FDA awards QIDP status to Acurx's Clostridium difficile infection drug | Joint structural damage data added to Novartis' Cosentyx label | CytoDyn files protocol amendments for Phase II GVHD study
June 21, 2018
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FDA awards QIDP status to Acurx's Clostridium difficile infection drug
Acurx Pharmaceuticals' ACX-362E, being developed to treat patients with Clostridium difficile infection, received qualified infectious disease product status from the FDA. The company intends to launch an early-stage clinical trial of the candidate in the fourth quarter.
eMPR (6/20) 
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2018 Life Sciences Accounting & Financial Reporting Update
How can life sciences companies keep pace with emerging accounting and financial reporting challenges? Learn about new accounting standards for revenue recognition, leases, and definition of a business and existing rules for R&D, income taxes and more. Download Deloitte's ninth annual update here.
Health Care & Policy
Joint structural damage data added to Novartis' Cosentyx label
The FDA approved the inclusion of new evidence from a late-stage study that Novartis' Cosentyx, or secukinumab, slows progression of joint structural damage at week 24 in patients with active psoriatic arthritis.
PharmaTimes online (UK) (6/20) 
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CytoDyn files protocol amendments for Phase II GVHD study
CytoDyn submitted to the FDA protocol amendments for a Phase II study of PRO 140 in patients with graft-versus-host disease, which includes switching pretreatment conditioning to reduced intensity conditioning from aggressive myeloablative conditioning. The revision also includes switching to open-label design from a blinded 1-to-1 randomized placebo-controlled design and a 50% increase in the PRO 140 dose.
Seeking Alpha (6/20) 
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Moleculin Biotech gains approval for leukemia drug trial in Poland
A regulator in Poland granted Moleculin Biotech approval to begin a Phase I/II clinical trial of its experimental drug Annamycin, indicated for relapsed or refractory acute myeloid leukemia. The approval will allow Moleculin to start patient recruitment, with the study expected to begin later this year.
Proactive Investors (6/20) 
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FDA panel sets review date for 2 NDAs for Paratek's omadacycline
FDA's Antimicrobial Drugs Advisory Committee will meet Aug. 8 to discuss two new drug applications for Paratek Pharmaceuticals' qualified infectious disease product- and fast-track-tagged omadacycline, in oral and IV formulations, for the treatment of patients with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. The candidate achieved the primary endpoints of three late-stage studies for both indications.
BioCentury (6/20) 
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Company & Financial News
Follow-on funding pulls in $73.1M for ObsEva
Follow-on funding pulled in $73.1 million for ObsEva, which recently reported that its candidate OBE2109, or linzagolix, met the primary endpoint in the Phase IIb EDELWEISS study for endometriosis-associated pain indication. The company also has Phase III PRIMROSE 1 and 2 trials of the candidate for uterine fibroid-associated heavy menstrual bleeding.
BioCentury (6/20) 
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Aminex pulls in $10M in funding from untranched Series B round
An untranched round of Series B financing pulled in $10 million for Aminex Therapeutics. The company recently dosed the first patient in an early-stage trial of AMXT 1501 as monotherapy or in combination with eflornithine to treat solid tumors.
BioCentury (6/20) 
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Industry Deals
TG, Novimmune partner to develop bispecific antibody for B cell malignancies
TG Therapeutics and Novimmune of Switzerland will collaborate on developing the latter's bispecific antibody TG-1801 to treat hematologic B cell malignancies, with the partners planning to launch clinical testing of their candidate, to be developed and marketed by TG, this year or early next year. In addition to an undisclosed exclusive option, Novimmune will gain $3 million in TG stock upfront plus early clinical development milestones, with additional milestones totaling up to $185 million and royalties if TG exercises its own undisclosed exclusive option.
BioCentury (6/20) 
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Food & Agriculture
Biotech pigs immune to PRRS
Editing a section of pigs' DNA left them immune to the virus that causes porcine reproductive and respiratory syndrome, a disease that causes abortion and breathing problems for which there is no effective vaccine or treatment. The technology could improve herd health and reduce the need for antibiotic use, experts said.
The Guardian (London) (6/20) 
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Industrial & Environmental
Energy Dept. to award $40M for 31 biofuels, bioproducts projects
A total of $40 million will be awarded by the Energy Department to 31 projects furthering studies on how organisms such as yeast, fungi, cyanobacteria and rare thermophilic microbes can be used to produce bioproducts including biofuels from renewable resources.
Biofuels Digest (6/20) 
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The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com.
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