Durata Looks Beyond FDA: Reimbursement Changes May Offer Opening for Long-Acting Anti-infective

Is the FDA regulatory climate getting better for anti-infective development? One clear “yes” emerges from the approach being taken by Durata Therapeutics in a series of recent investor presentations: Durata is focusing beyond FDA on the next challenge – finding the right commercial opening for long-acting anti-infectives.

Durata Therapeutics Inc. is sending a message on the improving regulatory environment for anti-infectives at the Food & Drug Administration by what it is not telling Wall Street.

The company is not focusing on the hurdle posed by FDA approval for its second-generation IV lipoglycopeptide antibiotic, dalbavancin, and...

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 Market Access

Faster HTA Reviews & Pricing Reform Could Help Fix Canada’s Drug Access Woes

 

Canadian politicians must “move quickly” to introduce policies that will speed up access to medicines, such as by broadening criteria for the temporary reimbursement of medicines, the Canadian Chamber of Commerce says.

Most Favored Nation Pricing: Trump Ups Pressure On Voluntary Action, Clarifies Demands

 

The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.

340B Rebate Model Gets HRSA Endorsement; Pilot Program Limited To Medicare Negotiated Drugs

 
• By 

Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.

Mexico Speeds Up Market Access With Regulatory Reliance Guidelines

 

Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.

More from Pink Sheet

Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.

Mexico Speeds Up Market Access With Regulatory Reliance Guidelines

 

Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.

UK Approves Biogen’s Qalsody After England Revises Reimbursement Approach

 

Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.