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US Election 2016

Set Alert for US Election 2016

Woodcock Tries To Calm US FDA Staff Fears About Trump

CDER Director's' video advises focusing on the work and "keeping our heads down."

FDA Elections Leadership

Latest From Elections & BioPharmaceutical

J.P. Morgan Notebook Day 1: No Big Deals, But Plenty Of Pipeline, Commercial Highlights

Daily round-up from the J.P. Morgan Healthcare Conference in San Francisco: There was no big M&A, but biopharma CEOs discussed deals they're pursuing. Also, Novartis's Zolgensma reimbursement insights, Sarepta's third DMD filing, Bristol's post-merger progress and more highlights.

Deals Business Strategies

J.P. Morgan Notebook Day 1: No Big Deals, But Plenty Of Pipeline, Commercial Highlights

Daily round-up from the J.P. Morgan Healthcare Conference in San Francisco: There was no big M&A, but biopharma CEOs discussed deals they're pursuing. Also, Novartis's Zolgensma reimbursement insights, Sarepta's third DMD filing, Bristol's post-merger progress and more highlights.

Deals Business Strategies

Scrip Asks…What Does 2020 Hold For Biopharma? Part 3: Policy And Regulation

The US election will intensify  the spotlight on drug costs, regulators will have their hands full with advanced therapy filings, and the need to address rising infectious disease threats will mount. Biosimilars, cannabis and Brexit are among other hot topics for 2020.

Policy Regulation

“B” Best? Handicapping The Democratic Field For Pharma

Drug pricing is bound to be a dominant theme in the 2020 Democratic primaries and US Presidential election. But there are some differences in the crowded field of candidates, including several who are more likely to emphasis protecting innovation alongside controlling prices.  
Elections Pricing Debate

India Unbranded Generics Plans An Industry Threat As Elections Loom?

As national elections loom, India’s prime minister has said the government will expand a retail scheme to sell cut-price no-name generic drugs intended to make medicines more affordable for the poor, and some analysts are expecting a potentially significant commercial impact on the country's main branded generics sector.

India Generic Drugs

“Lame Duck” Congress Has High Stakes For Pharma Companies

Industry faces an uphill fight in a last-ditch effort to reverse the Medicare “donut hole” changes enacted at the start of 2018. At the same time, a stand-off over OTC monograph reform could have ripple effects on the plans to modernize the US FDA Office of New Drugs.

FDA Legislation

Triangulation Or The Bermuda Triangle: Can Trump Work With House Dems On Drug Prices?

President Trump is highlighting drug pricing as an area where he may be able to work with the new Democratic majority in the House. The political wisdom of building common ground on the topic is hard to ignore – but the tempestuous personality of the President is still the overriding factor. Instead, focus on whether HHS can win some breathing room to keep going with administrative changes.
Elections Pricing Debate

Gottlieb Renews Call For New Opioid Review Paradigm As Democrats Prepare For House Control

US FDA's controversial approval of Dsuvia may prompt incoming House Democrats to pay special attention to commissioner's remarks on how agency reviews opioids. 
Neurology Elections

US FDA May Largely Avoid House Democrats' Investigation Agenda

Drug pricing hearings likely will involve FDA, but most pressing issue facing agency following midterms may be whether Commissioner Gottlieb will depart.
Elections Legislation
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