The top trial flops of 2022

This Week

Feb 24, 2023

Pfizer pulls 50% of people from phase 3 Lyme disease study for GCP violations at US trial sites


After 3-plus years and multiple FDA approvals, Gilead's cell therapy head Christi Shaw leaving next month


2022's 10 top clinical trial flops   


'The Top Line': Could a SITC checklist maximize the value of immuno-oncology combo late-stage trials


Philips recall of 21K previously recalled, repaired ventilators nets FDA Class I tag


'It's the right call': GSK expresses no regrets on abandoning cell therapy as oligo strategy heats up

 

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Pfizer pulls 50% of people from phase 3 Lyme disease study for GCP violations at US trial sites

Pfizer and Valneva’s phase 3 Lyme disease vaccine clinical trial has gone badly wrong. After discovering good clinical practice violations at some trial sites, the partners have removed around half of the enrolled participants from the study.
 

Top Stories

After 3-plus years and multiple FDA approvals, Gilead's cell therapy head Christi Shaw leaving next month

Gilead on Friday said Shaw will be leaving as Kite Pharma's CEO at the end of March. The company didn't give a reason for her departure, but the drugmaker said she'll work closely with Gilead CEO Daniel O'Day on the transition in the coming weeks.

2022's 10 top clinical trial flops

Thousands of studies are registered each year in the U.S. alone, so there is always a vast array of disappointing results to choose from as we compile our 10 top clinical trial flops.

'The Top Line': Could a SITC checklist maximize the value of immuno-oncology combo late-stage trials?

This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the top headlines from this week.

Philips recall of 21K previously recalled, repaired ventilators nets FDA Class I tag

Philips has identified two potential issues in some ventilators that were newly refurbished as result of the June 2021 recall of 5.5 million of the company's respiratory devices.

'It's the right call': GSK expresses no regrets on abandoning cell therapy as oligo strategy heats up

Rather than racing to get an “off-the-shelf” CAR-T into the clinic or going all-in on a solid tumor strategy, GSK executives told Fierce Biotech they believe the Big Pharma's genetics expertise will offer the smoothest path to market success.

Apellis wins FDA approval for first geographic atrophy drug

One of Fierce Pharma’s top three most anticipated drug launches of 2023 was also one of the year’s most uncertain. But on Friday, Apellis Pharmaceuticals bucked the industry’s losing trend in geographic atrophy (GA), scoring a second commercial nod for its C3 inhibitor pegcetacoplan.

Pfizer, targeting a younger demographic, enlists yet another celeb for its latest COVID vaccine ad

Pfizer has enlisted yet another celebrity to push its flagging COVID-19 vaccine franchise. After targeting seniors with its Martha Stewart wields a samurai sword spot, the Big Pharma has swung to the opposite end of the age spectrum with an ad featuring a singer who first made their name on YouTube.

As HQ move nears completion, Merck finds a buyer for its sprawling Kenilworth campus

Merck has reached a deal with real estate business Onyx Equities to sell its 108-acre campus in Kenilworth, New Jersey, where the drug behemoth relocated its main digs back in 2015. Merck will move out of Kenilworth in phases over the next “several years” as it completes an expansion at its new headquarters in Rahway, New Jersey.

Pfizer's maternal RSV vaccine filing gets priority review, setting up showdown with AstraZeneca, Sanofi

Pfizer is ready to ram home its advantage in the respiratory syncytial virus maternal vaccine race. With onetime close rival GSK still stalled, the Big Pharma has put itself on course to receive a landmark approval by August and go on to challenge AstraZeneca and Sanofi’s long-acting antibody for the market.

BD issues cybersecurity alert for hacking risk found in Alaris infusion pump software

A vulnerability found in software used to monitor some of BD’s infusion pumps could potentially give hackers access to personal data stored in the system.

As Sanofi contract wind-down prompts layoffs in Boston, Resilience is hiring elsewhere: CEO

Drug manufacturer National Resilience is laying off about 213 employees in Boston, a company spokesperson confirmed via email. The staff reduction is a “function of transition” tied to the end of a manufacturing contract with Sanofi, Resilience chief Rahul Singhvi told Fierce Pharma.

Apax takes big stake in French CRO Porsolt, expects to grow staff 40% in 4 years

French private equity firm Apax Partners SAS has taken a majority stake in Porsolt and expects to grow the French CRO by increasing staff as much as 40% in the next four years.
 
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'The Top Line': A checklist for immuno-oncology combo phase 3 trials

This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the top headlines from this week.

 

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