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Generic Drug Market Has Gaps, FDA Tells Firms In Solicitation For ANDAs

 
• By Derrick Gingery

US agency unveils plans to speed reviews of generic applications in areas with limited competition and offers a list of potential targets, but threat to brands may be limited.

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Janssen Pharmaceutical Cos.'s Elmiron (pentosan polysulfate) needs generic competition, FDA says.

The orphan drug indicated for relief of bladder pain or discomfort associated with interstitial cystitis was approved in 1996 and...

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Indegene Exec On DTP Distribution As A ‘Tactical Solution’, Feasibility Of MFN Model

 
• By Anju Ghangurde

Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US and underlines that it isn’t a comprehensive healthcare fix. Feasibility of MFN pricing and why it may be “catastrophic” to the industry were some of the other topics discussed.

Lilly Begins Rebalancing US/Ex-US Drug Costs By Raising Prices In Europe

 
• By Mandy Jackson

Lilly said prices governments pay in developed countries, including those in Europe, need to increase to make US drug prices lower, rebalancing costs as CEO David Ricks recently advocated.

Lilly CEO Ricks Advocates Rebalancing Drug Pricing Between US And Europe

 
• By Mandy Jackson

As President Trump focuses on “most favored nation” pricing to bring down US drug costs, CEO David Ricks used Lilly’s Q2 earnings call to advocate for a slow approach to reducing the difference between US and EU drug prices.

Pharma Is Cooperating With Trump On Direct Sale To Consumers, Bourla Says

 
• By Jessica Merrill

Pfizer is in active discussions with Trump on MFN pricing and collaborating with peers on direct sales as an approach to lower drug prices, CEO Bourla said.

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Finance Watch: Did Mid-Summer Usher In A Mega-Round Comeback?

 
• By Mandy Jackson

Private Company Edition: Hatteras Venture Partners now has more than $900m under management. Also, in recent $100m-plus VC rounds, Strand Therapeutics raised a $153m series A, ARTBIO revealed a $132m series B and Minghui Pharmaceutical secured a $131m pre-IPO round.

Tonix Ready To Revive Fibromyalgia Market With Tonyma

 
• By Joseph Haas

The first new drug for fibromyalgia since 2009, Tonyma is a reformulation of cyclobenzaprine intended for chronic therapy. Tonix said the drug targets non-restorative sleep.

AstraZeneca Launches At-Home Flu Vaccine Amid Industry DTC Push

 
• By Alaric DeArment

The drugmaker announced the launch of an at-home version of its nasal FluMist vaccine, as more companies are looking into direct-to-patient drug sales in response to Trump’s most favored nation pricing proposals.