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Treatment options for Crohn’s disease expand after Rinvoq approval

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. The FDA nod means Rinvoq is now approved for seven indications in gastroenterology, rheumatology and dermatology.

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Provention finally gets FDA nod for type 1 diabetes drug teplizumab

pharmaphorum

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.

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OpSens Announces FDA Clearance for the SavvyWire™ for Use in Transcatheter Aortic Valve Replacement (TAVR) Procedures

Legacy MEDSearch

Food & Drug Administration (“FDA”) for the SavvyWire (“SavvyWire”), its new guidewire for transcatheter aortic valve replacement procedures, or TAVR. For OpSens, FDA clearance is a key milestone and an achievement, introducing an entirely new category of innovation to the structural heart device market segment. OpSens Inc. ,

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Merck obtains favourable US court ruling on sitagliptin patent lawsuit

Pharmaceutical Technology

It will expire on 24 November 2026, and the paediatric exclusivity lasts until 24 May 2027. Viatris is seeking approval from the US Food and Drug Administration (FDA) to market Januvia and Janumet’s generic versions in the country. Merck has also permitted the sale of generic versions of Janumet XR to the market in July 2026 or before.

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Chasing rivals, AbbVie files migraine prevention drug atogepant in EU

pharmaphorum

The market research group recently predicted Vydura and atogepant will achieve sales of $35 million and $57 million, respectively, by 2030 in the five major European markets of France, Germany, Italy, Spain, and the UK. GlobalData has said it expects Qulipta to get approval for chronic migraine prevention in 2023, helping it to sales of $1.2

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Potential blockbuster drugs to watch in 2023

European Pharmaceutical Review

Treatments identified in the report are predicted to be potential blockbuster drugs by 2027 or have potential to serve unmet patient needs for millions of patients worldwide. They have accounted for over 25 percent of Food and Drug Administration (FDA) approvals for the last seven years, the report found.

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Acquisitive Ipsen builds again with $952m Albireo buy

pharmaphorum

Albireo secured approval in the US and Europe for the ileal bile acid transport inhibitor (IBATi) drug in 2021 for the treatment of pruritus (itching) in patients with rare disorder progressive familial intrahepatic cholestasis (PFIC), and has said sales should reach $24 million this year. billion deal.