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Will Radius Health's Abaloparatide Data Do The Trick In Osteoporosis?

 
• By Emily Hayes

Abaloparatide looks better for improving bone mass with less hypercalcemia than Lilly's first-in-class Forteo in the Phase III ACTIVE study, but it remains to be seen whether this will be enough to get ahead in the increasingly crowded osteoporosis market.

Osteoporosis

The potential forRadius Health Inc.'s abaloparatide to better improve hip bone mass and have a lower risk of hypercalcemia than earlier osteoporosis drugs "may be important distinguishing features," a new editorial in the Journal of the Medical Association concludes, but the article also suggests this may not be enough for commercial success.

The editorial – by Anne Cappola, University of Pennsylvania, and Dolores Shoback, University of California-San Francisco – was published in JAMA on Aug

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US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

‘We Can’t Keep Going On Like This’ – Biosimilars Forum’s Reed Calls For Urgent Changes In US

 
• By Dave Wallace

As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.

Biocon Biologics Plans To Slow Down After Five Planned Near-Term Biosimilar Launches

 
• By Urtė Fultinavičiūtė

With a lineup of five high-value biosimilars in the wings, Biocon Biologics may be more selective going forward and plans to take a one product per year approach.

Biocon Eyes Fundraising Round Amid Discussions On Merger With Biosimilars Branch

 
• By Urtė Fultinavičiūtė

As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.

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Biocon Eyes Fundraising Round Amid Discussions On Merger With Biosimilars Branch

 
• By Urtė Fultinavičiūtė

As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.

Micro Labs Agrees To 15-Year Freeze On US Bempedoic Acid Rival

 
• By Dean Rudge

Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.

Viatris Awaits ‘Significant Rebound’ At Indore In 2026 After Painful Q1 Bite

 
• By Dean Rudge

Viatris continues to make progress on remediation at the firm’s stricken manufacturing facility in Indore, India, following a warning letter and import alert delivered at the tail end of 2024.