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Bio Roundup: Healthcare Is Hard, “Slow” FDA, Drugging RNA & More

Xconomy National — 

In an address to Congress this week, President Donald Trump outlined many of his near-term goals, including an overhaul of the Affordable Care Act, also known as Obamacare, even as public opinion has begun to shift in favor of the law.

Trump toned down his typical blunderbuss rhetoric, but he had choice words for the drug industry and approval process, broadly attacking the high cost of medicines and a “slow and burdensome” regulatory path, even though the FDA is considered a relatively speedy agency compared to other health regulators around the world—and compared to itself in previous decades.

The threat of less FDA regulation, added to the changes already mandated by last year’s 21st Century Cures Act, have industry veterans and patient advocates nervous as they await Trump’s choice to fill the vacant commissioner’s seat.

Beyond Trump’s promises, however, few details about his administration’s healthcare plans have emerged, and the president himself is now realizing that healthcare is “incredibly complicated.” (Who knew?)

What do two former FDA commissioners think of the FDA in the political crosshairs? We’ve got that story, plus the latest news for CAR-T therapy and much more. Let’s get the roundup rolling.

THIS WEEK IN WASHINGTON, DRUG PRICING

—Making his case against the FDA Tuesday, Trump cited damage done to Cranbury, NJ-based Amicus Therapeutics (NASDAQ: FOLD), a developer of rare disease treatments. Here’s our coverage of the company’s most recent regulatory setback.

—Sen. Bernie Sanders (I-VT) and a group of Democratic senators introduced a bill to allow importation of drugs from Canada to force lower U.S. prices. It’s an idea Trump and several Republicans have backed at various times. Sanders and colleagues challenged Trump to support the bill, while the pharmaceutical lobby objected to the possibility of tainted drugs entering the U.S.

—Responding to the public and political pressure, more drug makers have taken up the mantle of responsible pricing. Johnson & Johnson (NYSE: JNJ) said this week it has in recent years kept its annual price increases under 10 percent and its net increases—after the rebates and discounts negotiated by insurers and their agents—mostly under five percent.

—Former FDA commisioners Robert Califf and Mark McLellan gave their perspectives on the agency, the role of regulation, and rising healthcare costs at the CED Life Sciences Conference in Raleigh, NC.

CAR-T WHEEL OF FORTUNE

—Kite Pharma (NASDAQ: KITE) of Santa Monica, CA, said it would ask the FDA to begin an approval review of its T cell therapy, axicabtagene ciloleucel, for non-Hodgkin lymphoma patients who have failed other treatment options. Data from its key study showed 36 of 101 patients in complete remission six months after treatment.

—Juno Therapeutics (NASDAQ: JUNO) of Seattle made official this week what many had expected for months: It will abandon its JCAR015 experimental product, once the company’s top candidate, after five deaths from cerebral edema halted a key trial last year in acute lymphocytic leukemia. Juno has not pinpointed the cause of the deaths.

—Roche unit Genentech said that its breast cancer drug pertuzumab, combined with an older Genentech drug trastuzumab and chemotherapy, helped patients with early stage HER2-positive cancer stave off the cancer’s return and live longer after surgery, compared to treatments of trastuzumab and chemotherapy alone. Roche did not release the full data, which will come later this year. Roche wants to protect its breast cancer business from “biosimilar” versions of trastuzumab that are coming to market.

BRAIN AND BLOOD

—More from Roche: The Swiss firm and its partner AC Immune said they would move the Alzheimer’s drug crenezumab into Phase 3 studies to treat early stage disease. Crenezumab returned disappointing results in Phase 2, but the partners saw promising signals from the early-stage patients in that trial.

—Accera of Boulder, CO, said its Alzheimer’s treatment failed to show benefit over placebo in a Phase 3 study, the latest in a long string of late stage failures in the field. The firm blamed a change in the drug’s formulation between Phase 2 and Phase 3.

—Menlo Park, CA-based Grail raised a $900 million Series B round from a group of drug makers, Amazon, and others, to fund massive trials for a blood-based screening test for cancer. Grail said other contributions will push the funding over $1 billion.

—A Grail challenger raised its own big round. Freenome, backed by Andreessen Horowitz and others, pocketed $65 million to pursue its own blood-based cancer screen. Like Grail, it believes sophisticated data analysis will help find early signs of cancer in otherwise healthy people. Freenome COO Riley Ennis said changes in a person’s immune system, evidenced by immune cell DNA floating in the blood, could be a key clue.

THE STARTUP SCENE

—A year after selling his latest biotech startup, Michael Gilman emerged as the CEO and chairman of Waltham, MA-based Arrakis Therapeutics, which raised $38.5 million in a bid to target RNA molecules with small molecule drugs.

—Academic labs around the country have been experimenting with … Next Page »

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