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BioWorld - Monday, May 11, 2026
Home » Topics » Briefs

Briefs
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Regulatory front

July 5, 2019
In an ongoing crackdown on repackers, the FDA recently issued warning letters to three repackers of active pharmaceutical ingredients (API) for significant violations of current good manufacturing practice requirements.
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Other news to note

July 3, 2019
Oncovita SAS, of Paris, said it entered a licensing agreement with Institut Pasteur, granting it an exclusive worldwide license to develop, manufacture and commercialize therapies based on the immuno-oncolytic measles virus platform. Financial terms of the agreement were not disclosed.
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Financings

July 3, 2019
Morphic Holding Inc., of Waltham, Mass., said it closed its IPO of 6.9 million common shares, including 900,000 shares sold for the full exercise of overallotments, at $15 apiece to raise $103.5 million. 
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Clinical data for July 2, 2019

July 3, 2019

Regulatory actions for July 2, 2019

July 3, 2019

Appointments and advancements

July 3, 2019
Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C., appointed Megan Sniecinski chief business officer.
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Financings

July 2, 2019
CNS Pharmaceuticals Inc., of Houston, filed an S-1 with the SEC for a proposed IPO to raise about $10 million by offering 2.1 million shares priced at $4 to $5 per share. Founded in 2017, CNS Pharmaceuticals is developing therapies for brain cancer and other central nervous system tumors. It is seeking a listing on Nasdaq under the ticker CNSP.
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Regulatory front

July 2, 2019
The FDA Monday released two draft guidances on the content and format of specific sections in prescription drug labeling. 
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Clinical data for July 1, 2019

July 2, 2019

Regulatory actions for July 1, 2019

July 2, 2019
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