FierceBiotech is a free daily email newsletter and web resource providing the latest biotech news, articles, and resources related to clinical trials, drug discovery, FDA approval and regulation, biotech company deals, and more. It serves as the biotech industry's daily monitor for more than 90,000 biotech professionals. FierceBiotech’s client base includes senior business executives and clinical operations leaders at biotech, pharmaceuticals, and related drug development companies. It provides information related to clinical stage drug development, FDA and EMEA regulations, drug licensing pacts, mergers and acquisitions involving developers, and biotech and pharma deals. FierceBiotech is based in Washington.

Fierce Pharma

FierceBiotech

Fierce Pharma covers the pharma waterfront, from late-stage drug development through the entire lifecycle—tracking regulatory approvals, payer negotiations, manufacturing, marketing, patent fights, government investigations and regulation, M&A deals and beyond.

This week on 'The Top Line', if you missed the Clinical Trials on Alzheimer’s Disease conference, catch up with our analysis of the biggest readouts. Plus, we cover the week's news including an investigation into Neuralink, Google’s DeepMind and more.

After a positive opinion from regulators back in October, Takeda's dengue vaccine scored a green light from the European Commission. The approval sets up potential nods in other endemic countries.

The odd saga of Oncopeptides' multiple myeloma drug—thriving in Europe while sidelined in the U.S.—continued Wednesday with the FDA requesting a withdrawal of the U.S. marketing authorization for Pepaxto.

Plaintiffs in the now-dismissed clutch of cases argued Merck's vaccine Zostavax caused their shingles. But the medical expert attempting to back up that claim failed to consider whether plaintiffs’ disease occurred naturally because they’d had chickenpox as kids, according to court filings published this week.

On ICER’s annual list of drugs that had unjustified price increases in 2021, Bausch’s Xifaxan and Johnson & Johnson’s Invega Sustenna caused the most additional spending in the U.S. The treatments displaced Humira as the top offender in 2020.

GSK's emerging oncology business just got a much-needed boost after several recent setbacks. A first glimpse at its PD-1 inhibitor's head-to-head data against Keytruda looks encouraging.

In an investigator-initiated phase 2 study of Enhertu in neoadjuvant HER-2 low breast cancer, just one patient achieved the trial's “tried and true” pre-surgery endpoint of pathologic complete response, Daiichi’s clinical oncology chief Mark Rutstein said in an interview ahead of the 2022 San Antonio Breast Cancer Symposium.

When Eli Lilly’s Verzenio snagged an FDA go-ahead to treat certain breast cancer patients after surgery, the first-in-class nod was weakened by an unexpected limitation. Now, the company hopes longer-term follow-up data will convince U.S. regulators to remove the restriction.

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