Radius Reveals Abaloparatide Delay, After Playing Up Launch Readiness

FDA's review of filing for osteoporosis abaloparatide delayed by three months to June 30, bringing it closer to the action date for Amgen's competing anabolic agent romosuzumab, which has an action date of July 19.

Shoulder fracture

Radius Health Inc. announced that FDA has extended the user fee date for its anabolic osteoporosis drug abaloparatide from March 30 to June 30, soon after the company discussed extensive plans for launch with no mention of a regulatory delay.

FDA needs more time to review the NDA for the daily subcutaneous formulation in postmenopausal osteoporosis "to allow time to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

Insmed Targets $5bn-Plus Market With Brinsupri For Bronchiectasis

 
• By 

The US FDA approved Insmed’s second product, the DPP1 inhibitor Brinsupri (brensocatib) for non-cystic fibrosis bronchiectasis. The company launched the drug immediately with a list price of $88,000 per year.

Boehringer Scores First Approval For Targeted Oral Drug In HER2-Mutant NSCLC

 

The US FDA approved Hernexeos for previously treated HER2-mutant NSCLC, making it the first oral option in a setting where drugs like AstraZeneca/Daiichi Sankyo’s Enhertu dominate.

Pipeline Watch: Five Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

PTC Projects Confidence In Sephience Launch With Royalty Buyback

 
• By 

The company will start shipping its newly launched phenylketonuria drug within two weeks and has bought back global net sales obligations for the treatment.

More from Scrip

Vedanta’s Live Bacteria Reach A Dead End In Ulcerative Colitis

 

The microbiome-based company’s trial of VE202 in ulcerative colitis has failed in Phase II, but its ongoing Phase III study in C difficile infection is more promising.

Finance Watch: OrbiMed’s New $1.86bn Fund Offers Financial Alternatives In Tough Market

 
• By 

Public Company Edition: OrbiMed partners Carter Neild and Matthew Rizzo spoke with Scrip about the firm’s fifth royalty and credit fund. Also, Ligand sold $400m worth of notes, BridgeBio’s oncology spinout went public via SPAC merger and raised $261m and Assembly raised $175m.

Asia Deal Watch: Lupin Picks Sandoz To Market Lucentis Biosimilar In Parts Of EU And Asia

Also deals involving Xspray/Handa, Fosun/Expedition, Kaken/Astria, Orchid/Allecra, Sanofi/Visirna, KKR/Healthcare Royalty Partners, Viridian/Kissei, Sandoz/Evotec, Dx&Vx, Dr. Falk/Allianthera, Madrigal/CSPC and Lilly/LTZ.