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Home » Authors » Randy Osborne

Articles by Randy Osborne

Novartis wins FDA blessing for Egaten fascioliasis drug, collects PRV along the way

Feb. 15, 2019
By Randy Osborne
After having donated the benzimidazole therapy to the World Health Organization (WHO) since 2005 as a way of helping to treat about 2 million patients in more than 30 countries, Novartis AG won approval by the FDA of Egaten (triclabendazole) for fascioliasis, or liver-fluke disease, in patients 6 years of age and older.
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The gift of GABAB: Indivior moves to backup but Addex conversation still animated

Feb. 15, 2019
By Randy Osborne
Tim Dyer, CEO of Geneva-based Addex Therapeutics SA, told BioWorld that Indivior plc's decision to stop research with addiction candidate ADX-71441 and focus work on other GABAB positive allosteric modulator (PAM) therapies is "not the end of the world. The most important thing for us is that we've got a committed partner. Shifting from a lead asset to a backup – that's the business we're in," he said.
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FDA panel nod for J&J in treatment-resistant depression high tide to raise all boats

Feb. 14, 2019
By Randy Osborne
CEO Shawn Singh of Vistagen Therapeutics Inc. called the favorable vote for ketamine derivative esketamine by a joint meeting of FDA advisory panels "the writing of a bright new chapter in the history of neuropsychiatry," telling BioWorld that the "next transformative step" will involve developing more convenient, at-home options. Esketamine is given under medical supervision.
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Esketamine dream maybe not uphill drill; FDA panel favorable to J&J TRD bid

Feb. 13, 2019
By Randy Osborne

Esketamine dream maybe not uphill drill; FDA panel favorable to J&J TRD bid

Feb. 13, 2019
By Randy Osborne
Trouble surfaced early in the joint FDA panel meeting to deliberate the drug-device combo esketamine 28-mg single-use nasal spray from Johnson & Johnson unit Janssen Pharmaceuticals Inc. when an agency official said U.S. gatekeepers didn't necessarily agree about the efficacy offered to support the ketamine-derived therapy for treatment-resistant depression (TRD).
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Getting Xirius with IRDs: Nightstar's gene therapy gains 'leadership' status

Feb. 12, 2019
By Randy Osborne
The recent deal between Meiragtx Holdings plc and New Brunswick, N.J.-based Johnson & Johnson (J&J) arm Janssen Pharmaceuticals Inc. drew more eyeballs to companies targeting inherited retinal diseases (IRDs), which can only mean good things for the likes of Nightstar Therapeutics plc.
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Solid gassed in DMD bid, plans to escalate dosing; Ignite Sarepta contrasts

Feb. 8, 2019
By Randy Osborne
Although Wall Street hammered shares of Solid Biosciences Inc. (NASDAQ:SLDB) down to $15.15, or 67.8 percent, to close them Thursday at $7.19, company officials told investors of a thesis based on preclinical work that could lead to better results with SGT-001 microdystrophin gene transfer for Duchenne muscular dystrophy (DMD)
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D'oh! Wall Street surprise puts marge in charge; BLA this year in HER2-positive breast cancer

Feb. 7, 2019
By Randy Osborne
Analysts during a conference call with Macrogenics Inc. characterized themselves as "dead wrong" and called the company's phase III victory "especially sweet" with margetuximab (marge) that was "written off by so many" in HER2-positive metastatic breast cancer. The news sent shares (NASDAQ:MGNX) up 130.4 percent, or $14.49, to close Wednesday at $25.60.
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Optical fusion: Like minds meld in $4.2B Merck KGaA, GSK vision for oncology

Feb. 6, 2019
By Randy Osborne
Luciano Rossetti, head of global R&D for Merck KGaA's biopharma branch EMD Serono, told BioWorld that "a very elegant molecule, fascinating from a protein-engineering point of view in addition to the biology" lies at the heart of the potential €3.7 billion (US$4.2 billion) deal with Glaxosmithkline plc (GSK).
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Film at eleventh hour: FDA Sunovion CRL asking more info but no further studies

Feb. 6, 2019
By Randy Osborne
Sunovion Pharmaceuticals Inc. stayed mostly mum on details regarding the FDA's complete response letter (CRL) related to the NDA for apomorphine sublingual film (APL-130277) to treat "off" episodes in Parkinson's disease (PD).
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