Tadalafil

Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

Retrieved on: 
Thursday, April 18, 2024
Eurostat, Blood pressure, Diagnosis, Tadalafil, Blood, Serotonin, Patient, Committee, Knowledge, Regulation, Prostacyclin, EMA, IRIS, Artery, Life expectancy, Heart failure, Orthostatic hypertension, European, Therapy, COMP, Heart, Safety, European Commission, Marketing, Pulmonary hypertension, Medicine, Pharmaceutical industry

Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

Key Points: 


Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
Friday, March 22, 2024
Diagnosis, ESC, Toxicity, ERA, Tadalafil, Internal medicine, European Respiratory Society, Disease, Risk, Pulmonary hypertension, Patient, PVR, Mitigation, Female, Nitric oxide, Connective tissue disease, Orthostatic hypertension, World Health Organization, PDE5, Johnson & Johnson, REMS, WHO, Pulmonary circulation, PAH, FDA, Constriction, ERS, Food, Pharmaceutical industry

RARITAN, N.J., March 22, 2024  /PRNewswire/ -- Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III.1 OPSYNVI® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. OPSYNVI® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.1

Key Points: 
  • Historically, this required patients to take multiple pills because no single-tablet combination therapy targeting two or more pathways was available," said Kelly Chin, M.D., Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at UT Southwestern Medical Center, and an investigator in the A DUE study.
  • The FDA's approval of OPSYNVI® is based on the results from the pivotal Phase 3 A DUE study , in which OPSYNVI® demonstrated greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks versus tadalafil or macitentan monotherapy.
  • "People with PAH often live with the burden of taking many pills each day, which can pose challenges," said James F. List, M.D., Ph.D., Global Therapeutic Area Head, whose team oversees a portfolio of programs including Pulmonary Hypertension at Johnson & Johnson.
  • "We're thrilled to bring this single-tablet combination therapy to patients, as it has the potential to optimize disease management and fulfill a significant unmet need in supporting recently updated treatment guidelines that call for initial or early combination treatment."

New Guidelines on Men with Erectile Dysfunction and Cardiac Health Published in the Journal of Sexual Medicine Concludes PDE-5 Inhibitors are Still Safe for the Cardiovascular System

Retrieved on: 
Thursday, January 4, 2024
Research, Seniors, Men, Cardiology, Biotechnology, Health, Consumer, Pharmaceutical, Science, Patient, Exercise, HMRI, ED, Risk, Nitrate, Woman, PDE5, Hypotension, Moyamoya disease, B cell, Mortality, Regenerative medicine, Pharmacist, Platelet-rich plasma, MBA, MD, Doctor of Philosophy, Huntington Medical Research Institutes, Pulmonary hypertension, Tadalafil, University, CVD, Death, CAC, System, CT scan, Oxygen, American College, Contra, Overalls, Dietary supplement, Princeton University, Ischemia, Journal, Female, Johns Hopkins, Erectile dysfunction, Pharmaceutical industry

Their summary and guidelines have now been published in the Journal of Sexual Medicine.

Key Points: 
  • Their summary and guidelines have now been published in the Journal of Sexual Medicine.
  • They determined that PDE-5 inhibitors are still safe for the cardiovascular system.
  • The conference was funded by an unrestricted grant from Sanofi to readdress the cardiovascular workup of men presenting with ED and the cardiovascular safety of the phosphodiesterase-5 (PDE-5) inhibitors for treating ED.
  • Patients with ED should be characterized as low-risk, intermediate (or indeterminable), or high-risk of developing a cardiac event with sexual activity.

Mangoceuticals Announces TV Air Dates for Interview Featuring CEO Jacob Cohen on Bloomberg TV and Fox Business

Retrieved on: 
Friday, October 13, 2023
Sildenafil, Tadalafil, Traction, Vasodilation, Arginine, Bloomberg Television, Mouth, Adam22, Growth, International, Marketing, New Haven State Street station, Fox Business, Tongue, Erectile dysfunction, Interview, FMW, Oxytocin, Barstool Sports, Television, Retail

In the interview, Mr. Cohen begins by laying out the Company’s potent strategy for differentiating itself as a new breed of men’s health product provider.

Key Points: 
  • In the interview, Mr. Cohen begins by laying out the Company’s potent strategy for differentiating itself as a new breed of men’s health product provider.
  • According to Cohen, it starts with the idea of an “Erectile Function” pill instead of an “Erectile Dysfunction” pill.
  • Through that idea, Cohen believes the Company is positioning itself to tap into the relatively untapped younger demographic, which is mirrored by MangoRx’s dynamic marketing strategy.
  • Through its network of syndication, FMW programming reaches an estimated 540 million homes across US and international markets.

Gossamer Bio Announces Addition of Rainer Zimmermann, MD, as VP of Medical Affairs

Retrieved on: 
Tuesday, October 3, 2023
Research, General Health, Radiology, Professional Services, Pharmaceutical, Clinical Trials, Science, Legal, Cardiology, Biotechnology, Finance, Health, Medical Affairs Bureau, University, GOSS, PAH, Rainer, Bio, Nasiriyah Heart Center, University of Giessen, Actelion, Pulmonary hypertension, Gossamer, MD, Patient, Tadalafil, Entrepreneurship, Johnson & Johnson, Orthostatic hypertension, University of Oxford, Pharmaceutical industry, CSF1R

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced that Rainer Zimmermann, MD, has joined the Company as Vice President of Medical Affairs.

Key Points: 
  • Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced that Rainer Zimmermann, MD, has joined the Company as Vice President of Medical Affairs.
  • Dr. Zimmermann brings more than 23 years of experience within the PAH/PH space, most recently having served as the Global Medical Lead, Medical Affairs, Pulmonary Hypertension, at Johnson & Johnson Innovative Medicine.
  • “We are thrilled to have Rainer join us at such a critical juncture for the seralutinib program.
  • For nine years, Dr. Zimmerman oversaw the clinic for children with PAH/PH at the Heart Center, University of Giessen, Germany.

Mangoceuticals Launches New High-Production Quality Ad Providing Fresh Insight into its Proprietary Mango Erectile Dysfunction Pill Formula

Retrieved on: 
Wednesday, August 30, 2023
Arginine, Marketing, Taboo, RDT, Mango, Entrepreneurship, Erectile dysfunction, Perfume, Tadalafil, Oxytocin

Differences between the newest Mango formulation (with Sildenafil) and the Company’s flagship Mango formulation (with Tadalafil) involve the main active ingredient and the lasting effects of each at effective levels in the bloodstream.

Key Points: 
  • Differences between the newest Mango formulation (with Sildenafil) and the Company’s flagship Mango formulation (with Tadalafil) involve the main active ingredient and the lasting effects of each at effective levels in the bloodstream.
  • Sildenafil is the active ingredient in Viagra™ while Tadalafil is the active ingredient in Cialis™.
  • Sildenafil lasts up to 4 hours, while Tadalafil may last up to 36 hours.
  • Otherwise, both formulations are compounded with Oxytocin (aka, the “cuddle chemical”, helping you connect with your partner during intimacy) and L-Arginine (a proven blood flow enhancer).

Mangoceuticals Launches New Sildenafil Based Erectile Dysfunction Product with Signature Mango Flavor & Rapid Dissolve

Retrieved on: 
Wednesday, August 16, 2023
Sildenafil, Arginine, Half-life, Marketing, Oxytocin, RDT, Tablet, Investment, Entrepreneurship, Erectile dysfunction, Fine chemical, Tadalafil

Interested consumers can now proceed through the Company’s telemedicine platform and select either a Sildenafil-based Mango or the Company’s original Tadalafil-based Mango ED product, which leverages the active ingredient found in Cialis™.

Key Points: 
  • Interested consumers can now proceed through the Company’s telemedicine platform and select either a Sildenafil-based Mango or the Company’s original Tadalafil-based Mango ED product, which leverages the active ingredient found in Cialis™.
  • Both the Sildenafil and Tadalafil-based Mango ED products are compounded with Oxytocin and L-Arginine in a tasty Mango-flavored, rapid dissolve tablet (RDT) and individually packaged in a master pack of six tablets per package.
  • For example, Tadalafil has been proven to last longer than Sildenafil due to a half-life more than four times as long.
  • Cohen added, “Perhaps the most important point here is that we are standing on the shoulders of billions of dollars of prior marketing spend.

Avoiding the Unpleasant Side Effects of ED Drugs

Retrieved on: 
Friday, July 28, 2023
NIDDK, Cleveland Clinic, Mayo Clinic, Headache, Boston University Chobanian & Avedisian School of Medicine, Rash, Diarrhea, Hearing loss, COVID-19, Tadalafil, Ageing, Quality of life, Research, Libido, Back pain, Kidney, Dizziness, National Institute of Diabetes and Digestive and Kidney Diseases, Male, Tribulus terrestris, Erectile dysfunction, Digestive, ED, Skin, Dietary supplement, Nursing, Sildenafil

NIDDK (the National Institute of Diabetes and Digestive and Kidney Diseases) puts the number at 30 million men .

Key Points: 
  • NIDDK (the National Institute of Diabetes and Digestive and Kidney Diseases) puts the number at 30 million men .
  • The only problem is that often the solution proposed is to take strong ED medications.
  • Harvard Health reports that ED drugs can leave men with headaches, upset stomachs, rashes, dizziness, diarrhea, and even vision problems.
  • The plethora of side effects undoes much of the positive elements that ED drugs can provide to a man’s quality of life.

Blue Water Biotech Issues CEO Shareholder Letter Providing Update on Commercial Launch Activities

Retrieved on: 
Monday, July 17, 2023
Telehealth, Business development, Senior, Marketing, Wake (Dead Can Dance album), IQVIA, BPH, Biotechnology, Eye, Prescription, Bluewater, Pharmacy, Master service agreement, Acquisition, Patient, Tadalafil, Physician, Finasteride, Capital, Pain management, Growth, Cardiology, FDA, Letter, Urology, Pharmaceutical industry, Management, Sales, Health insurance

In recent months, Blue Water Biotech, Inc. (“Blue Water”) has evolved from a preclinical vaccine development company to a commercial stage pharmaceutical company after the purchase of several FDA approved assets spanning multiple treatment areas.

Key Points: 
  • In recent months, Blue Water Biotech, Inc. (“Blue Water”) has evolved from a preclinical vaccine development company to a commercial stage pharmaceutical company after the purchase of several FDA approved assets spanning multiple treatment areas.
  • While each product has unique considerations for launch and we have analyzed each closely, we have developed a core framework for commercial operations as we progress towards official launch.
  • To begin, the core for any successful commercial operation is a dedicated, experienced management team to steer operations and make strategic decisions that will benefit Blue Water in the long run.
  • To summarize, the last few months have certainly been an exciting time for Blue Water, filled with acquisitions, growth, and execution.

Spruce Point Capital Management Announces Investment Opinion: Releases Report and Strong Sell Research Opinion on Hims & Hers Health, Inc. (NYSE: HIMS)

Retrieved on: 
Thursday, July 13, 2023
SPAC, Insurance, Humboldt Hill, California, American Urological Association, Prescription, AOV, Markup, STAT, Dermatology, Acquisition, California Franchise Tax Board, Patient, RO, Risk, Erectile dysfunction, ED, NYSE, Face, Pharmacy, DOJ, Drug Enforcement Agency, Fareva, Snap, Costco, Target, EPA, DEA, Social stigma, Mental, FTC, Amazon Pharmacy, FDA, Mental health, State, Business Insider, Record, AMG, Medicine, Hims & Hers Health, Outline, Mercedes-AMG, ITC, Public key certificate, Walmart, Drug, Clinic, Ground substance, Woman, GNC, Apostrophe, CAC, Physician, OTC, Sildenafil, Cerebral, Health, Social polarization, HIPAA, Keith Lemon's LemonAid, Pharmaceutical industry, Walgreens, Hers, Tadalafil

Download or view the report by visiting www.SprucePointCap.com and follow us on Twitter @SprucePointCap for additional information and exclusive updates.

Key Points: 
  • Download or view the report by visiting www.SprucePointCap.com and follow us on Twitter @SprucePointCap for additional information and exclusive updates.
  • Hims & Hers is a health and wellness e-commerce company that came public in January 2021 through a SPAC merger.
  • In fact, we believe they are “figureheads” who can be replaced at the whim of Hims & Hers management.
  • As a reminder, our full report, along with its investment disclaimers, can be downloaded and viewed at www.SprucePointCap.com .