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Latest Headlines in Biotech

The process leading to approval of Biogen Inc.'s Alzheimer's disease therapy took several unusual turns, including a decision for the FDA to work far more closely with Biogen than is typical in a regulatory review, a New York Times examination has found.

How an unproven Alzheimer’s drug got approved

Two months before the Food and Drug Administration’s deadline to decide whether to approve Biogen’s controversial Alzheimer’s drug aducanumab, a council of senior agency officials resoundingly agreed that there wasn’t enough evidence it worked.

Biogen's headquarters in Cambridge.

How an unproven Alzheimer’s drug got approved

Two months before the FDA's deadline to decide whether to approve Biogen’s controversial Alzheimer’s drug aducanumab, a council of senior agency officials resoundingly agreed that there wasn’t enough evidence it worked.

Amylyx co-founders Justin Klee and Joshua Cohen outside of their offices in Cambridge. A two-drug combination invented by Klee and Cohen when they were students at Brown University is one of many potential therapies being tested for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.

Cambridge biotech raises $135 million for experimental ALS drug

Amylyx Pharmaceuticals plans to use the money to continue work on its experimental medicine for amyotrophic lateral sclerosis, or Lou Gehrig’s disease.

A photo of the packaging for Gelesis' oral treatment for weight-loss management.

Weight-loss firm Gelesis to go public in $1.3 billion SPAC merger

Gelesis said it would use the money to fund the full commercial launch of its weight-loss treatment — which can be prescribed to adults with a BMI between 25 and 40 — later this year.

The preclinical biopharma company raised $100 million by selling 6.7 million shares at $15 each and trades on the Nasdaq Global Market under the symbol TCRX.

Waltham cancer-drug startup TScan sees stock fall in public market debut

TScan is working on programs for both solid and liquid tumors, and it expects to submit two investigational new drug applications for its lead programs, which aim to prevent relapses in blood cancers, by the end of the year.

Keith Gottesdiener is the CEO of Prime Medicines.

Startup Prime Medicine emerges with $315m to pioneer a new type of gene editing

The Cambridge company was founded by David Liu, a Broad Institute of MIT and Harvard researcher.

FDA head calls for federal probe into approval of Biogen’s Alzheimer’s drug

It’s the latest fallout over last month’s approval of Aduhelm, an expensive and unproven therapy from Cambridge drugmaker Biogen that the agency OK’d in June against the advice of its own outside experts.

Sen. Joe Boncore expects to become the next leader of the Massachusetts Biotechnology Council, according to multiple people close to the Winthrop Democrat.

Senator Boncore poised to leave post for top spot at MassBio

Boncore, who joined the Senate in 2016 after winning a special election, would succeed Robert Coughlin in the high-profile and high-paying lobbying role for one of the state’s most influential business sectors.