• Tues news: Prostate cancer trials to watch. Merck’s subcutaneous Keytruda. Apellis sees positive in Astellas CRL. Future of Medicare price negotiations. JNJ psoriasis results. See more on our front page

layoffs coming?

Quote
anonymous said:
Let’s be real, are all 3 reps in a tri-pod actually visiting 5 customers a day anyway? Who are we kidding entering fake calls
Click to expand...

Had several recruiters approach me about the job. Soon as I heard 3 Reps in a territory I stepped back. Hiring manager acted like 3 reps was logical in an area where 1 rep should cover a whole state or more based on access. The manager further acted like I was "not a fit". Damn right! Been around long enough to see a layoff coming and don't need to waste the time.
 




anonymous said:
Had several recruiters approach me about the job. Soon as I heard 3 Reps in a territory I stepped back. Hiring manager acted like 3 reps was logical in an area where 1 rep should cover a whole state or more based on access. The manager further acted like I was "not a fit". Damn right! Been around long enough to see a layoff coming and don't need to waste the time.
Click to expand...

three reps is definitely overkill. Especially if you have to enter bullshit calls on veeva. Who are we kidding? Ain’t nobody in pharma actually really working.
 
















The AbbVie led male testosterone study lilted "A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men (TRAVERSE)" with 5,246 participants will be coming out soon and should shed light on the following.
  • Time to Major Adverse Cardiac Event (MACE)
  • Assessing cardiovascular safety
  • Assessing prostate safety
  • Change from Baseline in overall sexual activity
  • Proportion of men whose persistent depressive disorder (PDD) remits during intervention
  • Proportion of men with bone fractures
  • Proportion of anemic men whose anemia is corrected during the intervention period
  • Proportion of men, who had pre-diabetes at Baseline, and who progress to diabetes

Additionally, On October 27th, 2021, the long term safety/efficacy trial titled "Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women (BLOOM)" shows that ted a Certification/Extension request was submitted delay submitting results. Interestingly the trial still lists AbbVie's Dr Michael Snabes as the Study Director. If the study was completed January 2013, as listed on the Clinical trial website. there is no obligation to post results or seek an extension, making it look like a certification (a requirement for an NDA filing) request was made. This trial enrolled 3,656 participants looking at the following:
  • The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects
  • The rate of adjudicated, predefined breast cancer events in LibiGel-treated subjects compared to that of placebo-treated subjects.
  • Efficacy in treating HSDD.
  • Ani additional outcomes, if any, are not listed.
Note: According to patent filings and subsequent prosecutions, by June 2011, based on 4,000 patient years of data, Dr. Snabes found that restoring testosterone reduced cardiovascular events by at least 70% over expected results. How it compared to placebo was never disclosed. In December 2015, claims that it also reduced breast cancer events by an undisclosed amount were added.

The following is the link to the patent application which was abandoned for failure to respond to an Office Action. The Patent office required that the CV and Breast claims be filed in separate patent applications.

United States Patent Application: 0170128462

AbbVie owns Intrinsa through their acquisition of Allergan, which would account for the second largest body of data in relation to female testosterone.

If Dr. Snabes is behind a potential certification submission, AbbVie is on the verge of providing the world with the largest body of testosterone related data for both men and women and could lead to the launch of the first FDA approved female testosterone drug and future job openings, no doubt leading to more R&D and sales positions.
 
























anonymous said:
AbbVie has a great history when it comes to testosterone. Bring back the Androgel glory days.
Click to expand...
This year is shaping up to be a huge year in understanding the potential benefits of Testosterone for both men and women. With Androgel facing generic competition, hopefully AbbVie is focusing on delivering the first FDA approved testosterone for women.

The 700,000 participant observational study titled "Evaluation of Association Between Testosterone Levels, Dementia and Adverse Mental Health Outcomes" is expected to be completed by November 2022.

The conditions being looked at include:
  • Anxiety Disorder
  • Depression
  • Genetic Disorder
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm
Primary Objective:
I. To use a Mendelian randomization study design to determine whether genetically predicted decreased testosterone levels are associated with an increased risk of dementia.
Secondary Objective:
I. To examine whether genetically predicted decreased testosterone levels are associated with worse cognitive function and adverse mental health outcomes.

Hopefully, AbbVie intends on deliver the first FDA approved testosterone drug for women, with proven reduction in Cardiovascular events and Breast Cancer events. If so, this study may give them a roadmap for future cognitive studies and potentially additional FDA approved indications.

Currently, an FDA filing would be supported by the Global Consensus Position Statement on the Use of Testosterone Therapy for Women first issued in September 2019., Which does support the use of Testosterone to gels / transdermals to treat HSDD. All 3,656 participants in the long term safety/efficacy trial led by Dr Snabes were diagnosed with HSDD and were at an elevated risk of experiencing cardiovascular events.

ISSWSH - Global Consensus Position Statement on the Use of Testosterone Therapy for Women
 




Top Bottom
Back
Quote