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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Lab glassware and scientist

BIO 2022: Despite record number, life sciences talent still hard to come by

June 17, 2022
By Michael Fitzhugh
Amid a convergence of demographic, economic and technological trends, more workers are engaged in U.S. life sciences research than ever before, a new analysis of U.S. Bureau of Labor Statistics shows. The analysis, by commercial real estate giant CBRE Group Inc., found that even with a doubling in the number of U.S. graduates in biological and biomedical sciences since 2005, biopharma companies continue to face major challenges finding talent and, increasingly, space in which to put that talent to work.
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Head filled with digital data

BIO 2022: Push to model disease biology advancing, but slowly

June 15, 2022
By Michael Fitzhugh
With just 10% of therapeutic programs successfully moving from first toxicity dose to market, drug developers are on a constant hunt for new tricks to put the odds in their favor. Strategies abound, from biomarker-guided patient selection to deeper regulatory engagement. But big pharma executives and an academic expert weighing the challenge at the BIO International Convention said June 14 they see another tool slowly gaining traction with the potential to decrease timelines and boost chances for approval: in-silico modeling.
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DNA repair

Roche joins the ATR inhibitor party with $1.33B Repare deal

June 2, 2022
By Michael Fitzhugh
A new $1.33 billion oncology deal between Roche Holding AG and Repare Therapeutics Inc. is poised to give the Swiss multinational access to what it hopes will be a best-in-class program targeting DNA damage repair for the treatment of solid tumors. The global licensing agreement, for Repare's midstage camonsertib, gives Roche entrée to a developing race to lead the class alongside other big players, such as Merck KGaA, Bayer AG and Astrazeneca plc.
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Stroke illustration: brain, artery, neurons

Athersys sees 'Treasure' in stroke data, despite trial's missed endpoint

May 24, 2022
By Michael Fitzhugh
Shares of Athersys Inc. fell sharply May 20 after its partner and top investor Healios K.K. reported that Multistem (invimestrocel), the experimental cell therapy they've co-developed since 2016, missed the primary endpoint of a Japanese phase II/III ischemic stroke study called Treasure. Many Athersys investors appeared to read the results as bad news for Athersys' ongoing pivotal phase III stroke study, Masters-2.
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Athersys sees 'Treasure' in stroke data, despite trial's missed endpoint

May 20, 2022
By Michael Fitzhugh
Shares of Athersys Inc. fell sharply May 20 after its partner and top investor Healios K.K. reported that Multistem (invimestrocel), the experimental cell therapy they've co-developed since 2016, missed the primary endpoint of a Japanese phase II/III ischemic stroke study called Treasure.
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CAR T illustration
Newco news

Inceptor Bio raises $37M to advance triplet of CAR therapies

May 19, 2022
By Michael Fitzhugh
Inceptor Bio LLC, a company developing cell therapies for difficult-to-treat cancers, has closed a $37 million series A financing led by Kineticos Ventures, the second fund founded by Inceptor CEO Shailesh Maingi. Altogether, about 40 investors have supported the company's efforts, he told BioWorld. Proceeds from the round, which follows a $26 million seed financing in 2021, will support moving Inceptor's lead CAR T program into phase I testing, a move targeted for the second half of 2023, and continued development of rare CAR-macrophage and CAR-natural killer cell programs.
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Syringe with Johnson & Johnson logo

Better than nothing: FDA limits use of J&J COVID-19 vaccine

May 6, 2022
By Michael Fitzhugh
A risk of rare but potentially life-threatening blood clots in combination with low platelet levels after a jab of Johnson & Johnson's Janssen COVID-19 vaccine has convinced the U.S. FDA to limit its use. The vaccine is now authorized in the U.S. only for adults who wouldn't otherwise be vaccinated and those who can't or shouldn't, for medical reasons, get another approved vaccine. Through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases of the condition, called thrombosis with thrombocytopenia syndrome – a rate of 3.23 cases per million doses of vaccine administered.
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Intercept finds cash, optionality in sale of ex-US business to Advanz

May 5, 2022
By Michael Fitzhugh
Intent on expanding both the reach and approved uses of its farnesoid X receptor agonist, Ocaliva (obeticholic acid), Intercept Pharmaceuticals Inc. is selling both its ex-U.S. operations and rights to the primary biliary cholangitis drug to U.K.-based Advanz Pharma Corp. Ltd. for $405 million up front. The deal, including an additional $45 million earnout tied to EU regulatory advances, represents an important step toward strengthening Intercept's balance sheet and options, said CEO and President Jerry Durso.
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Patient Square takes new tack, launching Enavate with $300M commitment

May 3, 2022
By Michael Fitzhugh
Health care private equity investor Patient Square Capital has launched Enavate Sciences, a new portfolio company with an initial capital commitment of $300 million devoted to "enabling innovation through both capital and company-building experience," CEO Jim Boylan told BioWorld. The firm, which plans to invest in both therapeutics startups and enabling technologies, plans to raise $200 million to $300 million more in 2022.
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Feet and scale

Lilly may seek expedited approval for weight loss drug

April 28, 2022
By Michael Fitzhugh
Eli Lilly and Co.'s tirzepatide, a high-profile entrant in the global anti-obesity race, hit a key milestone, becoming the first investigational medicine to deliver more than 20% weight loss on average for non-diabetics in a phase III study, said Jeff Emmick, vice president of product development at the company.
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