Bio Roundup: Cancer Wishes and Shopping Lists, Allergan Pricing & More

Xconomy National — 

[Corrected, 9/12/16, 4:28 p.m. See below.] What do cancer experts want? The moon, perhaps. As part of the Obama administration’s “cancer moonshot” program, a panel of scientists this week presented a set of broad, ambitious recommendations to speed up the pace of cancer research, treatment, and prevention.

The scientific goals, writ large, included nationwide data sharing among researchers and drug developers; better prevention through medicine (such as the HPV vaccine) and public education (anti-smoking campaigns); and a registry that could match cancer patients to trials based on genetics and other factors. (The full report is here; a summary is here.)

Xconomy reached Tyler Jacks, the co-chair of the panel and director of the Koch Institute for Integrative Cancer Research at MIT, to ask about the report. A condensed version of our conversation is here.

There were plenty of other cancer headlines, including an Xconomy report about problems that the predominance of immunotherapy—“taking over the field of cancer,” as Jacks put it—is causing for doctors and patients. For more on that and the rest of the week’s news, fire up the roundup rockets. Three… two… one…

—While the moonshot panel painted big pictures, the FDA came out with cancer recommendations of its own. The agency advised women and their doctors not to use screening tests that claim to detect ovarian cancer. They measure the level of a protein, CA-125, in the blood, but they’re not accurate enough, the FDA said, and could prompt women without cancer to pursue more medical procedures, or women with cancer to feel a false sense of security.

—One cancer screening test got positive news from a federal agency. Veracyte (NASDAQ: VCYT) reported that the largest of the eight Medicare administrators has given a tentative thumbs-up to covering Percepta, Veracyte’s test to help determine the likelihood that a suspicious lung nodule is cancerous. Such coverage is critical for a diagnostics business. Last year, Xconomy examined Veracyte and the push to provide tests that rule out cancer. [Updated with the correct number of Medicare administrators.]

—Xconomy reported that doctors are worried patients are signing up for immunotherapy trials but dropping out if they don’t get the drug they seek. The field is also wrestling with growing evidence that immunotherapy drugs actually make tumors look bigger just after treatment, which throws a wrench into traditional methods of assessing whether a drug is working.

—Allergan CEO Brent Saunders criticized “egregious price takers” and pledged his own firm would practice responsible pricing to get out in front of potential legislative action that Democratic presidential candidate Hillary Clinton has been threatening.

—Allergan (NYSE: AGN) also closed a deal, paying $60 million up front to acquire Ann Arbor, MI, gene therapy startup Retrosense Therapeutics, which is developing a potential treatment for retinitis pigmentosa.

—M&A rumors swirled around GW Pharma (NASDAQ: GWPH)… Gilead Sciences (NASDAQ: GILD) officials brushed away the possibility of breaking up… And one big-ticket deal actually went down: Danaher (NYSE: DHR) of Washington, DC, bought diagnostics maker Cepheid (NASDAQ: CPHD) for roughly $4 billion.

—Cambridge, MA-based Agios Pharmaceuticals (NASDAQ: AGIO) said this week that development partner Celgene (NASDAQ: CELG) aims to file for accelerated approval of one of Agios’s blood cancer drugs, enasidenib, by the end of the year. The application could put Agios well ahead of typical cancer drug development timelines; shares spiked more than 20 percent on the news.

—Bay Area regulatory blues: Biomarin Pharmaceutical (NASDAQ: BMRN) of San Rafael, CA, had its FDA review of cerliponase alfa (Brineura) delayed. The agency will now decide on approval by April 27 of next year… Dynavax Technologies (NASDAQ: DVAX) of Berkeley, CA, said the FDA’s advisory committee scheduled to weigh in on the company’s hepatitis B vaccine decided to cancel the meeting. Investors knocked about 30 percent off Dynavax’s share price last Friday, with only a modest recovery this week.

—Bluebird Bio (NASDAQ: BLUE) started a late stage trial of its gene therapy, LentiGlobin, in patients with the blood disease beta-thalassemia. Bluebird is tinkering with LentiGlobin to boost its effectiveness, and is also excluding a subgroup of patients—those with two copies of a genetic mutation called b0—who haven’t responded to LentiGlobin in the past. Bluebird said the FDA would let it incorporate the changes into the study, rather than start a new set of trials.

—Seattle’s Juno Therapeutics (NASDAQ: JUNO) published positive data from a study of one of its T cell treatments, JCAR014, in 32 people with advanced non-Hodgkins lymphoma. The treatment for one group of the patients included a cell-boosting chemotherapy, fludarabine, that Juno said was responsible for three deaths earlier this year in a trial for the product JCAR015. Juno briefly halted then restarted that trial without fludarabine, but explained that the chemo would remain part of the drug regimen in other trials and experimental products.

—More clinical news: Shares of CoLucid Pharmaceuticals (NASDAQ: CLCD) more than doubled after the company said its experimental migraine drug, lasmiditan, hit all goals in the first of two Phase 3 trials. Results from the … Next Page »

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