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Home » Newsletters » BioWorld

BioWorld

Nov. 26, 2018

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Holiday notice

BioWorld's offices were closed in observance of Thanksgiving in the U.S. No issue was published Thursday, Nov. 22, or Friday, Nov. 23. Read More

Bench Press: BioWorld looks at translational medicine

Researchers from Baylor College of Medicine have identified a metabolic target in prostate cancer, opening up the possibility for a target that could serve as an alternative or second-line treatment for hormone-targeting treatments. Read More

ASH readout a curtain raiser for Maat Pharma's main act

DUBLIN – Maat Pharma SA returns to the American Society of Hematology (ASH) annual meeting next month with a complete readout of its phase Ib/IIa trial of autologous fecal microbiota transfer (FMT) to combat dysbiosis in acute myeloid leukemia (AML) patients undergoing intensive induction chemotherapy. The company posted interim data from the same study last year. Read More

New AD vaccine crop aims to get efficacy without the tox

Like everything that's been tried against Alzheimer's disease (AD) to date, a vaccination approach has resulted in failure. In fact, that failure was worse than most. Read More

Fuji inks partnership to commercialize Alvotech's biosimilars in Japan

HONG KONG – Iceland biopharmaceutical firm Alvotech ehf has joined hands with Japan's Fuji Pharma Co. Ltd. in a deal to commercialize the former's biosimilar portfolio in Japan. Alvotech will develop and supply a few biosimilars from its product pipeline, while Fuji will work on those products' registration and commercialization in Japan. Fuji injected an investment of undisclosed size into the Iceland firm. Read More

Factor halts development on advanced wound healing therapy following trial failure

PERTH, Australia – Brisbane, Australia-based Factor Therapeutics Ltd. is stopping all development of VF-001 after a phase II trial in venous leg ulcer healing failed to meet all endpoints, which included reduction in wound size, proportion of patients with ulcers fully healed and time to achieve full wound healing. Read More

FDA approves new options for chemo-intolerant AML patients

Following more than a decade of development and a priority review, Pfizer Inc. has won FDA approval for Daurismo (glasdegib), a new drug that, when used with low-dose cytarabine (LDAC), has been shown to increase overall survival vs. cytarabine alone by a median of about four months for certain patients intolerant of intensive chemotherapy. The regulator also approved a supplemental new drug application in a similar indication for Venclexta (venetoclax), a drug marketed by Abbvie Inc. and Genentech/Roche Holding AG. Read More

Financings

Tiziana Life Sciences plc, of London, sold 442,910 shares of stock at $9.90 each to raise $4.4 million. The offer price is about the same as the as-converted price of Tiziana's common shares listed on London's stock exchange. The company is focused on cancer and autoimmune diseases. Read More

Clinical data for Nov. 21, 2018

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Regulatory actions for Nov. 21, 2018

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Regulatory front

Indivior plc, of Slough, U.K. said the U.S. Court of Appeals for the Federal Circuit vacated the preliminary injunction previously granted against Dr. Reddy's Laboratories Ltd., of Hyderabad, India, by the U.S. District Court for the District of New Jersey on July 13, 2018, which had prevented Reddy's from selling, offering to sell, or import its generic buprenorphine/naloxone sublingual film product.  Read More

Other news to note

Hitgen Ltd., of Chengdu, China, said it entered a drug discovery research collaboration with Cambridge, Mass.-based Biogen Inc. to identify small-molecule leads for targets of interest. Hitgen will apply its technology platform, based on DNA-encoded library design, synthesis and interrogation, to discover leads, which will be licensed exclusively to Biogen. Hitgen will receive up-front payments, and be eligible for milestone payments. Specific financial details were not disclosed. Read More

Santhera adds to DMD pipeline via Idorsia option deal

LONDON – Santhera Pharmaceuticals Holding AG is expanding its Duchenne muscular dystrophy (DMD) franchise in a deal to license rights to vamorolone, a new class of steroid drug designed to reduce side effects and allow for longer-term treatment than is possible with current glucocorticoid therapy. Read More

Biopharma's quest for new products keeps R&D investments flowing

The heightened attention that biopharma companies are paying to hot new technologies in the immuno-oncology and gene and cell therapy areas is translating to a significant increase in research and development investments being made by the sector. Drug discovery, however, does not come cheap, as evidenced from an in-depth analysis conducted by BioWorld. Read More

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