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Bio Roundup: Phase 3 Fails, Shkreli Jailed, Moderna Flip-Flops & More

Xconomy National — 

It was a week of realignments. President Trump, who used to be known as “The Donald” but now goes by “Amnesty Don,” kept up the parlay-voo with his new friends Chuck and Nancy. Martin Shkreli, who was once known—and still is!—as the “pharma bro,” will have a new perspective for a while, through the bars of a jail cell. In Cambridge, MA, Moderna Therapeutics promised more clinical data as it reasserts central control over its drug R&D.

A pair of industry-critic doctors tried to shift perspective of the estimated costs of bringing a drug to market. Spoiler alert: It’s not as expensive as the industry says it is. And there were plenty of clinical data points, both good and bad—the latter caused some realignments, too, in the form of big biotech layoffs.

If you feel the need to center yourself, we recommend starting with this week’s roundup. Let’s get to it.

MAKING LAWS, BREAKING LAWS

—As Senators Lamar Alexander (R-TN) and Patty Murray (D-WA) aim for short-term Affordable Care Act fixes, their colleagues unveiled dueling visions of healthcare overhaul this week. Fist-bumping Sens. Lindsey Graham (R-SC) and Bill Cassidy (R-LA) offered a more moderate version of earlier failed Republican efforts. And Bernie Sanders (I-VT) talked up a “Medicare for All” plan that would phase in a single-payer system over four years. Republicans have until the end of September to pass a healthcare bill with only 50 Senate votes.

—Are jailbirds allowed to tweet? Martin Shkreli is about to find out. Already convicted of securities fraud and conspiracy for bilking investors in his hedge funds, Shkreli is now going to jail for his Facebook offer of $5,000 to anyone who could grab a lock of Hillary Clinton’s hair on her book tour. Dismissing Shkreli’s claim of satire, a judge called it “solicitation of assault” and a violation of his bail. Sentencing for his fraud conviction is scheduled for January.

—Bloomberg reported that the one-and-only copy of a Wu-Tang Clan album that Shkreli once bought for $2 million might not be a Wu-Tang Clan album.

FDA SAYS OK

—In a first, the FDA approved a digital app to treat substance abuse. In 2015, Xconomy featured the app’s maker, Pear Therapeutics, in an examination of “pharmaco-digital” therapies for mental health disorders.

—In another first, the FDA approved the first biosimilar, or copycat, version of a cancer drug. In this case, it’s a generic version of Genentech’s bevacizumab (Avastin) manufactured by Amgen (NASDAQ: AMGN) and approved for several types of cancer.

DRUG PRICES

—Two cancer doctors who are noted drug industry critics published a study this week in JAMA Internal Medicine that examined the R&D costs associated with 10 approved cancer drugs. The study is meant as a recalibration of the often-cited figure from Tufts University that it requires $2.7 billion to bring a drug to market. One of the JAMA authors, Vinay Prasad, was also a coauthor of a recent study of doctors who tweet about approved drugs, and how often they do so without disclosing their financial ties to drug companies.

—Ken Kaitin, the director of the Tufts center that crunches drug data, is a finalist for one of our inaugural Xconomy Awards, coming up this month in Boston. In different ways, two other finalists—Stephen Pearson of the Institute for Clinical Economic Review and Andrew Lo of MIT—are also contributors to the national debate about drug costs and what to do about them.

DATA HIGHS…

—Regeneron Pharmaceuticals (NASDAQ: REGN) and partner Sanofi said their antibody drug dupilumab (Dupixent) succeeded in a Phase 3 asthma trial, paving the way for an FDA approval filing. But Regeneron shares sank 5 percent nonetheless, as the data were stronger in a previous trial and competition has gotten fiercer.

—Shares of Aldeyra Therapeutics (NASDAQ: ALDX) climbed more than 50 percent this week after the latest mid-stage test for its anti-inflammation drug, ADX-102, a trial in dry eye disease, succeeded. The drug has already passed Phase 2 studies in two other eye diseases over the past year.

—AstraZeneca (NYSE: AZN) made lung cancer headlines at the European Society for Medical Oncology conference. First, a trial called Pacific brightened the outlook for its cancer immunotherapy drug durvalumab (Imfinzi). The drug succeeded as a maintenance therapy for patients with stage 3 lung cancer whose tumors haven’t progressed after chemotherapy. Here’s more in STAT.

—Second, AstraZeneca’s osimertinib (Tagrisso) has emerged as a possible new standard of care for patients whose lung tumors have an EGFR mutation. The drug bested mainstay treatments erlotinib (Tarceva) and gefitinib (Igressa) in a Phase 3 study called Flaura.

—Early Phase 3 results for Pfizer’s (NYSE: PFE) enzalutamide (Xtandi) met the main goal of improving survival in prostate cancer patients, which the company says supports expansion of the drug’s label. The drug, which Pfizer acquired last year in its $14 billion purchase of Bay Area drug maker Medivation, is already approved to treat prostate cancer that has spread to other parts of the body.

—More from ESMO: Eli Lilly (NYSE: LLY) updated a Phase 3 study of a breast cancer drug that aims to compete with therapies from Pfizer and Novartis… Merck (NYSE: ticker:MRK]]) detailed the problems, first reported in July, that leading cancer drug pembrolizumab (Keytruda) had in a head-and-neck cancer study… But pembrolizumab continued to show that, combined with chemotherapy, it helps lung cancer patients live longer than chemo-only treatments… Over at Forbes, Elaine Schattner explained why so-called PARP inhibitors such as rucaparib (Rubraca) have gained so much momentum.

…AND DATA LOWS

—Shares of Sage Therapeutics (NASDAQ: SAGE) fell 20 percent after its most advanced clinical prospect, brexanolone, failed a Phase 3 trial in super refractory status epilepticus, a rare form of epilepsy. The news … Next Page »

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