The US electronic cigarette market recently got good news one day and bad news the next.
FDA, NIH Officials Encourage E-Cigarette NRT Innovation As Task Force Seizes Illegal Products
FDA tobacco programs chief emphasizes moving smokers to lower risk alternatives and NIDA executive encourages proposals for e-cigarettes as nicotine replacement treatments. FDA also seizes $76m in unauthorized e-cigarettes.
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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
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Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.
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FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.
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“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.
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Alliance shareholders overwhelmingly back takeover by DBAY Advisors after improved offer values UK-based firm at £362m.
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Like many European firms, Stada Arzneimittel's 2024 earnings were held back by a soft cough, cold and flu season. However, key launches in its home market Germany and in the Middle East offset this impact and led to 3% organic growth for Stada's Consumer Healthcare business.
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Key growth driver in consumer health and across Bayer’s sectors, says CEO Bill Anderson, is “dynamic shared ownership program” introduced in January 2024 to "reduce hierarchies, eliminate bureaucracy, streamline structures and accelerate decision-making processes."