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Content Summary
Pharma Regulation and Policy
New Translational Science Team Created In US FDA’s CDER To Aid Rare Disease Drug Development
The group is intended to help rare disease drug developers answer all the necessary questions about surrogate endpoints and markers before the application review cycle.
EMA Opens Discussion On Appropriate Use Of AI In Drug Lifecycle
The European Medicines Agency is inviting feedback on a draft reflection paper that outlines the scientific principles companies should follow when using AI tools in the medicinal product lifecycle.
Pharma Commercial News
Obesity Market Potential Is Huge, But Access To Drugs An Increasing Challenge
Despite double-digit weight loss across several drugs presented at ADA, experts note access to obesity therapies will be constrained without outcomes data to justify their widespread use and cost.
First Round Of Drugs Up For Medicare Negotiation Gets Soft Landing
Big pharma valuations mostly held steady as CMS released its list of the first 10 drugs subject to Medicare negotiations under the Inflation Reduction Act, which held few surprises and included products nearing the end of their patent lives by the time negotiated pricing takes effect.
Generics and Biosimilars
Novartis Sets Out Next Steps For Sandoz Spinoff
Following unanimous approval by the Novartis board of directors for the spinoff of Sandoz, the generics and biosimilars giant’s parent company has set out some key dates in the lead-up to separation later this year.
Viatris: Watch Out For Potential Complex Injectable Launches In 2023
Viatris has again the lauded the potential of its complex injectables and steriles pipeline, as it looks to build a business generating revenues of up to $1bn per year within the next five years.
Strategic Analysis for Leaders
Parkinson’s Disease: Ripe For A Rethink
Despite decades of R&D, there are no disease modifying therapies on the market for Parkinson’s disease, and few efficacious products for non-motor symptoms. Clinical setbacks have been rife but breakthroughs in diagnostics and a better understanding of disease pathology brings hope for the future. In Vivo speaks to some of those responsible for bringing innovation to the field.
It’s Time For A Billion-Dollar Women's Health Fund
Jessica Federer, former chief digital officer at Bayer, talks to In Vivo about making the jump into investing and why women’s health is a rich and deep market set for change.
Consumer Healthcare
Perrigo’s Pivot To Building Brand Market Share Boosted With Opill OTC Oral Contraceptive Approval
Year after acquiring HRA, Perrigo makes preparations to launch arguably the most anticipated OTC switch in US pharma history, Opill with 0.075-mg norgestel. Analysts estimate $100m annual market for OTC birth control.
Industry Seeks FDA Flexibility Around MoCRA Registration And Listing; Attorneys Discuss
Companies have concerns about how the FDA will respond if struggles to obtain data, or hiccups in the cosmetic product facility registration or listing process, lead to errors or deadline misses under the Modernization of Cosmetics Regulations Act. Attorneys from Duane Morris and Covington & Burling provide views on FDA’s related draft guidance, key challenges facing industry, and how the agency may proceed.
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