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Opioid Spotlight: Trump Announces Plans For More Spending As Congress Introduces Two Dozen Bills

Administration also plans to roll out slate of proposals to decrease drug prices and bring discounts to patients.

Legislation Neurology

340B Hospitals May Be Losing Transparency Debate In Congress

Biopharma industry's arguments on rebate pass-through to patients appear to carry the day at Senate HELP Committee hearing.

Pricing Debate Legislation

Gottlieb An Anchor For OTC Drug Industry On Stormy Congressional Seas

Commissioner Gottlieb has been a “very strong champion” of FDA and his interest in improving the OTC monograph and switch processes provides hope to the industry during a tumultuous legislative era, say CHPA executives at their annual meeting in Florida. They expect monograph reform will happen this year but doubt much else will happen before mid-term elections in November.

Prescription To Otc Switch Drug Approval Standards

New Right To Try Bill Fails To Persuade

US House rejects tempered legislation as many stakeholders remain opposed – but vote allows members to signal to the Trump administration that they tried.

Legislation Clinical Trials

MEPs Approve EMA Move To Amsterdam, But Insist Deadlines Must Be Met

An EU parliamentary committee has OKd the EMA’s move to Amsterdam, but with caveats. MEPs are unhappy with the way the agency’s new home was decided and have called for changes to the procedure used to choose EU agency locations in future.

Brexit Europe

What Pharma Firms Should Be Doing Now To Prepare For A ‘No Deal’ Brexit

As Brexit uncertainty continues and a “no-deal” scenario remains a possibility, pharmaceutical companies need to be looking at issues such as the renegotiation of supplier contracts, the transfer of key regulatory roles, and the mapping of trade flows, says EFPIA’s president, Stefan Oschmann. Meanwhile, industry and healthcare organizations have drawn up a list of “crucial unanswered questions” that they say the Brexit negotiators must address.

Brexit Business Strategies
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