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Updated: 2 hours 53 min ago

Aptinyx Moves Ahead With PTSD Therapy Study, Pauses 3 Other Trials

5 hours 53 min ago

Neurological drug developer Aptinyx has stopped enrollment in three of the four mid-stage trials it is conducting due to impacts from the coronavirus pandemic.

The Evanston, IL-based company disclosed the decision Monday in its report of fourth quarter and full year 2019 financial results.

Aptinyx (NASDAQ: APTX), which is advancing three clinical-stage drug candidates that target the NMDA receptor on neurons, stopped enrollment in two Phase 2b studies of its lead program, NYX-2925, in patients with painful diabetic peripheral neuropathy and in patients with fibromyalgia. The company said challenges related to patient recruitment, screening, and randomization had proved insurmountable.

The... Read more »

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A Baby’s Milestones and the Next Steps for Novartis in Gene Therapy

8 hours 43 min ago

Cameron Hewitt’s family celebrates the anniversary of her life not once, but twice yearly: Besides her September birthday, they commemorate a day in March—the anniversary of two-year-old Cameron receiving the gene therapy that gave her a new shot at life.

Cameron was born with spinal muscular atrophy (SMA), a genetic disorder that leads to the progressive loss of muscle function. In its most common and severe form, the disease leads to death within one or two years. The Hewitt family, which lives in Apex, NC, credits Zolgensma, a gene therapy approved by the FDA last year, as the reason Cameron... Read more »

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Tapping Into the Innovation Grid: J&J, Data, and a Shifting Healthcare Focus

11 hours 38 min ago

Johnson & Johnson’s global head of external innovation says there needs to be a shift in how healthcare research is funded to focus on early detection and curing rather than managing diseases.

“When you look at the investment in research in the pharma industry, it’s all designed to treat established diseases,” William Hait, global head of Johnson & Johnson (NYSE: JNJ) External Innovation, told delegates at the BIO-Europe Spring event, held digitally last week due to the coronavirus crisis.

While there have been notable exceptions—particularly in the cardiovascular diseases where Hait said it was realized early on that decreasing... Read more »

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Viracta Adds Nordic Nanovector’s Lisa Rojkjaer as Chief Medical Officer

Mon, 03/30/2020 - 15:21

Viracta Therapeutics has appointed Lisa Rojkjaer as its chief medical officer to oversee the clinical-stage precision oncology company’s efforts to advance treatments targeting virus-associated cancers.

Rojkjaer, who will start with the company on May 1, most recently served in the same role at Nordic Nanovector, a precision oncology company in Oslo, Norway. Previously she held roles at Novartis (NYSE: NVS), Molecular Partners, Morphosys, and Novo Nordisk (NYSE: NVO). San Diego-based Viracta’s lead compound, nanatinostat, is in a Phase 2 study in combination with valganciclovir, an antiviral, in patients with Epstein-Barr virus-positive lymphomas.

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Gilead’s Okazaki Named Assembly Bio Chief Legal and Business Officer

Mon, 03/30/2020 - 14:58

Assembly Biosciences (NASDAQ: ASMB) is adding another Gilead Sciences (NASDAQ: GILD) veteran to its executive team. Jason Okazaki is joining Assembly as its chief legal and business officer. He comes to South San Francisco-based Assembly after 14 years at Gilead, most recently as senior vice president, legal and assistant secretary. Okazaki follows John McHutchinson, the former Gilead chief scientific officer who was appointed Assembly’s president and CEO last August. Last November, Luisa Stamm, a Gilead executive in liver diseases, was named Assembly’s chief medical officer. Assembly is developing drugs for hepatitis B virus and diseases associated with... Read more »

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Bioventus CEO Tony Bihl to Retire, Ken Reali Appointed Successor

Mon, 03/30/2020 - 14:49

Bioventus has announced that CEO Tony Bihl will retire on April 30. The Durham, NC-based company has appointed Ken Reali as his successor. He will also join the privately held firm’s board of managers starting on April 20. Reali is coming to Bioventus from Utah-based Clinical Innovations, where he is president and CEO. His experience also includes positions at Baxano Surgical, Smith & Nephew (NYSE: SNN), Stryker (NYSE: SYK), and Biomet. Bioventus develops “orthobiologic” products, treatments that use the body’s own biological processes to treat arthritis and promote bone healing.

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Biohaven’s Acute Migraine Drug Bests Placebo in Prevention Study

Mon, 03/30/2020 - 14:27

Biohaven Pharmaceutical’s FDA-approved pill to treat migraine attacks is showing that it can prevent such headaches too.

According to preliminary results from a late-stage trial released Monday, the Biohaven drug beat a placebo at reducing the average number of days per month patients with chronic and episodic migraine experienced the debilitating condition.

The FDA OK’d the drug, rigemepant (Nurtec), as a treatment for acute migraine about a month ago. Based on the new results released Monday, the New Haven, CT-based company plans to ask regulators to approve expansion of the drug’s approval to cover migraine prevention.

Rimegepant is part of a... Read more »

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Axsome Plans to Try Again After Failure in Treatment-Resistant Depression

Mon, 03/30/2020 - 12:01

An experimental Axsome Therapeutics drug for treatment-resistant depression has fallen short of the main goal of a late-stage test. But the company says the pill is showing enough promise to warrant trying another Phase 3 study.

Axsome (NASDAQ: AXSM) tested its drug, AXS-05, in patients with major depressive disorder who had previously failed to respond to treatment with antidepressants. The study, which enrolled 312 patients, compared the Axsome drug to the antidepressant bupropion. Patients were evaluated according to the Montgomery-Åsberg depression rating scale, a diagnostic questionnaire used to measure the severity of depression episodes. Axsome reported Monday that patients treated... Read more »

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Xcelerating Life Sciences Seattle

Mon, 03/30/2020 - 08:06

Stay at the forefront of Seattle’s cancer treatment trends and technologies that are fueling today’s biotech investment and partnership opportunities

There is an outsize presence of cancer work in Seattle compared to other regions, and the investment in personalized diagnostics has grown considerably in the past year. But once companies get big enough to have an impact, they are often acquired like homegrown Juno, Immune Design, and Seagen. What does it take to have a successful merger? And how are acquisitions affecting the life science ecosystem in Seattle?

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San Diego Biotech Entrepreneurs, Innovation Lead to “Maturing” Ecosystem

Mon, 03/30/2020 - 03:00

The local biotech ecosystem is growing up thanks to its innovative science and collaborative ecosystem, advantages that put it nearly on par with the nation’s top life science regions, according to industry veterans.

San Diego has long been considered a second-tier primary biopharma hub in terms of number of companies and venture capital raised, falling behind the twin behemoths of Boston-Cambridge and the San Francisco Bay Area on those and other metrics.

At Xconomy’s Xcelerating Life Sciences San Diego event this month, investors, executives, and others noted under-looked strengths contributing to the region’s maturation.

Venture capitalist Nancy Hong recalled that some... Read more »

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Sanofi Adds mRNA COVID-19 Vaccine Bet Through Translate Bio Alliance

Fri, 03/27/2020 - 18:00

Sanofi is joining the array of companies pursuing a COVID-19 vaccine based on messenger RNA (mRNA), an experimental genetic technology intended to coax the body’s cells into producing proteins that treat a disease or spark immunity to one.

Sanofi (NYSE: SNY) announced Friday that it will develop COVID-19 vaccine candidates with Translate Bio (NASDAQ: TBIO), a Lexington, MA-based developer of mRNA therapies. The companies are already partners. In 2018, they began a three-year alliance aiming to develop vaccines for up to five infectious diseases. The COVID 19 research tacks a sixth vaccine target onto that pact.

For Sanofi... Read more »

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Equillium Continues Graft-Versus-Host Disease Trial, Pauses 2 Others

Fri, 03/27/2020 - 15:12

Equillium has halted two clinical trials of its lead drug candidate out of an “abundance of caution” related to the coronavirus outbreak but continues to enroll in a third, which is evaluating the antibody as a treatment for acute graft-versus-host disease.

The decision made by the San Diego biotech, revealed in its annual report filed Thursday with regulators, is one of the latest examples of clinical trial progress being stymied by the deadly virus, which is delaying the development of some new drugs as companies struggle to cope with challenges including site closures, travel limitations, and supply chain interruptions.

In... Read more »

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Bio Roundup: Clinical Trials Paused, New MS Drug, Kallyope’s Cash & More

Fri, 03/27/2020 - 07:03

Finding and enrolling patients for clinical trials is always challenging. The coronavirus pandemic has made it nearly impossible.

Fallout from the spread of COVID-19 infections led several companies to declare this week that they would stop enrolling patients in clinical trials or postpone studies that have not yet started. Eli Lilly (NYSE: LLY) said that many healthcare systems are devoting their resources to treating COVID-19 patients, which makes it difficult for these sites to also start new clinical trials. Pfizer (NYSE: PFE) is delaying new patient recruitment for three weeks. Bluebird Bio (NASDAQ: BLUE) said the pandemic could... Read more »

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Fusion Pharmaceuticals Taps James O’Leary as Chief Medical Officer

Thu, 03/26/2020 - 18:15

Clinical-stage oncology company Fusion Pharmaceuticals has appointed James O’Leary as its chief medical officer.

Fusion is developing new radiopharmaceuticals—pharmaceutical drugs containing radioactive isotopes—to treat a range of types of cancer.

O’Leary’s experience includes roles at biotechs including ImmunoGen (NASDAQ: IMGN), Idera Pharmaceuticals (NASDAQ: IDRA), Array Biopharma, and Deciphera (NASDAQ: DCPH), and pharma companies including Takeda (NYSE: TAK), Bayer, and Pfizer (NYSE: PFE). In his most recent role, at Takeda, O’Leary was a global project team leader for a late-stage asset directing global strategy and regulatory approvals.

Fusion’s lead program, FPI-1434, is in Phase 1 testing, a... Read more »

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Akcea Therapeutics Promotes Damien McDevitt to CEO

Thu, 03/26/2020 - 17:56

Akcea Therapeutics (NASDAQ: AKCA) has appointed Damien McDevitt as its chief executive officer, the company announced Tuesday.

Akcea, a subsidiary of Carlsbad, CA-based Ionis Pharmaceuticals (NASDAQ: IONS), is advancing a group of experimental rare disease drugs discovered by its parent company. McDevitt had been serving as Akcea’s interim CEO since September 2019, when CEO Paula Soteropoulos, president Sarah Boyce, and chief operating officer Jeff Goldberg left the Boston-based company in a sudden management shakeup.

McDevitt joined Ionis as its chief business officer in June 2018 from Acadia Pharmaceuticals (NASDAQ: ACAD), where he served as senior vice president,... Read more »

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Forge Inks Roche Deal For Antibiotic Aimed at Drug-Resistant Infections

Thu, 03/26/2020 - 17:13

Forge Therapeutics has set an agreement with Roche that gives the Swiss pharma giant the option to license a new antibiotic Forge is developing to treat serious drug-resistant bacterial lung infections.

This week the preclinical-stage San Diego-based biotech announced that under the deal Forge will retain control of the program, FG-LpxC LUNG, until Roche decides whether to exercise its exclusive option.

Forge’s experimental antibiotic is intended to address infections most commonly acquired by people with weakened immune systems and chronic lung diseases while in the hospital, such as Pseudomonas aeruginosa, or P.aeruginosa, infections. While generally treated with antibiotics, such... Read more »

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With $80M, ReCode Looks to Advance RNA Therapies for Lung Diseases

Thu, 03/26/2020 - 14:55

Two companies working on treatments for rare genetic lung diseases have combined efforts and raised $80 million to bring into human testing next year two investigational treatments that use types of RNA to tweak mutated proteins.

Dallas company ReCode Therapeutics and Menlo Park, CA-based TranscripTx have merged under the ReCode name and leadership of CEO David Lockhart to advance treatments for progressive pulmonary diseases caused by genetic mutations. On Thursday the company announced it would put proceeds from the Series A financing toward continued preclinical work on its lead programs, investigational therapies for two genetic pulmonary diseases: primary ciliary dyskinesia and... Read more »

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FDA Approves Bristol Myers MS Drug, But Pandemic Will Delay Launch

Thu, 03/26/2020 - 06:58

A multiple sclerosis drug that came to Bristol Myers Squibb via its acquisition of Celgene last year was approved Thursday but don’t expect it to reach patients any time soon. The company says the drug’s launch will be delayed due to the coronavirus pandemic.

The Bristol (NYSE: BMY) drug, ozanimod (Zeposia), is one of the medicines approaching commercialization that the pharmaceutical giant touted as justification for its $74 billion buyout of Celgene. Some analysts have projected that the drug could become a blockbuster seller. But when ozanimod does reach the market, it will compete against other MS medicines in... Read more »

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Oncology Needs Combo Therapies & More Data Analysis, Says Bio-Europe Spring Panel

Thu, 03/26/2020 - 00:52

Future improvements in cancer care are most likely to stem from combinations therapies and data-driven prevention efforts, as well as breakthrough drugs.

That’s the message life sciences experts shared this week during a webcast on the topic of “oncology’s next decade” recorded for the BIO-Europe Spring partnering conference. The event is produced by EBD Group, which is owned by the same parent company as Xconomy, and was held virtually given coronavirus concerns.

“I think the conversion of the coming together of different therapies and different paradigm shifts that we have been through, be it targeted therapy, biologics, or going back earlier,... Read more »

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Regenacy Pharma Raises $30M for Nerve Function Restoring Treatments

Wed, 03/25/2020 - 16:08

Regenacy Pharmaceuticals, a biotech formed as part of Celgene’s acquisition of Acetylon Pharmaceuticals in late 2016, has raised $30 million in Series A financing to move its lead program into a Phase 2 proof-of-concept trial this year.

The Waltham, MA-based company is developing treatments to address the underlying cause of peripheral neuropathies—a form of nerve damage in the fingers and toes that causes numbness and tingling—associated with diabetes and other conditions.

Regenacy plans to first evaluate its lead drug candidate, ricolinostat, in diabetic peripheral neuropathy.

Nerve damage caused by diabetes is a common and serious complication of both type 1... Read more »

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