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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Bridgebio closes $299.2M financing to back genetic disease portfolio

Jan. 24, 2019
By Michael Fitzhugh
Bridgebio Pharma LLC, an active creator of lean new ventures built around a common core, has closed a new $299.2 million financing round to support its efforts to target genetic disease through existing R&D programs. Its work spans subsidiaries focused on dermatology, oncology, cardiology, neurology, endocrinology, renal disease and ophthalmology. The round was co-led by existing investors KKR and Viking Global Investors. Other existing investors included Perceptive Advisors, AIG, Aisling Capital, Cormorant Capital and Hercules Capital. New investors Sequoia Capital and an unidentified blue-chip long-term investor also participated.
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Mediwound shares buoyed by phase III burn data; BLA planned for this year

Jan. 23, 2019
By Michael Fitzhugh
Shares of Israel-based Mediwound Ltd. (Nasdaq:MDWD) rose 11.6 percent to $4.89 Tuesday on news that Nexobrid, its EMA-approved enzyme for removing dead and damaged tissue, or eschar, in adults with thermal burns met the primary and secondary endpoints of a U.S.-based pivotal phase III trial. Jeremy Goverman, a Harvard Medical School professor and principal investigator for the study, said that, among other benefits, the product might help him and other doctors forgo use of the foot-long razor blade sometimes used to remove burnt skin layer by layer in surgical excision.
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Tyme draws mixed reviews of midstage pancreatic cancer data

Jan. 22, 2019
By Michael Fitzhugh
Shares of Tyme Technologies Inc. (NASDAQ:TYME), buoyed earlier this week on anticipation of new data for its lead program, SM-88, fell 35.4 percent to $2.41 on Friday as results of an open-label phase II study in heavily pretreated pancreatic cancer drew mixed reactions. Criticism over the company's headline claim of "improved survival" and questions about the drug's efficacy dominated commentary on Twitter, while analysts following the company seemed to see a brighter picture in a bleak indication, third-line therapy.
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Agenebio starts phase III AD trial with NIH support

Jan. 18, 2019
By Michael Fitzhugh
Baltimore-based Agenebio Inc. has enrolled the first patient in a phase III trial of a drug for amnestic mild cognitive impairment (MCI) due to Alzheimer's disease (AD). The medicine, an experimental once-daily, extended-release formulation of the common epilepsy medication levetiracetam, is called AGB-101. It targets the reduction of neuronal overactivity in the hippocampus, thought to drive downstream pathology and memory impairment. The trial, called Hope4MCI, is supported in part by $16 million in grant money from the NIH.
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Aptinyx drug disappoints in phase II diabetic neuropathy study

Jan. 17, 2019
By Michael Fitzhugh
Aptinyx Inc. shares (NASDAQ:APTX) fell 66.5 percent to $5.98 on Wednesday after the company's most advanced candidate, NYX-2925, failed to perform much better than a placebo in reducing pain associated with diabetic peripheral neuropathy (DPN) for most patients, missing the primary endpoint of a phase II study. Aptinyx President and CEO Norbert Riedel told BioWorld a deeper analysis of the trial's data is needed before deciding the program's future but that testing the drug in a longer study of DPN patients not on concomitant pain medication might be one potential path forward.
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Bioharmony, Boehringer to collaborate on lysin therapies for drug-resistant infections

Jan. 16, 2019
By Michael Fitzhugh
Bioharmony Therapeutics Inc., a New York-based startup developing lysins to fight bacterial infections, has secured support from Boehringer Ingelheim International GmbH to develop a therapy for multidrug-resistant Acinetobacter infections, a frequent cause of hospital-acquired pneumonia, blood and wound infections. Financial terms of the licensing and collaboration deal, arranged by Boehringer's Research Beyond Borders (RBB) program, were not disclosed.
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New Takeda to bring external focus to rare disease business

Jan. 11, 2019
By Michael Fitzhugh
SAN FRANCISCO - "Fast" seemed the watchword for Takeda Pharmaceutical Co. Ltd. this week, as it officially closed its $62 billion acquisition of rare disease specialist Shire plc. "We don't want to lose momentum in the business," Takeda President CEO Christophe Weber said during a Tuesday presentation at the J.P. Morgan Healthcare Conference. "We want to integrate the two companies very quickly and to really gain the full benefit of the combination as soon as possible," he said.
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Rare disease players' successes drawing big pharma's attention

Jan. 10, 2019
By Michael Fitzhugh
SAN FRANCISCO – Following a year in which, for the first time ever, the FDA approved more orphan drugs than non-orphans and the number of big pharma approvals fell, panelists at Biotech Showcase highlighted a litany of reasons the space is continuing to prove attractive, despite challenges. Citing cooperative regulators and compelling cost structures, they underscored some of the most convincing reasons to pursue orphan status and the growing interest from bigger companies in the space, most evident in Takeda Pharmaceutical Co. Ltd.'s recent acquisition of Shire plc.
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Big pharma's asset sourcing wizards shed light on dos and don'ts of courting

Jan. 9, 2019
By Michael Fitzhugh
SAN FRANCISCO – Aspiring entrepreneurs looking to get the attention of big pharma got a healthy helping of practical pointers from gatekeepers at Abbvie Inc., Astrazeneca plc, Bayer AG, Medimmune Inc. and Merck & Co. Inc. during RESI's annual meeting. Panelists said that in recent years, their attentions have gravitated toward ever-earlier-stage opportunities but that best practices, such as not spamming their colleagues via email, remained unchanged.
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Celgene and BMS envision prosperous future in JPM opener

Jan. 8, 2019
By Michael Fitzhugh
SAN FRANCISCO – For what J.P. Morgan analyst Cory Kasimov called "one of the most significant pre-conference announcements ever," the tradition-steeped J.P. Morgan Healthcare Conference broke form, just a little, turning an anticipated slide talk into a comfy fireside chat with Celgene Chairman and CEO Mark Alles and the chairman and CEO of Celgene acquirer Bristol-Myers Squibb Co., Giovanni Caforio, on Monday. With the typical Q&A session to follow canceled, runners poised to bolt from the back of the Westin St. Francis Hotel's Grand Ballroom sighed, just a little.
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