Nutrition

Analysis: COVID-19 Ranks as a Top 3 Leading Cause of Death in the U.S., Higher than in Almost All Other Peer Countries

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A new KFF analysis examines leading causes of death and mortality rates in the United States and comparable countries. The U.S. has a higher COVID-19 mortality rate than many of its peer countries, with COVID-19 ranking as the nation’s third-leading cause of death in 2020,… Read More »Analysis: COVID-19 Ranks as a Top 3 Leading Cause of Death in the U.S., Higher than in Almost All Other Peer Countries

FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment

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What You Should Know: – FDA awards AppliedVR Breakthrough Device designation for treating treatment-resistant fibromyalgia and chronic intractable lower back pain – AppliedVR’s EaseVRx program helps patients learn self-management skills grounded in evidence-based cognitive-behavioral therapy (CBT) principles and other behavioral methods. AppliedVR, a pioneer advancing… Read More »FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment

Babyscripts Forms Commercial Partnership with Roche to Develop RPM Programs for Pregnancy

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What You Should Know:   – Babyscripts today announced a commercial partnership with Roche Diagnostics, a division of the world’s largest biotech company and a global pioneer in pharmaceuticals and diagnostics.  – Roche will partner with Babyscripts on the development of Babyscripts’ remote patient monitoring (RPM) programs to leverage… Read More »Babyscripts Forms Commercial Partnership with Roche to Develop RPM Programs for Pregnancy

Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy

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Shots: The P-III study involves assessing Xywav vs PBO in patients aged ≥ 7yrs. with cataplexy or EDS with narcolepsy Results: study met its 1EPs & 2EPs i.e. differences in median change in a weekly number of cataplexy attacks and ESS scores. Results were published… Read More »Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy

Bayer and 111 Collaborate to Explore the Vast Blue Ocean of Online Healthcare in China

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Shots: The companies will collaborate on drug commercialization initiatives in China, including the commercialization of innovative drugs & healthcare products for chronic disease management, as well as providing reliable and convenient resources for patient education Bayer will leverage 111’s vast network of pharmacies and healthcare… Read More »Bayer and 111 Collaborate to Explore the Vast Blue Ocean of Online Healthcare in China

The new frontline of care: social services

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Radically improving health outcomes for vulnerable populations requires a multifaceted proactive, community-wide approach focused on better understanding social determinants of health and simultaneously addressing social and health inequalities.

Janssen’s Tremfya (guselkumab) Receives CHMP’s Positive Opinion for Approval to Treat Active Psoriatic Arthritis (PsA)

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Shots: The CHMP’s positive opinion is based on P-III DISCOVER-1 & -2 studies assessing guselkumab (100 mg, q4w/q8w) vs PBO in 381 & 739 patients with active PsA & patients who were biologic-naïve only & who had an inadequate response to standard therapies respectively Combined… Read More »Janssen’s Tremfya (guselkumab) Receives CHMP’s Positive Opinion for Approval to Treat Active Psoriatic Arthritis (PsA)

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

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Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3 FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study… Read More »Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

Fujifilm & Volpara Partner to Help Clinicians Determine Patient Breast Density

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What You Should Know: – FUJIFILM Medical Systems U.S.A., Inc. and Volpara Solutions announced the extension of their partnership to provide mammography facilities and clinicians with breast imaging solutions designed to improve image quality, streamline workflow and accurately assess a patient’s breast density. – Building… Read More »Fujifilm & Volpara Partner to Help Clinicians Determine Patient Breast Density

Humana, Fresenius Medical Care Expand Partnership to Improve Care Coordination for Medicare Advantage Members

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What You Should Know: – Humana Inc. and Fresenius Medical Care North America (FMCNA) today announced an agreement to broaden their collaboration toward improving the health of eligible Humana Medicare Advantage members – The agreement between Humana and Fresenius Medical Care North America goes into… Read More »Humana, Fresenius Medical Care Expand Partnership to Improve Care Coordination for Medicare Advantage Members

Takeda strikes $1B RNAi deal with Arrowhead Pharmaceuticals

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The companies will partner on development and commercialization of ARO-AAT, Arrowhead’s Phase II RNA-interference drug for alpha-1 antitrypsin-associated liver disease, a rare genetic disorder. An analyst wrote that the deal makes sense given Takeda’s position in the AAT-augmentation therapy market.

Lifetime Experiences Help Older Adults Build Resilience to Pandemic Trauma

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Older adults are especially vulnerable physically during the coronavirus pandemic. But they’re also notably resilient psychologically, calling upon a lifetime of experience and perspective to help them through difficult times. New research calls attention to this little-remarked-upon resilience as well as significant challenges for older… Read More »Lifetime Experiences Help Older Adults Build Resilience to Pandemic Trauma

AWS, PHDA Collaborate to Develop Breast Cancer Screening and Depression Machine Learning Models

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What You Should Know: – Amazon Web Services (AWS) and the Pittsburgh Health Data Alliance (PHDA) announce a collaboration to produce more accurate machine learning models for breast cancer screening and depression. – In work funded through the PHDA-AWS collaboration, a research team led by… Read More »AWS, PHDA Collaborate to Develop Breast Cancer Screening and Depression Machine Learning Models

ViewPoints Article: Digital Healthcare in India – Current Trends & Future

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Digital healthcare means using communications and information technologies in medicine to diagnose, predict, treat, and monitor diseases. It is also widely used for prognosis, rehabilitation, behavioral health, and public health.  Indians have witnessed a surge of smartphone and internet use since the last decade. This… Read More »ViewPoints Article: Digital Healthcare in India – Current Trends & Future

What’s New on Nutrition+ Membership

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Welcome to Nutrition+ Membership, the ultimate accountability tool designed to help you make good food choices and maintain your results. With your membership, you get access to The Monthly Fix and The Mindset Membership, continuations of Ilana and Autumn’s signature nutrition programs, Ultimate Portion Fix and 2B Mindset. Everything they… Read More »What’s New on Nutrition+ Membership

How Mindfulness Changes Your Brain

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How Mindfulness Changes Your Brain Mindfulness has a solid neuronal basis and there is increasing evidence of its salutary effect on emotional health and behavior. The Doctor Weighs In

Complimentary trend analysis report: Emerging trends in pancreatic cancer research

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Pancreatic cancer sadly remains one of the most deadly cancers in existence, partly because it often goes undiagnosed until it has already metastasized. Finding new and better therapies to fight pancreatic cancer means accelerating the research. A new report just released from Elsevier’s Professional Services… Read More »Complimentary trend analysis report: Emerging trends in pancreatic cancer research

Adult Exposure to Lead

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“Children in approximately 4 million households in the United States are being exposed to high levels of lead.” As I discuss in my video The Effects of Low-Level Lead Exposure in Adults, “Despite the dramatic decline in children’s blood-lead concentrations over the decades, lead toxicity… Read More »Adult Exposure to Lead

Recent Advances in Alzheimer’s Disease Prevention

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Recent Advances in Alzheimer’s Disease Prevention A prominent neurologist reviews what is known (and not known) about recent evidence-based advances in Alzheimer’s Disease prevention. The Doctor Weighs In

Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

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Shots: The NDA submission was submitted to NMPA’s CDE and is based on P-III VICTORIA study, seeking regulatory approval of vericiguat in China In Oct’2014, Bayer and MSD signed a WW agreement for sGC modulators. The therapy is being jointly developed by both the companies… Read More »Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

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Shots: Bio-Thera to receive $165M upfront, regulatory, and commercial milestones and is eligible to receive royalties on sales of the product. BeiGene to get the right to develop, manufacture, and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan while Bio-Thera will retain rights… Read More »BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

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Shots: Bio-Thera to receive $165M upfront, regulatory, and commercial milestones and is eligible to receive royalties on sales of the product. BeiGene to get the right to develop, manufacture, and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan while Bio-Thera will retain rights… Read More »BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

Trump Is Sending Fast, Cheap COVID Tests to Nursing Homes — But There’s a Hitch

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The Trump administration’s latest effort to use COVID-19 rapid tests — touted by one senior official as a “turning point” in arresting the coronavirus’s spread within nursing homes — is running into roadblocks likely to limit how widely they’ll be used. Federal officials are distributing… Read More »Trump Is Sending Fast, Cheap COVID Tests to Nursing Homes — But There’s a Hitch

AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer

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Shots: The approval is based on P-III CASPIAN study assessing Imfinzi + etoposide and either carboplatin/ cisplatin CT or Imfinzi & CT+ tremelimumab vs CT as monothx. as 1L treatment in 805 patients with ES-SCLC. The trial used an FD of Imfinzi (1,500mg, q3w for… Read More »AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer

Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

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Shots: The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence… Read More »Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

NICE recommends regular NHS funding for Roche’s lymphoma drug Polivy

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NICE has recommended regular NHS funding for Roche’s Polivy in certain lymphoma patients in final draft guidance, overturning a previous rejection. The new guidance recommends Polivy (polatuzumab vedotin) in combination with rituximab and bendamustine, for adults with diffuse large B-cell lymphoma (DLBCL), in second line… Read More »NICE recommends regular NHS funding for Roche’s lymphoma drug Polivy

Drugs for Migraine

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Date:  October 5, 2020 Issue #:  1608 Summary:  An oral nonopioid analgesic is often sufficient for acute treatment of mild to moderate migraine headache without severe nausea or vomiting. A triptan is the drug of choice for treatment of moderate to severe migraine headache pain… Read More »Drugs for Migraine

Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab Biosimilar in China

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Shots: On Aug 14, 2020, HLX02 (biosimilar, trastuzumab) received NMPA’s approval to treat HER2+ early BC, HER2+ m-BC and HER2+ m-gastric cancer. Additionally, On 27th July, HLX02 has received EC’s approval under the brand name Zercepac Henlius followed the NMPA and EMA’s biosimilar guidelines and… Read More »Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab Biosimilar in China

Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

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Shots: Isofol to receive $100M as up front, development, regulatory and commercial milestones, and clinical development cost and is eligible to receive royalties on sales of the therapy and retain its right to the therapy in ROW Solasia will lead clinical development activities in Japan… Read More »Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

[Podcast] How Cleveland Clinic Helps Employers Create a Safer Workplace During COVID-19

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Dr. Jim Merlino, Chief Clinical Transformation Officer, Cleveland Clinic Despite having entered the US eight months ago, COVID-19 remains a topic enshrouded in confusion, conflicting information, hyperbole, and even conspiracy theories. Everyone, informed or not, seems to have an opinion about the coronavirus pandemic. Fortunately,… Read More »[Podcast] How Cleveland Clinic Helps Employers Create a Safer Workplace During COVID-19

How Antiarrhythmic Drugs are Used in Cardiac Life Support

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One of the most interesting types of cardiovascular pharmaceuticals around is antiarrhythmic drugs, which can change the way your heartbeats. Antiarrhythmic drugs help counteract abnormal heart rhythms resulting from the irregular electrical activity. These could include atrial fibrillation, atrial flutter, supraventricular tachycardia, and Wolff-Parkinson-White syndrome,… Read More »How Antiarrhythmic Drugs are Used in Cardiac Life Support

Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

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Shots: The NMPA has accepted the sNDA for Tyvyt (sintilimab) in combination with Gemzar (gemcitabine) and platinum as 1L therapy in sq. NSCLC The sNDA is based on P-III ORIENT-12 study assessing sintilimab (200mg) vs PBO in combination with Gemzar and Pt (q3w for up… Read More »Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

FDA, Syapse Expand Research to Generate Real-World Data Related to COVID-19 and Cancer

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What You Should Know: The FDA and Syapse announce research collaboration expansion to address urgent public health challenges including supporting FDA’s goal of rapid understanding of COVID-19. As part of the research, Syapse is partnering with FDA’s Oncology Center of Excellence to investigate methods to… Read More »FDA, Syapse Expand Research to Generate Real-World Data Related to COVID-19 and Cancer

Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic HER2-Overexpressing Breast Cancer in Brazil

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Shots: The company launches its first oncology treatment Ontruzant (trastuzumab), a biosimilar referencing Herceptin in Brazil. The biosimilar has received ANVISA’s approval for the treatment of metastatic HER2-overexpressing BC, early HER2-overexpressing BC, and advanced gastric cancer Ontruzant is being supplied to SUS through a PDP… Read More »Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic HER2-Overexpressing Breast Cancer in Brazil

Blue Shield of CA Taps Cricket Health to Offer AI-Driven, Personalized Kidney Care Plans for Members At No Cost

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What You Should Know: – Blue Shield of CA and kidney care provider Cricket Health announced a partnership to offer a personalized, virtual, multidisciplinary care available for members with kidney disease or kidney failure at no extra cost – By offering remote care, via phone… Read More »Blue Shield of CA Taps Cricket Health to Offer AI-Driven, Personalized Kidney Care Plans for Members At No Cost

Cerner Invests in Xealth to Jointly Develop Digital Health Solutions for Clinicians

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What You Should Know: – Cerner and Xealth announce a collaboration to foster tighter physician-patient relationships by giving patients easier access to digital health tools. – These assets will be prescribed directly within the physician’s EHR workflow to manage conditions including chronic diseases, behavioral health,… Read More »Cerner Invests in Xealth to Jointly Develop Digital Health Solutions for Clinicians

How to Treat Bacterial Vaginosis

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Vitamin C is pitted head-to-head against antibiotics for bacterial vaginal infections. A study published in 1999 raised the exciting possibility that “cheap, simple, innocuous and ubiquitous vitamin C” supplements could prevent a condition known as preeclampsia, but after a decade of research, we realized that… Read More »How to Treat Bacterial Vaginosis

These 8 Life-Changing Tips Will Help You Age Well

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These 8 Life-Changing Tips Will Help You Age Well Ilchi Lee, the author of I’ve Decided to Live 120 Years shares his life-changing tips on how to feel content and fulfilled until the last moments of your life. The Doctor Weighs In

Vaccines provide good value for money in low- and middle-income countries

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That is according to a Health Affairspaper by So Yoon Sim et al. (2020). We estimated economic benefits using cost-of-illness and value-of-a-statistical-life approaches and combined this estimation with immunization program costs to derive the return on investment from immunization programs against ten pathogens for ninety-four… Read More »Vaccines provide good value for money in low- and middle-income countries

Armpit Shaving and Breast Cancer

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Shaving before applying underarm antiperspirants can increase aluminum absorption. Could this explain the greater number of tumors and the disproportionate incidence of breast cancer in the upper outer quadrant of the breast near the armpit? A famous case report called “The Mortician’s Mystery,” published in… Read More »Armpit Shaving and Breast Cancer

Home-Based Medical Care Can Reduce Hospitalizations and Lower Costs — But It’s Still Underutilized

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While home-based medical care has been shown to reduce hospitalization rates and lower costs for both homebound and non-homebound populations alike, it continues to be drastically underutilized in the current health care ecosystem. As a result, there are millions of older Americans — especially those… Read More »Home-Based Medical Care Can Reduce Hospitalizations and Lower Costs — But It’s Still Underutilized

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

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Shots: The BT designation is based on P-III ADAURA trial which involves assessing Tagrisso (80 mg) vs PBO in 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated across 20 centers and 200+ countries including the… Read More »AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

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Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including… Read More »Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

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Shots: The approval is based on the principle of extrapolation of its efficacy data in adults also supported by pharmacokinetic and safety data in children. Additionally, the safety and tolerability data of Brivlera in children 4 years and older were similar to observed in adults… Read More »UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

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Shots: Chi-Med to receive 70%-80% of Elunate sales in the form of royalties, manufacturing costs and service payments with no upfront regarding this amendment. Lilly will maintain the exclusive commercialization rights and will continue to consolidate the sales of Elunate in China while Chi-Med retains… Read More »Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis

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Shots: Then CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials involve a broad range of patients that met their 1EPs  In the trials, the drug achieved ACR20/50/70 and… Read More »Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis

Technology Divide Between Senior ‘Haves’ and ‘Have-Nots’ Roils Pandemic Response

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Family gatherings on Zoom and FaceTime. Online orders from grocery stores and pharmacies. Telehealth appointments with physicians. These have been lifesavers for many older adults staying at home during the coronavirus pandemic. But an unprecedented shift to virtual interactions has a downside: Large numbers of… Read More »Technology Divide Between Senior ‘Haves’ and ‘Have-Nots’ Roils Pandemic Response

Limited-time merch!

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Show off your love for NutritionFacts.org with these limited-edition products!  This summer, we’ve got brand new designs on a tee, tank, and mask. Funds raised help my team and I continue to bring you the bite-sized lifestyle medicine information you count on. Get the swag here. … Read More »Limited-time merch!

Daiichi Sankyo Signs a Research Agreement Gustave Roussy for DS-1062 and Patritumab Deruxtecan to Treat Lung and Breast Cancer

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Shots: Gustave Roussy to receive funding and support from Daiichi Sankyo for integrative research program including clinical, translational, and preclinical studies for DS-1062 and patritumab deruxtecan in lung and breast cancer respectively The research program includes two P-II studies evaluating the efficacy, safety, and markers… Read More »Daiichi Sankyo Signs a Research Agreement Gustave Roussy for DS-1062 and Patritumab Deruxtecan to Treat Lung and Breast Cancer

Eko Awarded $2.7M NIH Grant for Heart Murmur & Valvular Heart Disease Detection Algorithms

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What You Should Know: – The National Institutes of Health (NIH) has granted next-generation cardiac AI company Eko an award totaling $2.7 million to support continued collaborative work with Northwestern Medicine Bluhm Cardiovascular Institute – The grant will focus on validating algorithms and help more… Read More »Eko Awarded $2.7M NIH Grant for Heart Murmur & Valvular Heart Disease Detection Algorithms

Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India

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Shots: Mylan launches Desrem (remdesivir) addressing the unmet needs amid COVID-19. The drug is approved for the treatment of suspected or laboratory-confirmed incidences of COVID-19 in adults and children hospitalized with severe symptoms Mylan will manufacture Desrem in its state-of-the-art injectable facility in Bangalore, India,… Read More »Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India

Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

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Shots: The companies reported that most advanced of four COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program demonstrated the ability to elicit high SARS-CoV-2 neutralizing titers following the second dose in an ongoing P-I/II study in Germany The results divulge that BNT162b1 candidate induced… Read More »Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis

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Shots: The real-world evidence partnership will allow the Roche to access PicnicHealth’s set of de-identified patient records to gain insights on certain diseases and treatments The collaboration will initially focus on MS and may be extended to support Huntington’s disease (HD), paroxysmal nocturnal hemoglobinuria (PNH),… Read More »Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis