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BioWorld - Thursday, February 5, 2026
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Teva primes new delivery tech venture with $35M investment

June 19, 2015
By Michael Fitzhugh
Teva Pharmaceutical Industries Ltd. is partnering with drug delivery specialist Microchips Biotech Inc. to develop a tiny implantable chip capable of storing and releasing hundreds of therapeutic doses of drug for periods ranging from months to years. If successful, the platform could potentially help the company win the favor of doctors, patients and payers, all of which stand to realize distinct advantages from the technology.
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Synergy shares rise on positive CIC drug data

June 18, 2015
By Michael Fitzhugh
Synergy Pharmaceuticals Inc. shares (NASDAQ:SGYP) leapt 67.7 percent to close at $7.78 Wednesday on news that the company's wholly owned chronic idiopathic constipation (CIC) drug, plecanatide, met the primary endpoint in the first of two pivotal phase III studies, laying the groundwork for it to file a new drug application (NDA) with the FDA in the fourth quarter, with the expectation of an early 2017 launch.
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Vtv plots market debut to back Alzheimer's, diabetes drug trials

June 17, 2015
By Michael Fitzhugh
Vtv Therapeutics Inc., a new company formed by combining Transtech Pharma LLC and its affiliate High Point Pharmaceuticals LLC, has filed to raise up to $172.5 million in an IPO intended to help complete the company's formation and fund new trials of its lead programs, including a phase III study of its lead Alzheimer's disease (AD) drug candidate, azeliragon, and phase II trials of its type 2 diabetes drug candidates.
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Bioatla lands $30M to back new China collaborations

June 17, 2015
By Michael Fitzhugh
A group of China-based investors is backing Bioatla LLC's bid to address growing demand for new immunotherapies in the country with a $30 million equity buy-in. Bioatla President, CEO and Chairman Jay Short called it a "transformative event" that will help the company leverage expertise at its established Beijing lab to build new strategic partnerships with Chinese biophama companies in pursuit of further developing its conditionally active biologic (CAB) antibody platform and other technologies.
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FDA's reslizumab reCeption: Agency accepts Teva's BLA for uncontrolled asthma

June 16, 2015
By Michael Fitzhugh
The true value of reslizumab, recognition of which helped Teva Pharmaceutical Industries Ltd. win its 2011 bid for Cephalon Inc., moved a step closer to being more widely known Monday as the FDA accepted Teva's biologics license application (BLA) for the potential therapy.
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Bioatla lands $30M to back new China collaborations

June 12, 2015
By Michael Fitzhugh
A group of China-based investors is backing Bioatla LLC's bid to address growing demand for new immunotherapies in the country with a $30 million equity buy-in.
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Biosimilars continue their march on RA market, bolstered by bioequivalence studies

June 11, 2015
By Michael Fitzhugh
New head-to-head data proving biosimilar versions of some of the world's bestselling rheumatoid arthritis (RA) therapies are as safe and effective as their branded counterparts are being presented by Merck & Co. Inc., its partner Samsung Bioepis Co. Ltd. and competitors at the European League Against Rheumatism Annual Congress this week.
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Sage shares shine as '547 shows early potential against postpartum depression

June 10, 2015
By Michael Fitzhugh
Sage Therapeutics Inc. shares (NASDAQ:SAGE) rose 15.4 percent to $86.71 on Tuesday after hitting a 52-week high on news that the company is accelerating plans to begin testing its most advanced compound, SAGE-547, in a new trial for the treatment of postpartum depression before the end of this year.
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Reviewers question LDL-C endpoint in the mostly positive PCSK9 briefing documents

June 9, 2015
By Michael Fitzhugh
FDA reviewers spotlighting the first two drugs in a new class of cholesterol-lowering therapies to be considered by its advisors this week suggested that each injectable medicine provides benefits, but also expressed concerns about which patients might benefit most and what side effects patients taking the new drugs may encounter.
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Vertex inks potential $1.2B deal for rights to ENaC inhibitors

June 8, 2015
By Michael Fitzhugh
Vertex Pharmaceuticals Inc. is betting $80 million up front plus up to $490 million in milestones on a new avenue for addressing pulmonary pathology developed by Parion Sciences Inc., that could potentially improve the treatment of cystic fibrosis (CF) and other lung diseases.
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