dimarts, 30 de maig del 2017

X-Biotix to address antibiotic resistance with chemical scaffolds

X-Chem PharmaceuticalsX-Biotix Therapeutics launched today with technology from Harvard Medical School that the company said will aim to address the threat of antibiotic resistance.

According to the multi-year collaboration and license agreement, the team plans to identify antibiotic scaffolds that target multi-drug-resistant Gram-negative pathogens.

X-Biotix spun out of the privately-held biotech X-Chem, which develops novel small molecule therapeutics using its DNA-encoding technology platform, DEX. X-Biotix plans to use the DEX platform to discover and develop chemical scaffolds that target Gram-negative pathogens.

Get the full story at our sister site, Drug Delivery Business News.

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Sirtex hops after Aussie court dismisses shareholders injunction

Sirtex MedicalSirtex Medical (ASX:SRX) said yesterday that Australia’s Federal Court dismissed a lawsuit filed by shareholders alleging it breached continuous disclosure obligations and engaged in misleading and deceptive conduct.

The lawsuit alleges that the double-digit growth outlook for dose sales for its fiscal year 2017, which the company announced on Aug. 24 last year, “has no reasonable grounds.” Yesterday the Australian company said the Federal Court dismissed the shareholders’ bid for an injunction, freeing Sirtex to plan a June 7 share repurchasing plan worth $22.4 million (A$30 million).

Get the full story at our sister site, Drug Delivery Business News.

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FDA deals setback to Sunovion for inhaled COPD therapy

Sunovion PharmaceuticalsThe FDA issued a complete response letter to Sunovion Pharmaceuticals in regards to the new drug application for its eFlow chronic obstructive pulmonary disease drug-device combo.

The investigational eFlow closed-system nebulizer delivers a long-acting muscarinic antagonist bronchodilator, glycopyrrolate, to reduce airflow obstruction in COPD patients.

Get the full story at our sister site, Drug Delivery Business News.

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J&J’s Ethicon asks Supreme Court to review $3m pelvic mesh loss

EthiconJohnson & Johnson (NYSE:JNJ) subsidiary Ethicon last week asked the U.S. Supreme Court to review a $3.3 million loss in a product liability lawsuit brought over its TVT-O pelvic mesh.

A federal appeals court in January upheld a $3.3 million verdict against  in a product liability lawsuit brought over its TVT-O pelvic mesh.

A jury in the U.S. District Court for Southern West Virginia awarded Jo Huskey and her husband damages of $3.3 million, finding in September 2014 that the TVT-O transvaginal sling caused her injuries and that the company failed to warn about the stress urinary incontinence treatment’s risks. A federal judge later shot down Ethicon’s bid to overturn the verdict and denied the company’s move for a new trial; Ethicon then appealed to the U.S. Court of Appeals for the 4th Circuit.

In January a 3-judge panel at the 4th Circuit denied the appeal, ruling that the Huskeys proved their case.

Ethicon’s petition for certiorari to the Supremes, filed May 23, alleges that the appellate court improperly excluded product review evidence after misreading the relevant precedent, according to Law360.

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Revive Therapeutics, University of Wisconsin-Madison ink deal for cannabinoid drug delivery tech

Revive TherapeuticsRevive Therapeutics (OTC:RVVTF) said today that it inked a research agreement with the University of Wisconsin-Madison to develop a drug delivery technology for cannibinoids.

The research program, led by Jess Reed, is slated to evaluate chitosan-tannin composite biomaterial as a delivery mechanism for cannabinoids. Therapeutic biomaterials made from a composite of chitosan and tannin include nanoparticles, hydrogels, bio-foams, bio-gels or a liposomal coating.

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Medtronic increases stake in Saluda Medical

Saluda MedicalSaluda Medical said it raised nearly $40 million (A$53 million) for the Evoke closed-loop neuromodulation device it’s developing to treat axial back pain.

The round was led by a new investor, GlaxoSmithKline‘s (NYSE:GSK) Action Potential Venture Capital, joined by existing backer Medtronic (NYSE:MDT), Artarmon, Australia- and Bloomington, Minn.-based Saluda said.

The Evoke spinal cord stimulator is designed to tailor its therapy to each patient’s “neural fingerprint,” the company said, citing a 32-patient clinical study showing an average sustained improvement of 80% relief at 6 months and clinically meaningful improvements in function, disability and sleep.

Saluda said it plans to use the proceeds to back a U.S. pivotal trial and commercialize Evoke in Australia and the European Union.

“Action Potential Venture Capital shares our vision and enthusiasm for bringing innovative neuromodulation devices to market, and we welcome them at this critical time for Saluda Medical as we make progress toward our regulatory and commercial milestones,” CEO John Parker said in prepared remarks. “With support from our engaged investors, we remain committed to developing new approaches to bring relief to patients suffering from chronic pain and other disorders that may be treated with our technology.”

“Saluda Medical is advancing and expanding the field of bioelectronic medicines. Saluda has developed the first therapeutic device that is designed to both constantly read and modulate signals on the spinal cord to treat chronic pain,” added APCV partner Juan-Pablo Mas. “We are encouraged by the international clinical results to date, and believe Saluda’s technology can potentially provide various clinical benefits to patients. We are very pleased to have Saluda among our portfolio of innovative bioelectronic companies.”

($1 = A$1.34221)

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Potential Alcon sale worries Novartis investors

Novartis eyes Alcon saleNovartis (NYSE:NVS) CEO Joe Jimenez’s consideration of the sale of the Alcon subsidiary has investors worried that the influx of cash – Alcon’s surgical devices and contact lens business could fetch as much as $35 billion – will result in another misguided acquisition.

The Swiss drugmaker paid $52 million for Alcon in 2011, but the division’s sales and earnings have been on the schneid for the past 2 years, prompting Jimenez to mull a sale. Also in play is a $ 14 billion stake in pharma rival Roche (PINK:RHHBY) and a $10 billion over-the-counter drug joint venture with GlaxoSmithKline (NYSE:GSK). Novartis faces a March 2018 deadline to exercise its put option for its 36.5%, with GSK said to be a willing buyer.

But the Alcon fiasco has investors chary of another big buyout.

Get the full story at our sister site, Drug Delivery Business News.

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