1. Scrip
  2. >>New Products

Ten Approvals To Look Out For In Q4

 
• By Alexandra Shimmings

From AstraZeneca’s benralizumab in asthma to Kite Pharma’s CAR-T therapy, Scrip takes a look at some of the more interesting drug approvals expected by the end of the year, with the help of analysts from Informa's Biomedtracker.

Pipes
Plenty of Approvals Coming through the pipeline • Source: Shutterstock

Catalyst: PDUFA for sNDA – First Review

Target action date: Nov. 6

Biomedtracker's LOA Opinion*: Above

*Biomedtracker’s proprietary rating of the likelihood of approval of a particular drug, in comparison to average approval rates for drugs in that class

As it is already approved for hyperphosphatemia, the chances for approval of the sNDA for Keryx Biopharmaceuticals Inc.'s Auryxia (ferric citrate) in iron-deficiency anemia appear hopeful, BMT analysts believe. Current oral iron formulations are over-the-counter and efficacy can be limited by side effects or compliance due to multiple doses, so the company is hoping that Auryxia could fill a needed gap in treatment.

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
Start Free Trial

Already a subscriber?

More from New Products

Pipeline Watch: Eight Approvals And Ten 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.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

Nuvation Set For First Launch With Ibtrozi In Lung Cancer

 
• By Jessica Merrill

The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.

Pipeline Watch: ASCO Dominates 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.

More from Scrip

Stock Watch: Generics Firms Trapped Between US Tariffs And European Austerity

 
• By Andy Smith

Successive annual reductions in European drug prices following the pandemic are affecting the global sales of generic pharmaceutical companies. Additionally, the imposition of US import tariffs may result in generic drug supply becoming unprofitable.

Innovent Builds Metabolic Pipeline While Retaining Oncology Backbone

 
• By Xu Hu

Innovent presented data on multiple pipeline assets at ASCO, including promising OS results for its first-in-class anti-PD-1/IL-2α-bias bispecific. The Chinese firm is also continuing to build out its metabolic disease portfolio and consider its partnering strategies, its CEO tells Scrip.

BIO Notebook: IPO Window Stays Shut, PRVs Need To Be A Priority, And Focusing On Gene Therapy Safety

 
• By Mandy Jackson and Sarah Karlin-Smith

Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.