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Aduhelm, Biogen's recently approved drug for Alzheimer's disease, is seen at Butler Hospital in Rhode Island, one of the clinical research sites.

Internal documents reveal FDA clash over Biogen’s Alzheimer’s therapy

Statisticians at the Food and Drug Administration didn’t support approval of Biogen's Alzheimer’s therapy, internal documents released by the agency show.

Blueprint Medicines wins FDA approval for drug to treat rare blood disorder

It’s the Cambridge biotech’s fourth approval from the US Food and Drug Administration in less than two years.

US to buy 200 million more doses of Moderna’s COVID-19 vaccine

The deal includes the potential for buying additional Moderna vaccine candidates that are in testing, including booster shots, according to the company.

Trump’s FDA commissioner joins Flagship, the Cambridge firm that launched Moderna

While at the FDA, Stephen Hahn oversaw the federal agency's pandemic-related efforts, including therapeutics and vaccine development, devices, diagnostics, and clinical trials.

Noubar Afeyan is CEO of Flagship Pioneering.
Flagship Pioneering raises more cash for new biotech fund
The Cambridge venture capital giant, which spawned Moderna, now has $3.4 billion to spend on startups.

Dr. Aaron Kesselheim resigned from an FDA advisory panel in protest over the agency’s decision to approve Biogen Inc.’s Alzheimer’s drug Aduhelm.)
‘It should send shock waves to the White House’: Backlash over FDA approval of Biogen’s Alzheimer’s drug is spreading
A Harvard Medical School professor who resigned from a US Food and Drug Administration advisory panel over approval of a controversial Alzheimer’s treatment called the agency’s decision “perhaps the worst” drug authorization in its recent history.

Latest Headlines in Biotech

Vertex Pharmaceuticals signage is displayed at the entrance to the company's building in Boston/

Vertex tumbles after halting development of liver-disease drug

Vertex ended a closely watched effort to develop a therapy for liver disease, a setback in the biotech’s quest to broaden its offerings beyond cystic fibrosis drugs. The shares fell as much 15 percent after US markets closed Thursday.

Moderna’s production and lab facility in Norwood.

Moderna files for clearance of COVID-19 vaccine in adolescents

Authorization by the Food and Drug Administration would make it the second vaccine cleared for this age group in the US.

The approval of Biogen’s new Alzheimer’s disease treatment spurred broad gains in the sector, driving the Nasdaq Biotech Index up to its highest level in more than a month.

Biotech shares soar as Biogen drug approval stokes optimism

Traders viewed the approval as a precedent-setting event which could signal the Food and Drug Administration’s stance on other new medicines, not just those tied to the brain-wasting disease

Blackstone recently put local executive Nick Galakatos, who runs Blackstone Life Sciences out of Cambridge, on BioMed’s board of directors.

How a New York private equity giant became Boston’s biggest commercial landlord and biotech investor

Blackstone has invested billions in the Boston-area economy in recent years, through real estate and life sciences deals. This huge bet underscores how Boston and Cambridge represent the industry’s most important global hub.

The CEO of Invaio Sciences, Ignacio Martinez.

Agricultural biotech Invaio raises $89 million to improve crop health

The Cambridge startup, launched out of Flagship Pioneering, hopes to develop targeted approaches to warding off insects and preventing diseases in vegetables and other plants.

Biogen's headquarters in Cambridge.

Biogen taps Ginkgo Bioworks to work on gene therapy manufacturing program

The companies’ goal is to make the production process more efficient.

Jason Kelly, cofounder and chief executive of Ginkgo Bioworks.

Ginkgo unveils its stock ticker, a biotech venture fund raises $515m, and a unicorn is born

Here’s a roundup of local life-science deals and fundraising events that people are talking about this week.

Dr. Dan Barouch, head of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, is the senior author of the new study.

Pfizer and Moderna vaccines produce robust immune responses in pregnant and nursing women

The results of the Beth Israel study are similar to those in another study published in March in the American Journal of Obstetrics and Gynecology by researchers from Massachusetts General Hospital and Brigham and Women’s Hospital.