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Xconomy National — 

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Six years ago, a biotech alleged Amarin won FDA approval of a decree fish-oil pill, Vascepa, because it could lower triglycerides, a blazon of fat in the blood. But Amarin didn’t accept the affirmation that blurred triglycerides with angle oil would absolutely advice people. Sales lagged. Amarin’s shares sank. While added groups activated added angle oils and activate no affirmation of accurate cardiovascular benefits, Amarin apprenticed on with a massive study, bleeding banknote for years.

The action seems to accept paid off. Amarin said this anniversary that the REDUCE-IT abstraction showed Vascepa bargain the accident of affection disease, appearance a huge abruptness achievement for the aggregation and a new about-face in a long-running accurate debate.

Elsewhere, there was affluence of account out of a big lung blight affair in Toronto, a bassinet of biotechs went public, and the second-ever RNA arrest biologic could anon be headed for an FDA review. Let’s get the assembly rolling.

TOP STORIES

—For the aboriginal time, a us absolute angle oil showed in a ytic balloon that it ability advice abate the adventitious of affection ache in bodies already demography statins to ascendancy aerial cholesterol. The us is Vascepa, from Amarin (NASDAQ: AMRN), and the 8,379-patient balloon alleged REDUCE-IT assured that patients were 25 percent beneath likely, about to those on statins and a placebo, to ache a cardiovascular event. Crucial abounding capacity will be arise in November, but investors aren’t waiting. Amarin’s shares accept skyrocketed added than 360 percent this week.

—Gilead Sciences (NASDAQ: GILD) arise it would activate authoritative all-encompassing versions of its own hepatitis C drugs that amount up to 75 percent less. The branded versions accept years of apparent activity actual but are adverse acknowledged and banking challenges.

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THIS WEEK IN LUNG CANCER

—AstraZeneca (NYSE: AZN) arise absolute Phase 3 lung blight abstracts for its biologic durvalumab (Infimzi), which aback accumulated with chemotherapy baffled chemo abandoned in patients with avant-garde cancer.

—Roche abundant the after-effects of a study, IMpower132, that activated a aggregate of its immunotherapy atezolizumab (Tecentriq) and chemotherapy in anew diagnosed avant-garde non-small corpuscle lung blight patients. Though cross-trial comparisons arise with caveats, the all-embracing after-effects didn’t arise to bout an immunotherapy-chemo admixture from Merck (NYSE: MRK). Still, Roche’s dieting conspicuously showed affiance in peoples whose tumors don’t accurate the protein PDL1, EP Vantage reports.

—Roche is abaft rivals in non-small corpuscle lung cancer, but in the beneath common, added advancing form—small-cell lung cancer—its biologic aggregate is ahead. Roche abundant the after-effects of IMpower133, through which an atezolizumab-chemo dieting continued the lives of bodies with SCLC by two months, compared to chemo alone. Roche’s rivals aren’t far abaft with their own combos, however, as Reuters letters here. (And Bristol-Myers Squibb’s nivolumab (Opdivo) was austere for SCLC patients aftermost month.)

—Roche additionally said it will book for approval of entrectinib for patients whose non-small corpuscle lung blight has a specific abiogenetic alteration, a ROS1 fusion. Roche is additionally testing entrectinib in a array of tumors with alleged NTRK fusions and is aiming for a tissue-agnostic biologic approval—that is, approval to amusement tumors with NTRK fusions behindhand of area in the anatomy they form.

—A aggregate of the Blueprint Medicines (NASDAQ: BPMC) targeted blight biologic BLU-667 and osimertinib (Tagrisso), from AstraZeneca, showed affiance in two patients with lung blight and an EGFR alteration whose tumors resisted above-mentioned treatment.

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IPO-PALOOZA

—Six activity science companies bankrupt out the final anniversary of the third division with IPOs, adopting a absolute of $586 actor in new capital. Amid the newcomers to Wall Street: Gritstone Oncology (NASDAQ: GRTS), a developer of alone blight vaccines; Arvinas (NASDAQ: ARVN), which is advancing protein abasement drugs; and Sutro Biopharma (NASDAQ: STRO, a developer of protein-based drugs with a long-running accord with Celgene (NASDAQ: CELG).

—Equillium of La Jolla, CA, filed for an IPO to accounts ytic testing of a biologic to amusement graft-versus-host disease.

—LogicBio Therapeutics, a gene ysis developer, filed for an IPO to armamentarium ytic tests of its beginning ysis for a attenuate affiliated alarmist disease.

STARTS, STOPS, & MORE CASH

—KSQ Therapeutics, a Cambridge, MA, startup application the CRISPR gene alteration arrangement as a biologic ysis tool, aloft addition $80 actor and appear a activity of 13 beginning blight drugs.

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—Morphic Therapeutic, a startup from Boston-area accurate administrator Tim Springer, aloft an $80 actor Series B to accompany its aboriginal oral, integrin-blocking drugs to animal tests.

—Novartis (NYSE: NVS) is laying off 2,550 bodies in Switzerland and the U.K., allotment of a about-face amid big biologic makers from high-volume pills to added big-ticket “specialty” drugs, like biologics. Swiss unions are blame back. Reuters has more.

—The FDA accustomed the latest in a new crop of drugs meant to abate the abundance of migraines, galcanezumab (Emgality) from Eli Lilly (NYSE: LLY). The biologic has a account amount of $575 per month, or $6,900 per patient, per year.

—The FDA austere Sarepta Therapeutics (NASDAQ: SRPT) to resume testing … Next Page »

Ben Fidler is Xconomy’s Deputy Biotechnology Editor. You can e-mail him at [email protected]

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