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Today's Rundown

Europe OKs Johnson & Johnson's COVID-19 vaccine, but deliveries won't start till April
Vir, GSK COVID-19 antibody slashes hospitalizations and deaths in phase 3, spurring FDA filing plans
Cigna: Some COVID-19 patients report lingering neurological, heart conditions post-recovery
Seven European countries clamp down on AstraZeneca COVID-19 vaccine as safety worries threaten rollout
Roche's Actemra adds another failure to spotty COVID-19 results—this time with Gilead's remdesivir
More than a quarter of rare disease trials are culled due to low patient rates: report
Healthcare roundup—CVS offering vaccines in 29 states
Biopharma roundup—Los Angeles slows rollout amid shot shortage
Abbott launches pandemic defense coalition to detect future variants, outbreaks
Boosted by Microsoft's tech, Adaptive Biotechnologies' new diagnostic test for COVID-19 gets FDA nod
Merck plant in Durham, N.C. gets $105M to upgrade for J&J vaccine production
Former FDA chiefs pressure President Biden to nominate a new commissioner—and quickly
AstraZeneca's COVID-19 vaccine faces distrust in Europe, even as it gets rave reviews in neighboring UK, survey finds

Featured Story

Europe OKs Johnson & Johnson's COVID-19 vaccine, but deliveries won't start till April

By Eric Sagonowsky

Europe's COVID-19 immunization campaign has been challenged by early supply problems and now safety concerns for AstraZeneca’s shot. A fourth vaccine is now on its way—though it's not going to fix the supply shortfall immediately.

Vir, GSK COVID-19 antibody slashes hospitalizations and deaths in phase 3, spurring FDA filing plans

By Nick Paul Taylor

Vir Biotechnology and GlaxoSmithKline are stopping a phase 3 clinical trial of their COVID-19 antibody early for efficacy after seeing an 85% reduction in hospitalization or death at an interim review. The trial provided further evidence of the efficacy of anti-SARS-CoV-2 antibodies in ambulatory patients.

Cigna: Some COVID-19 patients report lingering neurological, heart conditions post-recovery

By Paige Minemyer

People who have recovered from a COVID-19 diagnosis face potentially new diagnoses for neurological, behavioral health and cardiovascular conditions, new data from Cigna show.

Seven European countries clamp down on AstraZeneca COVID-19 vaccine as safety worries threaten rollout

By Eric Sagonowsky

AstraZeneca’s COVID-19 vaccine rollout has gotten off to a rocky start in Europe. First, a supply shortfall triggered a public back-and-forth between executives and government officials. Then, several countries raised efficacy doubts for people over 65. Now some countries are raising safety concerns.

Roche's Actemra adds another failure to spotty COVID-19 results—this time with Gilead's remdesivir

By Angus Liu

Roche’s arthritis therapy Actemra posted another COVID-19 failure, further muddying a pool of data that has yet to offer a conclusive answer to the anti-inflammatory drug’s pandemic role. But this flop—in a combo test with Gilead's standard-of-care remdesivir—may bear more weight.

More than a quarter of rare disease trials are culled due to low patient rates: report

By Ben Adams

Rare disease drugs are a gold mine for biopharmas if they are approved, often becoming some of the most expensive medicines available and catering to tiny numbers of people.

Healthcare roundup—CVS offering vaccines in 29 states

By Healthcare Staff

Follow along with the latest COVID-19 news straight from the Fierce Healthcare team.

Biopharma roundup—Los Angeles slows rollout amid shot shortage

By Kevin Dunleavy,Fraiser Kansteiner,Eric Sagonowsky,Angus Liu,Conor Hale

With a positive opinion from a key committee, Johnson & Johnson's one-shot vaccine is closer to winning approval in Europe. Roche's Actemra failed a test as an add-on to Gilead's Veklury in patients with COVID pneumonia. Denmark and several other EU nations have temporarily stopped using AstraZeneca's vaccine to investigate reports of blood clots.

Abbott launches pandemic defense coalition to detect future variants, outbreaks

By Conor Hale

A year into this global pandemic, Abbott is preparing for the next one: the medtech giant has launched a network of centers with expertise in lab testing, genetic sequencing and public health to help catch and track emerging viruses and potentially dangerous mutations.

Boosted by Microsoft's tech, Adaptive Biotechnologies' new diagnostic test for COVID-19 gets FDA nod

By Heather Landi

Adaptive Biotechnologies launched a new diagnostic test for COVID-19 that uses machine learning technology from Microsoft to detect prior coronavirus infections.

Merck plant in Durham, N.C. gets $105M to upgrade for J&J vaccine production

By Kevin Dunleavy

Johnson & Johnson will produce bulk substance for its COVID-19 vaccine at a Merck & Co. site in Durham, N.C. And to get the plant ready for the job, the government is shelling out $105.4 million for facility upgrades.

Former FDA chiefs pressure President Biden to nominate a new commissioner—and quickly

By Beth Snyder Bulik

The clock is ticking on an FDA commissioner nomination and public pressure is increasing on President Joe Biden to make a choice. Six former FDA commissioners wrote the White House this week urging Biden to choose someone in light of the decisions and guidance needed during the ongoing pandemic.

AstraZeneca's COVID-19 vaccine faces distrust in Europe, even as it gets rave reviews in neighboring UK, survey finds

By Sharon Klahr Coey

AstraZeneca’s coronavirus vaccine is facing a wave of mistrust in Europe—a striking difference from its stellar reputation in the U.K. While 81% of Britons believe the AZ vaccine is safe, which is on par with similar 79% of U.K. citizens who trust of the Pfizer vaccine, only 43% of Germans and 33% of French citizens consider it safe, accoriding to a surveyed by YouGov.

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