With the world heading straight into a "very tough" stretch of the COVID-19 pandemic in which "too many countries are seeing an exponential increase in cases," according to World Health Organization Director-General Tedros Adhanom Ghebreyesus, two lucrative deals announced Wednesday showed little slack in efforts to confront the virus, even as evidence is still developing. In one, Novartis AG agreed to pay Molecular Partners AG as much as CHF210 million (US$231 million) for global rights for two early stage direct-acting antivirals that might help prevent or treat COVID-19. In the second, the U.S. government agreed to pay Eli Lilly and Co. as much as $812.5 million for nearly 1 million doses of the experimental antibody therapy, bamlanivimab, even as the FDA continues to ponder whether to grant a requested emergency use authorization for the medicine.

Miragen takes over Viridian, phase II in TED planned next year

Shares of Boulder, Colo.-based Miragen Therapeutics Inc. (NASDAQ:MGEN) were trading midday at 85 cents, up 33 cents, or 63%, after the company disclosed plans to take over Viridian Therapeutics Inc., of Waltham, Mass., conducting at the same time a private placement to raise $91 million. The proceeds will be used for clinical studies of VRDN-001, a clinical-stage insulin-like growth factor-1 receptor monoclonal antibody in development for thyroid eye disease (TED). More than 100 oncology patients have been treated with the candidate under the name AVE-1642 in U.S. and EU studies, giving Miragen some understanding of its pharmacokinetic and pharmacodynamic profile, as well as safety and tolerability. The company hopes to start a phase II trial with the compound in TED next year.

With a $56M boost, Longboard leaps from Arena

Longboard Pharmaceuticals Inc. is spinning out from Arena Pharmaceuticals Inc., courtesy of a $56 million financing to help develop CNS-targeted therapies. On the table to be developed are LP-352, a program for treatment-resistant developmental and epileptic encephalopathies and two preclinical programs, LP-143 and LP-659, for treating microglial neuroinflammatory diseases. In its most recent life, Longboard was a wholly owned Arena subsidiary called Arena Neuroscience. The financing was led by Farallon Capital Management LLC along with a group of investors that include Arena, Cormorant Asset Management, HBM Healthcare Investments, Highside Capital Management and T. Rowe Price Associates.

Australia’s Opthea lists on Nasdaq in $128M IPO, gears up for phase III wet AMD trials

PERTH, Australia – Opthea Ltd. completed a $128.2 million IPO on the U.S. Nasdaq market, which will fund two phase III trials in wet age-related macular degeneration (AMD) and bring the company’s lead candidate OPT-302 to market if successful. OPT-302 is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) or “trap” molecule that blocks the activity of VEGF-C and VEGF-D, which causes blood vessels to grow and leak. Opthea is positioning the product as an add-on therapy to existing standard-of-care VEGF inhibitors. Melbourne, Australia-based Opthea will be dual listed in the U.S. and Australia with its ordinary shares listed on the Australian Securities Exchange (ASX:OPT) and its U.S. shares trading on Nasdaq under the same OPT ticker.

Bio-Europe: Taking a spin on biotech’s virtuous circle

DUBLIN – The biotechnology sector may be more awash with cash now than at any other time in its history. But that does not alter the fundamental dynamic between biotech and big pharma. If anything, the roles are becoming better defined, as biotechs learn how to build value into their programs to the point where big pharma is willing to step in and take on the financial risk of scaling a program where it can truly go global. For its part, big pharma has long conceded that external innovation is where much of the action is in terms of new therapies. For those who can access significant amounts of capital, taking a spin on the virtuous circle has never been more rewarding, as illustrated during two sessions at Bio-Europe on Oct. 28.

ASHG 2020: New inflammatory disease, and maybe, a new classification system

Anthony Wynshaw-Boris, professor and chair of the department of genetics and genome sciences at Case Western Reserve University School of Medicine, set a positive tone in his opening talk at the 2020 annual meeting of the American Society of Human Genetics (ASHG). "This is guaranteed to be the best-ever virtual ASHG annual meeting," he told the audience. The opening plenary abstract session, for one, did not disappoint. It began with the definition of a new disease, identified through a new approach, and possibly leading to a new way to think about rheumatic diseases.

Kangstem completes research, takes next steps for Korea’s first artificial liver

HONG KONG – Kangstem Biotech Co. Ltd. has completed research on the country’s first artificial liver and is taking the next steps toward the device’s clinical trials. The research outcome was published in a paper authored by Kyung-Sun Kang, CEO at Kangstem, and his team titled ‘Development of highly functional bioengineered human liver with perfusable vasculature’ in Biomaterials. “Our bioengineered artificial liver, which is as yet unnamed, is currently in what we view as rehearsals ahead of in-human trials. We completed preclinical trials on rats and are currently conducting trials on pigs, with the transition from rats to pigs taking around one year,” Kang told BioWorld. Achieving vascular reconstruction without organ rejection was key to the team’s research, with organ rejection in patients who receive transplants a major obstacle in the field. A vascularized, bioengineered human liver was the reconstructed using the novel strategy of using decellularized liver scaffolds efficiently, with the decellurization process critical to preventing organ rejection.

EU court sides with Pharmamar in Aplidin approval dispute

The old adage of “if at first you don’t succeed, try, try again,” seems to be working for Pharmamar SA – at least when it comes to getting EU approval for its multiple myeloma drug, Aplidin (plitidepsin). In a rare move today, the EU General Court annulled the European Commission’s decision refusing marketing authorization for the drug and ordered the commission to pay all court costs. The Madrid-based drug company filed the suit Oct. 1, 2018, after the EMA’s Committee for Medicinal Products for Human Use, upon re-examination, decided once again that the drug’s risks didn’t outweigh its benefits. The suit was based on the strict verification of conflicts of interest held by EMA-appointed experts and the correct analysis of the scientific evidence Pharmamar presented.

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