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Content Summary
Pharma Regulation and Policy
EU Pharma Reform Proposes Cuts In Regulatory Protections & Faster Drug Approval Times
Proposals for the overhaul of the EU pharmaceutical legislation will make medicines more widely available, accessible and affordable while supporting innovation and boosting the “competitiveness and attractiveness” of Europe’s pharma industry, the European Commission claims. The research-based industry thinks otherwise, saying cuts in regulatory protections will undermine R&D.
Decentralized Clinical Trials Could Affect Validity Of Non-Inferiority Finding, US FDA Says
Draft guidance notes that data obtained from a decentralized clinical trial may be less precise than that from a site-based trial, creating challenges in calculating a non-inferiority margin. FDA specifies what should be included in DCT data management, trial monitoring and safety monitoring plans.
Pharma Commercial News
Top 10 Things To Watch For At DDW
At Digestive Disease Week, Celltrion will seek to strengthen its hold on the IBD market, Ironwood hopes to expand Linzess into pediatric functional constipation, and competitors will showcase competing short bowel syndrome treatment and colorectal cancer companion diagnostics.
Finance Watch: Royalty Deals Pick Up As Alternative Financings Find Appeal
Public Company Edition: Seven companies revealed $2.1bn worth of royalty financings in the first quarter of 2023 and the deals keep coming in Q2, with uniQure monetizing Hemgenix royalties for up to $400m. Also, Legend grossed $350m in a follow-on offering and Athenex is liquidating via bankruptcy.
Generics and Biosimilars
Will Teva’s New Strategy Shift Towards Innovation?
Teva is just about to unveil a fresh strategy under new CEO Richard Francis, who has emphasized the firm’s “emerging innovative business” and talked up the company’s branded assets ahead of an investor day on 18 May where full details will be revealed.
Viatris Is ‘Not Walking Away’ From Generics
After reporting sliding sales for both generics and complex generics in Q1, Viatris has nevertheless reaffirmed its commitment to the off-patent sector, highlighting in particular a planned launch this year of its Breyna rival to Symbicort.
Strategic Analysis for Leaders
Where Are The Women? Nordic Biotech Searches For The ‘She-Suite’
For all its good intentions and lauded action toward gender equality, the biotech industry in Scandinavia and the Nordics has a female CEO rate hovering around 23%. While the number of women entering academia, innovative companies and laboratories is healthy, gender equality in the C-suite leaves a lot to be desired.
In Vivo’s 2023 Rising Leaders: Healthcare Innovators At The Top Of Their Game
The fourth annual listing of In Vivo’s ‘Rising Leaders’ includes entrepreneurs and innovators from across the world who represent the next wave of creativity in healthcare.
Consumer Healthcare
German Wellness Launches: Stada And Klinge Introduce Electrolytes, Orthomol Targets Aging
New OTC products on the German market: Stada extends its Elotrans line with an electrolyte supplement aimed at sporty and social youth; Klinge also launches an electrolyte product, but as a food for special medical purposes for diarrhea sufferers; and Orthomol introduces a multinutrient supplement to help people age healthily.
European Commission Lays Down ‘Zero Pollution’ Gauntlet To Consumer Health Industry
Europe's consumer health industry is faced with proliferating regulations under the EU's Green Deal policy program. Proposed revisions to the Urban Wastewater Treatment Directive, for example, expect pharmaceutical and cosmetics manufacturers to pay for the removal of micro-pollutants that are mostly flushed into the wastewater system by consumers.
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