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Today’s Big News

Jun 25, 2024

100 days with John Crowley: BIO’s new vision and a ‘wake-up call’ for the country

Teva agrees to fork over $750M to close the book on years of tax litigation in Israel

Illumina parts ways with Grail, with divestiture complete

Doctors support growth of at-home testing, survey finds, opening new avenues for biopharma patient outreach

Intellia doesn’t need to re-dose gene edited NTLA-2001. But new data shows it can be done.

AbbVie's Duopa successor in Parkinson's rejected again after FDA flags third-party manufacturer issues

Endotronix claims FDA approval for heart failure sensor implant

Featured

100 days with John Crowley: BIO’s new vision and a ‘wake-up call’ for the country

By Gabrielle Masson

The Biotechnology Innovation Organization’s CEO John Crowley isn’t shying away from the tough tasks. With only a little more than three months at the helm of the world’s largest biotech advocacy group, the leader has already implemented a wide-scale restructure and taken a firm stance with Congress regarding U.S. biosecurity.

Teva agrees to fork over $750M to close the book on years of tax litigation in Israel

By Zoey Becker

The deal with the Israel Tax Authority wraps up pending litigation over taxes payable from 2008 to 2020. Crucially, Teva also has to pay additional taxes on any equity dividends or share repurchases.

Illumina parts ways with Grail, with divestiture complete

By Conor Hale

Nearly four years after first pitching its multibillion-dollar plan to obtain Grail, Illumina has cut (nearly) all ties with the cancer blood test developer.

Doctors support growth of at-home testing, survey finds, opening new avenues for biopharma patient outreach

By Andrea Park

Physicians don’t mind patients choosing at-home testing options over coming in for an in-person clinic visit—in fact, they overwhelmingly support it, according to the results of a new survey.

Intellia doesn't need to re-dose gene edited NTLA-2001. But new data shows it can be done

By Annalee Armstrong

Intellia Therapeutics doesn’t need to redose patients with a CRISPR gene edited therapy for transthyretin (ATTR) amyloidosis. But new data suggests it could be done.

AbbVie's Duopa successor in Parkinson's rejected again after FDA flags third-party manufacturer issues

By Fraiser Kansteiner

A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established formulation of carbidopa and levodopa.

Endotronix claims FDA approval for heart failure sensor implant

By Conor Hale

The minimally invasive Cordella system keeps tabs on the pressure within the pulmonary artery. With a handheld scanner that connects with the implanted device, patients can take their own readings at home.

Merck KGaA drops xevinapant with phase 3 head and neck cancer trial on course for failure

By James Waldron

An interim analysis has concluded that Merck KGaA's TrilynX study is unlikely to meet its primary objective of prolonging event-free survival.

Drugmakers dig in their heels amid FTC's latest patent crackdown. What happens next?

By Angus Liu

In the U.S. Federal Trade Commission’s latest campaign against what the agency views as “junk” drug patent listings in the FDA’s database, drugmakers have decided not to play ball. A partner at the law firm MBHB explained to Fierce Pharma what could happen next in the fight.

Eli Lilly inks OpenAI deal for discovering new antibiotics

By Gabrielle Masson

Eli Lilly is teaming up with OpenAI on a quest to develop new treatments that overcome antimicrobial resistance.

AstraZeneca's Imfinzi counts a trial win in bladder cancer, a miss in lung cancer

By Angus Liu

While the PD-L1 inhibitor posted a clinical win in muscle-invasive bladder cancer, it also chalked up a failure in early-stage non-small cell lung cancer.

Terns’ ex-MASH drug cuts fat, not muscle or food intake, in GLP-1 combo in mice

By Helen Floersh

Terns Pharmaceuticals’ prediction that its shelved MASH drug TERN-501 could be effective against obesity in a combination treatment appears to be playing out, at least preclinically—apparently without decreasing calorie intake.

Fierce podcasts

Don’t miss an episode

A look at ‘friend-shoring’ and the drug shortage challenge

In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing.

Inside ASCO 2024: Biggest data drops and the best exhibit booth

Cybersecurity lessons from the Change Healthcare hack

Resources

Whitepaper

2024 Life Sciences Industry Outlook

The definitive report on the state of our industry. Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond.

Enhance your long-term cell & gene therapy success with pDNA manufacturing solutions

Watch our on-demand webinar video to learn more about the challenges in pDNA manufacturing for gene and cell therapy and how to resolve many of these barriers by partnering with our experts through the adoption of vital manufacturing technologies and strategies.

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

Whitepaper