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Sep 3, 2024

EU high court hands Illumina consolation prize, ruling in favor of its appeal over Grail

Sanofi's tolebrutinib fails 2 of trio of phase 3 MS trials, but pharma still plans FDA filing

Bayer's Kerendia reduced the risk of cardio death by 16% in tough-to-treat class of heart failure patients

In Europe, shortages of Novo Nordisk's Ozempic to persist into Q4: letter

Three execs resign as Dyne posts mixed data for DMD candidate

Featured

EU high court hands Illumina consolation prize, ruling in favor of its appeal over Grail

By Conor Hale

Though Illumina has already parted ways with Grail, the DNA sequencing giant will not have to pay the European Union its $476 million fine.

Sanofi's tolebrutinib fails 2 of trio of phase 3 MS trials, but pharma still plans FDA filing

By James Waldron

Sanofi is still set on taking its multiple sclerosis med tolebrutinib drug to the FDA, executives have told Fierce Biotech, despite the BTK inhibitor falling short in two of three phase 3 trials that read out on Monday.

Bayer's Kerendia reduced the risk of cardio death by 16% in tough-to-treat class of heart failure patients

By Kevin Dunleavy

At the European Society of Cardiology event, Bayer unveiled data from the phase 3 FINEARTS-HF trial that showed Kerendia reduced the risk of cardiovascular death as well as well as first and recurrent HF events by 16% compared to placebo in patients with mildly reduced or preserved ejection fraction.

In Europe, shortages of Novo Nordisk's Ozempic to persist into Q4: letter

By Zoey Becker

The company and the European Medicines Agency warned European healthcare providers to continue limiting new patient prescriptions until the shortages let up.

Three execs resign as Dyne posts mixed data for DMD candidate

By Fraiser Kansteiner

In tandem with a data drop on its Duchenne muscular dystrophy candidate in patients suited to exon 51 skipping therapy, Dyne Therapeutics has announced a slew of executive changes, including multiple appointments and departures.

UK's George Medicines posts positive results for triple-combo blood pressure drug on heels of FDA submission

By Fraiser Kansteiner

With a positive readout for its three-in-one hypertension drug, London-based George Medicines is one step closer to the market on its quest to tackle widespread conditions like high blood pressure, diabetes and other common cardiometabolic disorders.

Vaxcyte's 'stunning' 31-valent pneumococcal vaccine win against Pfizer's Prevnar 20 has analysts thinking big

By Angus Liu

Vaxcyte unveiled what analysts called “stunning” phase 1/2 data for its 31-valent pneumococcal vaccine candidate that, if replicated in a large pivotal study, could pose a serious threat to Pfizer’s stalwart Prevnar 20.

Embecta secures FDA clearance for insulin patch pump in Type 1 and Type 2 diabetes

By Conor Hale

The fully disposable device includes a 300-unit insulin reservoir, which embecta said could last most users with Type 2 diabetes about three days, based on the average amounts taken by people relying on multiple daily injections to control their blood sugar levels.

Novartis brings blood cancer sculptures to Scotland, continuing symptom awareness tour

By Nick Paul Taylor

Novartis’ blood cancer sculpture tour has reached a new destination. The Swiss drugmaker, which put the sculptures on show in London one year ago, is marking this year’s Blood Cancer Awareness Month by setting up the artwork at the University of Glasgow.

FDA scrutiny of India’s Zydus results in warning letter

By Joseph Keenan

Zydus Lifesciences continues to be under intense scrutiny from the FDA, which hit the Indian drugmaker’s production facility in Jarod with a warning letter.

New data reveal how Bayer's asundexian failed to prevent strokes, imperiling $5.5B blockbuster hopes

By Darren Incorvaia

The full picture of how Bayer's factor XIa inhibitor asundexian showed "inferior efficacy" compared to Eliquis has come into focus: patients receiving asundexian actually suffered strokes or systemic embolisms at a higher rate than those receiving Eliquis.

Daiichi study finds gender inequality in European cardiovascular care

By Nick Paul Taylor

Daiichi Sankyo has identified inequalities in cardiovascular disease treatment and outcomes, finding that women in Europe are less likely than men to receive lipid-lowering therapies and achieve LDL cholesterol goals.

Fierce podcasts

Don’t miss an episode

Driving flu vaccine uptake in the post pandemic era

In this week's episode of "The Top Line," we look at factors driving the continuing decline of flu vaccination rates in the U.S. and beyond.

The TROP2 race for supremacy

The Coalition for Health AI wants local governance and national standards for health AI

Resources

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