Study

Vigeo Reports Completion of VT1021 in P-I/II Study for the Treatment of Recurrent Glioblastoma and Pancreatic Cancer

Shots: The P-I/II dose expansion studies evaluate the safety & preliminary anti-tumor efficacy of VT1021 as monothx. in patients with dose-escalation & expansion cohorts with rGBM & PC. The results of both studies are expected in Q4’21 In the rGBM expansion cohort, the therapy showed a complete tumor regression & PR, patients remain on trial …

Vigeo Reports Completion of VT1021 in P-I/II Study for the Treatment of Recurrent Glioblastoma and Pancreatic Cancer Read More »

Study: Resilience, emotional support key to helping healthcare workers fight stress

Along with daily surveys, a research team from Mount Sinai used Apple Watches to measure how stress impacted healthcare workers’ bodies and pinpointed the characteristics that were associated with lower stress levels over time.

RedHill’s Opaganib (ABC294640) Fails to Meet its Primary Endpoints in P-II/III Study for the Treatment of Severe COVID-19

Shots: The P-II/III study evaluates opaganib +SoC vs PBO + SoC in a ratio (1:1) in 475 patients with COVID-19 pneumonia requiring hospitalization & treatment with supplemental oxygen The preliminary data showed that the study did not meet its 1EPs while efficacy EPs showed consistent trends. The therapy demonstrated good tolerability with balanced AEs & …

RedHill’s Opaganib (ABC294640) Fails to Meet its Primary Endpoints in P-II/III Study for the Treatment of Severe COVID-19 Read More »

Samsung Bioepis Reports Results of Post-Hoc Analysis from P-III Study of Byooviz (biosimilar, ranibizumab) for the Treatment of nAMD

Shots: The P-III study evaluates Byooviz (0.5 mg, IVT) vs ranibizumab in 634 patients with nAMD. The results will be presented at EURETINA 2021 The 1EPs are changed from baseline in BCVA @8wks. and change in CST @4wks. with both EPs, followed by 52wks. The post-hoc analysis showed that the baseline age, BCVA, CST, and …

Samsung Bioepis Reports Results of Post-Hoc Analysis from P-III Study of Byooviz (biosimilar, ranibizumab) for the Treatment of nAMD Read More »

Should we do away with ACOs? The answer depends on who you ask  

In a new study, researchers suggest ACOs are not helping CMS save substantial amounts of money as they were expected to do, so the model should be eliminated. But other experts in the industry disagree, taking issue with the study’s methods and conclusions.

Bone Therapeutics’s JTA-004 Fails to Meet its All Endpoints in P-III Study for Knee Osteoarthritis

Shots: The P-III study involves assessing JTA-004 (enhanced viscosupplement) vs PBO and the active comparator to reduce pain measured by the WOMAC pain subscale in patients with osteoarthritic pain in the knee The study showed that all treatment arms have similar efficacy, no significant difference in knee pain reduction b/w JTA-004, PBO, and active comparator …

Bone Therapeutics’s JTA-004 Fails to Meet its All Endpoints in P-III Study for Knee Osteoarthritis Read More »

Study: Private consultancies can influence hospital participation in CMS bundled payments model 

Partnering with private consulting firms can spur greater hospital participation in the Bundled Payments for Care Improvement initiative Advanced Model, in which hospitals earn rewards for spending less than CMS-set benchmarks on an episode of care or pay penalties if they spend more.

Bayer Reports Results of Eliapixant (BAY1817080) in P-IIb Study for the Treatment of Refractory Chronic Cough

Shots: The P-IIb clinical trial involves evaluating the efficacy and safety of eliapixant (25/75/150mg, PO, bid) vs PBO in 300 patients with refractory chronic cough for 12wks. The trial met its 1EPs that showed an improvement in 24hrs. cough counts @12wks. of treatment. The results showed a favorable safety and tolerability profile of the therapy …

Bayer Reports Results of Eliapixant (BAY1817080) in P-IIb Study for the Treatment of Refractory Chronic Cough Read More »

Study: Black, Hispanic beneficiaries driving MA enrollment growth

Enrollment in Medicare Advantage plans grew rapidly between 2009 and 2018, with the largest increases seen among Black, Hispanic and dual enrollee — that is enrolled in both Medicare and Medicaid — populations. This indicates that payers will need to play a key role in addressing health inequities.

New Research Finds J&J Vaccine Has Muscle Against Covid’s Delta Variant

In the past two weeks, many medical experts started to question whether the Johnson & Johnson vaccine, which is administered in a single dose, would be as effective as the two-dose Pfizer-BioNTech or Moderna vaccine in protecting against the new, highly transmissible delta variant that is poised to become the dominant strain in the U.S. …

New Research Finds J&J Vaccine Has Muscle Against Covid’s Delta Variant Read More »

Study: Poor care access, higher costs more likely with private than public insurance

People with private insurance report poorer access to care, higher costs and lower satisfaction as compared to those with public insurance plans, a new study shows. As the debate over health insurance reform continues, policymakers should consider efforts that expand Medicare and increase protections for those with private insurance.

Many New Moms Get Kicked Off Medicaid 2 Months After Giving Birth. Illinois Will Change That.

The U.S. is the only industrialized nation in which the maternal death rate has been rising. Each year, about 700 deaths are due to pregnancy, childbirth or subsequent complications, according to the Centers for Disease Control and Prevention. This story also ran on NPR. It can be republished for free. When someone dies while pregnant or within a …

Many New Moms Get Kicked Off Medicaid 2 Months After Giving Birth. Illinois Will Change That. Read More »

Pandemic Leads Doctors to Rethink Unnecessary Treatment

Covid-19 is opening the door for researchers to address a problem that has vexed the medical community for decades: the overtreatment and unnecessary treatment of patients. This story also ran on The Washington Post. It can be republished for free. On one hand, the pandemic caused major health setbacks for non-covid patients who were forced …

Pandemic Leads Doctors to Rethink Unnecessary Treatment Read More »

‘Kicking You When You’re Down’: Many Cancer Patients Pay Dearly for Parking

For cancer patients, the road from diagnosis to survivorship feels like a never-ending parade of medical appointments: surgeries, bloodwork, chemotherapy, radiation treatments, scans. The routine is time-consuming and costly. So, when hospitals charge patients double-digit parking fees, patients often leave the garage demoralized. This story also ran on NBC News. It can be republished for …

‘Kicking You When You’re Down’: Many Cancer Patients Pay Dearly for Parking Read More »

Study: PE firms acquire hospitals with high operating margins, boosting them further

Hospitals acquired by PE firms tend to have higher operating margins than those that are not acquired — and that gap widens over time, a new study shows. But it is too early to say whether these glowing financial figures equate to better support for clinical care.

Trouble Managing Money May Be an Early Sign of Dementia

After Maria Turner’s minivan was totaled in an accident a dozen years ago, she grew impatient waiting for the insurance company to process the claim. One night, she saw a red pickup truck on eBay for $20,000. She thought it was just what she needed. She clicked “buy it now” and went to bed. The …

Trouble Managing Money May Be an Early Sign of Dementia Read More »

Mental Health Services Wane as Insurers Appear to Skirt Parity Rules During Pandemic

Therapists and other behavioral health care providers cut hours, reduced staffs and turned away patients during the pandemic as more Americans experienced depression symptoms and drug overdoses, according to a new report from the Government Accountability Office. Use Our Content It can be republished for free. The report on patient access to behavioral health care …

Mental Health Services Wane as Insurers Appear to Skirt Parity Rules During Pandemic Read More »

Celltrion Reports Results of Regdanvimab (CT-P59) in Pre-Clinical Study Against the South African Variant (B.1.351)

Shots: The preclinical results have demonstrated that CT-P59 has neutralizing effect against the South African variant and showed a reduction in viral load of SARS-CoV-2 and in binding affinity against RBD in the three mutations of the South African variant The company has completed patient enrolment of 1,300 people in an ongoing P- III trial …

Celltrion Reports Results of Regdanvimab (CT-P59) in Pre-Clinical Study Against the South African Variant (B.1.351) Read More »

I-Mab Reports Results of Olamkicept (TJ301) in P-II Study for Ulcerative Colitis

Shots: The P-II study involves assessing Olamkicept (300/600mg, q2w, IV) vs PBO in 91 patients in a ratio (1:1:1) who had active UC with a full Mayo score ≥5, a rectal bleeding subscore ≥1, an endoscopy subscore ≥2, and had an inadequate response with conventional UC therapy The study met its 1EPs & 2EPs, demonstrating …

I-Mab Reports Results of Olamkicept (TJ301) in P-II Study for Ulcerative Colitis Read More »

Novo Nordisk to Initiate P-IIIa Study for Oral Semaglutide to Treat Obesity

Shots: The company plan to initiate a pivotal P-IIIa program to assess the efficacy and safety of oral semaglutide (50mg) vs PBO in ~1000 people with obesity or overweight with comorbidities for 68wks. The initiation follows the completion of the STEP P-IIIa clinical program with semaglutide (2.4mg, qw, SC). The study is expected to initiate …

Novo Nordisk to Initiate P-IIIa Study for Oral Semaglutide to Treat Obesity Read More »

COVID-19 Treatment Trial Reaches Out to Communities of Color

An ongoing problem in clinical trials over the years has been a failure to procure diverse enough representation among the participants. For a long time, this was due to bias and oversight on the part of the research community, and the consequence was a lack of full understanding in how medications and treatments affected women …

COVID-19 Treatment Trial Reaches Out to Communities of Color Read More »

Indiana’s Medicaid Expansion — Designed by Pence and Verma — Panned in Federal Report

Indiana’s Medicaid expansion — with its “personal responsibility” provisions that require enrollees to pay monthly premiums and manage health savings accounts — proved no better at improving health and access to care than other state expansions, a federally commissioned study found. Use Our Content It can be republished for free. Even when compared with states …

Indiana’s Medicaid Expansion — Designed by Pence and Verma — Panned in Federal Report Read More »

Dramática baja de enfermedades por virus comunes, ¿significa máscaras para siempre?

Las máscaras y el distanciamiento físico están demostrando tener importantes beneficios extra, evitando que las personas contraigan todo tipo de enfermedades, no solo covid-19. Pero no está claro si los protocolos valdrán la pena a largo plazo. Maestros de la Academia New Hope en Franklin, Tennessee, estaban charlando sobre el tema. La escuela cristiana privada …

Dramática baja de enfermedades por virus comunes, ¿significa máscaras para siempre? Read More »

Eli Lilly along with VIR and GSK Report Results of Bamlanivimab + VIR-7831 in P-II BLAZE-4 Study for Low-Risk Adults with COVID

Shots: The P-II BLAZE-4 study involves assessing bamlanivimab as monothx. and bamlanivimab (700mg) + VIR-7831 (500mg) vs PBO in 1000 participants with symptomatic low-risk COVID-19 in the outpatient setting across the US and Puerto Rico Results: The dual regimen met its 1EPs i.e. 70% relative reduction in persistently high viral load (> 5.27; cycle threshold …

Eli Lilly along with VIR and GSK Report Results of Bamlanivimab + VIR-7831 in P-II BLAZE-4 Study for Low-Risk Adults with COVID Read More »

Pfizer and Myovant Report Results of Relugolix Combination Therapy in P-III LIBERTY Withdrawal Study in Women with Uterine Fibroids

Shots: The P-III LIBERTY withdrawal study involves assessing Relugolix combination therapy [relugolix (40 mg) + estradiol (1.0mg) & norethindrone acetate (0.5mg)] vs PBO in women with uterine fibroids for 24wks. The study met its 1EPs i.e. achieving the sustained responder rate @76wks. (menstrual blood loss < 80 mL) (78.4% vs 15.1%). The study met 2EPs …

Pfizer and Myovant Report Results of Relugolix Combination Therapy in P-III LIBERTY Withdrawal Study in Women with Uterine Fibroids Read More »

Eli Lilly Report Result of Donanemab in P-II TRAILBLAZER-ALZ Study for Alzheimer’s Disease

Shots: The P-II TRAILBLAZER-ALZ study involves assessing donanemab vs PBO in 272 patients with early symptomatic AD who were selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau staging by PET imaging The study met its 1EPs, showed a slowing of decline by 32% @76wks. as measured by the iADRS. The …

Eli Lilly Report Result of Donanemab in P-II TRAILBLAZER-ALZ Study for Alzheimer’s Disease Read More »

CDC’s ‘Huge Mistake’: Did Misguided Mask Advice Drive Up Covid Death Toll for Health Workers?

Since the start of the pandemic, the most terrifying task in health care was thought to be when a doctor put a breathing tube down the trachea of a critically ill covid patient. This story also ran on The Guardian. It can be republished for free. Those performing such “aerosol-generating” procedures, often in an intensive …

CDC’s ‘Huge Mistake’: Did Misguided Mask Advice Drive Up Covid Death Toll for Health Workers? Read More »

Roche’s Actemra/RoActemra (tocilizumab) + Veklury Fail to Meet its Primary Endpoints in P-III REMDACTA Study for Patients with Severe COVID-19 Pneumonia

Shots: The P-III REMDACTA study involves assessing Actemra/RoActemra (tocilizumab) + Veklury (remdesivir) vs PBO + Veklury in hospitalized patients with severe COVID-19 pneumonia receiving SOC The study did not meet its 1EPs i.e. improvement in time to hospital discharge up to day28 and failed to meet its 2EPs compared to Veklury alone. The findings will …

Roche’s Actemra/RoActemra (tocilizumab) + Veklury Fail to Meet its Primary Endpoints in P-III REMDACTA Study for Patients with Severe COVID-19 Pneumonia Read More »

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata

Shots: The P-III BRAVE-AA2 study involves assessing Baricitinib (2mg & 4mg, qd) vs PBO in 546 adults with a SALT score ≥ 50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least 6mos. but no >8yrs. The P-III study met its 1EPs @36wks. and demonstrated significant improvement …

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Read More »

Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan

Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing the safety and immunogenicity of two vaccinations of TAK-919 (100μg, given 28 days apart) in 200 participants aged ≥20yrs. followed through 12mos. after the second vaccination. Takeda has completed enrollment …

Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Read More »

Roche Collaborates with Tempest to Evaluate TPST-1120 in a Combination Study as 1L Treatment for Hepatocellular Carcinoma

Shots: The companies collaborated to evaluate TPST-1120 + Tecentriq (atezolizumab) and Avastin (bevacizumab) in P-Ib/II study in ~60 patients with advanced HCC prior not treated with HCC Tempest will retain the global rights to develop & commercialize TPST-1120 while Roche will manage the study operations for a global study TPST-1120 is a first-in-class selective PPAR⍺ …

Roche Collaborates with Tempest to Evaluate TPST-1120 in a Combination Study as 1L Treatment for Hepatocellular Carcinoma Read More »

Coronavirus Deranges the Immune System in Complex and Deadly Ways

This story also ran on USA Today. It can be republished for free. There’s a reason soldiers go through basic training before heading into combat: Without careful instruction, green recruits armed with powerful weapons could be as dangerous to one another as to the enemy. The immune system works much the same way. Immune cells, …

Coronavirus Deranges the Immune System in Complex and Deadly Ways Read More »

Veru to Advance VERU-111 in P-III Study for COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

Shots: The US FDA agreed to advance VERU-111 into a P-III study which will evaluate VERU-111 vs PBO in ~400 hospitalized patients in a ratio (2:1) with COVID-19 and are at high risk for ARDS. The study is anticipated to begin in Apr’2021 with clinical results expected in Q4’21 The P-II trial has demonstrated clinically …

Veru to Advance VERU-111 in P-III Study for COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome Read More »

Samsung Bioepis Initiates P-I Study of SB17 Proposed Biosimilar to Stelara (ustekinumab)

Shots: The P-I study assesses the PK, safety, tolerability and immunogenicity of SB17 vs Stelara (US & EU sourced) in 201 healthy males in a ratio (1:1:1) aged 18-55yrs. All IPs will be administered subcutaneously in the abdomen Samsung Bioepis has four biosimilar candidates – SB12 (eculizumab), SB15 (aflibercept), and SB16 (denosumab) in P-III and …

Samsung Bioepis Initiates P-I Study of SB17 Proposed Biosimilar to Stelara (ustekinumab) Read More »

Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine

Shots: The companies reported the initiation of a P-II dose-finding study assessing the safety, reactogenicity, and immunogenicity of two injections given 21 days apart in 720 adults aged ≥18yrs. The P-II study assesses the potential for refined antigen formulation to achieve an optimal immune response, including in older adults. If P-II results are positive, the …

Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine Read More »

GSK Initiates P-III study for RSV Candidate Vaccine Programme for Older Adults

Shots: The first P-III AReSVi 004 study evaluates the immunogenicity, safety, reactogenicity and persistence of RSV candidate vaccine in 1650 adults ≥ aged 60 years. The study is expected to end in early 2024, with interim results expected to be available in the H1’ 2022 The second P-III AReSVi 006 study assessing the efficacy of …

GSK Initiates P-III study for RSV Candidate Vaccine Programme for Older Adults Read More »

Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis

Shots: The P-II AMBER2 study assessing the efficacy and safety of SHR0302 (8mg qd/4mg bid/4mg qd) vs PBO in 164 adults with moderate to severe UC across 84 sites in China, US, and EU. The AMBER2 study consisted of an 8wks. induction period, followed by an 8wks. extension period The study met its 1EPs i.e. …

Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Read More »

Daiichi Sankyo Initiates P-II Study of Patritumab Deruxtecan in Patients with EGFR-Mutated NSCLC

Shots: The P-II HERTHENA-Lung01 study involves assessing patritumab deruxtecan in 420 patients in a ratio (1:1) with EGFR-mutated m/ LA NSCLC prior treated with TKI and Pt-based CT. The first patient has been dosed in P-II study The 1EPs of P-II study include ORR and 2EPs include DoR, PFS, DCR, and time to response. Moreover, …

Daiichi Sankyo Initiates P-II Study of Patritumab Deruxtecan in Patients with EGFR-Mutated NSCLC Read More »

BMS’ Deucravacitinib Demonstrate Superiority Over Otezla (apremilast) in P-III POETYK PSO-2 Study for Plaque Psoriasis

Shots: The P-III POETYK PSO-2 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (30mg, bid) in 1,020 patients with moderate to severe plaque psoriasis The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile …

BMS’ Deucravacitinib Demonstrate Superiority Over Otezla (apremilast) in P-III POETYK PSO-2 Study for Plaque Psoriasis Read More »

Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations

Shots: The P-I CHRYSALIS study involves assessing of amivantamab (RP2D of 1050 mg [1400 mg for a patient weight of ≥80 kg]) as a monothx. and in combination with lazertinib in 460 patients with metastatic or unresectable NSCLC and EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based CT Results: ORR (40%); …

Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations Read More »

Amgen Report Results of Sotorasib in P-II Study for KRAS G12C-Mutated Advanced NSCLC

Shots: The P-II cohort of the CodeBreaK 100 clinical study involves assessing Sotorasib (AMG 510, 960mg, qd) in 126 patients with KRAS G12C-mutated advanced NSCLC. The findings will be presented at the IASLC 2020 WCLC Results: @median follow up of 12.2 mos., ORR (37.1%); DCR (80.6%); mDoR (10 mos.), PFS (6.8 mos.). Median tumor shrinkage …

Amgen Report Results of Sotorasib in P-II Study for KRAS G12C-Mutated Advanced NSCLC Read More »

Eli Lilly and AbCellera Report Results of Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV16) in P-II/III BLAZE-1 Study for Preventing COVID-19

Shots: The P-II/III BLAZE-1 trial involves assessing of Bamlanivimab + Etesevimab (2800 mg) vs PBO in 1035 patients recently diagnosed with COVID-19 in the ambulatory setting The results demonstrated an 70% reduction in risk of COVID-19 related hospitalizations and deaths in high-risk patients and improvements in all 2EPs including reductions in viral load and accelerated …

Eli Lilly and AbCellera Report Results of Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV16) in P-II/III BLAZE-1 Study for Preventing COVID-19 Read More »

Eli Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-III BLAZE-2 Study for Preventing COVID-19 at Nursing Homes

Shots: The P-III BLAZE-2 COVID-19 prevention trial involves assessing bamlanivimab (4,200mg) vs PBO in residents and staff at skilled nursing and assisted living facilities. The 965 &132 COVID-19 negative & positive participants were included in the analysis of 1EPS & 2EPs for assessing prevention & in exploratory analyses respectively The results demonstrated an 80% reduction …

Eli Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-III BLAZE-2 Study for Preventing COVID-19 at Nursing Homes Read More »

BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A

Shots: The ongoing P-III GENEr8-1 study involves assessing of valoctocogene roxaparvovec (6e13 vg/kg dose) in 134 patients with with severe hemophilia A. The patients received a single dose of valoctocogene roxaparvovec and completed a year or more of follow-up The study met 1EPs & 2EPs i.e. reduction in ABR by 84% demonstrating superiority to factor …

BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A Read More »

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD

Shots: The first patient has been dosed in P-III CIFFREO study assessing PF-06939926 vs PBO in 99 ambulatory male patients aged 4-7yrs. with DMD across 55 sites in 15 countries. The first patient was dosed at a site in Barcelona, Spain on Dec 29, 2020. The 1EPs of the study is the change in NSAA …

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD Read More »

Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy

Shots: The P-III HELIOS-A study assessing vutrisiran (25mg, SC, once every 3mos.) vs patisiran (0.3 mg/kg, IV, q3w) in 164 patients in a ratio (3:1) with hATTR amyloidosis with polyneuropathy The study met its 1EPs & 2EPs i.e. change from baseline in the mNIS+7 @9mos. & changes in QoL assessed by Norfolk QoL-DN and gait …

Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy Read More »

Children’s Hospitals Are Partly to Blame as Superbugs Increasingly Attack Kids

COLUMBIA, Mo. — A memory haunts Christina Fuhrman: the image of her toddler Pearl lying pale and listless in a hospital bed, tethered to an IV to keep her hydrated as she struggled against a superbug infection. “She survived by the grace of God,” Fuhrman said of the illness that struck her oldest child in …

Children’s Hospitals Are Partly to Blame as Superbugs Increasingly Attack Kids Read More »

RedHill Reports Results of Yeliva (opaganib) in P-II Study for COVID-19

Shots: The P-II US study involves assessing Opaganib + SOC vs PBO + SOC in 40 patients requiring oxygen support in a ratio (1:1) and were followed up for ~42days post-treatment initiation The study demonstrated improvement in reaching room air within 14days (52.6% vs 22.2%); improvement in reduction to 50% supplemental oxygen by Day 14 …

RedHill Reports Results of Yeliva (opaganib) in P-II Study for COVID-19 Read More »

Alligator Bioscience Submits CTA for the P-II OPTIMIZE-1 Study of Mitazalimab

Shots: Alligator reports that it has submitted a CTA application to the relevant regulatory authorities to start a P-II efficacy study of its CD40 targeting antibody mitazalimab Upcoming P-II OPTIMIZE-1 study is assessing mitazalimab + CT (mFolfirinox) in patients with metastatic pancreatic cancer and will be performed at several clinics in Europe involve up to …

Alligator Bioscience Submits CTA for the P-II OPTIMIZE-1 Study of Mitazalimab Read More »

Alzheimer’s Inc.: Colleagues Question Scientist’s Pricey Recipe Against Memory Loss

This story also ran on Daily Beast. It can be republished for free. When her husband was diagnosed with early-stage Alzheimer’s disease in 2015, Elizabeth Pan was devastated by the lack of options to slow his inevitable decline. But she was encouraged when she discovered the work of a UCLA neurologist, Dr. Dale Bredesen, who …

Alzheimer’s Inc.: Colleagues Question Scientist’s Pricey Recipe Against Memory Loss Read More »

Nektar Therapeutics Presents Preclinical Data of NKTR-255 in P-Ib/II Study at ASH 2020

Shots: Nektar presents two nonclinical data presentations for NKTR-255 at the 62nd ASH Annual Meeting, which include an oral presentation of translational research studies conducted in collaboration with researchers from Dana-Farber Cancer Center NKTR-255 is being tested in a P-Ib/II study as monothx. & in combination with rituximab or daratumumab in patients with MM & …

Nektar Therapeutics Presents Preclinical Data of NKTR-255 in P-Ib/II Study at ASH 2020 Read More »

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin lymphoma

Shots: The P-II ZUMA-5 study involves assessing Yescarta (axicabtagene ciloleucel) in patients with r/r iNHL after at least 2L of systemic therapy. After a single infusion of Yescarta, 92% of patients responded, including 76% of patients achieving a CR @median follow-up of 17.5 mos., results presented at ASH The data supports the US FDA’s acceptance …

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin lymphoma Read More »

Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC

Shots: The P-III ATLANTIS study involves assessing Zepzelca (lurbinectedin, 2.0mg/m2) + doxorubicin vs topotecan/ CAV in 613 adult patients in a ratio (1:1) aged ≥18yrs. with SCLC whose disease progressed following one prior Pt.-containing line The study did not meet its 1EP of OS in the ITT population while there were no adverse effects on …

Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC Read More »

Feds Look to Pharmacists to Boost Childhood Immunization Rates

Torey Watson is trained as a pharmacist but aims to do more than simply fill prescriptions. Pharmax Pharmacy — a small drugstore chain where Watson works as a clinical services coordinator, about an hour and 30 minutes southwest of St. Louis — will soon allow him to offer childhood vaccines to patients without a doctor’s …

Feds Look to Pharmacists to Boost Childhood Immunization Rates Read More »

First results of the DiabetRisk study

First results of the DiabetRisk study – Over 8% of patients identified with undiagnosed diabetes or pre-diabetes at dental practices The DiabetRisk study could contribute to early diagnosis of diabetes in thousands of dental patients each year – and in every country worldwide Simple screening process applied to 1,143 dental patients at 41 dental practices …

First results of the DiabetRisk study Read More »

AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol

Shots: The P-IIb study will evaluate three dose levels of ION449 (once a month, SC) vs PBO and will enroll ~108 patients aged 18-75yrs., who have LDL-C levels b/w 70-190 mg/dL and are receiving moderate/ high-intensity statin therapy The P-I study results demonstrated dose-dependent mean reductions in circulating plasma PCSK9 and LDL-C levels of >90% …

AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol Read More »

Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain

Shots: The P-IIa study involves assessing vibegron (75mg,qd) in 222 women with abdominal pain due to IBS with IBS-D (diarrhea) and IBS-M (mixed IBS) across 35 sites in the US The study did not meet its 1EPs i.e. at least a 30 percent improvement in average worst abdominal pain @12wks. ( 40.9% vs 42.9%), well …

Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain Read More »

Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD

Shots: The enrollment of the first P-III study is currently underway & has reached 85% of its enrollment goal. In a P-II study of 336 patients, NOV03 met its 1EP of efficacy i.e. improvement of total corneal fluorescein staining over control @8wks. Additionally, NOV03 showed improvement of certain symptoms, such as severity & frequency of …

Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD Read More »

For Nurses Feeling the Strain of the Pandemic, Virus Resurgence Is ‘Paralyzing’

For Christina Nester, the pandemic lull in Massachusetts lasted about three months through summer into early fall. In late June, St. Vincent Hospital had resumed elective surgeries, and the unit the 48-year-old nurse works on switched back from taking care of only COVID-19 patients to its pre-pandemic roster of patients recovering from gallbladder operations, mastectomies …

For Nurses Feeling the Strain of the Pandemic, Virus Resurgence Is ‘Paralyzing’ Read More »

ViiV’s PROgress Study Demonstrates Inclusion of PROs into Clinical Practice Can Improve HIV Care

Shots: In the PROgress study, 200 people living with HIV were provided with a pre-visit survey to guide their conversation with their HCP and assess PROs covering a range of measures, including treatment adherence, mental health, substance abuse, and intimate partner violence Results: the inclusion of the pre-visit survey made their visit better overall (82%), …

ViiV’s PROgress Study Demonstrates Inclusion of PROs into Clinical Practice Can Improve HIV Care Read More »

Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19

Shots: Following the successful completion of the interim analysis from the P-I & P-II clinical trials of Covaxin, the company has received the DCGI approval to conduct a P-III study of its COVID-19 vaccine The study will assess Covaxin (6mcg, IM at an interval of 28days) vs PBO in ~26,000 volunteers in a ratio (1:1) …

Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19 Read More »

GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine

Shots: Following the positive P-I results, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant The study will evaluate the immunogenicity and safety profile of the chosen formulation and dosing regimen of CoVLP (two doses of 3.75µg combined with GSK’s adjuvant given 21 days apart) in healthy adults 18-64yrs. of …

GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine Read More »

‘Breakthrough Finding’ Reveals Why Certain COVID Patients Die

Dr. Megan Ranney has learned a lot about COVID-19 since she began treating patients with the disease in the emergency department in February. But there’s one question she still can’t answer: What makes some patients so much sicker than others? Advancing age and underlying medical problems explain only part of the phenomenon, said Ranney, who …

‘Breakthrough Finding’ Reveals Why Certain COVID Patients Die Read More »

DispatchHealth adds to evidence backing safety, efficacy of hospital-at-home programs

Amid the Covid-19 pandemic and a growing interest in at-home care, DispatchHealth has published new data showing that its hospital-at-home program did not result in unexpected deaths, serious adverse events or patients being subsequently admitted to a skilled nursing facility.

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma

Shots: The P-II 218 study involves assessing Lenvima (14mg, qd) + everolimus (5mg, qd) vs Lenvima (18mg, qd) + everolimus (5mg qd) in patients with clear-cell RCC, following treatment with an anti-angiogenic therapy, with prior anti-PD-1/PD-L1 therapy permitted In the primary analysis, @24wks. ORR (32.1% vs 34.8%) i.e. lower dose did not meet the threshold …

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma Read More »

The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

Shots: The advisory committee voted 1-8, with 2 members voting uncertain that EMERGE study (without regard for ENGAGE study) provides strong evidence, supporting the effectiveness of aducanumab as a treatment for AD. The committee also voted 0-7 with 4 members voting uncertain that PRIME study provides supporting evidence for aducanumab The committee voted 5-0 and …

The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease Read More »

Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis

Shots: The P-IIIb ULTIMATE study involves assessing Cosentyx (300/150mg) vs PBO weekly for a mos. with treatment starting @4wks., followed by a once-a-month dose for the next 11mos. in 166 biologic-naïve patients in a ratio (1:1) with active PsA The study reduction of synovitis @12wks. with an early improvement observed as 1wk., ACR20 (68% vs …

Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis Read More »

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis

Shots: The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of …

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis Read More »

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Shots: The pivotal P-III MONALEESA-7 study assessing Kisqali + endocrine therapy vs PBO + endocrine therapy, in pre- & perimenopausal women with HR+/HER2- advanced or metastatic-BC The study met its 2EPs of OS, demonstrating a significant improvement in OS, and is consistent for the NSAI population & across exploratory subgroups, m-OS was not reached while …

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer Read More »

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Shots: The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) …

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020 Read More »

Tetra Therapeutics Reports Positive Results of BPN14770 in P-II Study for Fragile X Syndrome

Shots: The P-II study is a two-way crossover study assessing BPN14770 (25mg, bid) vs PBO in 30 adult male patients aged 18-45yrs. with FXS due to >200 CGG repeats in the FMR1 gene The study demonstrated benefits in oral reading recognition (+2.80), picture vocabulary (+5.79), cognition crystallized composite score (+5.29), benefits were maintained up to …

Tetra Therapeutics Reports Positive Results of BPN14770 in P-II Study for Fragile X Syndrome Read More »

They Work in Several Nursing Homes to Eke Out a Living, Possibly Spreading the Virus

To make ends meet, Martha Tapia works 64 hours a week at two Orange County, California, nursing homes. She is one of thousands of certified nursing assistants who perform the intimate and physical work of bathing, dressing and feeding the nation’s fragile elderly. “We do everything for them. Everything you do for yourself, you have …

They Work in Several Nursing Homes to Eke Out a Living, Possibly Spreading the Virus Read More »

UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis

Shots: The P-III BE SURE study involves assessing bimekizumab vs Humira (adalimumab) for 24wks. is followed until 56wks. in 478 adult patients with chronic PsO for at least 6 mos. before screening & with an affected body surface area of at least 10%, PASI of at least 12 & IGA score equal to or > …

UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis Read More »

AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis

Shots: The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1, ultIMMa-2, SustaIMM, IMMvent and NCT03255382) and the LIMMitless study Results: …

AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis Read More »

Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine

Shots: The P-II BLAZE-1 study assesses bamlanivimab (700, 2800 & 7000 mg) vs PBO in the outpatient setting in patients with mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than 3 days prior to drug infusion Results: The study showed that bamlanivimab may …

Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine Read More »

AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US

Shots: The US FDA authorizes the restart of the P-III clinical study in the US following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from studies globally and concluded it was safe to resume the trial A voluntary pause across all global studies was triggered on Sept …

AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US Read More »

Dicerna Presents New Interim Data of PHYOX 3 OLE Study Evaluating Nedosiran for Primary Hyperoxaluria at ASN Week 2020

Shots: The PHYOX 3 OLE study involves assessing of nedosiran in participants aged ≥6yrs. with PH1 or PH2 who have participated in any previous PHYOX clinical development program trial as well as their siblings aged 6-18yrs. with PH All participants regardless of PH subtype, achieved normal or near-normal Uox excretion @day180, 92% participants (100% & …

Dicerna Presents New Interim Data of PHYOX 3 OLE Study Evaluating Nedosiran for Primary Hyperoxaluria at ASN Week 2020 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

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 at World Sleep 2019 Xywav is an oxybate product with …

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

Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease

Shots: The companies will advance the prasinezumab into a P-IIb study in patients with early Parkinson’s disease based on positive signals of efficacy consistent with disease modification in the PASADENA study The study is designed to further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA study to include patients …

Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease Read More »

Celltrion Initiates P-I Study of CT-P59 Against COVID-19 in Korea

Shots: The Korean MFDS has approved Celltrion’s IND to initiate a P-I trial of CT-P59 in patients with COVID-19. The company has initiated the enrollment and is set to evaluate the safety, tolerability, efficacy, PK, and immunogenicity of CT-P59. The company anticipates the completion of study in Q3’20 The company anticipates the results of P-II …

Celltrion Initiates P-I Study of CT-P59 Against COVID-19 in Korea Read More »

AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19

Shots: The first participants have been dosed in a P-I trial of AZD7442 to assess safety, tolerability, and PK of the combination mAbs in up to 48 healthy participants aged 18-55 yrs. in the UK. The study is funded by DARPA If AZD7442 proves to be tolerated and has a favorable safety profile in the …

AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19 Read More »

Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

Shots: The P-III study involves assessing of spartalizumab (PDR001) + Tafinlar (dabrafenib) and Mekinist (trametinib) vs PBO + Tafinlar and Mekinist in previously untreated patients with unresectable or metastatic BRAF V600 mutation-positive melanoma The study was conducted in three parts while today’s results are from part 3 of the trial. The study did not meet …

Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma Read More »

One College’s Pop-Up COVID Test: Stop and ‘Smell the Roses’ (Or the Coffee)

If all goes according to plan, Penn State University students who opt for an on-campus experience this fall will start in-person classes on Aug. 24 under the banner of a “Mask Up or Pack Up” campaign. By returning to campus, students are agreeing to wear masks, adhere to social distancing practices and submit to random …

One College’s Pop-Up COVID Test: Stop and ‘Smell the Roses’ (Or the Coffee) Read More »

Fitbit Report Results of its COVID-19 Study for Early Detection of Diseases

Shots: In May’2020, Fitbit has launched its COVID-19 study to build an algorithm that detects COVID-19 before symptoms starts. The study has enrolled 1000+ positive patients across the US and Canada is now delivering its first, preliminary results 90 days later The study demonstrated that its devices could detect ~50% of COVID-19 cases one day …

Fitbit Report Results of its COVID-19 Study for Early Detection of Diseases Read More »

Novo Nordisk Resumes P-III Study of Concizumab for Patients with Hemophilia A and B

Shots: The company resumes the P-III program (explorer6, 7, and 8) of concizumab. The clinical trials are evaluating concizumab (SC) prophylaxis treatment in hemophilia A and B patients regardless of their inhibitor status The trials will be resumed as soon as local procedures allow. This follows pausing of the trials in Mar’20 due to the …

Novo Nordisk Resumes P-III Study of Concizumab for Patients with Hemophilia A and B Read More »

Turning Anger Into Action: Minority Students Analyze COVID Data on Racial Disparities

As the coronavirus swept into Detroit this spring, Wayne State University junior Skye Taylor noticed something striking. On social media, many of her fellow Black classmates who live or grew up in the city were “posting about death, like, ‘Oh, I lost this family member to COVID-19,’” said Taylor. The picture was different in Beverly …

Turning Anger Into Action: Minority Students Analyze COVID Data on Racial Disparities Read More »

Bereaved Families Are ‘the Secondary Victims of COVID-19’

Every day, the nation is reminded of COVID-19’s ongoing impact as new death counts are published. What is not well documented is the toll on family members. New research suggests the damage is enormous. For every person who dies of COVID-19, nine close family members are affected, researchers estimate based on complex demographic calculations and …

Bereaved Families Are ‘the Secondary Victims of COVID-19’ Read More »

Pandemic Hampers Reopening of Joint Replacement Gold Mine

Dr. Ira Weintraub, a recently retired orthopedic surgeon who now works at a medical billing consultancy, saw a hip replacement bill for over $400,000 earlier this year. “The patient stayed in the hospital 17 days, which is only 17 times normal. The bill got paid,” mused Weintraub, chief medical officer of Portland, Oregon-based WellRithms, which …

Pandemic Hampers Reopening of Joint Replacement Gold Mine Read More »

Roche’s Tecentriq (atezolizumab) + Paclitaxel Fail to Meet the Primary Endpoint in P-III IMpassion131 Study for Patients with Metastatic Triple-Negative Breast Cancer

Shots: The P-III IMpassion131 study involves assessing of Tecentriq + paclitaxel vs PBO + paclitaxel, in 651 people in a ratio (2:1) with previously untreated, inoperable, LA/ m-TNBC The study did not meet its 1EPs of PFS for 1L treatment of people with m-TNBC) in the PD-L1+ population.  The data for 2EPs of OS showed …

Roche’s Tecentriq (atezolizumab) + Paclitaxel Fail to Meet the Primary Endpoint in P-III IMpassion131 Study for Patients with Metastatic Triple-Negative Breast Cancer Read More »

Lundbeck Halts P-II Study of Lu AF11167 in Patients with Negative Symptoms of Schizophrenia

Shots: The company discontinues P-II proof POC study of Lu AF11167 in patients with schizophrenia, who are experiencing persistent negative symptoms (NCT03793712). The P-II study evaluated two doses of Lu AF11167 vs PBO as monothx. in patients with schizophrenia and persistent prominent negative symptoms The discontinuation is based on the results of a futility interim …

Lundbeck Halts P-II Study of Lu AF11167 in Patients with Negative Symptoms of Schizophrenia Read More »

Health Care Workers of Color Nearly Twice as Likely as Whites to Get COVID-19

Health care workers of color were more likely to care for patients with suspected or confirmed COVID-19, more likely to report using inadequate or reused protective gear, and nearly twice as likely as white colleagues to test positive for the coronavirus, a new study from Harvard Medical School researchers found. The study also showed that …

Health Care Workers of Color Nearly Twice as Likely as Whites to Get COVID-19 Read More »

Eli Lilly in Collaboration with NIAID Initiate P-III Study of LY-CoV555 to Prevent COVID-19

Shots: Eli Lilly initiates P-III BLAZE-2 study assessing LY-CoV555 to prevent SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the US (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities) The company will enroll up to ~2400 patients and test whether a single dose of LY-CoV555 …

Eli Lilly in Collaboration with NIAID Initiate P-III Study of LY-CoV555 to Prevent COVID-19 Read More »

Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium

Shots: J&J’s Ad26 vector-based vaccine demonstrated robust immune response in the pre-clinical study by neutralizing Abs, preventing infection and provide complete/ near-complete protection in the lungs from the virus in NHPs Based on the preclinical studies, the company has commenced the P-I/IIa study of Ad26.COV2.S, in healthy volunteers in the US and Belgium with expected …

Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium Read More »

AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis

Shots: The P-III AD Up study involves assessing Rinvoq (15/30mg) + TCS vs PBO + TCS in patients (aged≥12) with the mod. to sev. AD who are candidates for systemic treatment. Patients receiving PBO + TCS were switched to either upadacitinib (15/30mg) + TCS @16wks. Results: @16wks. EASI 75 (65%/77% vs 26%); vIGA-AD 0/1 (40%/59% …

AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis Read More »

AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

Shots: The P-III DAPA-CKD involve assessing of Farxiga ((dapagliflozin, 10mg, qd) + SOC vs PBO in 4,304 patients with CKD Stages 2–4 and elevated urinary albumin excretion, with and without T2D The study met its 1EPs i.e. worsening of renal function or risk of death (defined as a composite of an eGFR decline ≥50%, the …

AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease Read More »

AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis

Shots: The P-III Measure Up 2 study involves assessing of Rinvoq (15/30mg) vs PBO in adults and adolescents aged 12-18yrs. or older with mod. to sev. AD who are candidates for systemic treatment. Placebo patients were switched to either upadacitinib (15/30mg) @16wks. The study met its co-1EPs @16wks. i.e. improvement in EASI 75 (60%/73% vs …

AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis Read More »

Scientists Want to Know More About Using UV Light to Fight COVID-19 Spread

High up near the ceiling, in the dining room of his Seattle-area restaurant, Musa Firat recently installed a “killing zone” — a place where swaths of invisible electromagnetic energy penetrate the air, ready to disarm the coronavirus and other dangerous pathogens that drift upward in tiny, airborne particles. Firat’s new system draws on a century-old …

Scientists Want to Know More About Using UV Light to Fight COVID-19 Spread Read More »

NIH Project Homes In on COVID Racial Disparities

While the disproportionate impact of COVID-19 on Black and Hispanic Americans is no secret, federal officials have launched studies of the disparity that they hope will better prepare the country for the next great epidemic. The National Institutes of Health began the ambitious “All of Us” research project in 2018 with the goal of enrolling …

NIH Project Homes In on COVID Racial Disparities Read More »

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

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 strong CD4+ and CD8+ T-cell responses. BNT162b1 elicits RBD-specific, interferon-g+, …

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

AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Shots: The P-II/III COV001 designed to determine the safety, immunogenicity, and efficacy of the AZD1222 (single dose or two doses of AZD1222 at 5×1010 viral particles) vs single dose of meningococcal conjugate vaccine (MenACWY) as control vaccine in up to 1,077 healthy adults aged 18-55yrs. in 5 trial centers in the UK The study demonstrated …

AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19 Read More »

Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Shots: The P-I study follows positive pre-clinical results and the Korean MFDS’ IND approval. The study will enroll ~32 healthy volunteers in collaboration with Chungnam National University Hospital to assess the safety of the antiviral Ab treatment candidate in patients who have not been diagnosed with COVID-19 The trial is expected to be completed in …

Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea Read More »

Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis

Shots: The P-III OASIS-2 study involves assessing mirikizumab vs PBO & Cosentyx (secukinumab) in 1,465 patients with mod. to sev. PsO. The patients were randomized in a (4:4:4:1) ratio to one of the following induction and maintenance period treatments: mirikizumab (250mg) @ 0, 4, 8, 12wks. followed by 250 & 125mg, q8w starting @16wks; 300mg …

Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis Read More »

Why Doctors Keep Monitoring Kids Who Recover From Mysterious COVID-Linked Illness

Israel Shippy doesn’t remember much about having COVID-19 — or the unusual auto-immune disease it triggered — other than being groggy and uncomfortable for a bunch of days. He’s a 5-year-old, and would much rather talk about cartoons, or the ideas for inventions that constantly pop into his head. “Hold your horses, I think I …

Why Doctors Keep Monitoring Kids Who Recover From Mysterious COVID-Linked Illness Read More »

La tasa de vacunación contra la culebrilla aumenta, pero muchos quedan atrás

Use Nuestro Contenido Este contenido puede usarse de manera gratuita (detalles). Preocupada por el alto costo del copago por la vacuna contra el herpes zóster (culebrilla), Jacky Felder, una beneficiaria de Medicare, optó por no vacunarse el año pasado. Forma parte del grupo de Facebook de Kaiser Health News en español “KHN-Hablemos de Salud”. KHN-Hablemos …

La tasa de vacunación contra la culebrilla aumenta, pero muchos quedan atrás Read More »