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Policy & Regulation

Scrip Asks…What Does 2021 Hold For Biopharma? Part 5: Business Environment And Strategy

A strong year is predicted for biopharma business with investment and deal making set to continue apace. Executives across industry share their forecasts for the year ahead.

Artificial Intelligence Brexit Business Strategies

AstraZeneca & Sputnik V COVID-19 Vaccine Combo To Enter Trial

There is growing in interest in boosting the first dose of a COVID-19 vaccine by administering a different vaccine as the second dose.

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Policy

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Scrip Asks…What Does 2021 Hold For Biopharma? Part 3: Patient Access To Health Care

Executives share their expectations and hopes around the multi-faceted topic of patient access to medicines. From health inequities to value assessment and reimbursement trends, expectations for change abound.

Clinical Trials Coronavirus COVID-19

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.”

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Coronavirus Update: South Korean Nod For AZ/Oxford Vaccine, Actemra Progesses In Japan

South Korea approves AstraZeneca’s COVID-19 Vaccine, while Actemra moves forward in Japan after local study results.

Coronavirus COVID-19 Vaccines

Big Pharma Holds Steady With One-Third Of Novel Agents Approved In US In 2020

Gilead and Roche ended the year involved in three novel agents apiece, thanks to a combination of internal research and external licensing. 

Approvals Companies

Coronavirus Update: US FDA Panel To Review J&J’s Vaccine On 26 February

Johnson & Johnson's vaccine produced a significantly lower efficacy readout than the mRNA frontrunners, but its success in preventing severe disease with one dose will be a gamechanger, if approved.

Coronavirus COVID-19 Vaccines

Amarin Builds Sales Infrastructure For EU Vazkepa Launch

With an approval nod from the EMA’s scientific committee for its fish oil product Vazkepa, launch plans for the EU for this “multi-billion dollar” opportunity are on track, says Amarin CEO.

EU Approvals

Aducanumab Approval Decision Delayed: Could This Be Good News?

Even analysts who still doubt the FDA will approve the anti-amyloid antibody as the first disease-modifying Alzheimer’s treatment said aducanumab’s likelihood of approval has improved.

Drug Review Neurology

Europe Takes Leap Of Faith On AstraZeneca Vaccine

A conditional marketing authorization for AstraZeneca/Oxford's COVID-19 vaccine came just hours after the European Medicines Agency’s CHMP voted unanimously to recommend it on Friday.

Approvals Coronavirus COVID-19
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