have gotten a high-enough dose of SER-109

One key mistake, says Pomerantz, was choosing the wrong diagnostic test. Most of the patients were chosen using a polymerase chain reaction test, he says, which doesn’t actually tell you if the C. difficile cytotoxin genes found by the test are producing disease-causing cytotoxins.

Switching to samples of patients who chose to join the open label extension study, fewer than half of the total of 72 who were enrolled, the cytotoxin test found that only 44% of the patients who tested positive with the PCR test also tested positive with the cytotoxin test.

http://www.bizjournals.com/boston/news/2017/01/31/seres-finally-explains-poop-pill-failure.html

Investigators concluded that the test results could have been simply screwed up through the use of the wrong test, also skewing the number of recurrences tracked in the two drug arms. That could be fixed by switching to the cytotoxin test, which they plan to do in the new trial.

They also found that the dose used was clearly “suboptimal,” suggesting a better dosing would have produced much better results.

In addition, Seres acknowledges that there was a significantly higher rate of serious adverse events in the drug group, 15% versus 10.3% in the placebo arm — though the investigators did not consider the SAEs drug related.

The big question for Seres is whether the FDA will look over its finding and ask for a new Phase II to clear the hurdle that now exists, or if it will allow the developer to shape this into a pivotal study that would position them to apply for marketing approval, if it proves successful

https://endpts.com/after-a-phii-catastrophe-wiped-out-a-billion-dollars-in-market-cap-seres-is-looking-for-a-do-over/

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#99343

Re: Farmas USA

Tema TRUMP con lobby farmas

Trump Will Oppose Anything That Makes It Harder For ‘Young, Small Drug Companies To Enter The Market’

Trump vows to get drug prices lower, streamline process for drug approvals

Trump says disturbed when FDA turns down drugs for terminally ill patients

TRUMP SAYS U.S. CAN SAVE TENS OF BILLIONS OF DOLLARS WITH LOWER PRICES, BETTER INNOVATION

TRUMP TELLS DRUGMAKERS I WANT YOU TO MANUFACTURE IN THE UNITED STATES

TRUMP SAYS HE EXPECTS TO NAME HEAD OF U.S. FDA FAIRLY SOON

Trump blasting FDA for not approving drugs for terminal patients before safety known; "we're going to be changing a lot of the rules"

We have a fantastic person for the FDA who I think I'll be naming very soon; approval going to be quick process, not take 15 yrs

Luego ya saldrán artículos con resúmenes, es por tener una idea de lo que anda sucediendo

#99344

Re: Farmas USA

IBB

Patadón pa'rriba de 268 a casi 274 ahora a ver cuanto tarda en desinflarse