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Policy & Regulation

Lilly Gets Second EUA, For Baricitinib In COVID-19 Patients

Weeks after FDA authorized emergency use of its antibody bamlanivimab, Lilly’s RA drug Olumiant can be used to shorten recovery time for hospitalized COVID-19 patients in the US. Authorizations are being pursued elsewhere as well.

Coronavirus COVID-19 Approvals Policy & Regulation

Bill Gates On Vaccine Distribution Challenges, Overcoming Vaccine Hesitancy

The public health advocate and billionaire philanthropist raised issues about how a mass COVID-19 vaccination effort is being handled so far in the US, speaking at the Stat Summit.

Coronavirus COVID-19 Vaccines Distribution

Policy

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Latest From Policy

Biden Administration May Push Rx Pricing To Back Burner With Senate That Stays Pharma Friendly

A Biden Administration with near-term priorities other than drug pricing and a Republican-controlled Senate dedicated to blocking any legislation that would enact government price controls is a relatively positive outcome for industry.

Elections Pricing Debate

President ????: What US Election Uncertainty Means For Biopharma

Worst case scenario is civil unrest that might disrupt clinical trials and manufacturing. Under a more moderate scenario, companies must delay business planning because the US policy environment remains cloudy.

Elections Politics

Can Pharma Rebuild Its Reputation? COVID-19 Means A Big Responsibility, And Opportunity

The global health crisis has presented a chance for the industry to improve its reputation by highlighting the value of its R&D engines. Pharma execs and observers talk to Scrip about why they are optimistic about industry’s chance to regain public trust.

Coronavirus COVID-19 Leadership

FTC Narrowly Approves Mylan-Upjohn Merger As Dissenters Call For Change

Mylan’s proposed $12bn combination with Pfizer’s Upjohn unit is expected to close next month following a settlement agreement with the FTC, with a requirement to address competition concerns in ten markets. The FTC was however strongly divided on the deal, with dissenters labelling the directives of the Commission as “deeply flawed, favoring routine over rigor.”

M & A Enforcement

AMR Action Fund Will Start Screening Antibiotic Candidates Early Next Year

The industry-backed investment fund to combat antimicrobial resistance hopes to be operational by end of year and begin assessing programs to invest in during the first quarter of 2021.

Policy Financing

Executive Privilege: How Giving Trump Special Access To Experimental COVID Treatment Could Backfire

Trump receives Regeneron’s experimental antibody under FDA’s expanded access program, Gilead’s remdesivir and dexamethasone. The president’s treatment choices could influence clinical trials of all COVID-19 medicines and even trial recruitment for other diseases, experts said.

Clinical Trials Elections
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Regulation

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Latest From Regulation

It Was Inevitable: FDA Inspection Delay Postpones BMS’s Liso-Cel Approval

Bristol Myers Squibb confirmed that approval for lisocabtagene maraleucel (liso-cel) will be delayed by the US FDA’s COVID-19-related restrictions on travel for manufacturing facility inspectors.

Drug Review Manufacturing

Adamis Gets Another CRL For Opioid Overdose-Reversal Drug

Adamis got its second complete response letter for Zimhi. While not apparently related to the first, it may complicate the company's outlook following a lackluster quarter.

Complete Response Letters Drug Delivery

President ????: What US Election Uncertainty Means For Biopharma

Worst case scenario is civil unrest that might disrupt clinical trials and manufacturing. Under a more moderate scenario, companies must delay business planning because the US policy environment remains cloudy.

Elections Politics

US COVID-19 Vaccine Adcomm: First Take-Aways

From efficacy endpoints to patient warehousing, US FDA advisors weigh in on vaccine development and regulatory review.

Coronavirus COVID-19 Vaccines

Purdue's $8.3bn Settlement With DOJ Requires Reconstitution As Public Benefit Company

Purdue pleads guilty to three felony charges over marketing of OxyContin under settlement that requires Purdue to be dissolved and transformed into an entity that provides addiction and overdose medicines. Twenty-five state AGs oppose creation of a PBC, arguing Purdue should be sold to another company.

Legal Issues Drug Safety

Coronavirus Update: Human Vaccine Challenge Study Gains UK Backing

The UK backs the world's first COVID-19 human challenge studies to accelerate research – though the first results will not be ready until mid-2021.

Coronavirus COVID-19 Regulation
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