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Bio Roundup: Obamacare Persists, FDA Approves, Vertex Wows & More

Xconomy National — 

The attempt to repeal and replace the Affordable Care Act took a major hit this week from Senate GOP holdouts who said the Better Care Reconciliation Act either tore down Medicaid too much or left too much of the ACA in place.

A straight-up repeal, floated by Senate majority leader Mitch McConnell, was also shot down. But as of this writing, McConnell will allow a vote next week to start open debate, much less tightly controlled than the secretive BCRA that went nowhere.

Those following the healthcare drama might need extra insurance for the whiplash of watching President Donald Trump take four different positions in three days: Repeal now, replace later (7/17); Let Obamacare fail (7/18); The GOP bill will get better over lunch (7/19); Senators must skip vacation until they have a new bill (7/19).

No surprise. Trump also threw House leaders a Rose Garden party for passage of their version of the health bill, then described the bill as “mean” not long after. Whatever happens with the GOP healthcare reform, it’s clear that the party’s leader has no idea what he wants, and it’s unclear if he really cares.

But you’re here because you know what you want: A roundup of the week’s life science headlines. Let’s get to it, starting with a whole lot of FDA action.

YES, NO, FEES, AND HIRES

—The FDA approved neratinib (Nerlynx) as an adjuvant therapy—to prevent recurrence of breast cancer in patients who have had treatment with trastuzumab (Herceptin) and surgery. The Los Angeles-based Puma Biotechnology (NASDAQ: PBYI) drug got a green light despite questions about the size of its benefit compared to placebo, as well as a side effect of severe diarrhea. One analyst said he was expecting neratinib to cost $10,000 a month, according to Fierce Biotech.

—The FDA approved a Gilead Sciences (NASDAQ: GILD) combination of three hepatitis C drugs into a single pill for chronic infection. But the Foster City, CA-based biotech’s combination of sofosbuvir, velpatasvir, and voxilaprevir (Vosevi) carries a black box warning about the risk of reactivating the hepatitis B virus.

— Radius Health (NASDAQ: RDUS) hired Novo Nordisk (NYSE: NVO) veteran Jesper Hoiland as CEO, to lead efforts to commercialize the Waltham, MA, biotech’s osteoporosis drug abaloparatide. The executive change follows the FDA’s rejection of romosozumab, from Amgen (NYSE:AMGN), that would have competed against abaloparatide.

—From freeze to thaw: The FDA is hiring, new commissioner Scott Gottlieb wrote Monday.

—But the agency’s budget remains in question. The Trump administration wants to increase user fees to make up for cuts in his proposed budget. That stance is at odds with Congress. Just like the House plan approved last week, the Senate’s draft budget for fiscal 2018 provides the FDA with $2.8 billion in funding—a $1 million increase compared to the current budget, Regulatory Focus reports.

IN THE CLINIC

—Vertex Pharmaceuticals (NASDAQ: VRTX) of Boston released excellent mid-stage data from three cystic fibrosis studies, each testing a different triple combination of Vertex’s own drugs. If all goes well, 90 percent of CF patients could end up with a treatment for their variant of the disease. The news got praise not just from investors, who boosted shares 25 percent, but also from NIH director Francis Collins.

—Paratek Pharmaceuticals (NASDAQ: PRTK) of Boston said its oral antibiotic omadacycline passed a third Phase 3 hurdle. (News of its first Phase 3 study is here, and of its second Phase study is here.) The company reiterated it would ask regulators early next year to approve the drug for certain types of skin infections and possibly pneumonia.

—Advocacy group USAgainstAlzheimer’s updated its industry drug pipeline this week. One day later, the list was one shorter, as Japan’s FujiFilm said its Phase 2 study of neuroprotective T-817MA failed to meet primary and secondary endpoints.

—Nektar Therapeutics (NASDAQ: NKTR) of San Francisco said its opioid NKTR-181, designed to enter the brain more slowly, did not provide as fast or strong a high as oxycodone in a study among people who were self-described recreational drug users. The data add to earlier Phase 3 results that lend hope to the possibility of a painkilling alternative to addictive opioids.

HEALTH AND TECH

— The latest in our series on artificial intelligence and healthcare: Two recent competitions have offered million-dollar prizes for A.I. technology that can read lung and breast scans and diagnose cancer. The contests are adding fuel to the debate about the possibility of automated systems replacing humans.

—Seattle’s Institute for Systems Biology published results of its Pioneer 100 Wellness study, which measured and tracked dozens of biological signals in 108 people for nine months and connected the participants with health coaches. The short study could not … Next Page »

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