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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Takeda strikes $662.5M CD38-targeting deal with Molecular Templates

Sep. 20, 2018
By Michael Fitzhugh
Takeda Pharmaceutical Co. Ltd. has agreed to pay Molecular Templates Inc. $30 million up front and potential milestone payments of as much as $632.5 million should the Austin, Texas-based company choose to co-develop CD38-targeted engineered toxin bodies (ETB) for the treatment of patients with diseases such as multiple myeloma. News of the deal lifted Molecular Templates' shares (NASDAQ:MTEM) 52.4 percent higher on Wednesday to $6.25.
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Viking shares vault higher as phase II points to potential in NASH

Sep. 19, 2018
By Michael Fitzhugh
Shares of Viking Therapeutics Inc. (NASDAQ:VKTX) shot up 87.3 percent to $19.46 Tuesday on news that, relative to placebo, its thyroid receptor beta agonist, VK-2809, reduced low-density lipoprotein cholesterol (LDL-C) and lowered liver fat content in people with elevated LDL-C and nonalcoholic fatty liver disease (NAFLD). The top-line phase II data suggest the drug may be effective in battling the progressive form of NAFLD, nonalcoholic steatohepatitis (NASH).
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Post-Roivant buy, IPF-related cough drug advances under Respivant flag

Sep. 18, 2018
By Michael Fitzhugh
Having sold its only candidate to Roivant Sciences Ltd., San Diego's Patara Pharma Inc. is re-launching as Respivant Sciences Inc., becoming the 13th "Vant" launched by the Basel-based conglomerate. Current plans call for a phase IIb dose-ranging study of the drug intended to reduce chronic cough in patients with idiopathic pulmonary fibrosis (IPF), which is set to begin in the first quarter of 2019. The drug, RVT-1601, is a new formulation of the well-known mast cell stabilizer cromolyn sodium, intended for delivery via a nebulizer already used in other approved products.
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Gottlieb calls for 'all-hands-on-deck' to tackle antibiotic resistance

Sep. 17, 2018
By Michael Fitzhugh
Seeking to unite FDA efforts to combat antimicrobial resistance (AMR), Commissioner Scott Gottlieb outlined a new strategy to use stewardship and science to slow the threat's pace and reduce its impact. The plan seeks to better facilitate and pep up new antimicrobial product development as the field wrestles with new ideas about how to overcome the market's discouraging economics.
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BMS psoriasis results highlight distinct appeal of Tyk2 target

Sep. 14, 2018
By Michael Fitzhugh
A positive phase II readout for Bristol-Myers Squibb Co.'s lead oral tyrosine kinase 2 (Tyk2) inhibitor in plaque psoriasis has shone a new light on signaling pathways explored by few drugmakers to date. Despite the pathway's implication in multiple immune-mediated diseases, the phase III program BMS is actively enrolling for patients with moderate to severe plaque psoriasis puts it at the head of a cohort that includes just two other clinical-stage drugs of the class – both Pfizer Inc.'s – and only four discovery-stage assets, according to Cortellis.
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Gilead strikes $445M+ HBV deal with Precision Biosciences

Sep. 13, 2018
By Michael Fitzhugh
A new strategic collaboration between Gilead Sciences Inc. and privately held Precision Biosciences Inc. will focus on developing therapies targeting the in vivo elimination of hepatitis B virus (HBV) with Precision's Arcus genome editing technology. Precision is eligible for milestone payments of up to $445 million under the terms of the deal and, if successful, could see tiered royalties on sales reaching the midteens. The agreement could eventually lead Gilead to a potent new offering in HBV, where generic medicines have decimated the once-formidable revenues generated by Viread (tenofovir disoproxil fumarate), and sales of its newer medicine, Vemlidy (tenofovir alafenamide), have yet to gain the same traction.
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Oncoresponse completes $40M series B, shifting from discovery to development

Sep. 12, 2018
By Michael Fitzhugh
Oncoresponse Inc., a company formed by Theraclone Sciences Inc. and the University of Texas MD Anderson Cancer Center to screen and discover therapeutically relevant antibodies from patients successfully treated with immunotherapy, has completed a $40 million series B equity financing. Proceeds of the round will support the advancement of five candidates into preclinical and clinical development, the Seattle-based company said.
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Chi-Med wins China approval for fruquintinib in patients with third-line colorectal cancer

Sep. 12, 2018
By Michael Fitzhugh
The first China-discovered and developed treatment for colorectal cancer (CRC), fruquintinib, won approval from the National Medical Products Administration of China, marking Hutchison China Meditech Ltd.'s (Chi-Med) first approval for an innovative medicine. The drug, a small-molecule inhibitor of VEGF receptors to be marketed as Elunate, is now approved for the treatment of metastatic CRC patients who have failed at least two prior systemic antineoplastic therapies.
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Aurobindo Pharma strikes $1B deal for parts of Sandoz generics portfolio

Sep. 7, 2018
By Michael Fitzhugh
Aurobindo Pharma USA Inc. has agreed to pay Novartis AG's generics division, Sandoz Inc., up to $1 billion for a basket of dermatology and generic oral medicines that the Swiss drugmaker is divesting as it pursues growth amid increasingly challenging forces in the generics space. With an up-front purchase price of $900 million plus up to $100 million in potential earn-outs, the deal will add about 300 products to Aurobindo's portfolio, including projects in development, as well as new U.S.-based commercial and manufacturing capabilities.
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Chi-Med wins China approval for fruquintinib in third-line CRC

Sep. 6, 2018
By Michael Fitzhugh
The first China-discovered and developed treatment for colorectal cancer (CRC), fruquintinib, has won approval from the National Medical Products Administration of China, marking Hutchison China Meditech Ltd.'s (Chi-Med) first approval for an innovative medicine. The drug, a small-molecule inhibitor of VEGF receptors to be marketed as Elunate, is now approved for the treatment of metastatic CRC patients who have failed at least two prior systemic antineoplastic therapies.
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