Clinical trials and evidence
Clinical trials and real-world evidence support evidence-based medicine in healthcare, playing a pivotal role in validating and advancing medical treatments and interventions. Clinical trials assess the efficacy and safety of new drugs and therapies, with real-world evidence providing data to inform clinical and regulatory decisions based on empirical data.
Top Stories
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News
13 Aug 2024
FDA approves first nasal spray for anaphylaxis
The FDA's approval of neffy offers a needle-free option for treating anaphylaxis, potentially improving patient access and compliance. Continue Reading
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News
30 Jul 2024
New mRNA vaccine initiative targets avian influenza (H5N1)
A new initiative led by WHO and MPP aims to develop mRNA vaccines for avian influenza (H5N1), boosting global pandemic preparedness. Continue Reading
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News
15 Oct 2021
AstraZeneca’s COVID-19 Antibody Prevents and Treats COVID-19
In other COVID news, Gavi purchases an additional 176.5 million doses of Moderna’s COVID-19 vaccine and the complete Phase 3 results of Novavax’s vaccine have been published. Continue Reading
By- Samantha McGrail
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News
14 Oct 2021
WHO Recommends Broad Roll-Out of GSK’s Malaria Vaccine For Children
GSK’s malaria vaccine, RTS,S is the first and only malaria vaccine studied in pivotal long-term trials that significantly reduces malaria in children. Continue Reading
By- Samantha McGrail
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News
13 Oct 2021
J&J’s Early-Stage Compound Shows Promise Against Dengue Virus
Pre-clinical data showed that the early-stage compound prevents the interaction between two viral proteins that play a role in the replication process of the dengue virus. Continue Reading
By- Samantha McGrail
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News
07 Oct 2021
J&J Submits Data to FDA to Support COVID-19 Vaccine Booster
A Phase 3 study found that Johnson & Johnson’s COVID-19 vaccine booster elicited 94% protection against the coronavirus. Continue Reading
By- Samantha McGrail
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News
06 Oct 2021
Johnson & Johnson Launches Phase 3 Trial of RSV Vaccine in Adults
The Phase 3 study will enroll individuals 60 years of age and older to receive either one dose of the RSV vaccine or a placebo. Researchers will follow patients for at least two RSV seasons. Continue Reading
By- Samantha McGrail
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News
05 Oct 2021
AstraZeneca Requests FDA EUA for COVID-19 Antibody Combination
If granted, AZD7442 will be the first long-acting COVID-19 antibody combination to receive emergency use authorization for coronavirus prevention. Continue Reading
By- Samantha McGrail
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News
04 Oct 2021
J&J’s Xarelto Evokes Fewer Blood Clots in Patients Than Aspirin
Pediatric patients treated with Johnson & Johnson’s Xarelto had a slightly lower prevalence of non-major clinically relevant bleeding and minimal bleeding than aspirin. Continue Reading
By- Samantha McGrail
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News
04 Oct 2021
Regeneron’s COVID-19 Antibody Cocktail Helps Hospitalized Patients
Regeneron’s COVID-19 antibody cocktail reduced patients’ risk of dying by 36 percent within 29 days of receiving treatment. Continue Reading
By- Samantha McGrail
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News
01 Oct 2021
Pfizer Submits Data to FDA For COVID-19 Vaccine in Children
Initial trial data found that the two-dose COVID-19 vaccine regimen in children elicited neutralizing antibody responses one month after the second dose. Continue Reading
By- Samantha McGrail
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News
30 Sep 2021
FDA Approves Abbott’s Epic Plus for Aortic Valve Disease
Abbott’s Epic Plus and Epic Plus Supra Stented Tissue Valve have shown strong clinical outcomes and enhance therapy options for people with mitral and aortic valve disease. Continue Reading
By- Samantha McGrail
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News
29 Sep 2021
Pfizer Launches Trial of COVID-19 Treatment for Post-Exposure
The trial will evaluate Pfizer’s COVID-19 treatment with a low dose of ritonavir in healthy adults living in the same household as an individual with confirmed symptomatic disease. Continue Reading
By- Samantha McGrail
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News
29 Sep 2021
AstraZeneca Invests in VaxEquity for saRNA Therapeutics Platform
The long-term research collaboration will optimize VaxEquity’s saRNA platform to target novel pathways not amendable to traditional drug discovery. Continue Reading
By- Samantha McGrail
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News
28 Sep 2021
Improving Adult Vaccination Rates, Health Outcomes Globally
In a new survey, 19.8% of adult participants were up to date on recommended vaccines for adults, with many people wanting more clear information on necessary vaccines. Continue Reading
By- Samantha McGrail
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News
28 Sep 2021
Roche’s Tecentriq Benefits Non-Small Cell Lung Cancer Patients
Tecentriq administered after surgery and chemotherapy reduced the risk of disease recurrence or death by 34 percent in individuals with Stage II-IIA non-small cell lung cancer. Continue Reading
By- Samantha McGrail
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News
27 Sep 2021
SAS, UNC-Chapel Hill to Transform Antiviral Drug Development
SAS and UNC-Chapel Hill will work together to accelerate antiviral drug development, initially addressing new treatments for COVID-19. Continue Reading
By- Samantha McGrail
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News
27 Sep 2021
Thermo Fisher Launches System to Scale Gene Therapy Workflows
The AAV-MAX system aims to simplify AAV vector production workflow, increase productivity, and boost cost efficiency to enable scalable gene therapy workflows. Continue Reading
By- Samantha McGrail
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News
23 Sep 2021
AbbVie Helps to Advance Gene Therapy for Chronic Retinal Diseases
AbbVie and Regenxbio will complete ongoing clinical trials of the gene therapy in patients with chronic retinal diseases, including wet AMD and diabetic retinopathy. Continue Reading
By- Samantha McGrail
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News
23 Sep 2021
FDA Authorizes Booster Dose of Pfizer, BioNTech COVID-19 Vaccine
After approving the COVID-19 vaccine last month, FDA authorized a booster dose six months after completion of the primary vaccination series based on scientific evidence. Continue Reading
By- Samantha McGrail
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News
21 Sep 2021
Second Dose of J&J’s COVID-19 Vaccine 94% Effective
The Phase 3 trial found that a booster shot of J&J’s single-dose COVID-19 vaccine was highly effective at protecting against the coronavirus and related adverse events, such as hospitalization and death. Continue Reading
By- Samantha McGrail
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News
21 Sep 2021
J&J’s Ebola Vaccine Generates Robust Antibody Responses
Johnson & Johnson’s Ebola vaccine regimen induced antibody responses to the Zaire ebolavirus species 21 days after the second dose in 98% of all patients. Continue Reading
By- Samantha McGrail
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News
20 Sep 2021
FDA Grants Breakthrough Designation for Eli Lilly’s Diabetes Drug
In a Phase 3 trial, Eli Lilly’s diabetes drug elicited a 21% percent relative risk reduction for cardiovascular death or hospitalization for heart failure compared to placebo. Continue Reading
By- Samantha McGrail
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News
20 Sep 2021
Pfizer, BioNTech COVID-19 Vaccine Effective in Pediatric Patients
The COVID-19 vaccine elicited a neutralizing antibody geometric mean titer of 1,197 in pediatric patients, demonstrating strong immune response one month after the second dose. Continue Reading
By- Samantha McGrail
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News
17 Sep 2021
Providers Hopeful of Immunotherapy to Treat Early-Stage Cancer
In a new Bristol Myers Squibb survey, most healthcare providers were hopeful of the potential of immunotherapy for earlier-stage cancer treatment, especially in lung cancer and melanoma. Continue Reading
By- Samantha McGrail
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News
15 Sep 2021
FDA Accepts Novartis BLA for Monoclonal Antibody in ESCC
Novartis submitted its application based on Phase 3 Rationale 302 trial data that found the antibody reduced the risk of death in patients by 30 percent. Continue Reading
By- Samantha McGrail
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News
13 Sep 2021
Pfizer Initiates Phase 3 Clinical Trial of RSV Vaccine in Adults
The placebo-controlled Phase 3 clinical trial will evaluate a single dose of Pfizer’s RSV vaccine candidate in adults 60 years of age and older. Continue Reading
By- Samantha McGrail
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News
13 Sep 2021
Medidata, Labcorp Collaborate to Boost Digital Biomarker Discovery
The companies will leverage Medidata Sensor Cloud to process sensor data within clinical trials and enhance digital biomarker discovery for medical devices and therapeutic areas. Continue Reading
By- Samantha McGrail
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News
13 Sep 2021
Moderna, ILCM to Develop mRNA Therapeutic for Ultra-Rare Disease
The mrRNA therapeutic, mRNA-3351, is designed to restore the missing proteins that cause CN-1. The companies aim to make the therapy available to patients at no cost. Continue Reading
By- Samantha McGrail
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News
10 Sep 2021
3 Use Cases for Real World Evidence in Pharma Drug Development
Real-world evidence (RWE) plays an essential role in pharmaceutical drug development by helping researchers identify potential patients and create the right criteria for clinical trials. Continue Reading
By- Samantha McGrail
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News
09 Sep 2021
Eli Lilly’s Jardiance Reduces Death for Heart Failure Patients
Jardiance also reduced the relative risk of first and recurrent hospitalizations for heart failure patients by 27% and substantially slowed kidney function decline. Continue Reading
By- Samantha McGrail
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News
08 Sep 2021
Thermo Fisher, AstraZeneca to Develop NGS-Based Targeted Therapies
The companies will develop next-generation sequencing (NGS)-based targeted therapies to support AstraZeneca’s pipeline of precision medicines. Continue Reading
By- Samantha McGrail
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News
07 Sep 2021
Cardiovascular Disease Clinical Trials Still Lack Diversity
A new paper found that half of the cardiovascular clinical trials examined in a study enrolled less than 25% of Black participants. Continue Reading
By- Samantha McGrail
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News
06 Sep 2021
Eli Lilly, Lycia Collaborate to Discover Targeted Drug Candidates
The multi-year research collaboration will leverage the lysosomal targeting chimera platform to discover and develop novel targeted drug candidates across various areas and diseases. Continue Reading
By- Samantha McGrail
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News
01 Sep 2021
Merck’s Pneumococcal Vaccine Meets Key Endpoints in Phase 3 Trial
Merck’s pneumococcal vaccine, Vaxneuvance, elicited a safety profile compared to the licensed 13-valent pneumococcal conjugate vaccine in infants 42 to 90 days of age. Continue Reading
By- Samantha McGrail
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News
31 Aug 2021
COVID-19 Convalescent Plasma Fails to Halt Disease Progression
A recent NEJM study found that coronavirus disease progression occurred in 30% of patients in the COVID-19 convalescent plasma group and 31.9% in the placebo group. Continue Reading
By- Samantha McGrail
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News
30 Aug 2021
J&J COVID-19 Vaccine Booster Elicits Strong Antibody Responses
Two Phase 1/2a clinical trials showed that Johnson & Johnson’s COVID-19 vaccine booster increased binding antibody responses in participants 18 to 55 years of age. Continue Reading
By- Samantha McGrail
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News
30 Aug 2021
Novartis Cancer Treatment Fails in Phase 3 Clinical Trial
Novartis cancer treatment Kymriah did not meet its primary endpoint of event-free survival compared to treatment with the standard-of-care in the Phase 3 clinical trial. Continue Reading
By- Samantha McGrail
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News
26 Aug 2021
FDA Accept Johnson & Johnson’s Expanded Indication for Xarelto
The indication for Johnson & Johnson’s Xarelto will now include patients following recent lower-extremity revascularization due to symptomatic peripheral artery disease. Continue Reading
By- Samantha McGrail
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News
26 Aug 2021
FDA Accepts Biologics License Application for BMS aGvHD Therapy
Bristol Myers Squibb’s aGvHD therapy is intended to prevent moderate to severe aGvHD in patients six years of age and older receiving unrelated donor hematopoietic stem cell transplant. Continue Reading
By- Samantha McGrail
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News
25 Aug 2021
AstraZeneca’s COVID-19 Antibody 77% Effective in Phase 3 Trial
Researchers reported no cases of severe coronavirus or coronavirus-related death in patients treated with the COVID-19 antibody combination, AZD7442. Continue Reading
By- Samantha McGrail
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News
24 Aug 2021
FDA Grants Accelerated Approval to GSK’s dMMR Antibody Drug
Other recent FDA approvals include Eli Lilly’s Jardiance to reduce the risk of cardiovascular death for adults with heart failure and Roche’s companion diagnostic test to identify solid tumors. Continue Reading
By- Samantha McGrail
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News
24 Aug 2021
CureVac’s Second COVID-19 Vaccine Elicits Improved Immune Response
In other COVID news, Pfizer and BioNTech submit Phase 1 COVID-19 vaccine data to FDA and Moderna revises supply agreement with Canada to provide 105M doses of its candidate. Continue Reading
By- Samantha McGrail
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News
23 Aug 2021
Novartis’ Diabetic Macular Edema Drug Successful in 2 Trials
In the global Phase 2 trials, Novartis’ diabetic macular edema drug elicited greater reductions versus aflibercept in CSFT and in the number of eyes with IRF/SRF. Continue Reading
By- Samantha McGrail
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News
23 Aug 2021
GoodRx, Boehringer Increase Affordable Drug Access for Patients
Patients with diabetes and COPD now have more affordable drug access to Boehringer Ingelheim’s portfolio of medications through the GoodRx platform. Continue Reading
By- Samantha McGrail
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News
19 Aug 2021
FDA Approves Abbott’s Atrial Fibrillation Device to Prevent Stroke
The device, Amplatzer Amulet Left Atrial Appendage Occluder, immediately closes the left atrial appendage to prevent blood clots and stroke in patients atrial fibrillation. Continue Reading
By- Samantha McGrail
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News
19 Aug 2021
Moderna Doses First Patient in Study of mRNA Therapeutic for MMA
The open-label landmark study will evaluate the safety and tolerability of up to five different dosing regimens of the mRNA therapeutic in patients with isolated methylmalonic acidemia. Continue Reading
By- Samantha McGrail
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News
18 Aug 2021
FDA Authorizes Thermo Fisher’s PCR-Based COVID-19 Test Kits
The COVID-19 test kits are designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants. Continue Reading
By- Samantha McGrail
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News
17 Aug 2021
WHO Launches Next Trial Phase to Test COVID-19 Drugs in Patients
The Solidarity PLUS trial will enroll hospitalized patients to test three potential COVID-19 drugs from Ipca, Novartis, and Johnson & Johnson. Continue Reading
By- Samantha McGrail
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News
16 Aug 2021
FDA OKs 3rd COVID-19 Vaccine Dose for the Immunocompromised
FDA determined that immunocompromised individuals may benefit from a third dose of the currently authorized COVID-19 vaccines as the US enters into a new wave of the pandemic. Continue Reading
By- Samantha McGrail
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News
11 Aug 2021
Kite, Appia Bio to Research Allogeneic Cell Therapies for Cancer
The companies will develop chimeric antigen receptor-engineered invariant natural killer cell therapies directed toward cancer. Continue Reading
By- Samantha McGrail
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News
10 Aug 2021
Moderna Doses First Patient in Study of Autoimmune mRNA Candidate
Moderna’s autoimmune mRNA candidate is a modified mRNA-encoded IL-2 and the first autoimmune candidate to enter the clinic. Continue Reading
By- Samantha McGrail
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News
10 Aug 2021
FDA Grants Fast Track to Moderna’s mRNA RSV Vaccine for Adults
Moderna’s RSV vaccine, mRNA-1345, generated a geometric mean rise in neutralizing antibodies relative to a baseline of at least 11-fold in a Phase 1 study. Continue Reading
By- Samantha McGrail
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News
09 Aug 2021
51% of Retail Pharmacy Customers Used Wellness Services in 2020-21
A new J.D. Powers study found that retail pharmacy customers’ most used wellness services in 2020 and 2021 included vaccinations and routine screenings. Continue Reading
By- Samantha McGrail
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News
05 Aug 2021
FDA Expands Authorization of Regeneron’s COVID-19 Antibody Cocktail
The expanded authorization allows the COVID-19 antibody cocktail to be used for post-exposure prophylaxis in individuals exposed to SARS-CoV-2 or who are at high risk of exposure. Continue Reading
By- Samantha McGrail
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News
04 Aug 2021
Eli Lilly, Kumquat to Discover Drug Candidates for Tumors
The companies will discover novel small molecule drug candidates that stimulate an enhanced tumor-specific immune response. Continue Reading
By- Samantha McGrail
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News
03 Aug 2021
AstraZeneca, Regeneron to Develop Drug Candidates to Treat Obesity
The companies will research and develop novel small molecule drug candidates directed against GPR75 to address obesity and related co-morbidities. Continue Reading
By- Samantha McGrail
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News
02 Aug 2021
Biogen’s Alzheimer’s Disease Drug Safe, Effective in Trial
The Alzheimer’s disease drug developed with Ionis Pharmaceuticals showed robust and dose-dependent lowering of tau protein in cerebrospinal fluid in patients. Continue Reading
By- Samantha McGrail
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News
29 Jul 2021
AbbVie, Calico Extend Partnership for Age-Related Disease Therapies
The collaboration will further the 20 early-stage programs already discovered that address age-related diseases and neurodegeneration. Continue Reading
By- Samantha McGrail
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News
28 Jul 2021
FDA Approves Merck’s Keytruda for Triple-Negative Breast Cancer
The FDA approval follows findings from a Phase 3 clinical trial showing that Keytruda combined with chemotherapy helped patients with triple-negative breast cancer. Continue Reading
By- Samantha McGrail
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News
26 Jul 2021
Pfizer, Arvinas to Develop Protein Degrader for Breast Cancer
The collaboration will combine Arvinas’ investigational estrogen receptor-targeting breast cancer therapy with Pfizer’s deep experience in breast oncology therapeutics. Continue Reading
By- Samantha McGrail
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News
23 Jul 2021
High-Dose Buprenorphine Helped Untreated Opioid Use Disorder
A high dose of buprenorphine was safe and well-tolerated in patients with untreated opioid use disorder in the emergency department. Continue Reading
By- Samantha McGrail
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News
22 Jul 2021
Lilly Enters Collaboration for Phase 3 Trial of Alzheimer’s Drug
The placebo-controlled Phase 3 trial will evaluate whether treatment with Lilly’s Alzheimer’s drug can slow clinical progression of the disease in patients at risk of complications. Continue Reading
By- Samantha McGrail
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News
21 Jul 2021
Pfizer Completes Trial Enrollment for Lyme Disease Vaccine
The Phase 2 trial enrolled 625 adult and pediatric participants aged five to 65 years of age to support the acceleration of the Lyme disease vaccine’s pediatric program. Continue Reading
By- Samantha McGrail
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News
20 Jul 2021
J&J COVID-19 Vaccine Elicits Antibody Responses Against Variants
The COVID-19 vaccine elicited dual mechanisms of protection against the virus and variants of concern, including B.1.1.7, B.1.351, P.1, B.1.429, B.1.617.1, and the original Wuhan strain. Continue Reading
By- Samantha McGrail
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News
19 Jul 2021
Biogen, InnoCare Pharma Partner for Multiple Sclerosis Treatment
The multiple sclerosis treatment, orelabrutinib, is a Bruton’s tyrosine kinase inhibitor developed to treat cancer and in development for the treatment of autoimmune diseases. Continue Reading
By- Samantha McGrail
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News
19 Jul 2021
FDA Authorizes Ortho Clinical’s COVID-19 Antibody Test
The VITROS Anti-SARS-CoV- IgG Quantitative Test targets the S1 spike protein and is the first COVID-19antibody test to receive FDA emergency use authorization. Continue Reading
By- Samantha McGrail
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News
15 Jul 2021
Study Finds Major Medicare Overspending Generic Prescription Drugs
Medicare overspent by 13.2% in 2017 for generic prescription drugs, while Costco’s streamlined distribution system could have saved $2.6 billion on drugs. Continue Reading
By- Samantha McGrail
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News
14 Jul 2021
Moderna Doses First Patient in Study of Flu mRNA Vaccine Candidate
mRNA-1010 is Moderna’s first seasonal flu mRNA vaccine candidate to enter clinical trials and target lineages recommended by WHO to prevent the flu, including H1N1 and H3N2. Continue Reading
By- Samantha McGrail
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News
14 Jul 2021
Medicare Prescription Drug Prices Doubled Since 2005
The increase in prescription drug prices is linked to a 2005 change in how Medicare reimburses doctors and other providers for Part B medications, Duke researchers said. Continue Reading
By- Samantha McGrail
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News
13 Jul 2021
FDA Updates J&J COVID-19 Vaccine Label to Include Rare Disorder
An estimated 100 cases of Guillain-Barre syndrome have been reported among recipients of the Johnson & Johnson COVID-19 vaccine, of which 95% were deemed serious. Continue Reading
By- Samantha McGrail
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News
12 Jul 2021
FDA Seeks Investigation Over Approval of Alzheimer’s Drug, Aduhelm
FDA’s acting commissioner requested a federal investigation into interactions between Biogen and FDA staff during the approval process of its Alzheimer’s drug. Continue Reading
By- Samantha McGrail
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News
12 Jul 2021
Thermo Fisher, UC Davis Launch Center of Excellence for Metabolomics
The research collaboration will provide the metabolomics community with innovations, best practices, and standard operating procedures to support clinical studies and research. Continue Reading
By- Samantha McGrail
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News
08 Jul 2021
FDA Issues Complete Response Letter for Type 1 Diabetes Antibody
In the CRL, FDA stated that a single, low-dose pharmacokinetic/ pharmacodynamic bridging study in healthy volunteers failed to show pharmacokinetic comparability. Continue Reading
By- Samantha McGrail
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News
08 Jul 2021
Merck Gains FDA Approval for Expanded Indication of Keytruda
Keytruda is now approved to treat patients with recurrent or metastatic locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation. Continue Reading
By- Samantha McGrail
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News
07 Jul 2021
GSK, Alector to Develop Antibodies for Neurodegenerative Diseases
The antibodies AL001 and AL101 will elevate progranulin levels, a key regulator of immune activity in the brain with genetic links to various neurodegenerative diseases. Continue Reading
By- Samantha McGrail
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News
06 Jul 2021
AstraZeneca’s Antibody Favorable in RSV in Phase 2/3 Trial
AstraZeneca’s long-acting antibody, nirsevimab, was safe and tolerable compared to placebo when given to infants at high risk of RSV, chronic lung disease, or congenital heart disease. Continue Reading
By- Samantha McGrail
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News
05 Jul 2021
Pfizer Halts Distribution of Smoking Cessation Drug, Chantix
The smoking cessation drug is designed to partially activate the nicotinic receptor, but Pfizer paused distribution after finding carcinogens in the pills. Continue Reading
By- Samantha McGrail
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News
02 Jul 2021
Gilead Submits New Drug Application to FDA for HIV Treatment
In a Phase 2/3 trial, a higher proportion of patients who received the HIV treatment achieved a clinically meaningful viral load reduction compared to those who received a placebo. Continue Reading
By- Samantha McGrail
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News
01 Jul 2021
DTC Pharmaceutical Marketing Linked $324B in Medicare Drug Spending
Over two years, Medicare drug spending on DTC pharmaceutical marketing focused on three therapeutic categories: arthritis, diabetes, and depression. Continue Reading
By- Samantha McGrail
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News
01 Jul 2021
Higher Dose of Ozempic Further Advances Diabetes Care Management
Ozempic 2.0mg elicited a reduction of 2.2% in HbA1C, compared to a reduction of 1.9 % in patients who were treated with Ozempic 1.0mg, boosting diabetes care management. Continue Reading
By- Samantha McGrail
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News
29 Jun 2021
Kite’s T-Cell Therapy 60% Effective Against Large B-Cell Lymphoma
In a Phase 3 trial, Kite’s CAR T-cell therapy met the primary endpoint of event-free survival and the key secondary endpoint of objective response rate against large B-cell lymphoma. Continue Reading
By- Samantha McGrail
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News
29 Jun 2021
ViiV Healthcare, Halozyme to Develop Long-Acting HIV Treatment
ViiV Healthcare will have access to Halozyme Therapeutics drug delivery technology and recombinant human hyaluronidase PH20 enzyme to develop long-acting HIV treatment. Continue Reading
By- Samantha McGrail
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News
25 Jun 2021
Lilly’s Drug Receives Breakthrough Therapy for Alzheimer’s Disease
FDA granted the drug breakthrough therapy for Alzheimer’s disease based on clinical evidence from the company’s Phase 2 trial. Continue Reading
By- Samantha McGrail
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News
25 Jun 2021
FDA Gives EUA for Genentech's Actemra for COVID-19 Hospitalizations
Genentech's COVID-19 monoclonal antibody treatment is the latest therapy to receive emergency use authorization. Continue Reading
By- Kyle Murphy, PhD, Vice President of Editorial
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News
24 Jun 2021
Health Officials Say Myocarditis After COVID-19 Vaccination “Rare”
Although a small number of individuals have experienced myocarditis or pericarditis after their second COVID-19 vaccination, organizations such as HHS and the CDC say the side effect is rare. Continue Reading
By- Samantha McGrail
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News
23 Jun 2021
GoodRx Users Save an Average $30B on Prescription Drug Costs
In 2020, GoodRx users saved $30 billion on prescription drug costs and an average of 79% on retail drug prices for the 100 most purchased medications. Continue Reading
By- Samantha McGrail
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News
21 Jun 2021
Bristol Myers Squibb to Co-Develop Eisai’s Antibody Drug Conjugate
Bristol Myers Squibb will jointly develop and commercialize the antibody drug conjugate in Japan, China, US, Canada, Europe, and UK. Continue Reading
By- Samantha McGrail
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News
16 Jun 2021
Regeneron’s COVID-19 Antibody Cocktail Reduces Death by 20%
In the Phase 3 UK RECOVERY trial, 24% of patients in the COVID-19 antibody cocktail group died, compared to 30% of patients in the standard care group. Continue Reading
By- Samantha McGrail
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News
16 Jun 2021
FDA Guidance Addresses Patient Outcomes in Cancer Clinical Trials
The guidance addresses how to incorporate assessment of patient-reported outcomes in cancer clinical trials of drugs and biological products. Continue Reading
By- Samantha McGrail
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News
15 Jun 2021
Novavax COVID-19 Vaccine 100% Effective in Phase 3 Clinical Trial
Novavax’s COVID-19 vaccine-elicited 100% efficacy against moderate or severe coronavirus and 91% efficacy in high-risk populations. Continue Reading
By- Samantha McGrail
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News
09 Jun 2021
Breaking Down the Approval of Biogen’s Aducanumab
Earlier this week, FDA approved Biogen’s drug for Alzheimer’s disease, aducanumab, after longstanding debate over the drug’s efficacy. Continue Reading
By- Samantha McGrail
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News
07 Jun 2021
FDA Greenlights Biogen Alzheimer’s Drug Aducanumab Amidst Debate
The OK comes after serious pressure from Alzheimer’s patients and their advocates to get another drug for the disease on the market. Continue Reading
By- Sara Heath, Executive Editor
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News
04 Jun 2021
EU Approves AstraZeneca’s Non-Small Cell Lung Cancer Drug
In a Phase 3 clinical trial, AstraZeneca’s non-small cell lung cancer drug reduced the risk of disease recurrence or death by 83% in patients with Stage II and IIIA disease. Continue Reading
By- Samantha McGrail
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News
26 May 2021
J&J’s Biologic Therapy Stelara Helps Crohn’s, Ulcerative Colitis
Johnson & Johnson’s SEAVUE study found that 64.9% of patients treated with the biologic therapy, Stelara achieved clinical remission at one year. Continue Reading
By- Samantha McGrail
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News
25 May 2021
Moderna’s mRNA COVID-19 Vaccine 100% Effective in Adolescents
The TeenCOVE study found that Moderna’s COVID-19 vaccine was 93% effective in seronegative participants 14 days after the first dose and 100% effective 14 days after the second dose. Continue Reading
By- Samantha McGrail
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News
25 May 2021
FDA Approves Janssen’s Targeted Non-Small Cell Lung Cancer Therapy
The therapy from Janssen elicited a response rate of 40% in a study of 81 patients with non-small cell lung cancer and EGFR exon 20 insertion mutations. Continue Reading
By- Samantha McGrail
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News
24 May 2021
GSK-Medicago COVID-19 Vaccine Elicits High Antibody Responses
After the second dose of the COVID-19 vaccine, both age cohorts responded with neutralizing antibody titers that were 10 times higher than those in patients recovering from coronavirus. Continue Reading
By- Samantha McGrail
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News
24 May 2021
Thermo Fisher, UCSF Boost Manufacturing of Cell-Based Therapies
Thermo Fisher Scientific will build and operate a center on UCSF’s Mission Bay Campus to discover, manufacture, and distribute cell-based therapies. Continue Reading
By- Samantha McGrail
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News
21 May 2021
GSK, Sanofi COVID-19 Vaccine Elicits Strong Antibody Response
The COVID-19 vaccine candidate elicited a 95% to 100% seroconversion following a second injection in all age groups and across all doses in a Phase 2 clinical trial. Continue Reading
By- Samantha McGrail
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News
19 May 2021
Biogen’s XLRP Gene Therapy Fails in Phase 2/3 Clinical Trial
The gene therapy did not meet the primary endpoint of statistically significant improvement in the proportion of treated study eyes with ≥7 dB improvement from baseline. Continue Reading
By- Samantha McGrail
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News
18 May 2021
Merck’s Keytruda Helps Patients with High-Risk Breast Cancer
A Phase 3 clinical trial found that Keytruda met its primary endpoint of event-free survival when compared with chemotherapy alone in patients with high-risk triple-negative breast cancer. Continue Reading
By- Samantha McGrail