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BioWorld - Friday, February 13, 2026
Home » Newsletters » BioWorld

BioWorld

March 22, 2019

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VC investors: Asia's biopharma, med-tech ecosystem is maturing

SINGAPORE – Several talks and forums at the recent Phar-East Pharma and Biotech Festival focused on funding and its relation to the ecosystem in Asia. Naturally, much of this discussion centered on Singapore, the host country for the event and the most developed biotech and med-tech hub in Southeast Asia. Tong Hsien-Hui, head of venture investing at SGInnovate, said it makes sense for Singapore, given its size, to build its ecosystem to focus on niches. Read More

Biomérieux puts Astute to work in Baxter deal to develop AKI biomarkers

Biomérieux Inc. acquired Astute Medical Inc. last April for a scant $90 million. It markets the U.S. FDA-cleared Nephrocheck test for acute kidney injury (AKI) that it gained from the startup, which had previously been a partner under a deal dating back to 2015. Read More

France unveils $153M public-private Innobio 2 fund to boost health care technology

PARIS – Bpifrance and Sanofi SA, of Paris, reported the launch of Innobio 2, an investment fund worth $153 million that is slated to back life sciences. Read More

Other news to note

Lead Pharma Holding BV, of Oss, the Netherlands, triggered the fourth milestone under its agreement with Paris-based Sanofi SA with the start of dosing in a phase I study of SAR-441169, an inverse agonist of nuclear hormone receptor RORyt, in healthy volunteers.  Read More

Financings

Vaxart Inc., of South San Francisco, said it closed its registered direct offering of 1.2 million shares at $2.50 each for gross proceeds of $3 million. Read More

Clinical data for March 21, 2019

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Regulatory actions for March 21, 2019

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On schedule: PDUFA date hit, DEA to deliberate Jazz sleep drug listing position

Now that Dublin-based Jazz Pharmaceuticals plc has gained FDA marketing clearance for Sunosi (solriamfetol), investors are waiting to see how the DEA will schedule the compound, and J.P. Morgan analyst Jessica Fye said her "base case for DEA scheduling for Sunosi is [schedule] IV." The human abuse liability study compared the drug to phentermine and Sunosi "appeared less 'likable' than that schedule IV agent (note that [methylphenidate and d-amphetamine] are schedule II given their higher potential for abuse/dependence)," Fye wrote in a report. Read More

Regulatory front

Following an EU-wide review of safety, the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) is introducing new restricted indications for the fluoroquinolone antibiotics ciprofloxacin, levofloxacin, moxifloxacin and ofloxacin.  Read More

RWD starting to deliver on its promise, but challenges continue

With the world awash in big data, the hope is that the many currents of health care data can be harnessed to streamline and reduce the costs to develop medical treatments and to deliver on the promise of personalized medicine. Read More

Futility at the interim: Biogen, Eisai pull plug on aducanumab for Alzheimer's

Quarter after quarter, analysts have been pestering management on Biogen Inc.'s conference calls about whether there would be an interim analysis for the phase III program testing its Alzheimer's disease drug aducanumab. Read More

Imago Biosciences raises $40M series B financing for developing myeloid disease treatment

Imago Biosciences Inc. has received a boost in the form of $40 million series B financing led by Omega Funds. "These funds will support two phase IIb studies in two myeloproliferative diseases and several investigator-initiated studies in related diseases," Hugh Rienhoff Jr., Imago's CEO told BioWorld. Other investors in the financing include Frazier Healthcare Partners, Amgen Ventures, MRL Ventures Fund, Highlight Capital, Pharmaron and Greenspring Associates. Read More

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