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Whitehouse Labs expands drug delivery device testing capabilities
Whitehouse Laboratories, a division of Albany Molecular Research, said today that it has expanded its drug delivery device testing capabilities to include services for ISO 80369 standards. The 8...
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OpGen prices $10m public offering
OpGen (NSDQ:OPGN) said earlier this month that it priced a $10 million public offering of 25 million units of common stock and warrants at 40¢ apiece. The molecular diagnostics company said each common...
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Anika inks $350k settlement with former CMO Mascioli, hits $5m milestone
Anika Therapeutics (NSDQ:ANIK) said last week that it agreed to pay former chief medical officer Dr. Stephen Mascioli $350,000 “for all alleged damages and attorneys’ fees.” In return, Mascioli agreed...
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FDA grants regenerative medicine advanced therapy status to Mallinckrodt’s...
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that its StrataGraft regenerative skin tissue won regenerative medicine advanced therapy status from the FDA. The tissue-based therapy is among the...
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Voluntis wins regulatory nod to integrate Toujeo insulin with Insulia mobile app
Voluntis said today its digital management system for people with Type II diabetes, Insulia, won FDA clearance and CE Mark approval to integrate Sanofi‘s (NYSE:SNY) Toujeo insulin glargine. The...
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Corium touts clinical data for transdermal delivery of Alzheimer’s drug
Corium (NSDQ:CORI) touted data today from a pilot bioequivalence study, comparing its Corplex Donepezil transdermal patch to oral Aricept as delivery method for the most commonly prescribed treatment...
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Provention Bio evaluates vaccine to prevent onset of T1D
Provention Bio said today that it licensed an enterovirus vaccine platform that it plans to evaluate as a way to prevent the onset of Type I diabetes by vaccinating against infection by a...
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Novartis sales down -2% but ahead of estimates in Q2
Shares in Novartis (NYSE:NVS) rose today after the pharmaceutical company met expectations on Wall Street with its second quarter results. The company posted profits of $1.98 billion, or 84¢ per share,...
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CDC gives $12m to states to fight opioid epidemic
The Centers for Disease Control and Prevention said today that it plans to award more than $12 million this week to 23 states and the District of Columbia to support their efforts in tackling the...
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Employee alleges Teva hid DOJ antitrust probe in lawsuit
Teva Pharmaceuticals (NYSE:TEVA) employee Robert Huellemeier launched a proposed class action suit against the generic drugmaker this week, alleging that the company hid that it was under investigation...
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Drugmakers talk competition & innovation with FDA leaders
Drugmakers, payers and patient advocates convened at the FDA’s White Oak campus yesterday to present before a panel of regulatory leaders about competition and innovation in the pharmaceutical...
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EU watchdog: EU drug agency may be too cozy with industry
(Reuters) – The European Medicines Agency (EMA), eager to accelerate access to promising new drugs, may be getting too cozy with the pharmaceutical companies it regulates. That is the concern of the...
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Report: Pipeline of Alzheimer’s drugs ‘due for big victories’ in next 5 years
There are twenty-seven Alzheimer’s drugs in late-stage clinical trials and eight candidates in Phase II programs that could launch in the next 5 years, according to an analysis presented this week at...
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Leukemia trial to match patients with drugs based on genetic biomarkers
The Leukemia & Lymphoma Society said today that its expanding its Beat AML Master trial to include five investigational treatments for acute myeloid leukemia. The trial, which launched in October...
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Antibiotic-eluting polymer could help treat prosthetic joint infections
Researchers from Massachusetts General Hospital have developed an antibiotic-eluting polymer that could be used to treat infections in orthopedic implants, according to a report published in Nature...
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Report: Cardinal Health puts Chinese drug distro biz on the auction block
Cardinal Health (NYSE:CAH) is reportedly shopping its Chinese drug distribution business, drawing keen interest from state-backed pharmaceutical firms in a deal that could be worth as much as $1.5...
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Inovio prices $75m public offering
Inovio Pharmaceuticals (NSDQ:INO) said today that it priced its underwritten public offering of 12.5 million shares of common stock at $6.00 apiece. The offering is expected to bring in nearly $75...
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Mylan, Theravance’s inhaled COPD therapy proves safe in late-stage trial
Mylan (NSDQ:MYL) and Theravance Biopharma, Inc. (NSDQ:TBPH) touted safety data yesterday from the late-stage trial of its once-daily inhaled bronchodilator, revefenacin, in patients with chronic...
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Akorn shareholders approve merger deal with Fresenius Kabi
Akorn Inc. (NSDQ:AKRX) shareholders voted yesterday to approve its $4.75 billion merger deal with German healthcare company Fresenius (ETR:FRE). Fresenius’ Kabi division announced in April that it...
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Lawsuit stalls approval of Merck’s insulin injection
Merck (NYSE:MRK) said today that the FDA granted tentative approval for its Lusduna Nexvue insulin glargine injection. The biologic basal insulin met regulatory standards, the company said, but a...
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