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Policy & Regulation

Can Pharmas Come Out Unscathed As China-US Trade War Escalates?

As a simmering trade dispute between the US and China looks set to continue worsening, many companies in the pharma sector are closely watching what's coming and getting ready for any disruption. But what is the actual and predicted impact on exporters and producers in China, India and the US?

Trade China United States

FDA Tells RegeneRx It Needs 3rd Phase III Trial On RGN-259 For Dry Eye Syndrome

The FDA is requiring an additional RGN-259 Phase III trial to further show efficacy in both signs and symptoms of dry eye in a larger patient population.

Analysis Approvals Clinical Trials
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Policy

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Latest From Policy

Lilly's Prices After Concessions Rise 6% In 2017, While Merck's Net Prices Decline

Price transparency reports from the big pharmas also show continued increases in price concessions in 2017, but a slow-down in list price increases.

Pricing Debate Pricing Strategies

Mehta Analysis: Welcome To The PBM Realm, Derica Rice and Andrew Witty

As two high-profile pharma veterans make their move into pharmacy benefit management leadership, Viren Mehta, founding partner of Mehta Partners LLC, ponders the challenges they face and the impact their actions will have on the pharma industry.

Pharmacy Benefit Management Leadership

J&J Stays Within Price Pledge, But Average Doesn't Tell The Whole Story, Analyst Says

Bernstein analyst looks into J&J's average net price decline in 2017 and notes average sales price hikes for growth products Darzalex and Imbruvica are offset by price cuts for drugs facing competition. All products had single digit increases, though.
Pricing Strategies Pharmacy Benefit Management

Drug Pricing: A Game Of Chutes & Ladders

The US drug pricing policy environment is facing changes. Much of the action, whether Congressional or regulatory, is good for industry – but there have been a few setbacks and more may come.

Market Access Pricing Debate

The Ups and Downs Of US Drug Pricing Policy

If 2017 was the year of talk (tweets) on prescription drug pricing policy, 2018 is shaping up to be the year of action.

Pricing Debate Market Access

FDA's Gottlieb: 'Pricing And Reimbursement Mischief' Holding Back Biosimilar Market

The FDA Commissioner called on payers to take steps to build the US biosimilar market and discouraged some early contracting schemes, calling them pay-for-delay tactics "dressed in the guise of rebates" in a notable speech at AHIP.

Biosimilars Pricing Debate
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Regulation

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Latest From Regulation

Modus CEO Says Rare Disease Priority Review Voucher To Be Key Catalyst

The US FDA gives Sweden's privately held Modus Therapeutics rare pediatric disease designation for sickle cell disease.

Business Strategies Companies

FDA Reversal Puts Alkermes Depression Drug Back On Track For January Approval

Reversing an earlier decision, FDA accepted Alkermes' new drug application (NDA) for ALKS 5461 for review, with a target action date of Jan. 31. But the company could still face a tough FDA review.

Drug Review Neurology

FDA Refuse-To-File Letter For Alkermes Depression Drug Suggests A Lengthy Commercial Delay

CEO Richard Pops called FDA's letter for ALKS 5461 "surprising and troubling." Alkermes had been ramping up to launch the depression drug later this year, though some investors had remained skeptical.

Drug Review Neurology

More Bad News: Celgene Reveals Refuse-To-File Letter For Ozanimod In MS

Celgene said the US FDA issued a refuse-to-file letter for ozanimod in multiple sclerosis because "the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a review." It's yet another big blow for a company whose value has been falling since October.

Business Strategies Neurology

US FDA Advisory Cmte. Review Of Charleston's Hydexor Exposes Flaws In Commercial Strategy

Physicians may be hesitant to prescribe the opioid/anti-emetic combo for several reasons; panelists were concerned the company hasn't figured out a specific commercial audience for Hydexor at this point in the review process.
Advisory Committees Neurology

Bristol Debuts Opdivo/Yervoy Data In New First-Line Lung Cancer Bid

The pharma hopes showing a PFS benefit in first-line NSCLC patients with a high tumor mutation burden may provide a way to compete with Merck in that setting, but analysts think it will need overall survival data.

ImmunoOncology Cancer
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