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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Gilead-Galapagos MS drug filgotinib rejected by FDA

Aug. 19, 2020
By Michael Fitzhugh and Lee Landenberger

CBMG shareholders move to take company private

Aug. 18, 2020
By Michael Fitzhugh
A bid by top shareholders and managers of the U.S.-China cell therapy developer Cellular Biomedicine Group Inc. to take the company private pushed shares (NASDAQ:CBMG) 35% higher Wednesday to $19.27, just shy of the offering price.
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Unity shares untied as osteoarthritis of the knee drug fails phase II test

Aug. 17, 2020
By Michael Fitzhugh
Shares of Unity Biotechnology Inc. (NASDAQ:UBX) fell 66.6% to $4.15 on Aug. 17 after UBX-0101, its one-time lead candidate, failed to best a placebo on an established measure of osteoarthritis pain in a phase II study.
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IPO line graph

Curevac IPO, bolstered by COVID-19 vaccine, debuts to surging demand

Aug. 14, 2020
By Michael Fitzhugh
Fresh off raising $640 million in private financing earlier this summer, Germany's Curevac BV burst onto the public market Friday with a $213.3 million Nasdaq IPO. Priced at a top-of-range $16 per share (NADAQ:CVAC), the company's stock rose more than 249% to close at $55.90 Aug. 14, buoyed by enthusiasm for its mRNA vaccine program against SARS-CoV-2. Majority shareholder and longtime Curevac backer Dievini Hopp Biotech Holding GmbH & Co. KG invested €100 million (US$118.3 million) in the company through a concurrent private placement.
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Nanotechnology illustration

FDA works to leverage nanotech investment, better capacity for evaluation

Aug. 13, 2020
By Michael Fitzhugh
Two decades after the federal government jumpstarted U.S. R&D investment in its understanding and control of nanoscale matter, funding for the efforts across the government reached about $1.4 billion in fiscal 2020, part of a total cumulative investment of about $29 billion. Though FDA-budgeted nanotech research has accounted for just a fraction of that, at a modest $133 million since 2009, substantial advances have still been made, according to a presentation on the state of nanotech progress and innovation issued this summer.
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CBMG shareholders move to take company private

Aug. 12, 2020
By Michael Fitzhugh
A bid by top shareholders and managers of the U.S.-China cell therapy developer Cellular Biomedicine Group Inc. to take the company private pushed shares (NASDAQ:CBMG) 35% higher Wednesday to $19.27, just shy of the offering price. "As a private company, we will have access to the resources and long-term commitment needed to better pursue new capital investment in existing assets and targeted acquisition opportunities as our sector continues to evolve, including further geographic and product diversification," CBMG CEO Tony Liu told employees.
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Fennec's Pedmark lands CRL over manufacturing issues

Aug. 11, 2020
By Michael Fitzhugh
Manufacturing deficiencies triggered an FDA complete response letter for Fennec Pharmaceuticals Inc.'s Pedmark, a medicine intended to prevent ototoxicity associated with cisplatin use in children with certain solid tumors.
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Omeros finds narsoplimab benefits COVID-19 patients in small trial

Aug. 10, 2020
By Michael Fitzhugh
Shares of Omeros Corp. (NASDAQ:OMER) jumped 50.9% to $21.32 on Aug. 10 after it reported that six critically ill COVID-19 patients treated with its investigational lectin-pathway inhibitor, narsoplimab, recovered from the disease. The company said it will now seek government support to accelerate the drug’s large-scale manufacture. "We look forward to being able to make narsoplimab broadly available to hospitalized COVID-19 patients," said Omeros CEO Greg Demopulos.
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Eagle draws CRL for new Ryanodex indication: heat stroke

Aug. 10, 2020
By Michael Fitzhugh
Nearly three years after an FDA rejection of Eagle Pharmaceuticals Inc.'s initial effort to add exertional heat stroke (EHS) to the list of approved indications for Ryanodex (dantrolene sodium), its efforts have again been met with a complete response letter. The calcium channel modulator is already approved for the treatment of malignant hyperthermia (MH), but Eagle said it has decided to drop further pursuit of EHS.
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Brain illustration

Biogen bets big on Denali's neurodegenerative pipeline, with $1B+ commitment

Aug. 6, 2020
By Michael Fitzhugh
Biogen Inc., one the world's top neurological disease specialists, is committing to invest more than $1 billion in cash and equity in Denali Therapeutics Inc. for rights to co-develop and co-commercialize a potential therapy for Parkinson's disease (PD) and options to secure up to four more neurodegenerative disease programs from its new partner.
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