Medtronic trims forecasts amid slow sales

Today's Big News

Nov 22, 2022

In surprise move, GSK pulls Blenrep's accelerated approval only days after confirmatory trial flop

Walgreens plots 'aggressive' strategy to build out healthcare services, CEO Roz Brewer says

Medtronic trims financial forecasts as currencies complicate slow sales

Pfizer's $1B protein degradation bet yields 3% response rate in Arvinas' midphase breast cancer trial

‘Monopoly' allowed Bristol Myers and generics makers to 'steal' from Revlimid purchasers, lawsuit says

MetroHealth System board ousts CEO after investigation reveals $1.9M in unapproved performance bonuses

 

Featured

In surprise move, GSK pulls Blenrep's accelerated approval only days after confirmatory trial flop

GSK is setting a new standard for speed when it comes to withdrawing an accelerated approval after a confirmatory trial failure. The British drugmaker is pulling Blenrep off the U.S. market just 15 days after announcing a phase 3 flop. The move comes despite potentially imminent readouts from two other phase 3 trials.
 

Top Stories

Walgreens plots 'aggressive' strategy to build out healthcare services, CEO Roz Brewer says

On the heels of several high-profile healthcare acquisitions, Walgreens aims to be a point of entry for consumers for healthcare services ranging from urgent care to specialty care and even in-home health.

Medtronic trims financial forecasts as currencies complicate slow sales

"Slower than predicted procedure and supply recovery drove revenue below our expectations this quarter,” said CEO Geoff Martha.

Pfizer's $1B protein degradation bet yields 3% response rate in Arvinas' midphase breast cancer trial

Pfizer’s $1 billion bet on Arvinas’ protein degradation technology has delivered phase 2 data. After a publication snafu, Arvinas posted the breast cancer results ahead of schedule—and revealed one partial response among 35 patients at its phase 3 dose.

'Monopoly' allowed Bristol Myers and generics makers to 'steal' from Revlimid purchasers, lawsuit says

The courtroom drama surrounding Bristol Myers Squibb and its subsidiary Celgene over their efforts to restrict competition for lymphoma drug Revlimid has raged for more than a decade. And it's not going away any time soon, as three union pension funds have brought a class action antitrust suit against Bristol Myers and a raft of generic drugmakers.

MetroHealth System board ousts CEO after investigation reveals $1.9M in unapproved performance bonuses

Akram Boutros, M.D., who has repaid the money with interest, was terminated with cause shortly before his planned retirement. He said that a statement released by MetroHealth's board chair detailing his undisclosed self payments "is full of misinformation and outright lies" and now threatens the four-hospital system with a lawsuit for "retaliatory" behavior.

FDA extends deadline to decide on Gamida Cell's stem cell transplant therapy by three months

Gamida Cell will need to wait a while longer to know whether regulators greenlight its stem cell transplant therapy, with the FDA extending the review period for the approval application by three months. The company said recent data provided to the FDA was considered a major amendment, prompting the extension.

Teleflex plans layoffs amid restructuring plan costing up to $40M

More than half of Teleflex's restructuring costs—between $18 million and $22 million—will come from termination benefits paid out to laid-off employees.

ASH: AbbVie, J&J's Imbruvica under serious threat as BeiGene's Brukinsa delivers head-to-head trial win

BeiGene has shared detailed results from a Brukinsa head-to-head trial, and it’s bad news for rival Imbruvica from AbbVie and Johnson & Johnson. The latest update makes Brukinsa the first BTK inhibitor to top Imbruvica on a hard efficacy endpoint.

House lawmakers press Biden admin to change latest surprise billing rule

Leaders of the House Ways and Means Committee are pressing the Biden administration to change a rule that implements the arbitration process as part of a ban on surprise medical bills.

Masimo’s pulse oximeter is accurate for both Black and white patients, study finds

Masimo has declared racial bias a non-issue in its flagship SET pulse oximeter: Study results published this month found no clinically significant difference in the device’s accuracy when used on both Black and white patients.

Novo Nordisk invests $74M to boost API manufacturing for clinical trials

With all the talk of drugmakers cutting pipelines and laying off staff, it’s good to occasionally report on some investment back into the sector. For Novo Nordisk, that means investing 5.4 billion Danish kroner ($74 million) to boost R&D manufacturing needed for its clinical trials.

Shionogi's COVID-19 antiviral nabs Japanese approval to rival drugs from Pfizer, Merck

Shionogi’s Xocova COVID-19 approval marks the first green light for a drug under Japan’s new emergency regulatory approval system. Shionogi is also angling for approval of its antiviral pill in the United States.
 
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'The Top Line': Celebrating the 2022 Fiercest Women in Life Sciences honorees

This week on “The Top Line,” we share this week's headlines and discuss the 2022 honorees in our annual Fiercest Women in Life Sciences report.
 

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