Kepplah Thu, 10 Jun 2021 12:05:41 +0000 en-US hourly 1 Kepplah 32 32 UCSF Rosenman Institute Announces Rosenman Innovators 2021 Thu, 10 Jun 2021 12:00:00 +0000

SAN FRANCISCO, June 10, 2021 / PRNewswire / – UCSF Rosenman Institute is proud to announce the 2021 Rosenman Innovators Cohort, a group of early stage health technology companies chosen for their innovative technologies and impact on patients.

2021 is the sixth year of the Rosenman Innovator Selection Round, which aims to identify promising companies seeking funding from the seed stage to Series A. The number of applicant companies has increased by 20 % compared to 2020 figures, itself a record year.

“I am delighted to welcome these ten amazing companies to our program,” said Christine winoto, Founder and Executive Director of UCSF Rosenman Institute. “We chose them because their technologies meet important patient needs and have great market potential, and we believe their teams can do the job. In addition, the founders of Rosenman Innovator are an increasingly vital group at the heart of our ecosystem, sharing their knowledge and connections with other founders. “

Rosenman Innovators from previous years include Koya Medical, which recently received FDA clearance for Dayspring™ active compression therapy system to treat lymphedema; GT Medical, which recently enrolled its first patient in a clinical trial evaluating GammaTile® Therapy in patients with metastatic brain tumors; and EMME, maker of the EMME smart case for birth control pills, named by Fast Company as one of the 10 most innovative wellness companies of 2021.

The Rosenman Innovator 2021 cohort:

  • Auricle, Inc. is a medical device company focused on commercializing the first validated and effective therapy that treats tinnitus at the source.
  • Avenda Health built a male “lumpectomy” for prostate cancer to preserve quality of life. Their AI-based laser ablation can be performed in a doctor’s office under local anesthesia.
  • Evren Technologies Advances PTSD treatment with user-friendly products including a headset that treats PTSD via neurostimulation, symptom tracking app, remote clinician monitoring, and PTSD patient database.
  • Fibralign Corporation produces therapeutic devices using its patented Nanoweave technology that creates a bio-scaffold that precisely mimics human tissue. Fibralign’s first product tackles lymphedema, an incurable global chronic disease.
  • imvaria is a healthcare technology company that develops and markets digital biomarkers, machine learning tools to drive diagnosis and risk stratification in severe and rare diseases.
  • Invenio imagery develops the NIO laser imaging system, designed to streamline intraoperative histology, reduce operating room downtime and allow examination of specimens from multiple sites in the surgical cavity.
  • Noleus Technologies, Inc. is developing a low-risk therapeutic device to reduce postoperative ileus. It’s a $ 5.8 billion TAM, and Noleus is a start-up company with intellectual property issued with a 510K FDA route.
  • Novela Neurotechnologies, Inc. markets nEureka®, a patient-centric data platform that enables personalized remote care for epilepsy. nEureka® harnesses smart wearable devices to enable users to manage all aspects of their epilepsy 24/7.
  • OOTify, Inc. is an online mental health center serving the entire spectrum of mental health, from psychoeducation for all, to digital phenotype matching with the best clinical / subclinical resources for them, to teletherapy.
  • SpineX inc. develops TESCoN, a non-invasive spinal cord neuromodulator to activate and recycle spinal neural circuits responsible for the control of function.

About the Rosenman Institute at UCSF
UCSF Rosenman Institute, a QB3 health technology initiative at University of California, San Francisco, is a community of investors, clinicians and technology entrepreneurs who create solutions for unmet clinical needs. Its mission is to drive innovation and education and improve patient care by helping entrepreneurs from concept to commercialization. No UC affiliation is required to gain support from the UCSF Rosenman Institute. Visit

CONTACT: Kaspar Mossman, (415) 514-9790, [email protected]

SOURCE UCSF Rosenman Institute

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US Online Pharmacy Market Report 2021-2026: Increase Thu, 10 Jun 2021 11:33:43 +0000

Dublin, June 10, 2021 (GLOBE NEWSWIRE) – The “US Online Pharmacy Market – Industry Outlook and Forecast 2021-2026” report was added to offer.

The US online pharmacy market in terms of revenue is expected to grow at a CAGR of approximately. 19% over the period 2020-2026.

Automated prescription filling, automated customer relationship management, direct selling of drugs to patients are other major factors that are increasing the uptake of online pharmacies in the United States.

The market is moving towards the direct-to-patient model as the ever-expanding digital world opens doors to new services and user-friendly online experiences. The ease and familiarity of shopping online prompts many patients to seek out virtual care drugs and wellness options.

This has prompted online pharmacies to advertise more and acquire more consumers through digital platforms. The COVID-19 pandemic has further accelerated this change, as most healthcare professionals and patients have adapted to the virtual way of buying drugs. The trend is expected to increase dramatically in the United States after COVID-19.


The United States Online Pharmacy Market research report comprises detailed segmentation by drug type, product, modality, and pharmacy type. The US prescription online pharmacy market is expected to exceed $ 132 billion by 2026.

Profitability is an important factor in the growth of prescription drugs via the online mode. Consumers prefer to buy drugs from online stores because they offer drugs at lower prices than retail outlets. Among American adults taking prescription drugs, 1.5% reported purchasing drugs outside of the United States because of the high costs. Hence, online pharmacies are considered to be the best solution to provide prescription drugs at discounted prices, thus watching the growth.

In 2020, the drug segment represented approx. 76% market share of online pharmacies in the United States. The increase in the patient population as well as the increase in the geriatric population increases the demand for drugs. There is an increase in consumers preferring online pharmacy platforms to purchase drugs due to the great convenience of purchasing. Many customers and patients prefer to use online pharmacies to stock up on long-term medications.

The mobile application based segment is likely to grow at a CAGR of over 19% from 2020 to 2026. Mobile applications play an important role in the global online pharmacy market. They help online pharmacies get in direct contact with consumers, thereby increasing the patient base. Mobile applications help online pharmacies to effectively position their pharmacies.

Mobile apps offering prescription refills, secure two-way messaging, and a HIPAA-compliant mobile app will increase the number of online pharmacies. Providers prioritize digital advertising and marketing to attract more audiences, as many patients spend their time online.

The US online pharmacy market by the online brick and mortar branch expects to reach approx. $ 80 billion by 2026. Most retail businesses in the United States tend to have an online channel to promote their products and increase their customer base. This trend has prevailed in the United States for a long time. However, during the COVID-19 pandemic, the country further accelerated the adoption of online pharmacy channels.


The US online pharmacy market is experiencing a constant flow of start-ups entering the industry. The COVID-19 pandemic has increased the importance of online pharmacies in the country.

Many doctors, patients and health care providers have increased the adoption of telehealth, which has increased the number of teleconsultations in the country. Large hospitals received 500% more online consultations and electronic prescriptions among healthcare providers also increased.

These factors have accelerated the growth of the online pharmacy market in United States. A shift in consumer behavior patterns has increased the growth opportunities in the market. However, strict adherence to regulatory guidelines and the prevalence of counterfeiting and bogus websites selling unhealthy products are hampering the market.

Kroger, CVS Health, CIGNA (Express Scripts), Walgreens Boots Alliance and Rite Aid are the main players in the US online pharmacy market.

Leading suppliers

  • Kroger
  • CVS Health
  • CIGNA (Express Scripts)
  • Alliance of Walgreens boots
  • Rite Help

Other important suppliers

  • Alto pharmacy
  • Flashing Health
  • BioPlus Specialized Pharmacy
  • Drug Batell
  • Carepoint pharmacy
  • Foundation care
  • Fruth Pharmacy
  • Giant eagle
  • Health warehouse
  • High school pharmacy
  • Health for him and for her
  • Henry Ford Health System
  • Kinney Drugs
  • KwikMed
  • MedVantx
  • Medicine
  • Medly Pharmacy
  • Pharmacie du
  • OptumRx
  • Pillbox
  • Pharmacy Ro
  • Walmart Stores
  • Woori pharmacy

Main topics covered:

1 Research methodology

2 Research objectives

3 Research process

4 Scope and coverage

5 Hypotheses and caveats in the report
5.1 Key caveats
5.2 Currency conversion
5.3 Market derivation

6 Market overview

7 Presentation
7.1 Overview
7.2 Impact of COVID-19 on Us Online Pharmacy
7.3 Regulations for online pharmacies in the United States
7.4 Comparison of Electronic Pharmacy in US Market vs Global Market
7.5 Online pharmacy start-ups and their investments

8 Market opportunities and trends
8.1 Increase in direct sales of drugs to patients
8.2 Increased demand for advanced e-commerce technologies
8.3 High adoption of electronic prescriptions among US customers

9 market growth catalysts
9.1 Increase in teleconsultation and diagnostic assistance
9.2 Growing Penetration of Internet and Mobile Applications
9.3 High adoption of automated prescription renewal and CRM solutions

10 market restrictions
10.1 Sale of unapproved drugs and FDA warnings
10.2 Competition from traditional and medical product retailers
10.3 Strict regulatory framework for the online sale of medicines

11 Market landscape
11.1 Market overview
11.2 Market Size and Forecast
11.3 Analysis of the five forces

12 Type of drug
12.1 Market Overview and Growth Driver
12.2 Market overview
12.3 Prescription
12.4 Over The Counter (OTC)

13 Product
13.1 Market Overview and Growth Driver
13.2 Market overview
13.3 Medicines
13.4 Health, well-being and nutrition
13.5 Personal care

14 Modality
14.1 Market Overview and Growth Driver
14.2 Market overview
14.3 Mobile application
14.4 Web Based

15 Type of pharmacy
15.1 Market Overview and Growth Driver
15.2 Market overview
15.3 Online branch of the Brick & Mortar pharmacy
15.4 Independent online pharmacies only
15.5 Partnership site with neighborhood pharmacies

16 Competitive landscape
16.1 Competition overview
16.2 Market share analysis

For more information on this report, visit


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Vulvodynia Treatment Market Research Report by Type, Indication, Supplier, Region – Global Forecast to 2026 Thu, 10 Jun 2021 08:53:00 +0000

Vulvodynia Treatment Market Research Report By Type (Biofeedback & Physiotherapy, Intralesional Injections & Oral Treatment), By Indication (Generalized Vulvodynia & Localized Vulvodynia), By Vendors, By Region (Americas, Asia Pacific & Europe, Middle East and Africa) – Global Forecast to 2026 – Cumulative Impact of COVID-19

New York, June 10, 2021 (GLOBE NEWSWIRE) – Announces the Publication of the “Vulvodynia Treatment Market Research Report By Type, By Indication, By Vendor, By Region – Global Forecast To 2026 – Cumulative impact of COVID- 19 “-

The global vulvodynia treatment market size was estimated to be $ 42.52 billion in 2020 and is expected to reach $ 46.39 billion in 2021, at a compound annual growth rate (CAGR) of 9.43% from 2020 to 2026 to reach USD 73.04 billion by 2026.

Market Statistics:
The report provides market size and forecast in five major currencies – USD, EUR GBP, JPY and AUD. It helps organizational leaders make better decisions when currency data is readily available. In this report, the years 2018 and 2019 are considered as historical years, 2020 as the base year, 2021 as the estimated year and the years 2022 to 2026 are considered as the forecast period.

Market segmentation and coverage:
This research report categorizes Vulvodynia Treatment to forecast revenue and analyze trends in each of the following submarkets:

Based on type, the vulvodynia treatment market has been studied in the areas of biofeedback and physiotherapy, intralesional injections, oral treatment, surgical treatment, and topical treatment.

Based on the indication, the vulvodynia treatment market has been investigated for generalized vulvodynia and localized vulvodynia.

Based on the vendors, the Vulvodynia Treatment market has been studied in hospitals and healthcare providers, pharmaceutical and biotechnology companies, and research and development centers.

On the basis of geography, the Vulvodynia Treatment market has been studied to America, Asia-Pacific, Europe, Middle East & Africa. The Americas are further explored in Argentina, Brazil, Canada, Mexico, and the United States. Asia-Pacific is further explored in China, India, Indonesia, Japan, Malaysia, Philippines, South Korea and Thailand. Europe, Middle East and Africa are also studied in France, Germany, Italy, Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, Arab Emirates United and the United Kingdom.

Cumulative impact of COVID-19:
COVID-19 is an incomparable global public health emergency that has affected nearly every industry, and the long-term effects are expected to impact the growth of the industry during the forecast period. Our ongoing research amplifies our research framework to ensure the inclusion of the underlying issues of COVID-19 and potential pathways to follow. The report provides insight on COVID-19 considering changes in consumer behavior and demand, purchasing patterns, supply chain diversion, dynamics of current market forces, and significant government interventions . The updated study provides information, analysis, estimates and forecasts, considering the impact of COVID-19 on the market.

Competitive strategic window:
The Competitive Strategy Window analyzes the competitive landscape in terms of markets, applications and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for suppliers to adopt successive strategies of merger and acquisition, geographic expansion, research and development, and new product introduction strategies to continue the expansion and growth of the business during a forecast period.

FPNV positioning matrix:
FPNV Positioning Matrix assesses and ranks vendors in the vulvodynia treatment market based on business strategy (company growth, industry coverage, financial viability, and channel support) and product satisfaction (value for money, ease of use, product features, and customer support) that helps businesses make better decisions and better understand the competitive landscape.

Market share analysis:
The market share analysis offers the analysis of the suppliers considering their contribution to the overall market. It provides the idea of ​​its revenue generation in the overall market compared to other space providers. It provides insight into the performance of vendors in terms of revenue generation and customer base compared to others. Knowing the market share gives an idea of ​​the size and competitiveness of the suppliers for the base year. It reveals the characteristics of the market in terms of traits of accumulation, fragmentation, dominance and fusion.

Company usability profiles:
The report deeply explores the significant recent developments of leading vendors and innovation profiles in the global Vulvodynia Treatment market including Allergan, Inc., AstraZeneca Pharmaceuticals, Cellegy Pharmaceuticals, Inc., Depomed Inc., Dipharma Francis Srl, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Lumen Therapeutics, LLC, Novartis Pharmaceuticals, Noven Pharmaceuticals, Inc., Pfizer Inc., Sanofi Aventis, Upsher-Smith Laboratories, LLC and VuVatech LLC.

The report provides information on the following pointers:
1. Market penetration: provides comprehensive information on the market offered by the major players
2. Market Development: Provides detailed information on lucrative emerging markets and analyzes penetration into mature market segments.
3. Market diversification: provides detailed information on new product launches, untapped geographies, recent developments and investments
4. Competitive Assessment and Intelligence: Provides a comprehensive assessment of market shares, strategies, products, certification, regulatory approvals, patent landscape and manufacturing capabilities of key players
5. Product Development and Innovation: Provides intelligent information on future technologies, R&D activities and breakthrough product developments

The report answers questions such as:
1. What is the market size and forecast for the global Vulvodynia Treatment market?
2. What are the inhibitory factors and impact of COVID-19 shaping the global Vulvodynia Treatment market during the forecast period?
3. What are the products / segments / applications / areas to invest in during the forecast period of the global Vulvodynia Treatment Market?
4. What is the competitive strategic window for opportunities in the global Vulvodynia Treatment market?
5. What are the technological trends and regulatory frameworks in the global Vulvodynia Treatment market?
6. What is the market share of the major vendors in the global Vulvodynia Treatment market?
7. What strategic fashions and moves are considered appropriate for entering the global Vulvodynia Treatment market?
Read the full report:

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ReportLinker is an award winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need – instantly, in one place.


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Q-State Biosciences Announces Presentation at XVI Symposium on Trials of Antiepileptic Drugs and Devices | Business Wed, 09 Jun 2021 21:02:34 +0000

CAMBRIDGE, Mass .– (BUSINESS WIRE) – June 9, 2021–

Q-State Biosciences (“Q-State”), a discovery and therapy technology company that develops programs for the treatment of epilepsy, pain and other central nervous system disorders, today announced that the company will present at the next 2021 Antiepileptic Drug and Device Trials (AEDD) XVI Symposium to be held from June 16-18.

The presentation, titled “Technology-derived Antisense Oligonucleotide Therapeutics for Severe Monogenic Epilepsies”, will highlight the company’s platform validation for the therapeutic discovery of epilepsy and initial proof of concept data targeting UBE3A for the Dup15q syndrome.

The details of the presentation are as follows:

Session title:

Session VIII: Drug pipeline – Preclinical

Date and time of the session:

June 18, 2021, 8:50 a.m. to 10 a.m. EST

About Q-State Biosciences

Q-State Biosciences is a discovery and therapy technology company based in Cambridge, Massachusetts. We integrate advanced human neural models, proprietary determinative measurement engineering, and powerful AI / machine learning to discover and develop novel therapies for epilepsy, pain, and other CNS disorders. For more information, please visit

View source version on

CONTACT: Business Development

Chani maher

+1 617-945-5433


Carolyn Noyes

+1 781-235-3060



SOURCE: Q-State Biosciences

Copyright Business Wire 2021.

PUB: 06/09/2021 17: 00 / DISC: 06/09/2021 17:02

Copyright Business Wire 2021.

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March trial date set for three ex-cops implicated in George Floyd’s death Wed, 09 Jun 2021 19:51:30 +0000

A trial date has been set for three of the former Minneapolis police officers who were implicated in the death of George Floyd.

According to ABC News, an order from Judge Peter Cahill indicates that the opening statements of the trial of Thomas Lane, J. Kueng and Tou Thao – all of whom are accused of aiding and abetting both murder and manslaughter – will begin on March 28, 2022. The tribunal will sit on March 7 to deal with any administrative matters or evidentiary requests. Jury selection for the trial will begin on March 8. The judge also set deadlines for lawyers to file documents relating to the case.

In May, Justice Cahill postponed the trial until March 2022 to ensure the federal case was completed before trial. He said the distance was necessary given the publicity surrounding Derek Chauvin’s case.

In April, Chauvin was convicted of unintentional second degree murder, third degree murder and manslaughter for his involvement in Floyd’s death. He is due to be sentenced on June 25.

Prosecutors are seeking to add a new count of complicity in third degree murder against Lane, Thao and Kueng. In their argument, they asked the three-judge panel to send the case back to a lower court to add the new charge, citing the reinstatement of Chauvin’s third degree murder charge as a reason why the judges should rule in their favor. They said the court is supposed to “treat cases the same.”

The four ex-cops also face federal charges for Floyd’s death. The men are accused of willfully violating Floyd’s constitutional rights while he was detained over a year ago. Chauvin is charged with unreasonable force by a police officer, while the other three former cops are accused of violating Floyd’s right to be free from unreasonable seizure because they “deliberately failed to ‘intervene to prevent Chauvin from using unreasonable force. In addition, the four men are accused of failing to provide Floyd with medical attention.

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Liquid diet for T2DM lowers blood pressure and reduces drug use Wed, 09 Jun 2021 19:46:55 +0000

Liquid Total Diet Replacement (TDR) provided approximately 830 kcal / day with automatic reductions in all nutrients to induce rapid weight loss over 12 to 20 weeks. Antihypertensive drugs were withdrawn at the start of the regimen and BP was monitored regularly. The reintroduction of treatment was based on clinical guidelines.

Participants were randomized to an intervention or control group and all had been diagnosed with T2DM within the past 6 years. Other inclusion criteria included a glycated hemoglobin level of ≥ 6.5%, or ≥ 6.1% if on T2DM treatment, aged 18 to 65, and a body mass index (BMI) of 27 to 45 kg / m2.

Of 143 participants, 62 did not have hypertension and 81 did; of these 81 patients, 78 were taking antihypertensive drugs.

Of the 78, most stopped taking their medication completely at the start of the regimen, and 9 did not.

The overall mean BP decreased significantly from the start of the RDT and was significantly lower when the total diet replacement of the RDT ended at week 20. It remained below 12 and 24 months.

Of the 78 participants previously on treatment for hypertension, 65 (83%) stopped all antihypertensive and diuretic drugs according to protocol, and 4 stopped certain drugs.

These 69 participants saw no immediate BP change, but their average BP dropped significantly from 9 weeks onwards. While BP did not increase excessively, antihypertensive drugs were reintroduced during RDT to manage the increase in BP for 27.5% of the participants, even though they lost weight.

Participants who took 2 medications, as opposed to 1, were more likely to need to reintroduce their BP therapies.

At 24 months, 28% of those who stopped their antihypertensive therapy did not take any.

Of the 53 participants who achieved remission from T2DM through diet, 31 had previously been treated for hypertension.

The researchers said that although the protocol was safe and effective, careful monitoring of BP is necessary; 51 participants reported mild to moderate dizziness during RDT, suggesting orthostatic hypotension. Of these participants, 15 had a history of dizziness before starting the diet.

The study was carried out by researchers from the universities of Glasgow and Newcastle.

“We wanted to assess the safety and effectiveness of withdrawing hypertension medication at the start of our weight loss program designed specifically for type 2 diabetes, and we are really happy with the results,” Mike Lean, MD , MA, MB, FRCPS, FRSE, University of Glasgow Principal Clinical Investigator said in a press release. “Our study shows that in addition to possible remission of type 2 diabetes, there are other very important health benefits, as weight loss is a very effective treatment for hypertension and the serious risks for it. health associated with it. “


Leslie WS, Ali E, Harris L. et al. Antihypertensive Drug Needs and Blood Pressure Control with Weight Loss in the Diabetes Remission Clinical Trial (DiRECT). Diabetology. Published online May 31, 2021. doi: 10.1007 / s00125-021-05471-x

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Summary of FDA approvals: Aduhelm, Brexafemme, Tembexa Wed, 09 Jun 2021 14:18:08 +0000

A weekly update on new drug approvals and indications from the United States Food and Drug Administration (FDA).

New approvals
Aduhelm approved for slowing Alzheimer’s disease by targeting motor disease process

Aduhelm (aducanumab) by Biogen received acceleration approval for the treatment of patients with Alzheimer’s disease, making it the first new treatment of the disease since 2003.

Human monoclonal antibody is also a unique therapy for disease in that it targets the underlying disease process and not the symptoms of the disease. The therapy is aimed at slowing the progression of the disease rather than reversing the process.

Aduhelm’s Fast Track Approval Was Based on the Brain Beta Amyloid Plaque Reduction Surrogate Endpoint in the Double-Blind, Randomized, Placebo-Controlled Dosing Study EMERGE, TO HIRE, and FIRST clinical trials involving a total of 3,482 patients with Alzheimer’s disease. Patients receiving study drug experienced a significant reduction in plaque depending on dose and time, while controls showed no such reduction.

The drug’s approval was marked by concerns, including from some members of the agency’s independent advisory committee who raised questions about the efficacy data. Two of the trials, EMERGE and ENGAGE were put on hold for unnecessary in 2019. Biogen later said that a re-analysis of EMERGE data showed that the trial met its primary endpoint of slowing clinical decline, and that ENGAGE data supported Emerge’s results, although this trial did not meet its primary endpoint (RELATED: FDA approves aducanumab for use in Alzheimer’s disease, Regulatory guidance June 7, 2021).

Under the fast-track approval provisions, current approval is contingent on the results of a new randomized controlled trial required to verify the clinical benefit of Aduhelm. Approval could be withdrawn if the follow-up trial fails to verify clinical benefit.

Aduhelm obtained the expedited designation.

Brexafemme Approved As One Day Oral Therapy For Vaginal Yeast Infection

Brexafemme (ibrexafungerp tablets) from Scynexis has been approved as a treatment for vulvovaginal candidiasis (CVV), also known as vaginal yeast infection, in adult women and younger postmenarchal patients.

One-day oral treatment with nonazole is the first drug approved in a new triterpenoid antifungal class for over 20 years. Its approval was based on the efficacy results of phase 3 multicenter, randomized, double-blind, placebo-controlled VANISH 303 and 306 studies in women with CVC.

Brexafemme has received Qualified Infectious Disease Product (QIDP) and Fast Track designations. Under the designation QIDP, the therapy is expected to enjoy 10 years of commercial exclusivity in the United States. The drug is also protected by multiple patents, including one for the ibrexafungerp molecule, under which it will enjoy 14 years of protection in the United States, until its expiration in 2035.

Ibrexafungerp is also in development treat Candida auris infections, including candidemia. C. auris is an emerging fungal disease that is considered a global health threat because it can cause epidemics in healthcare facilities and is often multidrug resistant.

Tembexa gets green light for smallpox treatment

Tembexa (brincidofovir) from Chimerix has been approved for the treatment of smallpox in adults and children.

The disease has been considered eradicated since 1980, but concerns remain about the use of the variola virus as a biological weapon. The therapy was developed in conjunction with the Advanced Biomedical Research and Development Authority of the US Department of Health and Human Services.

The effectiveness of Tembexa has been studied in animals infected with the virus. It was approved under the Animal rule, which allows the results of animal studies as the basis for an approval when it is not feasible or ethical to conduct trials in humans (RELATED: Smallpox antiviral approved under the FDA’s Animal Rule, Regulatory guidance June 7, 2021).

The results of the animal study showed that more animals treated with Tembexa survived infection with a smallpox virus compared to those given a placebo.

Tembexa has undergone priority review and expedited designations and orphan drugs.

Ryplazim approved as the first treatment for plasminogen deficiency in adults and children

Ryplazim from ProMetic (plasminogen, human-tmvh) has been approved as therapy for adults and children with type 1 plasminogen deficiency, also called hypoplasminogenemia.

The rare genetic disorder, for which there were no previous treatment options, is characterized by impaired normal function of tissues and organs, which can lead to blindness.

The approval of Ryplazim was based on the results of an open-label, single-arm (unblinded) clinical trial in 15 adult and pediatric patients from the indicated population who were treated with the study drug for 48 weeks. There was a 50% improvement in the 11 patients who had lesions at baseline. At 48 weeks, there were no new or recurrent lesions in any of the 15 patients.

Ryplazim has achieved orphan and fast track designations and has received a priority review and a priority review voucher for rare pediatric diseases.

New indications
Zeposia obtains expanded indication for active ulcerative colitis

Bristol Myers Squibb’s Zeposia (ozanimod) received a extended indication for the treatment of adults with moderate to severe active ulcerative colitis, a chronic inflammatory bowel disease.

Approval of the 0.92 mg dose for this indication was supported by the efficacy and safety results of two multicenter, randomized, double-blind, placebo-controlled clinical studies, study UC 1 (induction) and study UC 2 (maintenance) in the indicated population. Patients who received and responded to Zeposia in Study 1 were re-randomized to either study drug or placebo in the maintenance arm for 52 weeks, during which time they had to reduce their concomitant dose of corticosteroids. A total of 80% of patients on Zeposia and 54.6% of patients on placebo completed the study. Eligible patients were entered into an ongoing open-label extension trial to assess the long-term profile of Zeposia.

Zeposia was originally approved in 2020 for the treatment of adults with relapsing forms of multiple sclerosis.

Wegovy approved for chronic weight management

Wegovy (semaglutide injection) from Novo Nordisk obtained a extended indication for chronic weight management in adults with obesity or overweight and at least one weight-related condition, such as hypertension, type 2 diabetes or high cholesterol.

The use of the glucagon-like peptide-1 (GLP-1) receptor agonist for this indication should be combination with a reduced calorie diet and increased physical activity.

Wegovy’s approval was based on the safety and efficacy results of four trials in which over 2,600 patients received Wegovy and over 1,500 patients received placebo for up to 68 weeks. In one trial, which included patients without diabetes, those treated with Wegovy lost an average of 14.9% of their initial body weight, an absolute difference of 12.4% more than those given a placebo. In another trial, in adults with type 2 diabetes, those given Wegovy lost 6.2% more of their initial body weight than those given a placebo.

Semaglutide was first approved as Ozempic in 2017 as therapy for type 2 diabetes.

Ultomiris obtains new indication for the treatment of children with rare blood disease

Alexion’s Ultomiris (ravulizumab-cwvz injection) received extended indication for the treatment of patients 1 month or older with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease caused by genetic mutations.

The approval of Ultomiris was based on the results of a study involving 13 patients aged 9 to 17 years with PNH. Of the 13 patients, 5 had not received previous treatment with a complement inhibitor and 8 had been treated with eculizumab, a complement inhibitor approved for the treatment of PNH. After 26 weeks, 60% of previously untreated patients avoided a transfusion, and the 8 patients who had previously received eculizumab avoided a transfusion.

Ultomiris has received priority review and orphan drug designation for the indication of pediatric PNH.

It was originally approved in 2018 for the treatment of adults with PNH and in 2019 for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome.

© 2021 Society of Regulatory Affairs Professionals.

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No digital equivalent to Impulse aisle found as online grocery shoppers buy fewer sugary treats than in real life • The Register Wed, 09 Jun 2021 08:00:00 +0000

There is no digital equivalent to the supermarket’s love or hate impulse aisle, with shoppers spending significantly less on candy, cookies and other treats online than in the real world.

At least that’s what a study published in the Journal of Nutrition and Behavior Education, which examined 137 top domestic shoppers in the state of Maine who have purchased at least once in-store and online, and analyzed over 5,500 transactions made between 2015 and 2017. Conclusion: We are much less likely to buy treats online. than in person, despite the more comprehensive purchase.

“When study participants shopped online, they spent about 44% more per transaction, and they bought more and a wider variety of items than when they shopped in-store,” said Dr. Laura Zatz, lead researcher.

“We also found that online shopping was associated with reduced spend per transaction on candy, cold or frozen desserts, and cereal-based desserts like cookies and cakes.”

However, that doesn’t mean that online shopping is healthier. While spending on many of the items you might find tempting on the supermarket shelves fell on average by just over $ 2.50 per transaction, this was not true for all. The study found that online and offline shoppers spent equal amounts on sugary drinks and sweet and savory snacks.

“Sugary drinks and snacks might have been an intended purchase for many members of our study sample,” said co-author Dr. Eric Rimm of the apparent flavorful anomaly. “This would be consistent with other industry research showing that neither sweet and savory snacks nor sugary drinks are among the top five categories of unplanned food purchases.”

“With more and more people shopping online, it will be really important to understand how this affects the nutritional profile of the foods they buy,” concluded Dr. Zatz.

“Encouragingly, our results suggest that online grocery shopping is associated with reduced spending on several unhealthy items. However, we’ll want to monitor buying habits to make sure that sophisticated online marketing tactics, like personalized contextual ads, don’t replace this. . “

The complete study is available in free access on the site Journal of Nutrition and Behavior Education website. ®

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Former NFL player climbs Mount Everest while blind Wed, 09 Jun 2021 05:42:00 +0000

SUN VALLEY, Idaho (KMVT / KSVT) – A local resident has returned home after climbing Mount Everest.

With this feat, Mark Pattison became just the second NFL player to climb the Seven Summits, or the highest peaks of each continent.

May 23, 2021 will be a day Pattison will never forget, the day he reached the top of Mount Everest.

“When we woke up that morning and started our ascent at 12:30 pm, it was awful, we had snow, slush blowing hard,” Pattison said. “It all resolved around 4.30am and we had a beautiful sunrise, my problem is that I ended up getting snow blind.”

Pattison couldn’t see one of his eyes.

“And it can be a very scary experience when you rely on your safety lines hanging on the mountain and they don’t work and you look straight off that cliff,” he exclaimed.

And due to a language barrier with his Sherpa, provided an even greater challenge.

“He didn’t understand exactly what I was going through,” Pattison said. “I had no energy and I couldn’t see with my eyes and on the way down I ran out of oxygen, and he was in such a rush to get back to base camp, he left me, so I was on the balcony about 27,500 feet with no oxygen and no gasping air A Russian comes down and he is checking my tank and he {speaks Russian} so I say ‘please tell my Sherpa to stop. ‘

After climbing Mount Everest, he had hoped to climb Mount Lhotse, the world’s fourth highest peak in 24 hours, but his mind and body canceled those efforts.

“I came down and thought to myself that there was no way I would end up as a permanent resident on the mountain.”

The mountain is known as the tallest cemetery in the world, claiming the lives of over 300 climbers over the past 80 years.

“So when I passed Hillary Step there is my Antarctic tentmate that I spent three weeks with and he failed in 2019 and he is lying there,” explained Pattison.

In fact, one of the Sherpas delivering supplies to his party also died.

“You have to do what you have to do to survive and get through this, that you don’t have time for empathy.”

The trip lasted 70 days and it endured bad weather.

“You hear an avalanche in your tent and say oh, it’s just another avalanche.”

And while the Mount Everest Climbing Award will provide a lifetime of memories, the support behind the climb, from the community to the NFL, has raised more than $ 56,000 for epilepsy awareness by the foundation bias called Higher ground.

“There’s so much danger up there, I’ve had a lot of people who were just seriously worried and sending a lot of prayers my way,” Pattison said.

It’s because of his daughter Emilia, who is the driving force.

“I kept saying that if Emilia can fight this epilepsy, I can climb this mountain.”

Pattison was a wide receiver for the Los Angeles Raiders and New Orleans Saints. The NFL Network is working on a documentary about Pattison’s trip which is scheduled to air around September 1. He would like it to premiere at Sun Valley, with a panel discussion.

Follow Mark Pattison on social media:

Facebook: @ NFL2SevenSummits

Instagram: @MarkPattisonNFL

Twitter: Mark PattisonNFL

LinkedIn: Marc Pattison

Copyright 2021 KMVT / KSVT. All rights reserved.

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Indian hypochondriacs make self-medication a deadly second-wave problem Wed, 09 Jun 2021 03:58:20 +0000

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New Delhi: At the end of April, a patient approached Dr Ashwani Goyal, a general practitioner in Delhi, breathless. The patient had all the obvious symptoms of Covid-19 and eventually succumbed to the disease. Seeing a doctor sooner might have saved his life, but he only got to Dr Goyal’s door when his condition became critical. This is a trend that Goyal observed often during the Covid-19 pandemic.

“He took a prescription from a family member, written by a pulmonologist, and immediately started taking these drugs instead of seeing the doctor first. By the time he came to see me, his oxygen was at 72 and I had to refer him elsewhere. I found out later that he was dead, ”Dr Goyal told ThePrint. “This is not a stray case, there are countless such cases,” he added.

Among the medications the patient had started, Goyal said, was the antiparasitic ivermectin, in addition to the antibiotics doxycycline and azithromycin.

In the revised guidelines issued on May 27 by the General Directorate of Health Services (DGHS), which reports to the Union Ministry of Health and Family, the mention of these drugs had been deleted, just like that of hydroxychloroquine, zinc and vitamins, although the latest rules set out on the The ministry of health (updated May 24) and Indian Council of Medical Research (May 3) websites suggest otherwise.

As the second wave of Covid took hold in India and flooded hospitals, many patients resorted to self-medication, which was also reported in the first wave. Prescriptions were shared among acquaintances on WhatsApp, and people anxious to develop severe Covid infection skipped the pills, often without individual medical consultation.

Doctors say lax oversight in pharmacies has fueled the trend, and constant updates to government guidelines – which typically define when a drug cannot be administered without medical supervision – have fueled the confusion.

“The guidelines changed quite frequently, which made the situation very confusing for doctors and patients,” said Dr. Goyal, adding, “Over time, we can see changes in the way people work. self-care, but they will continue to exchange prescriptions on WhatsApp and consult their friends. It happened before Covid too. “

Read also : “Fearing Covid”, Indians burst ivermectin, HCQ, dexamethasone – all self-prescribed

Why patients self-medicate

As noted by Dr Goyal, Indians have been associated with a propensity for self-medication, the side effects of which include side effects and drug resistance.

A 2020 meta-analysis from 17 self-medication articles in India found that the practice had an average prevalence rate of 53.57 percent, and that the most common reasons for self-medication included minor ailments and familiarity with medications. Another reason given was “the lack of regulation of over-the-counter drugs and the failure to adhere to rational drug use practices and policies”.

Doctors say the pandemic has exacerbated these trends, aided by social media, changing drug guidelines, increased health anxiety and a bombardment of information about new drugs and treatments for Covid- 19.

“Initially, it was hydroxychloroquine, then it became ivermectin and doxycycline, then azithromycin. Now it’s remdesivir and steroids, ”said Dr Jugal Kishore, head of community medicine at Safdarjung Hospital in Delhi.

“Pharmacies distributed them to people in packs, sometimes mixing them with Ayurvedic treatments like Coronil.”

Like Goyal, Dr Kishore says government guidelines are for doctors and people to follow, but cannot be strictly enforced.

Dr Rajeev Jayadevan, endocrinologist and former president of the Indian Medical Association, who has lectured several times on irrational drug use during the pandemic, described the trend towards self-medication – and over-medication – as a vicious cycle .

“When patients turn to doctors, they expect them to ‘do something’ – prescribe medication, in other words. It’s not uncommon for doctors to be asked why they don’t prescribe certain drugs, ”said Dr Jayadevan. “Doctors and patients compare prescriptions with each other, which has created a sort of unhealthy vicious cycle. The immediate availability of drugs in pharmacies and the lack of strict regulations allowed this to happen. “

Role of mental health

Patients with particular health concerns can also visit online forums and discussion forums, in addition to looking for online consultations.

“A patient will usually come to the hospital physically when he has really good reasons to do so. But with online consultations, doctors are just a phone call away. I am getting more and more calls for minor issues and from overly cautious people, ”said Dr Sampath Chandra Prasad Rao, cranial surgeon at Manipal Hospitals in Karnataka.

“The very fact that people resort to online consultations, when they are superfluous, indicates that people are anxious about Covid and other diseases. I know many around me who suffer from this anxiety.

Doctors from the Government Institute of Medical Sciences (GIMS), Noida, have found a strong bond between health anxiety and the tendency to self-medicate. The study, conducted during the first wave of Covid-19 in 2020, included an online survey. Of the 1,100 responses, a quarter “of respondents reported self-medication, 60% of which were anxious”.

Among those who self-treated, 56.6% were doing it for the first time, according to the study. “The drugs were taken mainly for symptoms such as headache, abdominal pain, ghabrahat (anxiety) and inability to sleep, ”the study added.

The most commonly used drugs were nonsteroidal anti-inflammatory drugs, such as aspirin and ibuprofen.

“We did this study in the first wave, it must be a lot worse now,” Dr. Bharti Bhandari, one of the study’s co-authors, told ThePrint.

Read also : Self-medication for Covid has become disastrous. Families should not take on the role of doctors

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