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Policy & Regulation

Regulators Reassure On AZ Vaccine Safety After Rare Side Effect Deemed Plausible

The EMA and MHRA issue parallel safety updates on the vaccine, with the UK offering an alternative of the Pfizer/BioNTech or Moderna vaccines to the under 30s.

Companies Coronavirus COVID-19 Drug Safety

Roxadustat CKD Doubts Fanned By FibroGen Data Blunder

AstraZeneca's partner FibroGen stunned investors and regulators by announcing that previously disclosed cardiovascular safety data for CKD candidate roxadustat included changes made post hoc, rather than as pre-specified with the US FDA.

Clinical Trials Companies Renal

Policy

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Pharma Gets Warm Spotlight At White House Event Showcasing J&J-Merck Collaboration

Biden Administration seeks to put its stamp on a new phase of the US government’s collaboration with the pharma industry against COVID-19.

Coronavirus COVID-19 Politics

ACIP Shies Away From COVID-19 Vaccine Comparative Efficacy And Safety Evaluations

The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.

Vaccines Coronavirus COVID-19

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

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
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Regulation

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Latest From Regulation

Stockwatch: The Two Sides Of A Complete Response Letter

The FDA’s rejection of Acadia’s label expansion into a broader patient population for its only approved drug resulted in an aggrieved reaction. Better disclosure from both sides would have helped.

Complete Response Letters Companies

Servier Guilty Of ‘Involuntary Manslaughter’ in Mediator Safety Affair

The long-running Mediator saga reached a conclusion of sorts on 29 March when fines and sentences were handed out to those involved in delaying the withdrawal of a fenfluramine derivative that is thought to have caused many thousands of serious cardiac side-effects.

Commercial Companies

AbbVie’s Rinvoq Delay By US FDA Could Foreshadow More Trouble For JAKs

The expansion of upadacitinib for a new indication in psoriatic arthritis has been pushed out three months to late in the second quarter.

Drug Safety Immune Disorders

US, EU and UK Antitrust Enforcers Form Pharma Monitoring Taskforce

Antitrust regulators in the US, Europe and elsewhere say they will now collaborate on how to best assess pharmaceutical mergers, in a move that could restrict deals on grounds they excessively raise prices paid by consumers or dampen medical innovation. 

Commercial Companies

Soleno Shaken By FDA Demand For Second DCCR Phase III Trial In PWS

The US FDA has asked Soleno to conduct another Phase III Study evaluating its chief asset in Prader-Willi syndrome patients prior to any NDA submission, rattling investors and clouding the company’s prospects.

Clinical Trials Companies

Coronavirus Update: What’s The Window For J&J's COVID-19 Vaccine?

A round up of COVID-19 developments, including the CDC advising that it is "prudent" to start testing variant vaccines in case the South African B.1.351 strain gains a foothold in the US.

Regulation Coronavirus COVID-19
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