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Lilly Reports Results of Tirzepatide in P-lll SURPASS-2 Trial for Type-2 Diabetes

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Shots: The P-III SURPASS-2 trial involves assessing Tirzepatide (5/10/15mg) vs Semaglutide (1mg) in 1,879 patients in a ratio (1:1:1:1) with T2D inadequately controlled with ≥1500 mg/day metformin alone for 40wks. Results: A1C reduction: (-2.09% /-2.37%/-2.46% vs- 1.86%); Weight reduction: (-7.8/-10.3/-12.4kg vs -6.2 kg); patients achieving… Read More »Lilly Reports Results of Tirzepatide in P-lll SURPASS-2 Trial for Type-2 Diabetes

US picks up vaccination pace, averaging 2M doses per day

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The United States is administering an average of 2 million doses of COVID-19 vaccines per day, according to an analysis from The New York Times. The average is up from one month ago, when the daily average was about 1.3 million doses, according to…

Is Olive Oil Good for You?

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“Is olive oil good for you?” That’s probably not a question that crosses your mind when you grab that bottle of olive oil to cook with. Olive oil is ubiquitous, after all. It’s the go-to oil for almost any recipe, whether you’re cooking something savory… Read More »Is Olive Oil Good for You?

‘We’re a Strong Alternative to Nursing Homes’: PACE Giant InnovAge Executes $350M IPO

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InnovAge (Nasdaq: INNV), a Program of All-Inclusive Care for Elderly (PACE) provider, officially went public Thursday. Denver-based InnovAge offers one of the largest PACE programs in the U.S. The company has about 1,900 employees and serves 6,600 seniors in Colorado, New Mexico, California, Pennsylvania and… Read More »‘We’re a Strong Alternative to Nursing Homes’: PACE Giant InnovAge Executes $350M IPO

Florida governor faces growing charges of vaccine favoritism

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Florida Gov. Ron DeSantis pushed back on allegations that wealthy Floridians are getting earlier access to coronavirus vaccines, saying a local hospital—not the state—was behind the vaccinations of more than 1,200 Key Largo residents.

US in talks with allies to counter China’s vaccine diplomacy

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The United States, India, Australia and Japan are in talks to provide coronavirus vaccines to Asian nations in an effort to battle both COVID-19 and a Chinese push to extend its global influence through vaccine diplomacy.The discussions come as…

Kaiser Permanente, Big Player in California Vaccine Effort, Has Had Trouble Vaccinating Own Members

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USE OUR CONTENT It can be republished for free. As managed-care giant Kaiser Permanente assumes a prominent role in California’s new covid-19 vaccination strategy, it is drawing mixed reviews from members across the country for the way it has run its own vaccine program over… Read More »Kaiser Permanente, Big Player in California Vaccine Effort, Has Had Trouble Vaccinating Own Members

Reducing the Clinician Burden: Shaping Health IT as an Asset

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Health IT has helped drive progress in health care over the last decade, but it has also introduced a variety of different challenges, many reported by the clinical community. As we explored in our latest article published in the Journal of the American Medical Informatics Association, ONC and other federal partners have taken and continue to take… Read More »Reducing the Clinician Burden: Shaping Health IT as an Asset

NCPCR issues summons to DGCI over lack of uniform test for carcinogenic substances in J&J’s baby products

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Time and again the commission has made attempts to seek definite information on the standardised and validated method for analysing the presence of formaldehyde in baby shampoo and asbestos in talcum powder manufactured and marketed by Johnson & Johnson Private Limited, the summons issued by… Read More »NCPCR issues summons to DGCI over lack of uniform test for carcinogenic substances in J&J’s baby products

Fauci: Decisions to ease virus restrictions ‘inexplicable’

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Anthony Fauci is calling decisions by the governors of Texas and Mississippi to lift coronavirus restrictions “inexplicable” and warning the moves could lead to another spike in cases.“What we don’t need right now is another surge, so…

A Plan to Conquer U.S. Drug Shortages

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By JESSICA DALEY and WAYNE RUSSELL COVID-19 has focused the nation’s attention on the risks associated with complex, global supply chains, particularly related to healthcare products and prescription drugs. While supply disruptions of personal protective equipment (PPE) captured headlines, the pandemic also compromised the drug supply chain. With… Read More »A Plan to Conquer U.S. Drug Shortages

How industry collaboration and partnerships are supporting COVID-19 vaccine manufacturing

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Across the industry, biopharmaceutical companies are working around the clock to meet the demands of COVID-19 vaccine manufacturing. Companies are working to source needed raw materials and other supplies and increasing manufacturing capacity to get COVID-19 vaccine shots in as many arms as possible. Even… Read More »How industry collaboration and partnerships are supporting COVID-19 vaccine manufacturing

Aurobindo Pharma (Auro Peptides) -Openings for DQA-API Dept. -Executive/ Senior Executive-Apply Now

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Aurobindo Pharma (Auro Peptides) -Openings for DQA-API Dept. -Executive/ Senior Executive-Apply Now Job Description Company: Aurobindo Pharma Limited(Auro Peptides) Qualification: M.Sc Organic Chemistry, Analytical Chemistry Experience: 3-8 years Location: Hyderabad •Receiving and review of Technology transfer documents from dqa to site qa (PDR/ tech pack, Specifications and MOAs… Read More »Aurobindo Pharma (Auro Peptides) -Openings for DQA-API Dept. -Executive/ Senior Executive-Apply Now

People on the Move: March 2021

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The companies announcing acquisitions, new hires, promotions and other news this month include Syneos, Elligo, PCI Pharma Services, I Holland and more.

Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics Guidance for Industry

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This guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of a regulatory submission to FDA to provide information on their use of RWE in a simple, uniform format. FDA will use this… Read More »Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics Guidance for Industry

Vir and GSK Provide Update on ACTIV-3 Trial of VIR-7831 in Hospitalized Adults with COVID-19

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Shots: The DSMB has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature. The recommendation was based on pre-planned safety & efficacy data review of the first 300 patients hospitalized with COVID-19 enrolled in ACTIV-3 The companies will… Read More »Vir and GSK Provide Update on ACTIV-3 Trial of VIR-7831 in Hospitalized Adults with COVID-19

Biden promises enough coronavirus vaccine for ‘every adult in America’ by the end of May

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Biden promises enough coronavirus vaccine for ‘every adult in America’ by the end of May Tue, 03/02/2021 – 19:00 cbaker_admin Thu, 03/04/2021 – 07:00 President Biden announced Tuesday there will be ample COVID-19 vaccine for “every adult in America” to be protected by the end… Read More »Biden promises enough coronavirus vaccine for ‘every adult in America’ by the end of May

Severe hypoglycemia risk with long-acting insulin analogs vs. neutral protamine Hagedorn insulin

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Severe hypoglycemia risk with long-acting insulin analogs vs. neutral protamine Hagedorn insulin Tue, 03/02/2021 – 19:00 cbaker_admin Thu, 03/04/2021 – 07:00 Compared with neutral protamine Hagedorn (NPH) insulin, researchers say long-acting insulin analogs may lower the risk of severe hypoglycemia in older adults with type… Read More »Severe hypoglycemia risk with long-acting insulin analogs vs. neutral protamine Hagedorn insulin

State officials, community leaders try to dissuade residents from vaccine ‘shopping’

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State officials, community leaders try to dissuade residents from vaccine ‘shopping’ Tue, 03/02/2021 – 19:00 cbaker_admin Thu, 03/04/2021 – 07:00 State and community leaders in Massachusetts are discouraging residents from “shopping” for a particular brand of COVID-19 vaccine, asserting that all three types now available… Read More »State officials, community leaders try to dissuade residents from vaccine ‘shopping’

Effect of a multifaceted clinical pharmacist intervention on medication safety after hospitalization in persons prescribed high-risk medications

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Effect of a multifaceted clinical pharmacist intervention on medication safety after hospitalization in persons prescribed high-risk medications Tue, 03/02/2021 – 19:00 cbaker_admin Thu, 03/04/2021 – 07:00 Researchers wondered if a pharmacist-directed intervention would improve medication safety among patients discharged from the hospital with high-risk prescriptions.… Read More »Effect of a multifaceted clinical pharmacist intervention on medication safety after hospitalization in persons prescribed high-risk medications

How COVID-19 could usher in a new role for continuous glucose monitoring in hospitals

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How COVID-19 could usher in a new role for continuous glucose monitoring in hospitals Tue, 03/02/2021 – 19:00 cbaker_admin Thu, 03/04/2021 – 07:00 Hospitals typically monitor patients’ blood glucose using blood tests taken multiple times a day. In response to the pandemic, however, FDA allowed… Read More »How COVID-19 could usher in a new role for continuous glucose monitoring in hospitals

Administration boosts requirements for COVID-19 testing without cost sharing and reimbursement for administering COVID-19 vaccines to uninsured

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Administration boosts requirements for COVID-19 testing without cost sharing and reimbursement for administering COVID-19 vaccines to uninsured Tue, 03/02/2021 – 19:00 cbaker_admin Thu, 03/04/2021 – 07:00 New guidance released by CMS, the Labor Department, and the Treasury Department seeks to strengthen requirements that plans and… Read More »Administration boosts requirements for COVID-19 testing without cost sharing and reimbursement for administering COVID-19 vaccines to uninsured

State seeks to regulate PBMs

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State seeks to regulate PBMs Tue, 03/02/2021 – 19:00 cbaker_admin Thu, 03/04/2021 – 07:00 Several bills are advancing through the Indiana General Assembly to provide tighter regulation of PBMs, hold them accountable, and give more protection to consumers and pharmacists. Senate Bill 143 would allow… Read More »State seeks to regulate PBMs

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

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

Experts warn US risks delaying ‘normal’ summer

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President Biden’s announcement that there will be enough vaccines for all adults by May is raising hopes for a return to normal soon.But the next few months in the pandemic are critical. Concern is growing over moves by some states to lift…

Study suggests people recovered from COVID-19 respond faster to the Covishield vaccine

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The study on the immune response to Covishield was carried out by researchers from New Delhi’s CSIR-Institute of Genomics and Integrative Biology (IGIB), Max Super Speciality Hospital and Institute of Endocrinology, Diabetes and Metabolism as well as the Academy of Scientific and Innovative Research (AcSIR)… Read More »Study suggests people recovered from COVID-19 respond faster to the Covishield vaccine

Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA for Review of Dupixent to Treat Moderate-to-Severe Asthma in Children

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Shots: The sBLA is based on P-III study assessing Dupixent + SOC maintenance therapy in children aged 6-11yrs. with moderate-to-severe asthma with type 2 inflammation The study resulted in a reduction of severe asthma attacks and rapidly improved lung function within 2wks, safety results were… Read More »Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA for Review of Dupixent to Treat Moderate-to-Severe Asthma in Children

Pfizer’s Lorbrena (lorlatinib) Receives FDA’s Approval for Expanding its Indication to Treat ALK-Positive Metastatic Lung Cancer

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Shots: The approval is based on P-III CROWN study assessing Lorbrena vs Xalkori (crizotinib) monthx in 296 people in a ratio (1:1) with prior untreated advanced ALK-positive NSCLC The P-III study resulted in a 72% reduction in risk of progression or death as assessed by… Read More »Pfizer’s Lorbrena (lorlatinib) Receives FDA’s Approval for Expanding its Indication to Treat ALK-Positive Metastatic Lung Cancer

THE CONVERSATION: Between Us, About Us, A New Campaign By Black Health Care Workers for Black People about the COVID-19 Vaccines

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March 4, 2021 – THE CONVERSATION: Between Us, About Us. is a new campaign to provide Black communities with credible information about the COVID-19 vaccines co-developed by KFF (Kaiser Family Foundation) and the Black Coalition Against COVID. Black doctors, nurses and researchers dispel misinformation and… Read More »THE CONVERSATION: Between Us, About Us, A New Campaign By Black Health Care Workers for Black People about the COVID-19 Vaccines

Takeda Signs an Exclusive License Agreement with Ovid for Soticlestat to Treat Dravet Syndrome and Lennox-Gastaut Syndrome

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Shots: Ovid to receive $196M as up front and an additional $660M as development, regulatory and sales milestones along with royalties and up to 20% on sales of soticlestat. The agreement is expected to close by end of March 2021 Takeda to get all global… Read More »Takeda Signs an Exclusive License Agreement with Ovid for Soticlestat to Treat Dravet Syndrome and Lennox-Gastaut Syndrome

Boston Scientific Signs an Agreement with BPEA to Acquire Lumenis’ Surgical Business

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Shots: Boston Scientific to acquire the global surgical business of Lumenis for $1.07B as an up front in cash. The transaction is expected to be completed in H2’21 BPEA will retain ownership of the Lumenis global aesthetics and ophthalmology businesses. The acquisition will expand Boston… Read More »Boston Scientific Signs an Agreement with BPEA to Acquire Lumenis’ Surgical Business

2% Cut to Home Health Agencies, Other Medicare Providers Nearing Unwanted Return

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Among its many provisions, last year’s Coronavirus Aid, Relief and Economic Security (CARES) Act pressed pause on the government’s 2% payment cut to all Medicare-reimbursed health care providers. The “sequestration holiday” was immediately seen as a common-sense lifeline for cash-strapped home health providers on the… Read More »2% Cut to Home Health Agencies, Other Medicare Providers Nearing Unwanted Return

Google E-A-T and Healthcare Content: How to Deliver the Quality Google Demands

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Did you know that Google demands exceptionally high standards from healthcare websites? Due to the potential consequences of misinformation, the search engine expects sites in the medical and health fields to produce content that demonstrates especially high levels of “expertise, authority, and trustworthiness” (E-A-T). If… Read More »Google E-A-T and Healthcare Content: How to Deliver the Quality Google Demands

Overnight Health Care: Biden slams Texas, Mississippi for lifting coronavirus restrictions: ‘Neanderthal thinking’ | Senate panel splits along party lines on Becerra |Over 200K sign up for ACA plans during Biden special enrollment period

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Welcome to Wednesday’s Overnight Health Care, where the phrase of the day is “neanderthal thinking.”Follow us on Twitter at @NateWeixel and @PeterSullivan4. President Biden responded to Texas and Mississippi lifting COVID-19 restrictions, his…