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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

The field of drug development has always seen fewer successes than failures, with 90% of programs missing the cut being a commonly quoted stat. Last year had its share of clinical trial letdowns, but some had much larger impacts than others—especially in the continued fight against COVID-19. Others included a prospective HIV vaccine and drugs for cancer and neurodegenerative diseases, both notoriously tough nuts to crack. Fierce’s list of 2021’s top 10 clinical trial flops follows below, plus our other top reads of the week.

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UPDATE: Editas shares boosted as patent office rules in favor of Broad's CRISPR patents, but the fight will continue

By Annalee Armstrong

The U.S. Patent and Trademark Office has ruled in favor of the Broad Institute in a dispute over the patents around CRISPR gene editing technology, sending Editas' shares up.

Johnson & Johnson, Legend's CAR-T Carvykti enters myeloma ring with FDA nod

By Angus Liu

An FDA approval for Johnson & Johnson and Legend Biotech’s CAR-T therapy may be three months late, but it still came. Having watched first-in-class Bristol Myers Squibb stumble with supply during the roll-out, the two companies have devised a game plan to ensure a smoother launch.

2021's top 10 clinical trial flops

By Phil Taylor

Thousands of studies are registered each year in the U.S. alone, so there is always a vast array of disappointing results to choose from as we compile our top 10 clinical trial flops.

Intellia now has the data for No. 1 unanswered gene editing question: Does it last?

By Annalee Armstrong

Intellia proved last year that gene editing can work in humans. But a lingering question was, for how long? Now, the biotech has the data to begin to answer that question.

Novartis sells pair of manufacturing plants as Sandoz strategic review rolls on

By Fraiser Kansteiner

Novartis has reached a deal to sell its Ringaskiddy campus near Cork, Ireland, to contract manufacturer Sterling Pharma Solutions. Separately, CDMO compatriot Delpharm has completed its acquisition of a Quebecois manufacturing plant from Novartis’ generics unit, Sandoz.

BMS, Novartis, Akebia and more face FDA approval decisions soon, with big sales on the line

By Kevin Dunleavy

An interesting and varied group of drugs—ranging from two first-in-class cancer therapies to a treatment that removes frown lines—face target dates for approval this month. Many of the decisions bear watching as their status could have far-reaching implications in the industry and for patients.

Pfizer fails phase 3 C. diff vaccine test but still spies possible path forward

By Nick Paul Taylor

The casualties in the Clostridium difficile vaccine race are starting to pile up. Having been vaulted to the front of the queue by Sanofi’s failure, Pfizer has now missed the primary endpoint in its phase 3 trial.

FDA approves J&J’s allergy-fighting contact lens infused with an antihistamine

By Conor Hale

Johnson & Johnson’s Acuvue Theravision lenses are laden with ketotifen, the same drug used in a variety of eye drops for taming reactions to pollen, grass, pet dander or dust.

Alnylam explores the rare disease journey in a new, hard-hitting documentary

By Ben Adams

The patient voice is a powerful one when it comes to healthcare advocacy, and Alnylam has put together a new documentary that maps the often-difficult journey for those suffering with acute hepatic porphyria.

2 new compounds might help intervene in Type 2 diabetes, a disease that's 'foxed scientists for generations'

By Kyle LaHucik

Researchers at University of Leeds said they found two new compounds, known as molecule modulators, that might lead to new drug development options for Type 2 diabetes. The modulators help slow down and speed up the process that creates amyloid fibrils, which are associated with the disease's development.