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Policy & Regulation

DBV Soars As Path For Peanut Allergy Patch Approval Clears

The French biotech's chances of competing with Aimmune's Palforzia in the peanut allergy market have been boosted after US regulators decided that a fresh Phase III trial for the Viaskin Peanut patch would not be required for resubmission.

Immune Disorders Drug Review Clinical Trials

One Year On: WHO Probe In Wuhan, Mixed Vaccine Results For Sinovac

One year after the first cases of a novel coronavirus emerged in Wuhan, a team from the World Health Organization has arrived in the city to investigate its origin. Meanwhile, mixed results are reported for some of the leading Chinese vaccines being developed to fight the pandemic still wreaking global havoc.

China Coronavirus COVID-19 Vaccines

Policy

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Latest From Policy

J.P. Morgan Day 2: Pharma Offers (Some) Views On Drug Pricing Reform

Daily round-up from the virtual J.P. Morgan Healthcare Conference: Novartis explains its PD-1 deal; Biogen partners with Apple; Sanofi and Merck discuss business development priorities; and why AbbVie is confident it can grow without relying on deals. 

Pricing Debate Business Strategies

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
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Regulation

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Latest From Regulation

FDA Approval Opens Up Gastric Cancer To Daiichi Sankyo/AZ’s Enhertu

The two companies can now market their HER-2 targeting antibody-drug conjugate in its second tumor type as they look to expand beyond breast cancer.

Approvals United States

Coronavirus Update: Moderna Vaccine Gets UK Go-Ahead As EU Approval of Oxford/AZ Vaccine Due In Weeks

Moderna’s mRNA COVID-19 vaccine has received an approval from the UK’s MHRA, while AstraZeneca is expected to apply for the EU approval of its COVID-19 vaccine next week.

Coronavirus COVID-19 Vaccines

Moderna’s COVID-19 Vaccine Wins EU Approval

The first deliveries of Moderna’s vaccine are expected to begin next week to EU countries.

Approvals Coronavirus COVID-19

2020 Drug Launches, Like Everything, Will Be Remembered For COVID-19

Gilead's Veklury for the treatment of COVID-19 was a clear commercial standout among new drugs in 2020, but cancer drugs like Seagen's Padcev and Tukysa are poised for long-term potential.

Launches Approvals

AstraZeneca Sees SOURCE Tezepelumab Failure In Asthma

The SOURCE failure is a reversal for the novel Amgen-partnered TSLP inhibitor after NAVIGATOR success last month, and comes just days after the US FDA requested more analyses of the pivotal data for the kidney disease anemia therapy roxadustat.

Approvals Clinical Trials

Pfizer/BioNTech COVID-19 Vaccine Wins EU Green Light

The first COVID-19 vaccine will shortly be available to the EU member states. The European Medicines Agency says that uncertainties remain over the ability of the vaccine to prevent transmission of the coronavirus and whether the new variant strain will render this and other vaccines less effective.

EU Coronavirus COVID-19
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