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AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease

Pharmaceutical Technology

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 It can be used as a monotherapy or along with cholesterol-lowering medicines. We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.”

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Disruption in healthcare is coming

World of DTC Marketing

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). Then there is the cost of generic drugs. Generic drugs versus branded is also a considerable expense.

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FDA greenlights first OTC topical gel for erectile dysfunction

Pharmaceutical Technology

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Both drugs have generic equivalents available and are PDE5 inhibitors that can take 30 to 60 minutes to kick in.

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Ipsen concludes purchase of Albireo Pharma

Pharmaceutical Technology

Albireo’s pipeline includes its lead asset, Bylvay (odevixibat), a potent, once-a-day, oral, non-systemic, ileal bile acid transport inhibitor (IBATi). Last month, the US Food and Drug Administration (FDA) accepted Bylvay for Priority Review to treat Alagille syndrome (ALGS) in paediatric and adult patients.

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Could digital therapeutics provide a solution against opioid abuse?

pharmaphorum

The struggle to manage pain for individuals has been one that goes back a long way in history, with one of the earliest recorded medical prescriptions being for opium. This leads to psychological harm becoming a significant factor in chronic pain, alongside the physical symptoms. The potential for a digital solution.

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Three regulators accept Bristol Myers’ applications for myeloma therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics licence application for Abecma. This will lead to cytokine secretion, CAR T cell proliferation and subsequent cytolytic killing of BCMA-expressing cells.

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Pharma within planetary boundaries

European Pharmaceutical Review

In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Interestingly, this is not the case for veterinary medicines, where the authorisation can actually be refused if the risk is not adequately mitigated.

Pharma 82