Anorectics

Once-weekly Trulicity® (dulaglutide) demonstrates significantly higher adherence and more persistence compared to once-weekly semaglutide and exenatide injections

Retrieved on: 
Saturday, June 20, 2020

At six months, people taking Trulicity showed higher adherence and persistence than people taking semaglutide or exenatide.

Key Points: 
  • At six months, people taking Trulicity showed higher adherence and persistence than people taking semaglutide or exenatide.
  • Further, significantly fewer people discontinued treatment with Trulicity compared to semaglutide or exenatide.1
    Adherence and persistence are integral factors when applying a holistic approach to patient care.
  • We are pleased that the new real-world data shows that Trulicity provides significantly better outcomes in this regard, when compared to weekly injections of semaglutide or exenatide in people with type 2 diabetes, says Dr. Doron Sagman, Vice President, R&D and Medical Affairs, Eli Lilly Canada.
  • Trulicity users were propensity-matched 1:1 to semaglutide users (3,852 pairs) or exenatide users (1,879 pairs) users.

Psychemedics Announces First Quarter Results

Retrieved on: 
Wednesday, May 13, 2020

ACTON, Mass., May 13, 2020 (GLOBE NEWSWIRE) -- Psychemedics Corporation (NASDAQ:PMD) today announced first quarter financial results for the period ended March 31, 2020.

Key Points: 
  • ACTON, Mass., May 13, 2020 (GLOBE NEWSWIRE) -- Psychemedics Corporation (NASDAQ:PMD) today announced first quarter financial results for the period ended March 31, 2020.
  • The Companys revenue for the quarter ended March 31, 2020 was $7.5 million versus $9.8 million for the quarter ended March 31, 2019, a decrease of 23%.
  • Despite the COVID-19 pandemic, domestic revenue declined only 10% in the first quarter of 2020 compared to the prior-year quarter.
  • The new offering once again builds on Psychemedics unmatched technology to advance drug detection science and equips client companies with results to lower risks associated with cocaine in the workplace.

Rhythm Pharmaceuticals Announces FDA Acceptance of New Drug Application for Setmelanotide for the Treatment of POMC and LEPR Deficiency Obesities

Retrieved on: 
Wednesday, May 13, 2020

Under Priority Review, the FDA aims to take action on an application within six months, compared to 10 months under standard review.

Key Points: 
  • Under Priority Review, the FDA aims to take action on an application within six months, compared to 10 months under standard review.
  • The FDA previously granted Breakthrough Therapy designation to setmelanotide for the treatment of obesity associated with genetic defects upstream of the MC4R in the central melanocortin pathway, which includes POMC deficiency obesity and LEPR deficiency obesity.
  • Rhythm estimates there are approximately 100 to 500 patients in the U.S. with POMC deficiency obesity and approximately 500 to 2,000 patients in the U.S. with LEPR deficiency obesity.
  • Both the FDA and EMA have granted orphan drug status to setmelanotide for POMC and LEPR deficiency obesities.

Psychemedics Test for Cotinine (metabolite of Nicotine) Detection Cleared by FDA

Retrieved on: 
Wednesday, April 29, 2020

Hair testing provides several significant advantages over other methods of testing including a 90-day lookback period for the ingestion of drugs.

Key Points: 
  • Hair testing provides several significant advantages over other methods of testing including a 90-day lookback period for the ingestion of drugs.
  • Psychemedics new cotinine test is an accurate and economical way to equip educators and companies alike with the capability to quickly detect people using nicotine.
  • We believe Psychemedics superior science delivers the most sensitive FDA 510(k) cleared tests in the world resulting in unmatched detection rates.
  • Psychemedics is the standard against which all others measure themselves for sensitivity, quality, and innovation to stay ahead of the ever-changing illicit drug landscape.

Rhythm Pharmaceuticals Receives Orphan Drug Designation from U.S. FDA for Setmelanotide for the Treatment of Alström Syndrome

Retrieved on: 
Wednesday, March 18, 2020

BOSTON, March 18, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to setmelanotide for the treatment Alstrm syndrome.

Key Points: 
  • BOSTON, March 18, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to setmelanotide for the treatment Alstrm syndrome.
  • People living with Alstrm syndrome may experience an insatiable hunger, also known as hyperphagia, and severe obesity beginning early in life.
  • Orphan drug designation from the FDA reinforces the urgency of our work with setmelanotide in Alstrm syndrome, as we advance our pivotal Phase 3 trial to topline data expected by the end of this year or early next year.
  • Insatiable hunger, also known as hyperphagia, and severe obesity beginning early in life may be seen in individuals living with Alstrm syndrome.

Corbus Pharmaceuticals Reports Fourth Quarter and Year-End 2019 Financial Results

Retrieved on: 
Thursday, March 12, 2020

In November, the Company announced completion of enrollment in the Phase 2b study evaluating lenabasum in 426 individuals with CF.

Key Points: 
  • In November, the Company announced completion of enrollment in the Phase 2b study evaluating lenabasum in 426 individuals with CF.
  • Topline data expected in the summer of 2020 following RESOLVE-1 topline results.
  • Corbus second drug, CRB-4001, is a peripherally restricted CB1 inverse agonist, designed to avoid the central nervous system side effects seen with rimonabant.
  • Financial Results for Fourth Quarter and Year-End December 31, 2019
    Revenue from awards and licenses was $2.6 million for the three months ended December 31, 2019, compared to $1.9 million in the comparable period in 2018.

Achieve Life Sciences Announces Presentation of Additional Cytisinicline Analyses at the Society for Research on Nicotine & Tobacco (SRNT) Annual Meeting

Retrieved on: 
Thursday, March 12, 2020

A 4-week continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline was also observed compared to 8% for placebo (p= 0.005).

Key Points: 
  • A 4-week continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline was also observed compared to 8% for placebo (p= 0.005).
  • Additionally, clinical benefit was observed with cytisinicline regardless of prior smoking cessation treatments utilized, including Chantix (varenicline), Zyban (bupropion), or Nicotine Replacement Therapy (NRT).
  • New analyses also demonstrate cytisinicline biochemical efficacy via measurement of serum cotinine as well as the previously reported carbon monoxide (CO) efficacy.
  • Achieve's focus is to address the global smoking and nicotine addiction health epidemic and through the development and commercialization of cytisinicline.

VIVUS Completes Enrollment in Phase 4 Safety and Efficacy Study of Qsymia® in Adolescents

Retrieved on: 
Monday, March 2, 2020

Completing enrollment in this study is an important milestone in our ongoing efforts to expand the clinical use of Qsymia based on robust safety and efficacy data, said Santosh T. Varghese, MD, Senior Vice President, Chief Medical Officer at VIVUS.

Key Points: 
  • Completing enrollment in this study is an important milestone in our ongoing efforts to expand the clinical use of Qsymia based on robust safety and efficacy data, said Santosh T. Varghese, MD, Senior Vice President, Chief Medical Officer at VIVUS.
  • We believe that Qsymia has significant clinical and commercial potential, and we are committed to capturing a larger share of the global market for anti-obesity medications, said John Amos, Chief Executive Officer at VIVUS.
  • In December 2019 , VIVUS reported that data from a pharmacokinetic (PK) and pharmacodynamic (PD) study (NCT# 02714062)conducted in order to establish dosing levels for the ongoing Phase 4 post-marketing study demonstrated that Qsymia has favorable PK, efficacy, and safety/tolerability profiles when used for eight weeks to treat adolescents with obesity.
  • Food and Drug Administration(FDA) required as part of the approval of Qsymia in 2012, enrolled approximately 200 patients at 26 clinical sites inthe United States.

Rhythm Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results

Retrieved on: 
Monday, March 2, 2020

Fourth Quarter and Recent Business Highlights:

Key Points: 
  • Fourth Quarter and Recent Business Highlights:
    Today, Rhythm announced that its ongoing genetic sequencing programs have now sequenced more than 25,000 people with early-onset, severe obesity.
  • In December 2019, Rhythm announced the completion of enrollment in its pivotal Phase 3 clinical trial evaluating setmelanotide in BBS and Alstrm syndrome.
  • Fourth Quarter and Full Year 2019 Financial Results:
    Cash Position: As of December 31, 2019, cash, cash equivalents and short-term investments were $292.5 million, as compared to $252.1 million as of December 31, 2018.
  • R&D Expenses: R&D expenses were $24.8 million in the fourth quarter of 2019 and $109.5 million for the year ended December 31, 2019, as compared to $18.8 million in the fourth quarter of 2018 and $50.3 million for the year ended December 31, 2018.

VIVUS Announces Commercial Launch of Qsymia® in the Republic of Korea Establishing New Royalty Revenue Stream

Retrieved on: 
Wednesday, February 19, 2020

We are confident in Alvogens ability to make Qsymia a significant product in the South Korean market.

Key Points: 
  • We are confident in Alvogens ability to make Qsymia a significant product in the South Korean market.
  • Under the agreement, VIVUS is also eligible to receive royalties on Alvogen's net sales of Qsymia and future milestone payments contingent upon achievement of net sales goals within the covered territory.
  • Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy.
  • These risks and uncertainties could cause actual results to differ materially from those referred to in these forward-looking statements.