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Farmas USA

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#124665

Re: Farmas USA

Amrn

Y hace 2 días publicó este tweet.

415 asignados de un total de 900 observados

415 patients already randomized in PREPARE-IT Trial (900 screened) with #vascepa #EPA in 🇦🇷
#124666

Re: Farmas USA

REGN
Alegría, alegría

Regeneron Antibody Cocktail Lowers Virus in Covid-19 Patients


Anthony Fauci, the top U.S. infectious-disease official, has referred to antibody-based medicines that could treat infected patients sooner after they contract the virus as a bridge to a vaccine

https://www.bloomberg.com/amp/news/articles/2020-09-29/regeneron-antibody-cocktail-lowers-virus-in-covid-19-patients?__twitter_impression=true

REGENERON'S REGN-COV2 ANTIBODY COCKTAIL REDUCED VIRAL LEVELS AND IMPROVED SYMPTOMS IN NON-HOSPITALIZED COVID-19 PATIENTS

The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally-occurring immune response. These patients were less likely to clear the virus on their own, and were at greater risk for prolonged symptoms

The descriptive analysis included the first 275 patients enrolled in the trial and was designed to evaluate anti-viral activity with REGN-COV2 and identify patients most likely to benefit from treatment; the next cohort, which could be used to rapidly and prospectively confirm these results, has already been enrolled. Patients in the trial were randomized 1:1:1 to receive a one-time infusion of 8 grams of REGN-COV2 (high dose), 2.4 grams of REGN-COV2 (low dose) or placebo. All patients entering the trial had laboratory-confirmed COVID-19 that was being treated in the outpatient setting. Patients were prospectively characterized prior to treatment by serology tests to see if they had already generated antiviral antibodies on their own and were classified as seronegative (no measurable antiviral antibodies) or seropositive (measurable antiviral antibodies). Approximately 45% of patients were seropositive, 41% were seronegative and 14% were categorized as "other" due to unclear or unknown serology status.

Key data findings include:
Note that since this analysis was considered descriptive, all p-values are nominal.

  • As hypothesized, patients in the study consisted of two different populations: those who had already mounted an effective immune response, and those whose immune response was not yet adequate. These populations could be identified serologically by the presence (seropositive) or absence (seronegative) of SARS-CoV-2 antibodies, and/or by high viral loads at baseline.
  • Serological status highly correlated with baseline viral load (p<0.0001). Seropositive patients had much lower levels of virus at baseline, and rapidly achieved viral loads approaching lowest levels quantifiable (LLQ), even without treatment. In contrast, seronegative patients had substantially higher viral levels at baseline, and cleared virus more slowly in the absence of treatment.
  • Serological status at baseline also predicted how rapidly patients had alleviation of their COVID-19 clinical symptoms. In the untreated (placebo) patients, seropositive patients had a median time to alleviation of symptoms of 7 days, compared to seronegative patients who had a median time to alleviation of symptoms of 13 days.
  • REGN-COV2 rapidly reduced viral load through Day 7 in seronegative patients (key virologic endpoint). The mean time-weighted-average change from baseline nasopharyngeal (NP) viral load through Day 7 in the seronegative group was a 0.60 log10 copies/mL greater reduction (p=0.03) in patients treated with high dose, and a 0.51 log10 copies/mL greater reduction (p=0.06) in patients treated with low dose, compared to placebo. In the overall population, there was a 0.51 log10 copies/mL greater reduction (p=0.0049) in patients treated with high dose, and a 0.23 log10 copies/mL greater reduction (p= 0.20) in patients treated with low dose, compared to placebo.
  • Patients with increasingly higher baseline viral levels had correspondingly greater reductions in viral load at Day 7 with REGN-COV2 treatment. The mean log10 copies/mL reduction in viral load compared to placebo were as follows:
    -  Viral load higher than 105 copies/mL: high dose (-0.93); low dose (-0.86) (p=0.03 for both); approximately 50-60% reduction compared to placebo
    -  Viral load higher than 106 copies/mL: high dose (-1.55); low dose (-1.65) (p<0.002 for both); approximately 95% reduction compared to placebo
    -  Viral load higher than 107 copies/mL: high dose (-1.79); low dose (-2.00) (p<0.0015 for both); approximately 99% reduction compared to placebo
  • Patients who were seronegative and/or had higher baseline viral levels also had greater benefits in terms of symptom alleviation. Among seronegative patients, median time to symptom alleviation (defined as symptoms becoming mild or absent) was 13 days in placebo, 8 days in high dose (p=0.22), and 6 days in low dose (p=0.09). Patients with increasing viral loads at baseline had correspondingly increasing benefit in time to symptom alleviation.
  • There were a small number of medically-attended visits given that most non-hospitalized patients recover well at home. Patients in the seronegative group were at higher risk of medically-attended visits: 10 of the 12 medically-attended visits (defined as hospitalizations, or emergency room, urgent care or telemedicine visits for COVID-19) occurred in patients who were seronegative at baseline. In the seronegative group, 15.2% of placebo-treated patients, 7.7% of patients treated with high dose and 4.9% of patients treated with low dose required additional medical visits.
  • Both doses were well-tolerated. Infusion reactions were seen in 4 patients (2 on placebo and 2 on REGN-COV2). Serious adverse events occurred in 2 placebo patients, 1 low dose patient and no high dose patients. There were no deaths in the trial.
More than 2,000 people have been enrolled across the overall REGN-COV2 development program, and no unexpected safety findings have been reported by the Independent Data Monitoring Committee.

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

#124667

Re: Farmas USA

CPRX

Catalyst Pharmaceuticals Announces Ruling on Lawsuit against the FDA and Intent to Appeal

District Judge found that Catalyst’s interpretation of the Orphan Drug Act “is not necessarily wrong, but it is not the only reasonable way to interpret the plain language of the statute.”  The District Judge found that the relevant statutory language was ambiguous and adopted FDA’s interpretation rather than Catalyst’s.  The District Judge also rejected Catalyst’s argument that the approved labeling for Ruzurgi® is false and misleading.  As a result of the District Judge's decision, Ruzurgi® remains approved for the treatment of pediatric LEMS patients in the United States. 
Patrick J. McEnany, the Company's Chairman and CEO, stated: "We are of course disappointed with Judge Bloom’s decision to accept the Magistrate’s Report and Recommendation in our lawsuit challenging the FDA’s decision to approve Ruzurgi® for the treatment of pediatric patients with Lambert-Eaton Myasthenic Syndrome (LEMS). This decision in no way affects our Catalyst PathwaysTM patient services programs, market access for Firdapse® or our ongoing marketing efforts for Firdapse® to adult LEMS patients, which represent about 99% of the LEMS patient community."
Mr. McEnany continued: "Judge Bloom’s decision also does not alter the fact that Jacobus Pharmaceuticals is not permitted to market Ruzurgi® to adult LEMS patients in the United States, and Catalyst intends to continue to aggressively take all steps necessary to protect Firdapse®’s exclusivity under the Orphan Drug Act."

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

#124668

Re: Farmas USA

Gsk

Jode,si esto ocurre, sin tiburones en la bolsa jeje

06:30 Una vacuna contra el coronavirus pone en peligro de muerte a 500.000 tiburones

La farmacéutica británica GlaxoSmithKline trabaja con el escualeno de tiburones, que se obtiene a partir del aceite de hígado de los escualos, para encontrar una vacuna contra el coronavirus. La empresa, que ya ha utilizado esa sustancia para otras vacunas, necesitaría matar sobre 500.000 tiburones para poder fabricar una vacuna contra el coronavirus... si la logra crear.


#124670

Re: Farmas USA

Es desolador leer este tipo de noticias. Es lo que tiene intentar conseguir una vacuna a toda costa, que parece que todo vale...
#124671

Re: Farmas USA

MYOV 
Yo llevaba muy pocas y añadí ayer a $15.82. El resultado era más o menos esperable, le daban algunos analistas un +100/-10%.

No la controlo mucho pero por lo que he leído está barata. Aunque en el lado opuesto hay argumentos para pensar que no lo tendrá fácil. Veremos qué pasa. Este finde me la miro más a fondo y pongo los datos que tenga...