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Updated: 8 hours 55 min ago

Amarin’s Fish-Oil Pill Wins FDA Nod to Cut Heart Attack, Stroke Risk

Fri, 12/13/2019 - 17:33

A prescription pill derived from fish-oil pill received the regulatory nod Friday to expand its use as a supplementary treatment, alongside statins, to more patients at risk of heart attack or stroke.

The FDA approved the Amarin Pharma drug, icosapent ethyl (Vascepa), for use as a secondary treatment for adults who are taking statins and have elevated levels of triglycerides, a type of fat in the blood. Those patients must also have established heart disease or diabetes, and two or more additional heart disease risk factors.

High levels of triglycerides can contribute to an increased risk of heart attack or stroke... Read more »

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miRagen Promotes Diana Escolar to Chief Medical Officer

Fri, 12/13/2019 - 13:21

Diana Escolar has been appointed chief medical officer of miRagen Therapeutics (NASDAQ: MGEN). Escolar joined the Boulder, CO, biotech in 2018 as senior vice president of clinical sciences. She will be taking on the duties of Paul Rubin, miRagen’s executive vice president of R&D. The company says Rubin will leave at the end of this year to spend more time with his family. This week, miRagen announced a restructuring and strategy shift to focus its resources on its preclinical compound for idiopathic pulmonary fibrosis.

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Alector Appoints Suliman President & Chief Operating Officer

Fri, 12/13/2019 - 13:01

Shehnaaz Suliman has been appointed president and chief operating officer of Alector (NASDAQ: ALEC). She joins the South San Francisco biotech from Theravance Biopharma, where she was senior vice president of corporate development and strategy. Her experience also includes positions at Genentech, Roche Partnering, and Gilead Sciences (NASDAQ: GILD). Alector is developing drugs that target immune cells to treat neurodegenerative disorders.

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Pyxis Oncology Names Sullivan CEO, Steinberg Remains on the Board

Fri, 12/13/2019 - 12:56

Pyxis Oncology has appointed Lara Sullivan to serve as its CEO. She is also joining the Boston company’s board of directors. Sullivan succeeds David Steinberg, Pyxis’s founding CEO and a general partner at Longwood Fund. Steinberg will remain on the company’s board as an independent director. Sullivan was most recently founder and president of Pfizer (NYSE: PFE) spinout SpringWorks Therapeutics (NASDAQ: SWTX). Pyxis, a cancer drug developer, launched in July backed by a $22 million Series A round of financing.

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Bio Roundup: Sarepta’s Approval, Merck M&A, Drug Price Bill & More

Fri, 12/13/2019 - 05:31

If you’re keeping track, FDA drug approvals have been on a tear in the past month with several decisions coming well ahead of their targeted dates. And then there’s Sarepta Therapeutics.

Late Thursday, the FDA announced approval of the Cambridge, MA, biotech’s drug for Duchenne muscular dystrophy in patients who have a specific mutation. The drug, golodirsen (Vyondys 53), is the same one the agency rejected four months ago due to safety concerns. Responding to a rejection and addressing FDA concerns can take up to one year but Sarepta (NASDAQ: SRPT) says the issues were “rapidly evaluated... Read more »

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In an About-Face, FDA Approves Second Sarepta Muscular Dystrophy Drug

Fri, 12/13/2019 - 04:33

Sarepta Therapeutics received an early holiday gift Thursday—approval of golodirsen (Vyondys 53), its second Duchenne muscular dystrophy treatment, which the FDA rejected in August.

The agency had dinged the application over potential side effects, namely a risk of infections from the “ports” used to infuse the drug, and kidney problems observed in animals in which golodirsen and other RNA-based drugs like it were tested.

Sarepta (NASDAQ: SRPT), at the time, said it was “very surprised” by the rejection, and that the FDA hadn’t previously raised any issues about those side effects. Doug Ingram, CEO of the Cambridge, MA,... Read more »

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miRagen Restructures to Focus on Fibrosis, Inks $20M Stock Deal

Thu, 12/12/2019 - 10:51

MicroRNA therapies developer miRagen Therapeutics is scaling back work on its most advanced cancer drug candidate and shifting resources to a compound being developed to treat fibrosis in the lungs.

The pipeline shuffle will be accompanied by a corporate shakeup. Boulder, CO-based miRagen (NASDAQ: MGEN) is also laying off some of its staff. The company said late Wednesday that those changes will leave the company with enough cash to keep going until the fourth quarter of next year.

MiRagen is developing drugs based on microRNA, which are RNA molecules that regulate gene expression and can influence pathways associated with some... Read more »

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Amgen’s Osteoporosis Drug Wins European Nod, With a Heart Warning

Thu, 12/12/2019 - 06:12

An osteoporosis drug developed by Amgen now has marketing approval in Europe, but it carries a warning that the medicine can raise the risk of cardiovascular problems.

Romosozumab (Evenity) treats postmenopausal woman who have osteoporosis, a disease that weakens bones, making them susceptible to fracture. The antibody drug, given as a monthly injection, was developed to block sclerostin, a protein involved in the signaling pathway that regulates bone growth. The drug is intended to provide a dual effect: It increases bone formation and reduces bone loss in patients who have the disease, which in turn reduces the risk of fracture.

The... Read more »

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Aspen Neuro Bags $6.5M to Test Parkinson’s Disease Stem Cell Therapy

Thu, 12/12/2019 - 04:09

Nearly nine years ago Jeanne Loring and her colleagues at Scripps Research debuted a test that leveraged advances in genomics and data science to determine, without testing in animals, whether human stem cells were “pluripotent,” or able to become any type of cell in the body.

Being able to prove that has become increasingly important as scientists look to induced pluripotent stem cells (iPSCs)—mature, specialized cells that have been reprogrammed as immature cells, regaining the capability of becoming any type of cell—as material for new regenerative medicines.

Now Loring and Andres Bratt-Leal, who joined her lab in 2012 as a post-doctoral... Read more »

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Prometheus Bio Taps Thierry Dervieux as Chief Development Officer

Wed, 12/11/2019 - 12:41

Prometheus Biosciences on Tuesday said it has appointed Thierry Dervieux as chief development officer, diagnostics, and medical laboratory director. The San Diego-based biotech, created this summer through the acquisition of Prometheus Laboratories by Precision IBD, is working to create new drugs and companion diagnostics for people with gastroenterology disorders and autoimmune diseases.

Dervieux was most recently chief scientific officer and medical director at Exagen Diagnostics (NASDAQ: XGN). Prior experience includes stints at Cypress Bioscience and Proprius Pharmaceuticals (acquired by Cypress)—and at Prometheus Bio predecessor Prometheus Labs, as principal scientist and director of R&D.

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Locana Names Casebia Therapeutics’s Jim Burns as New CEO

Wed, 12/11/2019 - 12:26

Locana said Tuesday that it has appointed Jim Burns, most recently CEO of Casebia Therapeutics, as its new chief executive. Burns ran Casebia, a joint venture between CRISPR Therapeutics (NASDAQ: CRSP) and Bayer, for three years. Previously he spent three decades at Sanofi Genzyme.

He succeeds Jeffrey Ostrove, who was named to the top role at Locana in May when the company raised $55 million to advance a portfolio of RNA-targeting gene therapies. The San Diego-based biotech described Burns’s appointment as “part of a planned transition.”

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Iterum’s Antibiotic for Super Bugs Falls Short in Phase 3, Shares Sink

Wed, 12/11/2019 - 08:23

Iterum Therapeutics’ bid to bring patients a new antibiotic that’s safer than currently available drugs has fallen short of the main efficacy goal of a late-stage clinical trial. But the company is pinning its hopes on another Phase 3 study that will report data early next year.

Iterum (NASDAQ: ITRM) reported preliminary Phase 3 data late Tuesday for its antibiotic, sulopenem, which is being tested as a treatment for complicated intra-abdominal infections. The study’s primary goal was to show, after 28 days, a resolution of symptoms without the need for additional antibiotics or treatment.

The clinical trial compared the Iterum... Read more »

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Flagship’s Cellarity Aims to Advance Cell Behavior-Based Therapeutics

Wed, 12/11/2019 - 04:24

The latest startup to emerge from Flagship Pioneering aims to change drug discovery by starting the process with a clear understanding of cell behavior.

Cellarity—like many other startups looking to revamp the slow, costly process of developing new medicines—is using machine-learning tools to do so, leveraging computational advances to advance a new way of thinking about how to treat human illness.

Launched in 2017 and backed with $50 million from the Cambridge, MA-based venture capital firm, Flagship general partner and founding Cellarity CEO Avak Kahvejian traces the startup’s origins to an “almost naïve” conversation in the venture capital firm’s labs about... Read more »

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Flexion Co-Founder, Chief Scientific Officer Neil Bodick to Retire

Tue, 12/10/2019 - 14:09

Neil Bodick, chief scientific officer of Flexion Therapeutics (NASDAQ: FLXN), will retire on Jan. 3. After co-founding the company in 2007, Bodick served as its chief medical officer. He became chief scientific officer in 2017 following FDA approval of the company’s extended-release formulation of triamcinolone acetonide (Zilretta), a treatment for knee pain. After retiring, Flexion says Bodick will continue in a consulting role to help in the transition of his responsibilities. Burlington, MA-based Flexion develops therapies for musculoskeletal conditions.

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Replimune Taps Ex-Merrimack Exec for Chief Financial Officer Post

Tue, 12/10/2019 - 14:03

Replimune Group (NASDAQ: REPL) has appointed Jean Franchi to serve as chief financial officer, the same position she held most recently at Merrimack Pharmaceuticals (NASDAQ: MACK). Franchi’s experience also includes positions at Genzyme, Dimension Therapeutics, and Good Start Genetics. Woburn, MA-based Replimune is developing oncolytic immune-gene therapies to treat cancer.

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KalVista Pharma Eye Drug Partnered With Merck Flunks Phase 2 Test

Tue, 12/10/2019 - 11:05

A KalVista Pharmaceuticals eye drug at the center of a research collaboration with Merck has failed a mid-stage clinical trial.

KalVista (NASDAQ: KALV) developed its drug, KVD001, to treat diabetic macular edema (DME), a complication of diabetes that can lead to blindness. On Monday, Cambridge, MA-based KalVista said patients treated with the drug, given as a monthly injection to the eye, did not show enough vision improvement after 16 weeks to distance the experimental therapy from a sham treatment.

Merck signed on as a KalVista partner in 2017 after the biotech reported encouraging Phase 1 data. Under the agreement,... Read more »

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Zentalis Steps Out With $147M Raised to Develop “Tried and True” Small Molecules

Tue, 12/10/2019 - 05:43

Zentalis Pharmaceuticals is banking on small molecules for cancer—leaving the “cool technologies” aside for a “tried and true” approach, says the CEO, who wants to let the science speak for itself.

Since it was founded five years ago, the company has moved three compounds into the clinic. How? By operating under the radar. “If you take away the outside distractions, which is what we’ve been doing; when you have that singular focus, which is to develop drugs, it really helps,” Zentalis Pharmaceuticals CEO Anthony Sun tells Xconomy.

The company this week emerged from “stealth mode” after closing an $85 million (€77... Read more »

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Scripps Research, AbbVie Expand Drug Discovery Deal Beyond Cancer

Tue, 12/10/2019 - 04:25

The Scripps Research Institute and AbbVie have agreed to broaden an existing drug discovery agreement focused on cancer cell therapies to now encompass treatments for other kinds of disease.

Scripps’s early-stage drug discovery division, Calibr, last year inked a big partnership with North Chicago, IL-based AbbVie (NYSE: ABBV) to develop potential treatments for solid cancer tumors. An investigational drug developed under the deal, designed to target the cancer protein CD19 with “switchable” CART-T cells invented at the La Jolla, CA-based nonprofit organization, is in preclinical studies.

Financial terms of this latest agreement weren’t disclosed, but the deal expands the purview... Read more »

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Perceptive Unveils New $210M Fund to Invest in Early-Stage Biotechs

Tue, 12/10/2019 - 04:00

Perceptive Advisors, an investment firm with a long track record of life science investing across all points of development, is now stepping up to pump money into companies at the earliest stages with a new $210 million venture capital fund.

The Perceptive Xontogeny Venture Fund (PXV) is led by Chris Garabedian (pictured above, center), a veteran biotech executive whose experience includes stops at Gilead Sciences (NASDAQ: GILD), Celgene, and Sarepta Therapeutics (NASDAQ: SRPT). He’s currently the chairman and CEO of Xontogeny, a Boston-based life sciences accelerator.

PXV will favor investments in companies emerging from Xontogeny, which already has a... Read more »

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Eying Cancer Combos, Sanofi to Splash Out $2.5B on San Diego’s Synthorx

Mon, 12/09/2019 - 17:01

Synthorx is working to design new cytokine therapies for cancer using an “extended” genetic alphabet that could help avoid the shortcomings associated with earlier versions.

Now French biopharma Sanofi has struck a deal to add the startup to its oncology business in a transaction that values the company at about $2.5 billion. The move is the first acquisition the company has announced since CEO Paul Hudson joined the Paris-headquartered company Sept. 1.

Sanofi agreed to pay $68 per outstanding share of Synthorx, a 172 percent premium over its Friday closing stock price of $25.03 apiece. Its stock shot to $67.71 per... Read more »

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