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Advaxis Cancer Immunotherapy on Hold Due to Patient Death

The FDA placed a halt on clinical trials involving a cancer immunotherapy from Advaxis because of concerns a bacteria used to deliver the drug contributed to a patient death.

Exact Sciences Tumbles on Colon Cancer Screening Snub

An independent panel of health care experts did not include Exact Sciences' Cologuard on a draft list of recommended colon cancer screening tests in the U.S.

MannKind Silent on Debt Conversion, Suggesting Costly Cash Settlement

Using cash to settle the debt was MannKind's worst-case option because it leaves the company with little money to fund ongoing operations.

Amicus, Other Biotech CEOs Should Listen More, Talk Less About FDA Matters

There's a valuable, albeit painful, lesson here in Amicus' blow-up. Biotech CEOs should shut their mouths about regulatory plans until they receive definitive word from the FDA.

Biotech Stock Mailbag: Akebia, Neuralstem, Arrowhead

Biotech columnist Adam Feuerstein answers readers' questions about health care.

Sarepta Unveils New Data to Make Stronger Case for Duchenne Drug Approval

Sarepta hopes the new data will convince FDA to approve eteplirsen as a new treatment for Duchenne early next year.

Drug Pricing Fears Erase Biotech Stock Gains for the Year

The bloodletting in biotech stocks continued Monday with aggressive selling erasing the year's gains in a key sector exchange-traded fund. Another closely followed ETF is barely hanging on to outperformance.

Bristol, Exelixis Drugs Demonstrate Treatment Benefit in Kidney Cancer

Bristol's Opdivo is likely to be used ahead of Exelixis' Cometriq to treat advanced kidney cancer patients, doctor says.

Biotech Stock Mailbag: Rebounding From Hillary's Drug Tweet; Global Blood Weighs on Bluebird

Biotech columnist Adam Feuerstein answers readers' questions about health care.

Clinton Drug Plan Cuts Market Exclusivity, Sets Mandatory R&D Spending

If Clinton's proposal is implemented, biotech companies would have less time to generate profits from their expensive biologic drugs before other companies could enter the market with cheaper copies.

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