After AdComm rejection, Correvio Pharma hit with FDA complete response letter

FierceBiotech | December 27, 2019

After AdComm rejection, Correvio Pharma hit with FDA complete response letter
Correvio Pharma is not having a happy holiday. After being hit by an FDA AdComm rejection a few weeks back, its heart drug has now also been denied approval by the FDA.   In the AdComm, the Canadian company saw an overwhelmingly negative vote (11-2) against its drug to correct irregular rhythm in the upper chambers of the heart in adult patients. It was voted down over serious safety risks including low blood pressure and irregular rhythm in the lower heart chambers along with deaths during the trials. The drug, known as Brinavess (vernakalant IV), is approved outside the U.S. but needs U.S. sales to boost its share, which could swell to $150 million from the American market. The drug has a long record, as it tried and failed to gain FDA approval over the past 13 years and has also seen the regulator put the drug on a clinical hold.

Spotlight

Vitamin D is absolutely essential for good health. Also known as the sunshine vitamin, it is made in your skin when exposed to sunlight. In spite of that, vitamin D deficiency is one of the most common nutrient deficiencies in the world. Up to 42% of the adult population in the US has low vitamin D levels, which can cause health problems. Vitamin D is particularly important for bone health and immune system function. This article discusses how much vitamin D you need.

Spotlight

Vitamin D is absolutely essential for good health. Also known as the sunshine vitamin, it is made in your skin when exposed to sunlight. In spite of that, vitamin D deficiency is one of the most common nutrient deficiencies in the world. Up to 42% of the adult population in the US has low vitamin D levels, which can cause health problems. Vitamin D is particularly important for bone health and immune system function. This article discusses how much vitamin D you need.

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PHARMACY MARKET

Kedalion Therapeutics Secures Series B Funding and Announces Signing of Option to Acquire Agreement

Kedalion Therapeutics, | November 16, 2021

Kedalion Therapeutics is pleased to announce the completion of its Series B financing led by Novartis and involving a combination of new and existing investors. The Novartis investment includes an Exclusive Option to Acquire the company and its AcuStream™ technology. This agreement follows a Feasibility Study agreement with the AcuStream™ technology signed earlier this year. The subsequent feasibility study has been completed with successful results. Collaboration between the two parties is ongoing. The financial and other terms of this transaction are not disclosed. Kedalion’s AcuStream™ platform is a highly innovative, digitally connected, electromechanical topical ocular delivery device that aims to address a potential unmet need for a convenient, user-friendly device that reliably, accurately, and comfortably delivers topical ocular therapy with improved efficiency and patient comfort, and reduced reliance on patient skill and instillation technique when administered by a physician.1 The multi-dose, preservative-free platform strives to enable intended aim, potential for a comfortable patient experience, micro-dosing capability, and in phase 1 proof of concept studies, has shown a potential for a reduction in delivery dose of an intended therapy.1-4 Kedalion will continue to move forward with the development of the AcuStream™ platform across multiple disease categories, drug classes and compositions, including the treatment of presbyopia. The AcuStream™ technology has a potential to enhance the patient experience and optimize treatment outcomes of the company’s highly advanced portfolio of topical ocular drug products in development. The company looks forward to the opportunity to collaborate with Novartis Innovative Medicines as a valued investor and partner in developing our technology platform and therapeutic targets. “At Novartis, we are committed to reimagining medicine and investigating innovative approaches that have the potential to address unmet patient needs. The AcuStream™ technology is a novel platform with broad applicability in ophthalmics and we envisio that it could help us deliver transformative solutions to the patients who rely on our therapeutics to treat a range of eye conditions.” Jill Hopkins, Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals Dr. Mark Blumenkranz, the Chairman and Chief Executive of Kedalion Therapeutics, commented that “this transaction and associated further studies will help us accomplish our goal of revolutionizing the way drugs are delivered to the eye. The AcuStream™ technology, which strives to enable easier aiming, micro-dosing capability, and a potential for a reduction in delivery dose of an intended therapy, has the potential for a comfortable patient experience for patients worldwide.1 The platform could potentially provide convenience and enable micro-dosing capability for various ocular diseases.1 We see our capabilities coupled with the scientific and market leadership of Novartis in ophthalmics to be a winning formula for both organizations.” About Kedalion Therapeutics Kedalion Therapeutics is a venture-backed, clinical-stage biotechnology company whose mission is to bring to market transformative topical ophthalmic therapies for new and existing indications. Kedalion’s proprietary AcuStream™ platform technology delivers topical drugs to the eye in a precise and accurate manner that enables comparable effect with up to an 80% reduction in dose compared to standard eye drops. Kedalion is based in Menlo Park, CA.

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RESEARCH

UConn startup DIANT bags license for continuous nanoparticle manufacturing tech

UConn | November 20, 2020

Consistent assembling has just begun to override customary group handling in the domain of tablet creation. The following region due for an assembling update? Nanoparticle drug conveyance frameworks, one startup thinks—and it's currently prepared to pitch its foundation to drugmakers. The University of Connecticut as of late authorized its ceaseless nanoparticle fabricating innovation to DIANT Pharma, a startup helped to establish by the stage's designers Antonio Costa, Ph.D., and Diane Burgess, Ph.D. The high-throughput framework can possibly spare tidy up room space, bring down the quantity of preparing steps and diminish the quantity of bunches created every year. Since the stage is persistent, it should empower makers to hop in the event that anything turns out badly, redirecting or eliminating just a little bit of the item instead of rejecting a whole group, Costa, CEO at DIANT and partner research teacher at UConn, said in a meeting.

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Fixx Pharmaceuticals Wants to Dominate Hemophilia Market With Gene Editing

Prnewswire | August 28, 2020

Fixx Pharmaceuticals Inc. is pleased to announce the launch of its biotechnology business operations in Las Vegas, Nevada and San Francisco, California. The company is focused on developing a cure for Hemophilia through the use of CRISPR gene editing. There are currently 20,000 people in the U.S. who suffer from hemophilia and 400,000 globally. "We are looking to commercialize a product as soon as possible," says Jesse John Francis Clark, founder of Fixx. "We are going to develop a product that is more cost-effective for payers. We're looking to keep it under $2 million per patient," he said, saying that the overall cost of care of hemophilia patients will decrease. "If we are successful in developing a commercialized product, we are looking at upwards of $40 billion in sales from the U.S. market alone. I think our investors will be happy with that," says Clark.

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