Novartis Ups Ante In Acromegaly Injectables As Oral Contender Emerges

Novartis gears up to file new injectable pasireotide LAR by the end of 2012 for the niche acromegaly market, ahead of the patent expiration of its blockbuster Sandostatin LAR. But Israeli biotech Chiasma is hoping to deliver an oral option with Octreolin.

Novartis AGis hoping to maintain its hold on the acromegaly market by introducing a new injectable for the niche pituitary condition that has better efficacy than the company’s current market leader, Sandostatin LAR (octreotide). But Israeli biotech Chiasma Inc. is making its way through Phase III with an oral version of octreotide, buoyed by a cash infusion.

Novartis – the dominant player in the space – is set to file for approval of the multi-receptor targeting somatostatin...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Clinical Trials

CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
• By 

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By 

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

More from R&D

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By 

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.