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Rx For Industry: Key Provisions Of The 21st Century Cures Act

 
• By Michael Cipriano

Changes to the priority review voucher program, economic communications with payors, and approval of antimicrobial products all have the potential to impact the commercial prospects of drugmakers.

The roller-coaster ride of the 21st Century Cures Act is nearly complete, with the Senate voting 94-5 in favor on Dec. 7 in favor of the measure. It now moves on to President Obama, who said he will "sign it as soon as it reaches my desk."

While many of the pharmaceutical-related elements of the bill address a series of regulatory and R&D issues with the goal of getting drugs approved faster (see box), there are a few

More On The 21st Century Cures Legislation:

More from Anti-infective

Chinese Vaccine Makers Turn To Emerging Markets

 
• By Dexter Jie Yan

Chinese producers of novel vaccines are increasingly pivoting to developing markets overseas in the face of a collapse in their domestic sales.

Shionogi In $1bn Deal For Japan Tobacco’s Pharma Ops

 
• By Ian Haydock

Mid-sized Japanese pharma firm to acquire tobacco giant’s pharma operations and take private the listed Torii Pharmaceutical business, in bid to build sales reach and strengthen manufacturing.

In Brief: DIOSynVax And ACM Biolabs To Develop Bird Flu Vaccine

 
• By Sushmita Panda

The collaboration, supported by UK and Singapore government agencies, aims to develop an mRNA-based, needle-free universal bird flu vaccine suitable for use in a pandemic.

GSK’s Blujepa Brings Innovation To The Antibiotic Space

 
• By Jessica Merrill

The US FDA approved Blujepa for the treatment of uncomplicated urinary tract infections, marking the first new mechanism of action for the infection in more than 30 years.

More from Therapy Areas

Leo Roars To A Profit In Q1 As Adbry Grows In US

 
• By Kevin Grogan

The Danish firm's atopic dermatitis drug is holding its own despite strong competition from Sanofi/Regeneron’s Dupixent.

Multiple Launches Help Lilly’s Japan Growth

 
• By Ian Haydock

Lilly saw solid growth for its business in Japan last year on the back of several new launches and is building its obesity and Alzheimer's portfolios in the country.

Novo Nordisk Looks To Septerna For Oral Obesity Options

 
• By Mary Jo Laffler

Deal Snapshot: The Danish drugmaker is partnering with GPCR drug discovery expert Septerna to develop multiple small molecules for cardiometabolic targets.