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BioWorld - Tuesday, December 30, 2025
Home » Newsletters » BioWorld

BioWorld

Oct. 14, 2019

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Clinical data for Oct. 11, 2019

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Financings

Medicenna Therapeutics Corp., of Toronto, a clinical-stage immuno-oncology company, said it filed a short form prospectus, which has been received by the regulatory authorities in each of the provinces of British Columbia, Alberta and Ontario, in connection with the marketed offering of units.  Read More

Regulatory front

The Institute for Clinical and Economic Review (ICER), of Boston, said it released an updated draft evidence report assessing the comparative clinical effectiveness and value of treatments for rheumatoid arthritis. Read More

Other news to note

Pfenex Inc., of San Diego, said its partner, Alvogen Inc., entered exclusive commercialization agreements for PF-708 to treat osteoporosis in patients at high risk of fracture with Pharmbio Korea, Jamp Pharma in Canada and Kamada Ltd. in Israel. Under the agreement, Pfenex is eligible to receive milestone payments and a percentage of net sales or transfer price. Read More

Harvard researchers test in vivo, fluorescent, synthetic biology microbiome tool with Dx potential

Synthetic biology is seeing rapid advances, but the medical applications have thus far remained largely elusive. But now researchers from the Wyss Institute for Biologically Inspired Engineering at Harvard University and Harvard Medical School (HMS) have developed a tool that can track specific populations of bacteria in the gut of living organisms and document population changes over time. Read More

Pipeline of innovative technologies could pressurize FDA resources

Incremental budget increases and continuing resolutions that hold FDA spending of both tax dollars and user fees to the previous year's level aren't going to cut it as the agency faces the growing challenge of reviewing more and more innovative technologies on the condensed timeframe of priority review. Read More

New small-molecule inhibitors block apoptosis in mice

Australian researchers have developed the first potent new small-molecule inhibitors capable of blocking the activation of apoptotic cell death before it causes damage to mitochondria, they reported in a study published in the Oct. 7, 2019, issue of Nature Chemical Biology. Read More

3Q deals and M&A: Volumes down, values up; 2019 already topping last two years

The number of biopharma deals and mergers and acquisitions completed are on a downward slide quarter-by-quarter, although when taken as a whole, the industry in 2019 has completed as many transactions and is hitting a higher deal value than the year before, while M&A values are up by 32%. Read More

Kodiak begins phase II in macular degeneration

The first patients have been treated in Kodiak Sciences Inc.'s phase II DAZZLE trial of anti-VEGF antibody biopolymer conjugate KSI-301 in patients with treatment-naïve wet age-related macular degeneration. At least 368 patients worldwide are expected to enroll in the study. The primary endpoint will be assessed at one year and each patient will be treated and followed for two years. Read More

Vir Biotech shares suffer in $143M IPO, reflecting cool reception for recent offering

Even priced at a bottom-of-range $20, shares of Vir Biotechnology Inc. (NASDAQ:VIR) fell 30% to $14.02 in the first day of trading after the infectious disease specialist priced a $142.9 million IPO, intended to back its development of medicines targeting hepatitis B virus, influenza A, HIV and tuberculosis. The company, led by former Biogen Inc. CEO George Scangos, is largely owned by Arch Venture Partners and Softbank's Vision Fund. Read More

Bench Press: BioWorld looks at translational medicine

Researchers from Columbia University have demonstrated that correcting mutations in the schizophrenia risk gene SetD1 in adult mice reversed cognitive impairments, suggesting that, like a number of other brain disorders, schizophrenia's malfunctions begin in early development, but remain in place via ongoing active processes rather than reaching a point of no return.  Read More

Regulatory actions for Oct. 11, 2019

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