GW Pharma Plans Epidiolex Launch, Making It Stand Out Among Other Cannabis Products

GW Pharmaceutical’s Epidiolex, the cannabidiol CBD that received a green light from the FDA for management of rare variants of epilepsy, is determined to change physicians’ perspectives about it and make it stand out from the oils available at cannabis stores and hence, recruited around 66 sales executives related to neurology dedicated to persuading 5,000 specialists who treat epilepsy in the U.S.

 “We’re the leader in this area, we’re science-based, and we believe physicians and patients will desire medicines that have gone through the FDA review process. When a drug is prescribed that’s FDA approved, you know it’s exactly the same every time it’s prescribed and every time it’s taken,” said Stephen Schultz, VP of investor relations at GW.

In addition to the approval, GW was also granted with the change of class for Epidiolex from a Schedule I drug to a Schedule V which labels it under drugs that have the minimum addictive property like Robitussin AC and Pfizer's Lyrica. This rescheduling brought in glad tidings for GW.

The company has designed two specific websites specially designated to the marketing of the drug. One targets physicians and the other is intended to target patients. This will give a boost to the launch of the drug, while Schultz described the marketing as a “medically oriented education commercialization effort” towards doctors.

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AliveCor gets FDA breakthrough status for Hyperkalemia diagnosis

Hyperkalemia is defined as the condition where there would be a higher potassium level in blood. The potassium level goes higher due to chronic kidney disease and type 1 diabetes, suffered by millions of people. Irregular heartbeat is the common symptom of hyperkalemia. A blood sample is required to detect the potassium level till date.

But a Silicon Valley start-up company named AliveCor along with the doctors from Mayo Clinic have developed a novel technology, where the blood sample is not required. Just by looking at the electrocardiogram (ECG) pattern which records the electric signals of the heart, the level of potassium can be detected.

Hence, the U.S. Food and Drug Administration had given ‘breakthrough device’ designation on 10^th September 2018 for a novel way of potassium level measurement.

Vic Gundotra, the CEO of AliveCor, said "It was a pie-in-the-sky idea that we could use AI to see something like this in the ECG when no one else could; It's a big milestone for us."

This screening tool would prove beneficial for the patients who stay at home and don’t prefer to visit labs and give the blood sample.

AliveCor team expects that this product would reach the market in a year, after the submission of clinical trial results.

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Baxter’s new Actifuse Flow bone graft alternative gets FDA nod.

Actifuse Flow, Baxter International’s new synthetic bone graft surrogate from its osteobiologics surgery series, wins FDA approval for implementation in orthopedic surgeries.

In order to reach tine bony cracks and gaps of the skeletal structure, the new bone graft alternative is designed to reach these exact cranny locations. It is delivered via a syringe already containing it to speed-up bone growth. No preparatory procedure or mixing is needed to use this bone graft substitute and it maintains its fluid consistency during the surgery.

The surgical products manufacturer’s Actifuse Bone Graft Alternative constituting Actifuse Flow implements the silicate-substituted technology for bone formation via raised levels of silicon.

It becomes an ideal candidate for minimally invasive surgical procedures as the syringe facilitates the start and stop of flow to deliver the precise amount of substance. This also enables it to compact small done deformities as well as the intricate disorder of bone structure.

Additionally, when the bone is healing, the natural bone replaces this graft substitute as it gets reabsorbed, making it suitable for orthopedic surgeries on the posterolateral spine, extremities and the pelvis.

Baxter Advanced Surgery business president Wil Boren said, “As part of our growing product portfolio, Actifuse Flow builds on the extensive clinical experience of our Actifuse Bone Graft Substitute. We strive to pioneer products that provide surgeons with innovative and dependable tools to help enhance healing, improve outcomes and reduce the total cost of care.”

The Actifuse Flow will be available in the market in 1.5ml, 3ml and 5ml sizes in the upcoming months.

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Machine Learning Applied to Manage Treatment-Resistant Depression

In an effort to know more about the etiopathogenesis of non-treatment responding to depression and to improve its management, Takeda and ConvergeHEALTH, data science institute by Deloitte collaborate to analyze patient datastores.

Disease datasets of conditions like non- treatment responding migraine from insurance claims data including diagnoses, management protocols and prescribed medicines were used to conduct linear and non-linear models on.

The researchers aimed at spotting the key aspects of the data that brought out the maximum impact on treatment results. A right mix of the correct data and apt questions lead to the enhancement in result estimation of deep learning models. Hence, larger labyrinthine datasets were available for evaluation and a clearer perception of patient response was obtained.

"In severe depression, patients often go through multiple medications before finding one that works," said Dan Housman, chief technology officer at ConvergeHEALTH by Deloitte. "This testing process can be challenging for patients and their psychiatrists."

The method is "prescribed after other medications did not work in what is deemed a treatment-resistant patient,” he added. “We’re interested in looking at depression patients and their journey between treatments to better understand which patients may fall into the treatment-resistant category and when a certain switch will be sustained without further switches."

Machine learning is applied to claims data sets to design prognostic models that identify the resistant patients and the different drugs for depression which the patients can shift to. The successful prognostic models, so designed, enable organizations to alter protocols and offer digital diagnostic devices that evaluate past events of patients to pick which individual would be positively affected by a change in medication or which drug could be started as the primary treatment for that patient.

"The benefit to the patient is a shorter journey to a drug that will keep them well and less time struggling with their depression," Housman described. "The benefit to Takeda is to be able to build tools both with guidelines or decision support systems to help physicians find the patients who can benefit from our products.”

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Zipnosis Raises $3 Million in Funding for Telemedicine Tools

Zipnosis specializes in offering telemedicine tools to providers in order to launch their own telemedicine services, whereas other telemedicine companies offer services either directly or via health insurers.

Last week, Zipnosis raised $3 million through funding, which led to a total of up to $23 million due to existing investors like Safeguard Scientifics and Ascension Ventures among others.

Jon Pearce, the CEO of Zipnosis said, “As an organization focused on sustainable, organic growth, we were very intentional about the size of our Series B. In this industry, you hear about huge amounts of cash being splashed around. Zipnosis didn’t require a massive infusion of investment to achieve our growth objectives. It was more important for us to take precisely what we needed to move to the next level – no more and no less.”

In January, Zipnosis teamed up with Methodist Family Health Centers, to unveil an online diagnosis and treatment service named Methodist NOW and in February they launched Patient Outreach, which aids hospitals in patient visits.

In April, Zipnosis teamed up with The American Academy of Family Physicians to provide an online diagnosis and treatment system followed by the addition of post-surgical care.

Lastly, in June, they announced the expanded Surescripts certification to add medication history into patients’ data available to telemedicine doctors. 

Jon Pearce further added, “We absolutely believe that healthcare is still local and we believe that it’s the long-term and the right solution not only for the best quality care but also for the most affordable care for patients. The healthcare providers haven’t moved quick enough. The incentives haven’t been there and change is hard in healthcare.”

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Five Top Medical Device Start-Ups

The demand for novel medical technologies seems to grow continuously. Hence there has been an increasing number of start-ups in order to fill the gaps by providing innovative solutions to persisting health issues. In this article, we will have a brief look at five of the world’s most promising medical device start-ups.

Rubi Life

This US-based medical device start-up is one of the joint winners of the Digital Health Technology Show’s Start-Up of the Year Award 2018. Rubi Life has earned a good name in the pregnancy device market since it has created the world’s first sensor containing a passive fetal wearable monitor named Rubi that can track fetal movement in the third trimester.

Livongo Health

This California-based start-up enables diabetic patients to connect to a virtual care team. This company completed a $105m round of funding, which would be further used to support market growth by developing the consumer platform.

Day Zero Diagnostics

This medical device start-up combines machine learning and genome sequencing to diagnose and treat infectious diseases within five hours rather than spending days using current methods. Their Day Zero device can analyze entire genomic sequences using the microbial resistance database named MicrohmD.

Prellis Biologics

The mission of this company is to address the unmet need for transplant-ready organs. Hence, it is currently developing a laser-based 3D printing technology to create functional human organs.

Clinical Science Systems

This Netherlands based company is another winner of the Digital Health Technology Show’s Start-Up of the Year Award 2018. Their eeg.service platform specializes in developing a electroencephalography (EEG) related technique in order to provide better results, compared to the currently available models.

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Artios Pharma raises $84 Million to take DDR Programs to Next Level

Artios Pharma, a U.K. based company in Cambridge, has raised $84 million to take DNA damage response (DDR) programs to the next level of clinical proof of concept. The series B round reported more big-name investors who plan on investing in the research team, as their earlier work on PARP inhibitor Lynparza set the frame for the DDR programs.

Artios Pharma was founded in 2016 with DDR programs in-licensed from Cancer Research Technology, which had developed Lynparza at KuDOS Pharma. After two years, Artios now has advanced programs and it was in need of $84 million to proceed to the clinic. 

LSP and Andera Partners led the round with the support from Novartis Venture Fund and Pfizer Ventures. Other existing shareholders such as SV Health Investors, Arix Bioscience, M Ventures, AbbVie Ventures and IP Group have also contributed to the series B funding round.

DDR drugs target DNA polymerase theta (Polθ), which plays a significant role in DNA repair pathways. Polθ inhibitors selectively destroy cancer cells by disrupting the DNA repair process. The combination of the inhibitor with chemotherapy or radiotherapy could possibly increase the efficacy of cancer therapy. This validated concept has proven attractive to investors.

Rene Kuijten, the managing partner at LSP, said "Artios represents a unique opportunity to deliver a truly world class biotech company. LSP has worked with Artios' team before at KuDOS which developed olaparib, the first approved PARP inhibitor and used in ovarian and breast cancer, creating a billion dollar market.”

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