国际新闻精选周三（2017年2月1日）

Genentech oncology head jumps ship to Bellicum as CEO

As David Epstein moved from Novartis’ cancer unit to VC Flagship and Alessandro Riva also left the Swiss major for an exec role at Gilead in the last few weeks, Rick Fair has become the latest to leave a Big Pharma as he exits as head of oncology at Roche/Genentech to become the new CEO and president of Texas biotech Bellicum.

Fair, who played a key role in the launch of five SMEs at the company, including Roche’s new I-O med Tecentriq, joins Bellicum as it prepares its global regulatory and commercial strategy for its leading phase 1/2 med BPX-501 in blood cancers, as well as advancing its pipeline of controlled CAR-T and TCR product candidates.【阅读全文】

Cancer breath test shows promise in trial

New clinical data presented at the European Cancer Congress has raised hopes of a breath test that can successfully detect cancers of the oesophagus and stomach, side-stepping the need for endoscopy, the traditional method of diagnosis.

The test measures levels of five chemicals in the breath (butyric, pentanoic and hexanoic acids, butanal, and decanal) that in earlier research were indicated to be at different levels in patients with such cancers.【阅读全文】

Teva’s $1bn Copaxone blow

Teva’s efforts to extend the lifecycle of its multiple sclerosis therapy Copaxone have finally run out of steam. Yesterday’s US district court ruling means that a generic version of the 40mg formulation could be on the market as soon as February, several months earlier than expected.

The worst-case scenario for Teva now looks likely; it previously said Copaxone sales could fall by $1-1.2bn if two generic 40mg competitors emerged next month, and there are already several waiting in the wings. Teva had better news in the shape of approval of its generic version of Glaxosmithkline’s Advair, but this was not enough to stop its shares opening down 6% on the New York stock exchange this morning.【阅读全文】

Analysts write off Dimension’s lead program after seeing weak data on hemophilia B, shares plunge

Shares of Dimension Therapeutics $DMTX were pummeled on Tuesday, after the biotech posted subpar Factor IX scores on its gene therapy program for hemophilia B.

By the numbers: Patients in one cohort taking DTX101 had peak Factor IX (FIX) expression of 13%, 20% and 12% over 4 to 8 weeks, according to investigators. At the 12-week followup, though. the scores had slipped to 5% and 8% in two patients at 12-weeks follow-up, and 7% for the third patient at 7 weeks. “For the low-dose cohort, expression levels achieved 10-11% peak activity, stabilizing between 3-4% at last follow-up.”【阅读全文】

Eli Lilly shutters the last PhIII sola study, certain of failure

Eli Lilly has taken another big reverse step in its retreat from solanezumab, the Alzheimer’s drug once considered the company’s lottery ticket in R&D.

Following the failure of Expedition 3, Lilly’s massively expensive third attempt to come up with solid data of its efficacy, investigators have now washed their hands of Expedition Pro, another Phase III study mounted for patients with prodomal disease, when their memory begins to fade but they can still function well on a daily basis.【阅读全文】

Catabasis shares are shredded after lead drug flops in PhII Duchenne MD study

Catabasis’ lead drug just flopped in a Phase II study for Duchenne muscular dystrophy, eviscerating its stock after yet another clinical setback raises questions about its competence and direction.

The drug, CAT-1004 (edasalonexent), failed to register a significant biomarker effect on muscle inflammation, looking very much like the placebo.【阅读全文】

Pfizer drops phase 2 diabetes drug, two earlier-stage candidates

During its financials posted today, Pfizer quietly updated its pipeline showing that it has dropped three candidates from its testing programs, but as always, details were thin on the ground.

Its most advanced prospective med from this list was its Type 2 diabetes drug PF-06291874, a glucagon receptor antagonist that finished a midstage test last year.
According to clinicaltrials.gov, Pfizer was testing the drug in over 200 patients against placebo in a three-month study in Type 2 diabetics who couldn’t control their sugar levels using metformin. The study was completed in fall of last year, but data were not made available on the site.【阅读全文】

Keep Politics Out Of Science, Says Departing FDA Chief

President Donald Trump has not said who he wants to head the Food and Drug Administration, which regulates a quarter of the U.S. economy. But Trump has made headlines by meeting with candidates for the job who publicly proposed that newly approved drugs need not be effective or that regulations should be rolled back so more medicines could be approved.
Robert Califf, the legendary cardiologist who has run the FDA for the past year, has his own opinion about the agency’s direction. The system of collecting medical data used to test new drugs and medical devices is indeed “antiquated,” he says. But the way forward requires putting science above politics and focusing on creating new ways to prove medicines help patients without causing undue side effects. Throwing out the standards that made the U.S. a global hotspot for medical innovation is not an option.【阅读全文】

Seven Important Policy Agenda Items For Biopharma

President Trump’s tenure as the 45th POTUS has begun with even more fireworks than most pundits predicted–protests, marches, bans and lots of other drama. The coastal Twitter/Facebook bubbles are exploding with anger and rage, while the Trump populists in the “other” America are celebrating. Seems like the country has gone crazy.

Crazy also means unpredictable, which is a bad thing for investing. Long-term allocations of capital, especially illiquid pools like venture and private equity, require a some degree of predictability around the rules of the game.【阅读全文】

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