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Best Of BIO: Policy & Regulatory Updates From BIO 2017

 
• By Joseph Haas and Mandy Jackson

Antibiotic incentives, vaccine strategies, drug pricing, patent updates and more hot topics from the Biotechnology Innovation Organization's recent annual conference.

The gene-editing specialist Editas Medicine Inc. is working on preclinical studies to support the filing of its first investigational new drug (IND) application in mid-2018 for a therapy to treat leber congenital amaurosis 10 (LCA10). Patent disputes between two major CRISPR/Cas9 inventors have been going on while those preparations are under way, but decisions largely have been occurring in Editas's favor.

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US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By Sue Sutter

The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.

Raising Drug Prices In The EU Could Take Years, Even If Pharma Effort Succeeds

 
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Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.

Non-Submissions To England’s NICE Surge Across All Disease Areas

 
• By Leela Barham

Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.

PBMs No Longer Profit From Rebates But Plans Benefit; Should Sponsors Push More For Reform?

 
• By Cathy Kelly

Employers and other health plan sponsors may need to push for better targeted reforms that lower cost sharing for patients.

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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.