The US Food and Drug Administration (FDA) has set a date to decide on Ipsen’s new drug application for its drug candidate palovarotene in the treatment of fibrodysplasia ossificans progressive (FOP), a rare disorder where extra-skeletal tissues like muscles and tendons are converted into bone […]
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FDA Adcomm Recommends Paxlovid for Mild-to-Moderate COVID-19
Pfizer’s Paxlovid has received a nod from the US Food and Drug Administration’s (FDA’s) Antimicrobial Drug Advisory Committee for use in mild-to-moderate cases of COVID-19 in adults. The 16-1 vote came after Pfizer’s previous request for full approval hit a roadblock last year when the agency […]
Exclusivity Loss Looms for Ten Key Drugs in 2023
As the year marches on, Fierce Pharma takes a look at 10 major drugs facing exclusivity losses in 2023. One of the most notable is Humira, AbbVie’s historically expensive blockbuster, which will face stiff competition from several upcoming biosimilars. Other drugs on the list include J&J’s […]
Housing Instability Worsens Health Outcomes
Astronomical rent and home prices are driving the ever-worsening affordable housing crisis. A newly published article in JAMA Network Open explores the link between housing instability and health outcomes, finding that displacement and unsafe living situations related to unaffordable housing are […]
Sanofi Cuts Insulin Prices and Sets Out-of-Pocket Price Cap
Hot on the heels of Novo Nordisk and Eli Lilly, Sanofi announced it will cut the price of its main insulin formulation, Lantus, in January of next year. Just outstripping the others, the cuts amount to a 78% price drop for the life-saving drug used by millions of people with diabetes. In addition, […]
Teppeza Improves Vision for Patients with Thyroid Eye Disease in Real-World Data Study
Results from a real-world data analysis show that Horizon Therapeutics’ Teppeza improves vision for patients with dysthyroid optic neuropathy (DON), a progressive eye disease related to thyroid dysfunction. Blindness is a leading fear of patients with the disease, making the therapy a promising […]
Seagen Shares Patent Rights to Cell Therapy with Gracell Biotech
Recent SEC filings show that Seagen, recently bought out by Pfizer, will share patent rights to experimental cell therapies with Gracell Biotechnologies. The deal will see Gracell performing clinical and preclinical testing on certain cell therapies, the identities of which have yet to be revealed. […]
New Startup Launches Platform to Simplify Telehealth Insurance Verification Process
The new startup Opkit, formed by two former Brex software engineers, has launched a new platform to simplify the process of insurance verification for telehealth services. Currently, the process is slowed down by the need to accept insurance from across state line and the mish-mash of different […]
Talking Real-World Evidence and Individualized NSCLC Therapy with Daryl Pritchard
Precision therapy for non-small cell lung cancer (NSCLC) could save patients’ lives, but access to these treatments and the required genomic and biomarker testing are out of reach for many. In a new OncLive interview, Ashling Wahner talks about recently presented research into the impact of targeted […]
US CMS Releases Guidance on Upcoming Drug Price Negotiations
The pharma and biotech industry has waited with bated breath for more information on impending drug price negotiations with the US Centers for Medicare and Medicaid Services (CMS) that begin in 2026. The agency released its guidance on the process, laying out the process in detail. CMS has also put […]
