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Home » Authors » Michael Fitzhugh

Michael Fitzhugh

Articles

ARTICLES

Beigene enlists Ambrx to help it expand biologics portfolio, with $10M up front

March 7, 2019
By Michael Fitzhugh
On a quest to expand its portfolio of new biologics, Beigene Ltd. has tapped Ambrx Inc. to use the San Diego-based company's platform of site-specific conjugation technologies to identify at least one potential new cancer medicine, with $10 million up front. The Beijing-based company could pay Ambrx up to $19 million more to initiate additional programs, which would add to Beigene's pursuit of externally sourced molecules, such as those it licensed from Zymeworks Inc. in November.
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Pfizer exercises option on early stage Antolrx's T1D immunotherapy

March 6, 2019
By Michael Fitzhugh
Privately held Antolrx Inc. said Pfizer Inc. has exercised an option to exclusively license an immune tolerance therapy from the Cambridge, Mass.-based company's type 1 diabetes (T1D) program, triggering an up-front payment of undisclosed value and potential milestones of up to $51 million, Antolrx's co-founder, president and CEO, Mark Carthy, told BioWorld.
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Abpro inks $4B bispecifics development deal with China's NJCTTQ, aiming to progress pipeline

March 5, 2019
By Michael Fitzhugh

A new U.S.-China drug discovery deal focused on developing bispecific therapies for cancer could bring Woburn, Mass.-based Abpro Therapeutics Inc. as much $4 billion, including $60 million in near-term R&D funding from its Chinese partner, NJCTTQ, a subsidiary of Nanjing Chia Tai Tianqing Pharmaceutical Group Co. Ltd. Outside of China and Thailand, Abpro will retain all commercial rights for any approved molecules, while NJCTTQ will retain rights in China.


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Evoke's Gimoti evinces doubts about readiness for FDA review

March 5, 2019
By Michael Fitzhugh
Questions about the relevant efficacy, chemistry and production of Evoke Pharma Inc.'s diabetic gastroparesis candidate, Gimoti (metoclopramide), headlined a multidisciplinary review (DR) letter from the FDA, throwing into question whether a review of the drug will be completed by its April 1 PDUFA date. The company said it plans to respond to the deficiencies raised in the letter to allow time for potential FDA review prior to the PDUFA date. Nonetheless, investors sent company shares (NASDAQ:EVOK) down 57.2 percent to $1.30 on Monday.
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Immunogen ADC falls short in phase III ovarian cancer trial

March 4, 2019
By Michael Fitzhugh
Disappointing data from a closely watched phase III trial testing Immunogen Inc.'s mirvetuximab soravtansine against platinum-resistant ovarian cancer added yet another bead to the string of challenges folate receptor alpha (FRa)-targeting agents have faced in the clinic. 
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Abpro inks $4B bispecifics development deal with China's NJCTTQ, aiming to progress pipeline

March 1, 2019
By Michael Fitzhugh
A new U.S.-China drug discovery deal focused on developing bispecific therapies for cancer could bring Woburn, Mass.-based Abpro Therapeutics Inc. as much $4 billion, including $60 million in near-term R&D funding from its Chinese partner, NJCTTQ, a subsidiary of Nanjing Chia Tai Tianqing Pharmaceutical Group Co. Ltd. Outside of China and Thailand, Abpro will retain all commercial rights for any approved molecules, while NJCTTQ will retain rights in China.
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Blackstone launches CVD-focused Anthos with $250M investment

Feb. 28, 2019
By Michael Fitzhugh
Anthos Therapeutics Inc., a new company formed with a $250 million investment from Clarus Ventures successor Blackstone Life Sciences, has in-licensed an antithrombotic agent shelved by Novartis AG. The asset, MAA-868, has the potential to prevent a variety of cardiovascular disorders (CVD) with minimal or no bleeding risk within a new long-acting treatment paradigm, the company said. John Glasspool, a former leader of Novartis' cardiovascular franchise, will lead the company as its CEO and Novartis will hold a minority stake in the company.
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FDA adcom counsels delaying review decision for Karyopharm's selinexor

Feb. 27, 2019
By Michael Fitzhugh
Karyopharm Therapeutics Inc.'s lead agent, selinexor, endured a tough hearing before the FDA's Oncologic Drugs Advisory Committee Tuesday, leading agency advisors to ultimately vote 8-5 in favor of delaying approval until the results of the randomized phase III trial, BOSTON, are available. The outcome could delay selinexor's potential approval by about two years.
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Novartis exercises first of two options on Akcea CV drugs, triggering $150M payment

Feb. 26, 2019
By Michael Fitzhugh
Amid a growing global incidence of cardiovascular disease (CVD), Novartis AG has exercised the first of two options it holds on antisense drugs developed by Ionis Pharmaceuticals Inc. affiliate Akcea Therapeutics Inc., triggering a $150 million payment to Akcea from Novartis and boosting its shares (NASADQ:AKCA) by 16.7 percent to $31.91 on Monday.
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Voyager shares vault higher as Abbvie options Parkinson's candidates for $1.54B

Feb. 25, 2019
By Michael Fitzhugh
Energized by the opening of a second front in a high-stakes gene therapy collaboration with Abbvie Inc., investors in Voyager Therapeutics Inc. lifted company shares (NASDAQ:VYGR) 22.9 percent to $13.12 Friday. Under terms of the deal, Voyager's second in Parkinson's disease (PD) in as many months, Abbvie will pay the company $65 million up front in exchange for an exclusive option to license vectorized antibodies targeting misfolded alpha-synuclein proteins for synucleinopathies, like PD. Voyager will foot the bill for developing and testing the compounds through phase I.
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