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Japan­ese biotech pitch­ing iP­SC-de­rived med for the heart gains $26M; An­dreessen Horowitz leads $4.1M seed fund­ing for AI up­start

→ A longtime researcher in cardiac regenerative medicine has closed a $26 million Series B to advance his development of iPSC-derived cardiomyocytes as a treatment for heart failure. Keiichi Fukuda convinced a number of new investors, including SBI Investment, JMDC, Gene Techno Science, Nissay Capital and SMBC Capital, to join Astellas Venture Management in backing Tokyo-based Heartseed. The biotech expects to launch its own Phase I/II for the lead drug in HFrEF late next year, while supporting another trial for dilated cardiomyopathy initiated by Keio University.

Ex-Ed­i­tas CEO Ka­trine Bosley chairs Ar­rakis board; Car­du­ri­on touts Po­laris in­vest­ment

→ After a surprise exit from Editas Medicine in January — which left many in shock and the stock plunging 21% $EDIT — ex-CEO Katrine Bosley will be heading the board of directors at Michael Gilman-led Arrakis Therapeutics as chairman. She is also a board member of Galapagos and Genocea Biosciences.

→ Cardurion Pharmaceuticals — focused on the treatment of heart failure and other cardiovascular diseases — has completed a private investment from Polaris Partners. Polaris joined existing investor Takeda in backing the startup and is sending its managing partner Amy Schulman to the board.

Ac­tivist in­vestor wages suit on On­coSec over re­cent deal; Breast can­cer ex­perts de­but biotech with $12M seed

→ Having raised issues with OncoSec’s recent deal giving China Grand Pharmaceutical a controlling stake in the microcap biotech, activist shareholder Alpha Holdings is waging a full-on class action complaint against the drugmaker. In its briefs, South Korea-based Alpha Holdings is accusing OncoSec execs of selling control of the company on the cheap. OncoSec has filed a motion to dismiss the suit, and a hearing will take place early next week.

Alk­er­mes sub­mits long await­ed NDA for schiz­o­phre­nia, bipo­lar drug; Is a uni­corn bub­ble drag­ging the IPO mar­ket?

→ The Alkermes $ALKS team — who back in July laid out their plans to add bipolar I disorder to their list of conditions for ALKS-3831 (olanzapine/samidorphan), which they planned to pitch to the FDA in Q4 — has announced that they have submitted an NDA for the drug as a treatment of schizophrenia and bipolar I disorder.

→ Private unicorns have been growing since the passage of JOBS Act in 2012, according to Renaissance Capital, from under 25 back then to over 200 today in the US alone. But the bubble of over-valued startups, enabled by a provision allowing for many more shareholders in a company before it goes public, are starting to have negative effects on the IPO market, the research firm said in a new report. As high-flying unicorns struggle to find more backers to buy into their valuations, unicorns have been applying to list at a relatively slow pace. While the report focused on the larger trends, biotech has seen its fair share of unicorn IPOs this year, some of whom had to trim their valuations at their public debuts, like BioNTech and Vir Biotechnology.

Gene ther­a­py wins the in­side track at EMA; PPD files for IPO

→ Gene therapy maker Orchard Therapeutics has been granted an accelerated assessment for OTL-200 by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The gene therapy — in development in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy — being used towards the treatment of metachromatic leukodystrophy.

→ Pharmaceutical Product Development has announced that its parent company, PPD, Inc has submitted a draft to the SEC relating to the proposal of an IPO of the parent company’s common stock. Number of shares and price range have not yet been determined.

As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Bio­Marin breaks out pos­i­tive PhII achon­dropla­sia da­ta; Ther­mo Fish­er opens 'cus­tomer so­lu­tion­s' fa­cil­i­ty in Chi­na

→ After recently handing off its rare disease drug to Allievex, BioMarin provided an update on its ongoing Phase II study of vosoritide in children with achondroplasia. The study showed that in “over 54 months, children in cohort 3 (N=10) of the study, at a dose of 15 µg/kg/day, achieved a statistically significant (p< 0.005) cumulative additional mean height gain of 9 cm compared to children, matched for age and gender, in a new natural history achondroplasia dataset (N=619).” The company plans to release the data from its Phase III study by the end of the year.

Seat­tle and Dai­ichi Sankyo at each oth­er's throats; UC Berke­ley, UCSF and the Uni­ver­si­ty of Wash­ing­ton launch Weill Neu­ro­hub

→ Seattle Genetics and Daiichi Sankyo — once partners — are now bitter foes battling over intellectual property underpinning ADC technology. After going their separate ways, earlier this year Daiichi entered into a multi-billion dollar pact with AstraZeneca, which gave the British drugmaker the license to a HER2 antibody developed for use in gastric and breast cancers. Seattle Genetics has claimed that the drug in question has been engineered using an improved version of its technology, while Daiichi has categorically denied that claim, saying the drug has little to do with tech they worked on as partners. The two sides were locked in dispute resolution proceedings without the involvement of the courts, but Daiichi filed a lawsuit last week alleging that Seattle had made a “meritless” claim to the intellectual property. On Tuesday, Seattle said it had retaliated with an arbitration demand to the American Arbitration Association to resolve the situation.

FDA’s Pro­ject Or­bis may ex­pand to Sin­ga­pore and Switzer­land

The FDA may expand a pilot project that allows for simultaneous drug approval decisions from US, Canadian and Australian regulators to include Singapore and Switzerland, Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said Tuesday at the Friends of Cancer Research’s annual meeting in Washington, DC.

If Singapore and Switzerland are added, Pazdur said following visits to both countries, it would further collaborations between the regulators as there’s currently a work-sharing agreement known as the Australia-Canada-Singapore-Switzerland (ACSS) Consortium. Australia and Canada also previously worked together to approve two cancer drugs — Eli Lilly’s Verzenio (abemaciclib) in April for the treatment of metastatic breast cancer and the July 2018 approval for Janssen’s prostate cancer treatment apalutamide.

Am­gen ax­es 149 of its staff in Cam­bridge of­fice; Evotec, Mil­li­pore­Sig­ma en­ter re­search pact

→ Amgen has submitted a Worker Adjustment and Retraining Act (WARN) — a warning of impending mass layoffs 60 days in advance of the date — to the state of Massachusetts in the wake of the company’s exodus from the neurosciences R&D sector. Bob Bradway, CEO of the company, said in a Q3 earnings call that the company is cutting ties in the field to focus on its other pipelines in cardiovascular disease, inflammatory disease and cardiovascular disease, oncology. In its WARN notice, the Cambridge-based company stated that 149 of its employees would be affected — among the total 180 being let go. The company said that impacted employees, who are not relocating, will be departing the company between the end of 2019 to mid-2020.