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Roche’s Breast Cancer Strategy Paying Off, But Diversification Difficult

 
• By Sten Stovall and Mary Jo Laffler

Roche’s key HER2 breast cancer franchise boasted a stellar sales performance in the first-quarter – rising 27% in the U.S. alone – and the rest of the cancer business followed suit. But, the loss of schizophrenia candidate bitopertin casts a shadow on the firm’s plans for neuroscience.

Roche again has underscored its leadership position in the oncology space by unveiling strong first-quarter sales of its new cancer medicines Perjeta and Kadcyla, but the firm also announced another failed trial for its schizophrenia candidate bitopertin, setting back its ambitions of expanding in other areas.

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More from Europe

CSL Makes Landmark National-Level Pay-For-Performance Deal In Germany For Hemgenix

 
• By Francesca Bruce

A blanket pricing agreement CSL has formed with German health insurers for the gene therapy, Hemgenix, makes the cost of treatment budget-neutral compared to traditional treatment.

New Carbon Monitoring Initiative Could Help Future Proof Clinical Research

 
• By Francesca Bruce

A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.

Major Analysis To Help MHRA Fill Gaps In UK Clinical Trials Landscape

 
• By Vibha Sharma

A first-of-its-kind review of clinical trial applications submitted to the UK medicines regulator, the MHRA, shows there is a concentration of research in certain disease areas and identifies opportunities to enhance the representation of specific patient groups.

New Medicines Pricing Proposals Would Mean More Uncertainty For Spanish Supply Chains

 
• By Francesca Bruce

Proposals to reform Spain’s reference pricing system are out of whack with the national pharmaceutical strategy published in December, six industry associations have warned.

More from Geography

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Kennedy’s Comments On Novavax Delay Scientifically, Legally Inaccurate, Experts Say

 
• By Sarah Karlin-Smith

The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.