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Cambridge biotech Sarepta wins fast-track approval for the first muscular dystrophy gene therapy

The FDA limited the approval of Sarepta Therapeutics’ treatment to patients ages 4 to 5 years old who still have the ability to walk.

Flagship Pioneering unveils new biotech focused on ‘small molecule’ drugs
Cambridge-based Empress Therapeutics launches with at least $50 million from the venture firm behind Moderna.

Ultragenyx opens gene therapy plant in Bedford
The 110,000-square foot facility will manufacture treatments for ultra-rare and rare diseases.

Biogen nominates departing board member’s live-in partner as his replacement
Susan Langer’s nomination to the board, and Biogen’s failure to disclose her relationship with a current director, is certain to raise questions about the company’s corporate governance practices.

Biogen CEO calls new Alzheimer’s drug first breach of disease’s ‘fortress wall’
Chris Viehbacher defended the $26,500 annual price for Leqembi, days after an advisory panel recommended it for expanded approval.

Ironwood’s blockbuster GI drug approved for children and teens
It is the first approved medicine for the disorder in pediatric patients.

More Life Sciences Headlines

Biogen CEO calls new Alzheimer’s drug first breach of disease’s ‘fortress wall’

Chris Viehbacher defended the $26,500 annual price for Leqembi, days after an advisory panel recommended it for expanded approval.

Ironwood’s blockbuster GI drug approved for children and teens

It is the first approved medicine for the disorder in pediatric patients.

How data integrity issues roiled a biotech seen as ‘Moderna 2.0′

The concerns have led to major tumult at Somerville-based Laronde, according to a STAT and Boston Globe investigation.

After decades of neglect, sickle cell disease could soon be transformed with gene-based therapies

Two rival gene-based treatments developed by three biotech firms with headquarters, or most of their operations, in Mass. could be approved late this year or early in 2024.

FDA chief’s unwelcome message to biotech execs: ‘Prices of drugs are too high’

At the global BIO convention in Boston, Califf defended limiting reimbursements for accelerated approvals of treatments, saying they’re not fully proven.

Eisai and Biogen’s Alzheimer’s drug moves closer to full US approval

Studies indicate the drug — made by the Cambridge biotech and its Japanese partner — shows a “consistently favorable” treatment effect, the FDA said in briefing documents.

While other states, countries have biotech envy, Massachusetts can’t find enough workers

At the BIO convention in Boston this week, the competition for companies and investments is heated.

Wu launches workforce initiative to get 1,000 Boston residents into biotech jobs

The city’s initial commitment of $4 million is expected to grow over time as the program expands.