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Bio Roundup: Nobel Prizes, Placebo Effect Rises, ICER’s Fire & More

Xconomy National — 

Congrats to this year’s Nobel Prize winners in medicine… although, we have to ask: For the US researchers who are honored, isn’t there something crushing about a call in the middle of the night from Sweden, interrupting a dream about the perfect protein-protein interaction? Wouldn’t it be more logical for the committee to wait until it’s breakfast in America? Just a thought.

Moving on, we published a deep dive into a very big problem this week. Depression and suicide rates are sky-high, but new and better psychiatric drugs are a risky bet because the placebo effect throws an expensive wrench into the drug-development business. Some brilliant folks have ideas and high-tech tools to fight back—but will they work?

We’ve got plenty more for you in this week’s roundup, including biotech’s Silicon Valley bona fides, the latest deals, political news, and FDA pronouncements. As Kenny Rogers once sang, you got to know when to hold ’em, and when to fold ’em, know when to walk away, and know when to run. It’s roundup time, y’all.

RESEARCH & DEVELOPMENT

—The Nobel Prize in Physiology or Medicine was awarded to three scientists whose research revealed how cells respond to changes in oxygen levels.

—The placebo effect often confounds drug developers’ plans. As depression and suicide rates rise, an Xconomy report asked this week: can new ideas and technology help bring better drugs to market?

—Y Combinator’s decision to admit life science companies to the tech-focused accelerator was controversial five years ago. But today, life science startups rank among some of its biggest graduates, Xconomy reported.

—Xconomy profiled San Diego’s LabFellows, which launched to provide co-working areas for biotech companies. Its earliest customers wanted a better way to manage lab operations, so LabFellows developed online tools, and now more than 2,300 customers use its lab management platform.

—The FDA approved brolucizumab (Beovu) to treat the “wet” form of age-related macular degeneration. Owner Novartis (NYSE: NVS) priced Beovu at $1,850 per dose—identical to market-leading rival aflibercept (Eylea)—and aims to show that it may require less frequent injections. But higher inflammation than Eylea in head-to-head trials could cause “clinician concern,” wrote RBC Capital Markets analyst Kennen MacKay.

—Novartis also rolled out new Phase 1/2 data for its gene therapy Zolgensma that could bolster its case in older patients, according to Fierce Pharma. Zolgensma is currently approved for patients less than two years old.

—New York-based Neurotrope (NASDAQ: NTRP) said it would consider a sale or merger after its experimental Alzheimer’s drug failed a Phase 2 trial.

POLITICS, POLICY & PRICES

—Drug-price watchdog ICER says unjustified price hikes on seven drugs jacked up US drug spending more than $5 billion in 2017-2018.

—A Philadelphia jury ordered Johnson & Johnson (NYSE: JNJ) to pay $8 billion to a man who sued the company for not warning consumers that the side effects of antipsychotic drug Risperdal include male breast growth. J&J said it would appeal.

—The US Supreme Court denied an appeal by Acorda Therapeutics (NASDAQ: ACOR) to reinstate patents for its flagship multiple sclerosis drug dalfampridine (Ampyra), which expired last year. Here’s more from Bloomberg.

—Democratic presidential candidate Pete Buttigieg released a drug-pricing plan that would give negotiation rights to Medicare, penalize companies that refused to negotiate, and, in some cases, let the government revoke patents.

—Late last week, lawyers for former Theranos CEO Elizabeth Holmes asked to withdraw their service because, they said, Holmes hasn’t paid them for more than a year.

DEALS & DOLLARS

—UCB is acquiring Ra Pharmaceuticals (NASDAQ: RARX) and its Phase 3 drug for a rare autoimmune disorder for $2.1 billion. Shares of Cambridge, MA-based Ra doubled following the news.

—Prometheus Biosciences, formerly known as Precision IBD, has signed a deal with Japan’s Takeda Pharmaceutical (NYSE: TAK) to find up to three potential therapies for inflammatory bowel disease and to develop companion diagnostics. No upfront was disclosed but potential milestone payments could total $420 million.

—Lyell Immunopharma, a stealthy startup run by ex-National Cancer Institute head Rick Klausner, will work with GlaxoSmithKline (NYSE: GSK) to develop cell therapies for cancer.

—Alexion Pharmaceuticals (NYSE: ALXN) paid Stealth BioTherapeutics (NASDAQ: MITO) $30 million for an option to codevelop experimental drug elamipretide pending results from an ongoing Phase 3 study for a genetic mitochondrial disease.

—Ginkgo Bioworks, a company that engineers microorganisms for pharmaceutical manufacturing among other uses, launched a $350 million fund to support synthetic biology startups. Ginkgo CEO Jason Kelly told Reuters that the Ferment Fund will invest in two to three companies a year

—Late Friday, the San Francisco Business Times detailed the tick-tock of negotiations that led to Exact Sciences (NASDAQ: EXAS) offering $2.8 billion for Genomic Health (NASDAQ: GHDX) in late July. Shareholders are scheduled to vote next month.

—Cygnal Therapeutics spun out of venture capital firm Flagship Pioneering backed by $65 million in financing. Cambridge, MA-based Cygnal is developing cancer and inflammation drugs that target the peripheral nervous system.

—In its first move since its recent management overhaul, Akcea Therapeutics (NASDAQ: AKCA) sold an experimental heart disease drug to Pfizer (NYSE: PFE) for $250 million upfront. Shares climbed 25 percent.

—Oyster Point Pharma, a Princeton, NJ-based biotech developing a nasal spray to treat dry eye disease, filed … Next Page »

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