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AZ/Oxford Calculations

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We have a lot of vaccine news to catch up on! First up is the latest on the possible clotting side effects seen with Oxford/AstraZeneca. This is looking more and more likely to be a rare-but-real effect, and I’m not happy that it’s holding up.… Read More »AZ/Oxford Calculations

ViewPoints Interview: Aravive’ s Dr. Gail McIntyre Shares Insight on AVB-500 and its Potential Against ccRCC

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In an interview with PharmaShots, Dr. Gail McIntyre, CEO of Aravive shared her views on the AVB-500, its potential against ccRCC, and the design of the clinical trial evaluating the therapy. He also shed light on epidemiology of Clear Cell Renal Cell Carcinoma. Shots: AVB-500… Read More »ViewPoints Interview: Aravive’ s Dr. Gail McIntyre Shares Insight on AVB-500 and its Potential Against ccRCC

BMS Presents Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable NSCLC at AACR2021

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Shots: The P-III CheckMate-816 study involves assessing Opdivo (360mg) + CT (q3w for 3 doses) vs CT, followed by surgery as a neoadjuvant treatment in 358 patients with resectable stage Ib to IIIa NSCLC The study met its 1EPs, i.e. improvement in pCR (24% vs… Read More »BMS Presents Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable NSCLC at AACR2021

Bayer Reports Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

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Shots: The P-III CHRONOS-3 study involves assessing Aliqopa (IV) + rituximab vs PBO + rituximab in 458 patients with relapsed iNHL in extending PFS who have received at least one or more lines of prior rituximab-containing treatment Results: @median follow-up of 19.2mos., mPFS (21.5 vs… Read More »Bayer Reports Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

Daiichi Sankyo Initiates P-II Trial of Pexidartinib for Tenosynovial Giant Cell Tumor in Japan

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Shots: The first patient has been dosed in a P-II two-part OLE study that assesses the safety, efficacy, and PK of Pexidartinib {800mg/day (400mg, bid on an empty stomach)} in ~18 patients with symptomatic TGCT associated with severe morbidity or functional limitation and not amenable… Read More »Daiichi Sankyo Initiates P-II Trial of Pexidartinib for Tenosynovial Giant Cell Tumor in Japan

AstraZeneca’s Farxiga (dapagliflozin) Fails to Meet its Primary Endpoint in P-III DARE-19 Trial for COVID 19

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Shots: The P-III DARE-19 trial involves assessing the efficacy and safety of Farxiga vs PBO in addition to SoC therapy in 1,250 hospitalized patients with COVID-19 who are at high risk of developing serious complications The trial fails to meet its 1EP of prevention measures… Read More »AstraZeneca’s Farxiga (dapagliflozin) Fails to Meet its Primary Endpoint in P-III DARE-19 Trial for COVID 19

Take the next step into CROY 2021

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The 2021 Clinical Researcher of the Year – The Americas competition is reaching out to the very best in the industry to take the next step and claim gold.

Roche Report Results of Ab Cocktail (Casirivimab + Imdevimab) in P-III REGN-COV 2069 Trial for Symptomatic COVID 19 Infection

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Shots: The P-III REGN-COV 2069 trial involves assessing the efficacy and safety of Ab cocktail (casirivimab (1200 mg, SC) + imdevimab (1200 mg, SC) vs PBO in 1,505 people to prevent symptomatic infection in household contacts of individuals infected with COVID-19 The trial met its… Read More »Roche Report Results of Ab Cocktail (Casirivimab + Imdevimab) in P-III REGN-COV 2069 Trial for Symptomatic COVID 19 Infection

New advice on AstraZeneca vaccine

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There have been changes to the advice around the COVID-19 vaccines. The Pfizer vaccine is now preferred to the AstraZeneca vaccine for adults aged under 50 years.

Links

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Misperceptions of people with disabilities. A bundled payment success story.   Do people with COVID-19 tell their employers? The history of vaccine backlash. Oral COVID-19 vaccine? Things are getting better. Vaccines in Gibraltar.

Conference & CLE Calendar

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April 14, 2021 – “Protecting Software Related to a Medical Device: A Case Law Review & Strategy” (Intellectual Property Owners Association) – 2:00 pm to 3:00 pm (ET). April 15, 2021 – “Patenting Antibody Pharmaceuticals at the EPO” (J A Kemp) – 2:30 to 3:30… Read More »Conference & CLE Calendar

Biological E. Limited-Openings for Regulatory Affairs Dept. -Apply Now

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Biological E. Limited-Openings for Regulatory Affairs Dept. -Apply Now Job Description Openings in Regulatory Affairs Department- Biological E. Limited -Pharma Division-Shameerpet Location, Hyderabad. Job Requirements:  •Candidate must have good exposure on Injectable dosage forms. •Experience in Dossier fillings (Module 1 to Module 5). •Exposure on… Read More »Biological E. Limited-Openings for Regulatory Affairs Dept. -Apply Now

Zenotech Laboratories (A Sun Pharma)-Openings for Multiple Positions for Freshers & Experienced-Apply Now

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Zenotech Laboratories (A Sun Pharma)-Openings for Multiple Positions for Freshers & Experienced-Apply Now Job Description Openings for Multiple Positions for Freshers & Experienced in Microbiology/ QA/Upstream Process/ Production Departments @ Zenotech Laboratories (A Sun Pharma). We are hiring below Positions in Bologics Division, Interested Candidates may… Read More »Zenotech Laboratories (A Sun Pharma)-Openings for Multiple Positions for Freshers & Experienced-Apply Now

Hetero Labs -Openings for Freshers & Experienced-QA/ QC Dept.-Apply Now

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Hetero Labs -Openings for Freshers & Experienced-QA/ QC Dept.-Apply Now Job Description Greetings from Hetero!!! Openings for Freshers & Experienced at Jadcherla Location. Please find the details as below: Department: Quality AssuranceQualification: M. PharmacyExperience:0-0 yearsEligibility: 2020/2021 passed outs only with minimum 60% in their academics. Department: Quality ControlExperience: 2-5 yearsArea… Read More »Hetero Labs -Openings for Freshers & Experienced-QA/ QC Dept.-Apply Now

‘Better Systems, Better Controls and a Digitized Industry’: Analyzing PE’s Impact on Home-Based Care

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In late March, members of Congress argued fervently that private equity did not belong in health care, with senior care being a particularly egregious case of trespassing. During a special House hearing, lawmakers addressed the dangers of PE firms digging their heels deeper into the… Read More »‘Better Systems, Better Controls and a Digitized Industry’: Analyzing PE’s Impact on Home-Based Care

Seniors Helping Seniors Expands Service Lines with New Clinical, Telehealth Programs

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Seniors Helping Seniors has been providing non-medical home-based care services since the 1990s. But recently, the company announced the launch of “Seniors Helping Seniors 360,” a new business model that mixes both medical and non-medical care services. The strategy is one that’s becoming increasingly common… Read More »Seniors Helping Seniors Expands Service Lines with New Clinical, Telehealth Programs

Pentagon insists vaccine rollout a success despite spotty data

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The Pentagon is touting its rollout of coronavirus vaccines even as it is unable to say how many service members have actually received COVID-19 vaccinations. Defense Department (DOD) officials say they have delivered more than 2 million shots…

Hazard Communication Standard

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[Federal Register Volume 86, (Monday, April 12, 2021 )] [Proposed Rule] [Pages 18924-18925] Hazard Communication Standard

England to allow shops, restaurants to reopen Monday

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Shops, restaurants, bars and a number of other non-essential businesses will reopen in England on Monday, as the country continues its coronavirus vaccination effort.Prime Minister Boris Johnson announced the eased restrictions in a statement last…

Diabetes patients at high risk from COVID-19 are managing conditions more effectively

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The Southeast Michigan Hospital Collaborative, a partnership of four local health systems, the Greater Detroit Area Health Council and the National Kidney Foundation of Michigan, have been working to identify the state’s 2.5 million people with pre-diabetes to enroll them in a national diabetes prevention… Read More »Diabetes patients at high risk from COVID-19 are managing conditions more effectively

Lee Pharma Ltd- Walk-In Interviews for Freshers & Experienced On 14th to 17th Apr’ 2021

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Lee Pharma Ltd- Walk-In Interviews for Freshers & Experienced On 14th to 17th Apr’ 2021 Job Description Bulk Hiring for R&D Expansion R&D, AR&D, QC, QA, Production, EHS-API Background must Production Documentation-Freshers & Experienced. Looking for Immediate Joiners & more preference for Male Candidates. Carry… Read More »Lee Pharma Ltd- Walk-In Interviews for Freshers & Experienced On 14th to 17th Apr’ 2021

Better Therapeutics plans to go public through SPAC merger 

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Digital health startup Better Therapeutics plans to go public through a SPAC merger that would value it at $187 million. The company is currently running a pivotal study to see if its app-based program could be used as a treatment for type 2 diabetes. 

China admits its vaccines’ effectiveness is low

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China’s Centers for Disease Control (CDC) acknowledged the low efficacy of two COVID-19 vaccines produced by state-owned companies for the first time on Saturday.Gao Fu, the director of China’s CDC, said at a conference that two vaccines produced by…

Aurobindo Pharma-Openings for Quality Assurance-Apply Now

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Aurobindo Pharma-Openings for Quality Assurance-Apply Now Urgent Requirement for our Pharma API Plant located at VizagPost Name: Quality AssuranceQualification:  M.Sc with 3-8 years of experience IPQA, QMS & Validation Aurobindo Pharma-Openings for Quality Assurance-Apply Now

Biden eyes bigger US role in global vaccination efforts

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The Biden administration is taking initial steps toward an expanded role in global COVID-19 vaccination efforts, while stopping short of sharing excess doses on a wide scale.The federal government has been amassing doses, growing its supply into…

Intas Pharmaceuticals Ltd-Telephonic/ Virtual Interviews for QC On 21st, 22nd & 23rd Apr’ 2021

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Intas Pharmaceuticals Ltd-Telephonic/ Virtual Interviews for QC On 21st, 22nd & 23rd Apr’ 2021 Job Description Department: Quality ControlDesignation: Officer/ Sr. Officer/ ExecutiveSkills: HPLC &GC, Analytical Method Validation & Transfer, ReviewerQualification& Experience: M.Sc, B.Pharmacy, B.Sc, 2-8 years of experience Candidates may apply on hrinduction_sez@intaspharma.com on with subject line “QC… Read More »Intas Pharmaceuticals Ltd-Telephonic/ Virtual Interviews for QC On 21st, 22nd & 23rd Apr’ 2021

Amoli Organics Pvt. Ltd-Openings for QC/ ADL/R&D Synthesis/ Production Dept. -Apply Now

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Amoli Organics Pvt. Ltd-Openings for QC/ ADL/R&D Synthesis/ Production Dept. -Apply Now Job Description We are Hiring… Quality Control LabWork Profile: Analyst/ ReviewerExperience: 2-8 years in API Manufacturing (Only Male)Qualification: M.Sc Organic Chemistry Analytical Development  LabWork Profile: AnalystExperience: 2-8 years in API Manufacturing (Only Male)Qualification: M.Sc Analytical/ Organic Chemistry Research and… Read More »Amoli Organics Pvt. Ltd-Openings for QC/ ADL/R&D Synthesis/ Production Dept. -Apply Now

Rusan Pharma Limited-Walk-In Interviews for Regulatory Affairs Dept. On 13th Apr’ 2021

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Rusan Pharma Limited-Walk-In Interviews for Regulatory Affairs Dept. On 13th Apr’ 2021 Job Description Department: Regulatory Affairs (Formulation & API)Experience: 4-8 years (Dossier preparation, Review & submission for South East Asia, LATAM, GCC, MENA, African, CIS & European Countries)Date & Time: 13th April 2021 from 11:00 AM to… Read More »Rusan Pharma Limited-Walk-In Interviews for Regulatory Affairs Dept. On 13th Apr’ 2021

Global Calcium Pvt. Ltd-Walk-In Interview for Freshers & Experienced On 13th Apr’ 2021

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Global Calcium Pvt. Ltd-Walk-In Interview for Freshers & Experienced On 13th Apr’ 2021 Job Description Position: R&D AssociateQualification & Experience: M.Sc Chemistry/ Organic Chemistry with 0-1 year of experience API Bulk drug IndustryTime And Venue Details: Walk-In Interview On 13th April 2021 from 9:00 AM to 12:00 Pm… Read More »Global Calcium Pvt. Ltd-Walk-In Interview for Freshers & Experienced On 13th Apr’ 2021

Selmar Lab Pvt. Ltd- Walk-In Interviews for QC/ Warehouse On 10th & 12th Apr’ 2021

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Selmar Lab Pvt. Ltd- Walk-In Interviews for QC/ Warehouse On 10th & 12th Apr’ 2021 Job Description Department: QC/ WarehousePost: Officer/ Chemist/ Sr. ChemistQualification: B.Sc/ M.Sc / B.ComExperience : 2-4 yearsLocation: Jinnaram, Telangana Selmar Lab Pvt. Ltd- Walk-In Interviews for QC/ Warehouse On 10th & 12th Apr’ 2021

MedWatch Forms for FDA Safety Reporting

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Safety reporting portal for health professionals, patients, consumers and industry. Find pdf fillable forms in English and Spanish and a link to report safety concerns to the FDA online.

J&J to apply for bridging study, to approach DGCI next week for trial of its single-shot Covid vaccine

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J&J’s single-shot Covid vaccine has shown an overall efficacy of 66% in all age groups while it showed 85% efficacy in preventing death (severe disease) across all age and ethnic groups in a 30,000-participant trial in the US, South Africa and Brazil in the last… Read More »J&J to apply for bridging study, to approach DGCI next week for trial of its single-shot Covid vaccine

Fitbit tests if smartwatch could measure blood pressure

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Fitbit is launching a trial to see if its its newest smartwatch could use pulse arrival time to measure blood pressure. Other wearable companies have tried to add wrist-based blood pressure features to their devices, but so far, they have limited accuracy. 

3M files lawsuit against Florida company over fake N95 masks

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Manufacturer 3M has filed a lawsuit against a Florida company claiming trademark infringement and fraud for allegedly selling fake N95 masks to a Massachusetts hospital. The company claimed in the lawsuit filed in federal court late last month…

Analysis: Hospital Price Transparency Data Lacks Standardization, Limiting Its Use to Insurers, Employers, and Consumers

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In spite of a new price transparency rule that requires hospitals to publish the prices of common health services, comparing prices across hospitals remains challenging due to limited compliance with the law and a lack of standardization in the available data, a new KFF analysis… Read More »Analysis: Hospital Price Transparency Data Lacks Standardization, Limiting Its Use to Insurers, Employers, and Consumers

Early Results from Federal Price Transparency Rule Show Difficultly in Estimating the Cost of Care

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A new issue brief examines compliance with a new federal price transparency rule and variation in payer-negotiated rates at U.S. hospitals. The analysis looks at the websites of the two largest hospitals in each state and the District of Columbia, and finds that a lack… Read More »Early Results from Federal Price Transparency Rule Show Difficultly in Estimating the Cost of Care

Healthcare data breaches

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March’s 57 breaches marked a 37% increase from March of last year, and a 58% increase since January.

The Way Out of Brain Fog

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Debbie Gustafson of Dresher, Pennsylvania, was on the trip of a lifetime, touring the Galápagos with her family last March, when she began to feel the effects of COVID-19. Though her physical symptoms—diarrhea, dry cough, chills—were considered mild by doctors, her fatigue was crushing, and… Read More »The Way Out of Brain Fog

Key excerpts: PhRMA submits comments to NIST in effort to safeguard intellectual property protections

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Earlier this week PhRMA submitted comments to the National Institute of Standards and Technology (NIST) regarding the proposed rulemaking on implementing regulations of the Bayh-Dole Act. Passed in 1980, the Bayh-Dole Act was a landmark piece of bipartisan legislation that established a uniform framework across… Read More »Key excerpts: PhRMA submits comments to NIST in effort to safeguard intellectual property protections

FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for first-line treatment of patients with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression with no eGFR, anaplastic lymphoma kinase or receptor tyrosine kinase aberrations

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Listen to a soundcast of the February 22nd 2021 FDA approval of Libtayo (cemiplimab-rwlc) for first-line treatment of patients with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression

Notre Dame to require COVID-19 vaccination for fall attendance

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The University of Notre Dame declared this week that it will require the COVID-19 vaccine as a condition for enrollment in the 2021-22 fall semester, joining a slate of other universities that plan to mandate vaccines for most students.Executive…

How eConsent empowers more participant engagement in clinical trials

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Creating the simplest process for informed consent benefits the potential participant by allowing them the time and resources to understand fully what they are consenting to. Through eConsent processes, research also opens the door to a more diverse population to engage in trials.

Evotec and Exscientia Initiate Human Clinical Trials of their Novel Immuno-Oncology Drug

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Shots: The companies initiate the clinical trial of A2a receptor antagonist, co-developed by Exscientia and Evotec utilizing Exscientia’s AI-design platform, Centaur Chemist Exscientia will lead the clinical development phase of the molecule and Evotec retains co-ownership rights throughout clinical development The A2a receptor is currently… Read More »Evotec and Exscientia Initiate Human Clinical Trials of their Novel Immuno-Oncology Drug

PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab

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Shots: The agreement facilitates PlantForm’s collaborations in Brazil to provide affordable, effective cancer drugs to millions of Brazilians The 3yrs. research and development collaboration will culminate in protocols for P-I and P-III clinical trials. The companies will take biosimilar pembrolizumab to world markets, following the… Read More »PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab

CDC data shows rise in Brazil variant detected in US

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Data from the Centers and Disease Control and Prevention (CDC) shows that the cases of the COVID-19 variant first detected in Brazil are on the rise in the United States. According to the data released Thursday, there are 434 reported cases of…

BMS Reports Results of Opdivo (nivolumab) + CT or Yervoy (ipilimumab) in P-III CheckMate -648 Trial for Unresectable Advanced or Metastatic ESCC

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Shots: The P-III CheckMate -648 trial involves assessing Opdivo (nivolumab) + CT or Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w up to 24mos.) in patients with unresectable advanced or metastatic ESCC Results: Both the combinations demonstrated OS benefits in PD-L1 positive and all-randomized… Read More »BMS Reports Results of Opdivo (nivolumab) + CT or Yervoy (ipilimumab) in P-III CheckMate -648 Trial for Unresectable Advanced or Metastatic ESCC