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Key Developments from AMCP 2023 on Blockbuster Generics, Diabetes Drugs, PBM Legislation, and More

PM360

Attention deficit hyperactivity disorder (ADHD) drug Vyvanse (lisdexamfetamine dimesylate) , manufactured by Takeda, also is facing generic competition. In the respiratory area with inhalers, it’s tough to get drugs approved, so the competition comes slowly,” he said. Starting in 2026, the provision will affect 10 Part D drugs.

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FDA delays decision on Biogen’s ALS hope tofersen

pharmaphorum

Biogen’s global head of global safety and regulatory sciences, Priya Singhal, said that the company is “committed to providing any details the agency needs to complete the review of tofersen,” adding that in the meantime Biogen will continue to provide the drug to patients via its early-access programme.

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Five potential EU regulatory changes impacting the life sciences industry in 2023

European Pharmaceutical Review

In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. However, a delicate balance will need to be struck between the need for affordable and accessible medicinal products and the desire to foster innovation and competitiveness in the EU.

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Five points on CMS’s first ten picks for price negotiations

Clarivate

The initial list, which takes effect in 2026, has the potential to roil formularies since it includes a mix of high-volume, preferred brands and a group of high-cost specialty drugs for autoimmune conditions (psoriasis) and cancer. exclusions exist for orphan drug designation and biosimilar competition ).

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Pulsed field ablation re-energizes the atrial fibrillation market

Clarivate

In addition, the improved safety profile of PFA is making the cost-benefit of ablation an easier calculation for many patients. FDA approval in the fourth quarter, with Johnson & Johnson’s Varipulse system close behind, so competition will pick up. Abbott’s Volt should join the party in early 2026.

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T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

Pharmaceutical Technology

Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India).

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Transgene and BioInvent report positive data for oncolytic virus

Pharmaceutical Technology

According to the companies report, the BT-001 single agent treatment was completed in 18 patients and no safety concerns were reported. The independent Safety Review Committee has now approved initiation of the combination part of the trial with pembrolizumab.

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