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Home » Newsletters » BioWorld

BioWorld

June 13, 2019

View Archived Issues

Catalyst sues FDA over approval of Jacobus LEMS drug

Florida's Catalyst Pharmaceuticals Inc. is suing the FDA to overturn approval of a competitor's drug for the rare autoimmune disorder Lambert-Eaton myasthenic syndrome (LEMS), alleging the green light – arriving just months after its own approval – was "arbitrary, capricious" and violated the company's rights to market exclusivity for the medicine. Read More

ADC Therapeutics taking on Polivy with $76M in new cash

DUBLIN – ADC Therapeutics SA added $76 million in a belated extension to its series E round, taking the total raise to $276 million. The initial close of $200 million was back in October 2017, but progress with its two lead antibody-drug conjugates (ADCs) prompted the latest injection of cash. Read More

'Suite' series B nets $60M for Prelude; new overture in cancer-focused PRMT5

Prelude Therapeutics Inc. founder and CEO Kris Vaddi said the new $60 million in series B money – which brings to $95 million the amount raised since the firm's inception in 2016 – should pull the current phase I research through proof-of-concept stage, targeting protein arginine methyltransferase 5 (PRMT5) in cancer. Read More

Sobi reorganizes as it expands Novimmune deal on emapalumab

Swedish Orphan Biovitrum AB (Sobi) shed some old skin to grow some new by expanding its Novimmune SA deal by acquiring emapalumab (NI-0501, branded as Gamifant) and all its related assets. Sobi also gets all emapalumab employees involved in the drug's clinical and biopharmaceutical development. Read More

Traditional Chinese medicine gains WHO acceptance despite critics citing lack of evidence

The World Health Assembly, a decision-making body of the World Health Organization (WHO), included a chapter on Chinese traditional medicine in the latest version of its influential global compendium for the first time in history. Read More

Regulatory front

Florida Gov. Ron DeSantis Tuesday signed into law a bill establishing two prescription drug importation programs that will allow the import of FDA-approved drugs from Canada and other countries.  Read More

Financings

Innate Pharma SA, of Marseille, France, said it plans to conduct a registered public offering of American depositary shares (ADSs) in the U.S. and has confidentially submitted a form F-1 statement to the SEC.  Read More

Other news to note

Sorrento Therapeutics Inc., of San Diego, said it is exploring the possibility of an IPO of its majority-owned subsidiary, Scilex Holding Co.  Read More

Appointments and advancements

Clovis Oncology Inc., of Boulder, Colo., appointed Ginger L. Graham chair of its board. Read More

Clinical data for June 12, 2019

Read More

Regulatory actions for June 12, 2019

Read More

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