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US Election 2016

Set Alert for US Election 2016

President Trump And Drug Pricing: What To Expect

US President-elect Donald Trump is expected to work closely with congressional leadership on health care issues, potentially including drug pricing, but uncertainty is always the watchword with Trump.

US Election 2016 Pricing Debate United States

Latest From US Election 2016 &BioPharmaceutical

How US Tax Plan Could Affect Global Pharma Manufacturing Networks

Allergan, Pfizer, Bristol-Myers Squibb, AbbVie, GSK, Sanofi and Roche showed glimpses in recent earnings calls of potential impacts on their global manufacturing networks from a US plan to legislate border-adjusted tax cuts. But there was not a word about President Trump’s threat of tariffs.

Manufacturing Policy

Pharma Earnings Calls Reveal US/EU Trump Divide

Less than a month after his inauguration, President Donald Trump has both unnerved and empowered industry sectors with his immediate actions or divulged potential reforms. Execs offered measured reaction and some speculation during recent earnings calls.

Policy US Election 2016

Podcast: Former FDA Commissioner On “Smarter Regulation”

Former US FDA Commissioner Mark McClellan suggests the key with agency regulations may be how they are interpreted, and providing predictability and clarity, rather than just the scope of what’s written.

Regulation FDA

Value-Based Contracts: Relief From Regulatory Barriers In Sight?

Novartis CEO Jimenez suggests Trump Administration may help remove regulatory barriers to US outcome-based contracting between manufacturers and payers; Duke Margolis Center for Health Policy plans policy initiative to promote value-based purchasing for drugs, medical devices and gene therapy.

Pricing Debate US Election 2016

Medicaid Reform And Rebates: State “Opt-Out” Proposed At Hearing

Medicaid rebates have been a fact of life in the pharmaceutical industry for 25 years. But the Affordable Care Act repeal-and-replace debate may open up the possibility of eliminating the mandatory rebates – and the requirement that all drugs be covered by the program.

Government Payers Reimbursement

Rogue FDA Tweeters Archive Inspection Data, Fearing Deletion By Trump

Followers of rogue FDA twitter site AltFDA answered a call to back up inspection citations data the Obama administration made public in case the Trump administration erases it from the FDA website.

Compliance Quality

CEOs Tell Trump Tax Cuts Could Bring More Biopharma Plants To US

Lower taxes could entice biopharmaceutical sector to focus more on the US as it seeks to expand biotech manufacturing capacity where it can find highly educated and experienced scientists.

Manufacturing Quality

Carrots and Stick: Biopharma At The White House

Drug industry executives discuss drug pricing and tax and regulatory reform in a high-profile meeting with President Trump at the White House.

Pricing Debate US Election 2016

Lilly’s Failed Solanezumab: Could It Get Another Chance In A ‘Silicon Valley’ FDA?

Alzheimer drug’s development was discontinued after third disappointing Phase III trial, but given the kind of FDA commissioner candidates getting meetings with the President, maybe Lilly should reconsider.

FDA US Election 2016