Episodes

  • #25: Romvimza Receives FDA Approval for TGCT Treatment

    #25: Romvimza Receives FDA Approval for TGCT Treatment
    Feb 21 2025
    Ono Pharmaceutical's Romvimza has been approved by the FDA for treating adult patients with symptomatic tenosynovial giant cell tumor (TGCT) when surgery is not a viable option. This provides another option for patients, in addition to Daiichi Sankyo’s Turalio, as both drugs inhibit the colony-stimulating factor 1 receptor (CSF1R). The approval was based on the MOTION trial, where Romvimza showed a 40% response rate at Week 25, compared to 0% for placebo, and also demonstrated improvements in range of motion, physical functioning, and pain. Ono acquired Romvimza through the purchase of Deciphera Pharmaceuticals. Romvimza offers a more convenient dosage of 30 mg twice weekly compared to Turalio's 250 mg twice daily. Notably, Turalio carries a black box warning and REMS program due to liver injury concerns, while Romvimza does not have either.

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    5 mins
  • #24: US Pharma and Life Sciences Deals: 2025

    #24: US Pharma and Life Sciences Deals: 2025
    Feb 19 2025

    The pharmaceutical and life sciences sector anticipates a surge in merger and acquisition activity in 2025. Driving this trend are expected interest rate reductions by the Federal Reserve and the resolution of post-election uncertainties. While deal values and volumes are projected to rise, transactions in the $5 billion to $15 billion range are forecasted to be the most common. However, geopolitical issues could present obstacles to this growth.





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    13 mins
  • #23: Big Pharma's China Sourcing, New Strategy

    #23: Big Pharma's China Sourcing, New Strategy
    Feb 15 2025

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    8 mins
  • #22: Glatiramer Acetate : Anaphylaxis Risk and Warnings

    #22: Glatiramer Acetate : Anaphylaxis Risk and Warnings
    Feb 11 2025

    The FDA is alerting the public to the risk of anaphylaxis, a rare but serious allergic reaction, associated with glatiramer acetate (Copaxone, Glatopa), a drug used to treat multiple sclerosis (MS). Anaphylaxis can occur at any time during treatment, even after doses administered months or years after starting the medicine, and has sometimes resulted in hospitalization and death. Symptoms typically appear within one hour of injection.

    To communicate this risk, the FDA is adding a Boxed Warning to the prescribing information and patient Medication Guide. Patients should stop taking glatiramer acetate and seek immediate medical attention if they experience symptoms of anaphylaxis such as wheezing, difficulty breathing, swelling of the face, lips, or throat, or hives. While early symptoms of anaphylaxis can be similar to a temporary post-injection reaction, they are typically more severe and worsen over time. If symptoms are more than mild, worsen, or do not go away quickly, patients should seek immediate medical attention


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    4 mins
  • #22: Novo Nordisk's next gen weight loss drug

    #22: Novo Nordisk's next gen weight loss drug
    Feb 6 2025
    Novo Nordisk, known for its obesity drugs Ozempic and Wegovy, reported strong profit and revenue for 2024, surpassing Wall Street expectations. However, the company expects slower sales growth in 2025 due to rising competition, particularly from Eli Lilly, and pricing pressures. Despite this, Novo Nordisk remains optimistic, citing continued strong demand for obesity treatments and its drug pipeline, including CagriSema and amycretin. The company’s stock experienced volatility, partly due to concerns about obesity drug demand and geopolitical factors like tariffs. While uncertain about global trade impacts, Novo Nordisk is confident in the long-term potential of its drugs.

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    13 mins
  • #21 : Pfizer's New Obesity Drug

    #21 : Pfizer's New Obesity Drug
    Jan 13 2025
    Pfizer is heavily investing in its experimental obesity drug, danuglipron, aiming for a once-daily oral pill to compete with the currently dominant injectable weight-loss treatments from Eli Lilly and Novo Nordisk. CEO Albert Bourla expressed cautious optimism, anticipating data from dose-testing studies within months and a potential market entry as the second oral option. While Pfizer is not pursuing acquisitions in the injectable GLP-1 market, they remain open to acquiring other types of obesity treatments. The company's goal is to provide a convenient and competitive alternative in a market projected to reach $150 billion annually by the early 2030s. The unrelated mention of a "Bio Leg" device suggests extraneous information included in the source material.

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    4 mins
  • #20 : Acquiring Patient Social Networks

    #20 : Acquiring Patient Social Networks
    Jan 12 2025
    Swoop, an AI-driven healthcare marketing business, acquired MyHealthTeam, a company that runs condition-specific online patient communities1. MyHealthTeam has over 60 communities, some with over 100,000 members, focused on chronic and rare diseases. These communities feature articles, Q&A sections, and patient conversations. Swoop intends to use this acquisition to enable pharmaceutical companies to engage with patients, scale patient reach, and generate first-party data2. Swoop's offerings include marketing to healthcare professionals and consumers, and planning and tracking TV campaigns. The integration of MyHealthTeam into Swoop's business is intended to enhance its marketing capabilities

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    5 mins
  • #19 : RSV Vaccines To Include New Warning

    #19 : RSV Vaccines To Include New Warning
    Jan 12 2025


    The FDA will require GSK and Pfizer to include a warning about the risk of Guillain-Barré syndrome (GBS) on the labels of their RSV vaccines, Arexvy and Abrysvo, respectively. This decision was made after a postmarketing study showed an increased risk of GBS within 42 days of vaccination. The FDA estimates nine cases of GBS per million doses of Abrysvo and seven cases per million doses of Arexvy in adults 65 and older. Although a causal relationship hasn't been established, the FDA notes that the benefits of the vaccines still outweigh the risks. GSK reports that over 9 million people have received Arexvy with an acceptable safety profile.



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    4 mins