Contraindication

Pharma-Assisted Weight Loss Provider Telegenixx Reports 350% Increase in New Patients Year-To-Date

Retrieved on: 
Giovedì, Giugno 15, 2023

SAN ANTONIO, June 15, 2023 (GLOBE NEWSWIRE) -- Telegenixx, a leader in affordable pharma-assisted medically supervised weight loss, reports a 350% increase in new patients since the start of 2023. The company attributes its record growth to a variety of factors, including the popularity of medications used for weight loss such as Wegovy, Mounjaro and Ozempic. Telegenixx says that its medically supervised program delivered virtually, and its competitive price point are key drivers to its record growth.

Key Points: 
  • SAN ANTONIO, June 15, 2023 (GLOBE NEWSWIRE) -- Telegenixx, a leader in affordable pharma-assisted medically supervised weight loss, reports a 350% increase in new patients since the start of 2023.
  • At a monthly cost of $299, a Telegenixx subscription’s cost is considerably lower than those of other medication weight loss programs.
  • The company reports that:
    After completing the Telegenixx program, subscribers have lost an average of 15-25% of their total body weight.
  • With significant weight loss among our subscribers and a baseline cost of $299 a month, we are the most viable and affordable option for physician-guided weight loss.

Dignitana announces proposal for Local Coverage Determination of scalp cooling therapy

Retrieved on: 
Giovedì, Giugno 15, 2023

LUND, Sweden, June 15, 2023 /PRNewswire/ -- Dignitana announces that the Palmetto Medicare Administrative Contractor (MAC) has issued a Proposed Local Coverage Determination (LCD) to provide coverage guidance for Scalp Cooling for the Prevention of Chemotherapy-Induced Alopecia.

Key Points: 
  • LUND, Sweden, June 15, 2023 /PRNewswire/ -- Dignitana announces that the Palmetto Medicare Administrative Contractor (MAC) has issued a Proposed Local Coverage Determination (LCD) to provide coverage guidance for Scalp Cooling for the Prevention of Chemotherapy-Induced Alopecia.
  • This is the first LCD that has been proposed for scalp cooling.
  • This action proposing localized coverage further advances support for health care providers to receive reimbursement from Medicare to administer FDA-cleared scalp cooling therapy, such as The DigniCap Scalp Cooling System.®  Two separate CPT® Category III Codes for "mechanical scalp cooling," 0662T and 0663T, were issued by the AMA with an effective date of July 1, 2021.
  • The CPT® codes, coupled with coverage determinations such as the proposed LCD, will expand patient access to scalp cooling and enable oncology providers to appropriately offer the service and bill for the resources required to administer scalp cooling therapy.

DrSkin Med Spa Introduces Revolutionary Acne Treatment: AviClear

Retrieved on: 
Martedì, Giugno 13, 2023

DrSkin Med Spa launches groundbreaking technology, and life-changing acne treatment, delivering immediate and long-lasting results.

Key Points: 
  • DrSkin Med Spa launches groundbreaking technology, and life-changing acne treatment, delivering immediate and long-lasting results.
  • AviClear is the first FDA cleared energy-based device for the treatment of mild, moderate, and severe acne.
  • Through extensive clinical trials AviClear has been proven safe and effective to provide long-term resolution of acne no matter age, race, or gender.
  • DrSkin Med Spa continues to separate themselves as the industry leader in medical aesthetics with this novel offering.

Linear Health Sciences Announces Publication of Device Profile for Orchid SRV™

Retrieved on: 
Martedì, Giugno 6, 2023

Orchid SRV is a sterile, single-use connector for needle-free access that is placed between the existing IV extension set and general IV tubing connection.

Key Points: 
  • Orchid SRV is a sterile, single-use connector for needle-free access that is placed between the existing IV extension set and general IV tubing connection.
  • The Orchid SRV is cleared for use in adult and pediatric patients in patients two weeks of age and older.
  • “This publication underscores the impact that reducing catheter dislodgement can have on patient outcomes and healthcare’s bottom line,” said Dan Clark, co-founder and CEO of Linear Health Sciences.
  • Qualified clinical evaluations of Orchid SRV will continually quantify device utilization, driving Linear Health Science’s next generations of innovation.

Phil and Teva Pharmaceuticals Launch New Program to Improve Access to the Digihaler® Family of Inhalers to Support Asthma Management

Retrieved on: 
Martedì, Giugno 6, 2023

The goal of Phil and Teva Pharmaceuticals’ partnership is to help enable patients to receive and refill their Digihaler medication quickly, easily and affordably.

Key Points: 
  • The goal of Phil and Teva Pharmaceuticals’ partnership is to help enable patients to receive and refill their Digihaler medication quickly, easily and affordably.
  • Using the PhilRx Patient Access Platform, patients can fill their prescription, review prescription records and obtain assistance navigating insurance benefits.
  • The PhilRx Patient Access Platform provides end-to-end visibility into the entire prescription life cycle, starting when the physician writes the prescription.
  • Physicians can select the PhilRx Patient Access Platform directly from an electronic medical record (EMR) to submit a prescription for a Digihaler product.

Lexicon Announces FDA Approval of INPEFA™ (sotagliflozin) for Treatment of Heart Failure

Retrieved on: 
Giovedì, Giugno 15, 2023

THE WOODLANDS, Texas, May 26, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has approved INPEFA™ (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:

Key Points: 
  • The broad label encompasses heart failure patients across the full range of left ventricular ejection fraction (LVEF), including preserved ejection fraction and reduced ejection fraction, and for patients with or without diabetes.
  • “We expect this important innovation to be commercially available in the U.S. market by the end of June 2023.”
    The approval is based on two randomized, double-blind, placebo-controlled Phase 3 cardiovascular outcomes studies of INPEFA in patients with heart failure or at risk of heart failure.
  • Results from SOLOIST-WHF showed that INPEFA significantly reduced risk of the composite of hospitalizations for heart failure, urgent visits for heart failure, and cardiovascular death by 33% compared to placebo in patients who had been recently hospitalized for worsening heart failure.
  • The SGLT inhibitor class was recommended as first-line treatment for heart failure by the American Heart Association (AHA), the American College of Cardiology (ACC), and the Heart Failure Society of America (HFSA) in their joint 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure.

JAMP Pharma Group receives Health Canada approval for PrJAMP Dapagliflozin, a new generic alternative for the treatment of type 2 diabetes

Retrieved on: 
Martedì, Maggio 16, 2023

The JAMP Pharma Group has received authorization to market Dapagliflozin, offering a more affordable alternative to the reference product Forxiga® (marketed by AstraZeneca Canada Inc.).

Key Points: 
  • The JAMP Pharma Group has received authorization to market Dapagliflozin, offering a more affordable alternative to the reference product Forxiga® (marketed by AstraZeneca Canada Inc.).
  • The JAMP Pharma Group, a leader in product launches1, is expending its product line for the treatment of diabetes, bringing it closer to achieving its goal of providing health care professionals and patients with better access to high quality medicines.
  • The JAMP Pharma Group, established in Canada since 1988, contributes to the country's economic growth and is helping to build a future where all Canadians can live a full and healthy life.
  • It is estimated that in 2021, 29% of Canadian shad diabetes of prediabetes, and that 10% of them were living with diagnosed diabetes.

FDA's approval of the world's first vaccine against RSV will offer a new tool in an old fight – 4 questions answered

Retrieved on: 
Mercoledì, Maggio 10, 2023

The new shot represents six decades of starts and stops in the hunt for a vaccine to curb one of the most common winter respiratory viruses.

Key Points: 
  • The new shot represents six decades of starts and stops in the hunt for a vaccine to curb one of the most common winter respiratory viruses.
  • The vaccine, called Arexvy, made by the biopharmaceutical company GSK, is approved for use in adults ages 60 and over.
  • The Conversation asked Annette Regan, an epidemiologist and vaccine specialist, to discuss the significance of the first vaccine against RSV and the other RSV vaccine candidates that are in the pipeline.

1. How does the new vaccine protect against the virus?

    • The vaccine targets a protein known as RSV F glycoprotein, which is found on the surface of the virus.
    • The vaccine also includes an adjuvant, a substance that helps amplify the effect of the vaccine by boosting the immune system’s response.

2. When and for whom will it be available?

    • The committee is expected to meet in June 2023 to make a recommendation on the new RSV vaccine, after which the CDC would officially endorse it.
    • It could recommend the vaccine for all adults 60 and older, or a subset of older adults.
    • Given the lower efficacy for adults ages 80 and older, the committee could place an age cap on the recommendations.

3. Why has the first RSV vaccine been so long in coming?

    • One problem that has plagued vaccine manufacturers is the difficulty of identifying an antigen – the piece of the virus that the vaccine targets – that doesn’t change, or shape-shift.
    • The F protein of the RSV virus is notorious for changing its shape once it fuses with a host’s cell.
    • Early attempts to create an inactivated RSV vaccine in the 1960s were stalled after they caused an enhanced form of RSV disease.

4. What other RSV vaccine candidates are coming down the line?

    • The next RSV vaccine under review with the FDA is Pfizer’s RSV vaccine.
    • It is similar to the recently approved vaccine except that it has no adjuvant and is bivalent, meaning that it targets both RSV A and RSV B – the two strains of RSV.
    • The CDC advisory committee is scheduled to discuss vaccine recommendations in October 2023, making this the likely next possible vaccine available.

Calliditas Announces Late-Breaking Presentations at the 60th European Renal Association (ERA) Congress 2023

Retrieved on: 
Venerdì, Maggio 5, 2023

STOCKHOLM, May 5, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") announced upcoming data presentations from the NeflgArd Phase 3 Study at the European Renal Association (ERA) Congress 2023.

Key Points: 
  • STOCKHOLM, May 5, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") announced upcoming data presentations from the NeflgArd Phase 3 Study at the European Renal Association (ERA) Congress 2023.
  • "We are delighted that these data presentations have been selected for the upcoming ERA Congress 2023 and extend our congratulations to all the authors involved.
  • Poster presentation details are below and will be available on the Investor page on the Calliditas' corporate website following the meeting.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory clinical trial.

Calliditas Announces Late-Breaking Presentations at the 60th European Renal Association (ERA) Congress 2023

Retrieved on: 
Venerdì, Maggio 5, 2023

STOCKHOLM, May 5, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") announced upcoming data presentations from the NeflgArd Phase 3 Study at the European Renal Association (ERA) Congress 2023.

Key Points: 
  • STOCKHOLM, May 5, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") announced upcoming data presentations from the NeflgArd Phase 3 Study at the European Renal Association (ERA) Congress 2023.
  • "We are delighted that these data presentations have been selected for the upcoming ERA Congress 2023 and extend our congratulations to all the authors involved.
  • Poster presentation details are below and will be available on the Investor page on the Calliditas' corporate website following the meeting.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory clinical trial.