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Home » Newsletters » BioWorld

BioWorld

July 15, 2020

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3D illustration of virus with RNA inside

Shoot (up) the messenger: COVID-19 mRNA vaccine prospects bearing not-bad news

An editorial yesterday in The New England Journal of Medicine (NEJM) marveled that “the world has now witnessed the compression of six years of work into six months,” and went on to ask the question that’s on everyone’s pandemic-wrenched mind: “Can the vaccine multiverse do it again, leading to a reality of a safe, efficacious COVID-19 vaccine for the most vulnerable in the next six [months]?” Read More

Now it’s up to the FDA, again, as terlipressin gets positive vote, barely

While members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee all recognized the severity of hepatorenal syndrome type 1 (HRS-1) and the significant unmet need in the space, they were divided on whether the FDA should follow the decades-old lead of regulators in 60 other countries in approving Mallinckrodt plc’s terlipressin as an HRS-1 treatment. Read More

Arctic Vision closes $32M series A to move lead product to clinic

HONG KONG – Chinese eye disease specialist Arctic Vision (Shanghai) Biotechnology Co. Ltd. raised $32 million in a series A financing round to advance its lead program, ARVN-001 (triamcinolone acetonide suprachoroidal injectable suspension), for treating macular edema associated with uveitis and to bolster its R&D. Read More

Boasting antibody-cell conjugation, Acepodia licenses out two cell therapies to JW Therapeutics

BEIJING – U.S.-Taiwan biotech Acepodia Inc., of Burlingame, Calif., and Taipei, has licensed out two of its cell therapy candidates, ACE-1702 and ACE-1655, to Chinese CAR T therapy developer JW Therapeutics (Shanghai) Co. Ltd. to develop and commercialize them in China, Hong Kong and Macau. Acepodia will receive up-front and milestone payments from JW Therapeutics, plus royalties on sales. Read More

Australia garners first CARB-X award to fight antibiotic resistance with new class of antibiotics

PERTH, Australia – The University of Queensland’s Centre for Superbug Solutions has discovered a new class of antibiotics that has garnered an award from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X).

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Xofluza product packaging

Shionogi continues to chart global path for Xofluza on back of positive BLOCKSTONE results

HONG KONG – Osaka, Japan-based Shionogi & Co Ltd. continues to make global inroads with its influenza treatment, Xofluza (baloxavir marboxil), submitting supplemental new drug applications in Japan and Taiwan for a post-exposure prophylaxis indication on the back of positive results from its phase III trials. Read More
Man wearing Optune Lua on chest

Novocure, Merck to start combo trial of Keytruda with Tumor Treating Fields in first-line NSCLC

Novocure Ltd. and Merck & Co. Inc. will work together to test the use of electric fields at specific frequencies in combination with anti-PD-1 immunotherapy Keytruda (pembrolizumab) to treat non-small-cell lung cancer (NSCLC). The pair plan to start a phase II pilot study during the second half of Novocure’s Tumor Treating Fields in combination with Keytruda as a first-line treatment for intrathoracic advanced or metastatic, PD-L1 positive NSCLC. Read More

Appointments and advancements for July 15, 2020

New hires and promotions in the biopharma industry, including: Anaptysbio, Applied DNA, Arrakis, Autobahn, C4, Neurogene.

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Financings for July 15, 2020

Biopharmas raising money in public or private financings, including: Adaptive Biotechnologies, Bioatla, Biovie, Idera, Inventiva, Nkarta, Nugenerex, Otonomy, Proqr, Versameb.

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In the clinic for July 15, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adamas, Bellerophon, Bridge, Byondis, Cure, Deinove, Essa, Evofem, Moderna, Nicox, QED, Ribomic, Valbiotis, Vivoryon.

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Other news to note for July 15, 2020

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acacia, Anheart, Basilea, Bold, Bridge, BSP, Can-Fite, CNS, Cosmo, Dyadic, Eloxx, Evoke, Glaxosmithkline, Idbiologics, Immuneoncia, Moleculin, MSD, Newg, Nyrada, Octapharma, Orchard, Patheon, Pfizer, Pharmaceutics International, Samsung, Sterling, Tiziana, TLC, Twist, Valbiotis, Vivasc, Zyus.

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Regulatory actions for July 15, 2020

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Bioaegis, Boehringer, GSK, Knopp, Lintonpharm, Neoimmunetech, Oramed.

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Regulatory front for July 15, 2020

The latest global regulatory news, changes and updates affecting biopharma, including: Ono Pharmaceuticals.

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