10 clinical trials to watch in the first half of 2023

The biotechnology industry begins 2023 at a crossroads.

In many ways, the sector is coming off of one of its toughest years in recent memory. Initial …

'The Top Line': FDA's stance on cancer drug approval, plus this week's headlines

The FDA is making some changes in the accelerated approval process. In this episode, we’ll discuss the recent changes with the FDA’s regulation of can…

5 questions facing gene therapy in 2023

Sometime before the end of March, a person with the inherited blood disease beta thalassemia will receive an infusion containing hundreds of millions …

Sanofi moves into swanky new Paris HQ designed around hybrid work and sustainability

As the corporate world evolves in the wake of COVID-19, Sanofi has christened an innovative headquarters to help keep pace.

Navigate the complexities of cell and gene therapies

For cell and gene therapies, all stages of the drug development life cycle are complex. The patient, product and supply chain requires specialized set…

Pfizer CEO Bourla stung by UK's pharma marketing regulator over kids' COVID vax claims: report

Pfizer’s chief executive Albert Bourla, Ph.D., is in hot water for claims he made during a BBC interview late last year about the company's then-unapp…

FDA grants speedy review to Sarepta’s Duchenne gene therapy

The Food and Drug Administration has started the first regulatory review of a gene therapy for Duchenne muscular dystrophy, the treatment’s developer,…

Sanofi moves into swanky new Paris HQ designed around hybrid work and sustainability

Monday, the French pharma giant officially moved into its new global home base in Paris, dubbed La Maison Sanofi. The 9,000-square-meter (about 96,875…

Navigate the complexities of cell and gene therapies

For cell and gene therapies, all stages of the drug development life cycle are complex. The patient, product and supply chain requires specialized set…

Infex begins study of pseudomonas aeruginosa candidate RESP-X

Phase 1 research will evaluate tolerability and safety of therapy among healthy volunteers

Infex – a company focusing on anti-infectives specialist – …

Pfizer, BioNTech start study testing next COVID-19 vaccine

• Pfizer and BioNTech on Thursday announced the start of a Phase 1 study of a new COVID-19 vaccine candidate designed to spur a broader and potentially…

With Sanofi as its marketing partner, Provention Bio grabs long-awaited FDA nod for diabetes drug

What a long, strange trip it’s been for teplizumab, a drug developed to combat juvenile diabetes—36 years to be exact.

Under FDA pressure, GSK limits use of ovarian cancer drug

GSK will stop selling the drug Zejula for some ovarian cancer patients whose disease is stable after a second line of chemotherapy, the company said F…

A new way to access scientific papers?

Many researchers are surprised to find that leaving university also means leaving behind something they didn’t expect—easy access to peer-reviewed lit…

Trial failures end latest hope for Roche’s Alzheimer’s drug

An experimental Alzheimer’s disease medicine from Roche failed two large Phase 3 clinical trials, a major setback to the Swiss company’s yearslong eff…

Healthcare Twitter influencers beam over Pfizer's RSV shot data: report

Move over, COVID: Shots to stop respiratory syncytial virus (RSV) are providing the new must-watch trial data on Twitter as healthcare influencers on …

Galapagos to cut 200 jobs amid research revamp

The workforce reduction is part of a “new strategic direction” for Galapagos, which intends to stop developing drugs for fibrosis and kidney disease.

Eli Lilly, Boehringer Ingelheim bolster case for Jardiance to treat chronic kidney disease

With an FDA approval 19 months ago to treat chronic kidney disease, AstraZeneca’s Farxiga dominated the race against its primary SGLT2 rival—Eli Lilly…

Pfizer planning steep price hike for COVID-19 vaccine

Pfizer is considering hiking the price of its COVID-19 vaccine by roughly four times what it currently charges as it prepares for sales in the U.S. to…

Cancer patients want pharma's support, but many aren’t getting it: survey

Education and support are critical to getting—and keeping—patients on appropriate therapy. But many oncology patients have gaps in their knowledge of …

ICR’s new study tracks disease progression in children with rare type of cancer

Blood tests could help guide the treatment of children with the cancer rhabdomyosarcoma (RMS), according to a new study led by scientists at the Insti…

Novo Nordisk's Wegovy gets a surprise endorsement from Twitter's soon-to-be owner Elon Musk

How do you solve a problem like Elon Musk? Well, when it comes to his weight, there seems to be a simple answer: Novo Nordisk’s Wegovy.

GSK sets high bar with trial results for RSV vaccine

• GSK’s vaccine for respiratory syncytial virus proved strongly effective in a large Phase 3 trial, reducing cases of lower respiratory infection in pe…

Atara on verge of landmark approval for first allogeneic T-cell therapy

With a thumbs up from Europe’s Committee for Medicinal Products for Human Use (CHMP), Atara Biotherapeutics’ Ebvallo is poised to become the first all…

OPTIMA announce AstraZeneca and Mutabor as official partners

The companies will aim to improve treatment for patients with prostate, breast and lung cancer

The Innovative Medicines Initiative (IMI) – a joint und…

'The Top Line': Will Eisai's Alzheimer's med lecanemab sway the CMS, how Pfizer is upping its DTC ad push for its COVID shots

Eisai and Biogen's Alzheimer’s disease drug lecanemab did surprisingly well in a phase 3 trial. The results support the idea that an anti-amyloid drug…

Course Postponements Due to Covid

All of our delegates and members who had course places postponed over the last two years due to covid restrictions/illness have now been contacted dir…