Posts tagged NDA
FDA advisory vote on TLANDO not a knockout for Lipocine

Although Lipocine (NASDAQ:LPCN) is disappointed by a FDA advisory committee vote against the benefit/risk profile of TLANDO, its oral testosterone replacement therapy (TRT), the company believes there is still a path forward for TLANDO.

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Appili readies antibiotic bridging study

Closely-held Appili Therapeutics plans to begin late in the current quarter a Phase 1 bridging, or bioequivalence, study of its lead anti-infective, ATI-1501, a reformulated, taste-masked liquid suspension of metronidazole, targeting anaerobic bacterial infections, including Clostridium difficile.

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Microbix in talks with investors for Kinlytic relaunch

Following a meeting with the FDA last month, Microbix Biosystems (TSX:MBX) is entertaining expressions of interest from potential partners to license or acquire its anti-clotting urokinase drug, which has been rebranded as Kinlytic, and also provide funding for its re-launch in the U.S. market.

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In conversation with Chiara Russo

As a specialty pharmaceuticals analyst with Cantor Fitzgerald for the past 2 1/2 years, Chiara Russo covers developmental-stage companies that are on the cusp of changing the medical landscape as we know it. A philosophy major with an MBA from the Olin School of Business at Babson College, Ms. Russo was a R&D innovation consultant for Cubist Pharmaceuticals before becoming a sell-side equity research analyst. On the Street, she has been a research associate at ThinkEquity and VP and specialty pharmaceuticals analyst at Janney Montgomery Scott. In this interview with BioTuesdays.com, Ms. Russo discusses industry trends and some of the stocks she likes.

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IntelGenx sees 2017 milestones as transformational

IntelGenx (OTCQX:IGXT; TSX-V:IGX) has multiple milestones on tap this year with its oral film drug delivery platform, VersaFilm, as it continues building strategic partnerships in the pharmaceutical industry.

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NeuroproteXeon targets Q2 start of Phase 3 Xenex trial

Closely-held NeuroproteXeon has received agreement on a special protocol assessment from the FDA for a Phase 3 trial of its inhaled pharmaceutical grade product, XENEX, a xenon gas formulation, as a neuroprotecter against brain cell death following acute neurologic injury, such as cardiac arrest.

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ARIAD hopes to launch second oncology drug in early 2017

ARIAD Pharmaceuticals (NASDAQ:ARIA) is hoping to receive FDA approval to commercialize in early 2017 its second orphan oncology product, brigatinib, for the treatment of certain genetic forms of non-small cell lung cancer.

At the end of 2012, the company launched Iclusig (ponatinib) to treat patients with several genetic types of chronic myeloid leukemia.

“As an orphan oncology company, we address discrete populations of patients that are genetically defined,” Tim Clackson, president of R&D and CSO, says in an interview with BioTuesdays.com.

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EyeGate developing non-invasive ophthalmic treatments

EyeGate Pharmaceuticals (NASDAQ:EYEG) is developing a non-invasive drug delivery platform that uses an electrical process, known as iontophoresis, to deliver a corticosteroid to the front-and back-of-the-eye for the treatment of ophthalmic conditions, such as anterior uveitis, macular edema and post-cataract surgery inflammation.

“Our EyeGate II Delivery System addresses two of the most prevalent issues in ophthalmic care: the existing lack of patient compliance with eye drops and patient safety from the use of intravitreal injections,” president and CEO, Stephen From, says in an interview with BioTuesdays.com.

EyeGate, which went public 11 months ago, signed an exclusive, worldwide licensing agreement last summer with the Bausch & Lomb subsidiary of Valeant Pharmaceuticals International (NYSE, TSX:VRX) for its EGP-437 corticosteroid in the field of uveitis, as well as a right of last negotiation to license the product for other indications.

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Titan Pharma Phase 3 data validate ProNeura technology

Titan Pharmaceuticals’ (OTCQB:TTNP) positive topline results from a Phase 3 clinical study of Probuphine, its subdermal implant of buprenorphine for the long-term maintenance treatment of opioid addiction, validate the company’s ProNeura continuous drug delivery technology.

Yesterday, the company reported that the PRO-814 Phase 3 study, comparing maintenance treatment with Probuphine to treatment with a daily dosed sublingual buprenorphine/naloxone tablet, met the FDA’s pre-specified primary endpoint of non-inferiority, as well as all secondary efficacy endpoints.

Buprenorphine, the active ingredient in the Probuphine implant, is the standard of care for the treatment of opioid dependence, replacing methadone. It is currently available as daily dosed sublingual tablets and film formulations, with estimated 2013 sales of $1.5-billion for the oral formulation in the U.S.

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