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Jun 17, 2024

Big Pharma's 10 highest-paid CEOs of 2023

FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness'

From market withdrawal back to £3B peak sales: GSK dreams big for myeloma ADC Blenrep

Siemens Healthineers nets European approval for blood test to predict MS relapse risks

J&J to seek appeal of $150M verdict in long-spanning HIV meds off-label marketing case

Kyverna's CAR-T relapse in lupus dents autoimmune hopes amid biotech gold rush

Featured

Big Pharma's 10 highest-paid CEOs of 2023

By Fraiser Kansteiner,Eric Sagonowsky,Angus Liu,Kevin Dunleavy,Zoey Becker

After a period of leadership transition for many of the world's top drugmakers in recent years, the industry's CEO pay rankings appear to be returning to a state of equilibrium.

FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness'

By James Waldron

The FDA has slammed the brakes on MediLink Therapeutics’ trial of a BioNTech-partnered antibody-drug conjugate over the risk of “unreasonable and significant risk of illness or injuries.”

From market withdrawal back to £3B peak sales: GSK dreams big for myeloma ADC Blenrep

By Angus Liu

Two back-to-back pivotal trial wins have rekindled hopes at GSK that once-failed multiple myeloma drug Blenrep could reach more than 3 billion pounds sterling in peak sales after all.

Siemens Healthineers nets European approval for blood test to predict MS relapse risks

By Conor Hale

The CE-marked diagnostic measures the neurofilament light chain proteins released into the bloodstream when the brain’s neurons are under siege.

J&J to seek appeal of $150M verdict in long-spanning HIV meds off-label marketing case

By Zoey Becker

A New Jersey jury determined that the company caused submissions of almost 160,000 false claims across state and federal governments due to off-label marketing of its HIV meds Prezista and Intelence.

Kyverna's CAR-T relapse in lupus dents autoimmune hopes amid biotech gold rush

By Helen Floersh

The “remarkable” success of chimeric antigen receptor T-cell therapy in lupus has led to a gold rush as cell therapy companies shift their focus from oncology to immunology. But a new relapse in a clinical trial may dim the strategy’s glow, at least in the eyes of investors.

Takeda flunks pivotal epilepsy tests but mulls path to market for Ovid-partnered prospect

By Nick Paul Taylor

Takeda’s late-phase epilepsy program has failed a key test, chalking up misses on the primary endpoints in pivotal trials in two indications. But the Japanese drugmaker still plans to talk to regulators about the next steps for the Ovid Therapeutics-partnered prospect based on the “totality of the data.”

J&J’s DePuy Synthes orthopedics robot cleared for partial knee replacements

By Conor Hale

DePuy Synthes said partial replacements, also known as unicompartmental knee arthroplasty, have been underutilized due to the procedure's complexity.

Roche's Columvi win in earlier DLBCL faces questions over inconsistent patient survival data

By Angus Liu

Roche’s up-and-coming Columvi has shown it could save lives when used as a second-line therapy in diffuse large B-cell lymphoma. But the company still finds itself fielding questions about the bispecific drug’s market potential thanks to an imbalance noticed in the phase 3 data.

J&J's phase 2 Sjögren's data support FcRn strategy in the autoimmune disorder

By James Waldron

The unveiling of Johnson & Johnson’s full data from the phase 2 trial of nipocalimab in Sjögren's disease suggest that both the Big Pharma and its competitor argenx are on the right track by targeting FcRn antagonism at the automimmune disorder, according to analysts.

Fierce podcasts

Don’t miss an episode

Inside this year’s ASCO: Biggest data drops, trends and the best exhibit booth

In this week's episode of "The Top Line," journalists from Fierce Biotech and Fierce Pharma discuss the most talked-about data drops at ASCO and share on-the-ground details, including their experience with Gilead’s virtual reality Trodelvy ride.

Cybersecurity lessons from the Change Healthcare hack

A look at the top 10 pharma drug ad spenders

Coverage pathways for psychedelic therapies

Resources

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A Comprehensive and Flexible Approach to CMC for Fab and Fc-Fusion Development Programs

New molecular formats are gaining momentum in today’s market. Characterizing these products and developing robust manufacturing processes can help to usher them to market and provide new treatment options for diseases which are currently challenging to treat. Read this white paper to learn more.

Presented by: Lonza

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