Genetics and genomics in medicine
Genetics and genomics in medicine focus on analyzing and using genetic data to diagnose, treat and prevent diseases. The continued study of gene functions and interactions in health and disease informs emerging approaches to personalized medicine and population health management strategies for chronic, rare and novel diseases.
Top Stories
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04 Nov 2024
AMPEL develops a blood test for cardiovascular disease
Armie Grammer, AMPEL's co-founder, president, and chief scientific officer of AMPEL BioSolutions, explains the company's CardioGENE blood test for cardiovascular disease risk. Continue Reading
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28 Oct 2024
Addressing gene and cell therapy commercialization challenges
InspiroGene addresses some gene and cell therapy commercialization challenges by offering logistics programs, distribution services, a biologics specialty pharmacy and a patient hub. Continue Reading
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30 Sep 2024
Addressing CGT reimbursement challenges
The PharmaLifeSciences 2024 summit highlighted the reimbursement barriers to cell and gene therapies and discussed policy reforms to ensure patient access and sustainability. Continue Reading
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27 Sep 2024
Advancing medicine through cell and gene therapy
Cell and gene therapy is transforming medicine by offering potential cures for untreatable diseases, but navigating scientific and regulatory hurdles remains challenging. Continue Reading
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02 Aug 2024
FDA approves gene therapy for synovial sarcoma
Tecelra gained FDA approval for the treatment of unresectable or metastatic synovial sarcoma. Continue Reading
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08 Jul 2024
Exploring FDA-approved cell, gene therapeutic products
Despite wildly high costs, FDA-approved cell and gene therapeutic products are revolutionizing healthcare with innovative treatments for once-incurable diseases. Continue Reading
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28 Jun 2024
89% of cancer centers reported a systemic chemotherapy drug shortage
The NCCN report found that, although shortages of some drugs declined, most cancer centers still experienced shortages to some extent. Continue Reading
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05 Jun 2024
BMS, RayzeBio halt radiotherapy trial due to isotope shortage
A shortage of rare isotopes paused BMS' Phase 3 trial of cancer drug RYZ101, highlighting supply chain challenges for radiopharmaceuticals. Continue Reading
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03 Jun 2024
Combating the prescription drug shortage crisis
Prescription drug shortages have reached record highs in the United States, prompting companies to develop integrated technological solutions to address ongoing challenges. Continue Reading
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20 May 2024
Are compounded “DIY” peptides the answer to the GLP-1 shortage?
The short answer is no, according to Lydia Alexander, MD, president of the Obesity Medicine Association. Continue Reading
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10 May 2024
Gene therapy allows two children with congenital deafness to hear
Regeneron announces DB-OTO restores hearing in two congenitally deaf patients at 6 and 24 weeks. Continue Reading
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07 May 2024
Understanding gene therapy coverage for sickle cell disease
Precision AQ executives discuss the recently approved gene therapies for SCD and their implications for payers and providers. Continue Reading
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22 Apr 2024
Exploring 10 ethical considerations in genome editing
While gene editing may be critical for improving human health, ethical considerations must be made to mitigate risks. Continue Reading
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05 Apr 2024
Walgreens Specialty Pharmacy leads RVVC care with VIVJOA exclusivity
AllianceRx Walgreens gains exclusive access to VIVJOA, the first FDA-approved post-menopausal medication for reducing recurrent vulvovaginal candidiasis (RVVC). Continue Reading
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25 Mar 2024
How can gene therapies address inherited blindness?
With over 220 genes contributing to inherited blindness, researchers continue assessing how gene therapies and editing can treat or cure the conditions. Continue Reading
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19 Mar 2024
One-third of the global population is affected by neurological disease
Nervous system disorders are the leading causes of disease burden worldwide, according to a study in the Lancet Neurology. Continue Reading
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11 Mar 2024
Manufacturing complex pharmaceutical products with new technologies
As pharmaceutical products become increasingly complex, companies can leverage new technologies in their manufacturing process to improve efficacy. Continue Reading
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06 Mar 2024
Revolutionizing Vaccine Storage and Distribution with Innovative Solutions
Vaccine storage and distribution innovations are crucial for ensuring vaccine efficacy, expanding accessibility, and enhancing real-time monitoring. Continue Reading
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22 Feb 2024
NIH Precision Medicine Data Detects 275 Million New Genetic Variants
Data from the All of Us Research Program for advancing precision medicine helped researchers identify over 275 million new genetic variants. Continue Reading
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14 Feb 2024
Maximizing Personalized Approaches with Precision Vaccinology
Personalized vaccine development tailors immunization to individual needs, enhancing efficacy, safety, and disease prevention in a patient-centered approach. Continue Reading
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05 Feb 2024
Comparing Female Fertility Drugs: Use Cases, Effectiveness, Risks
Despite the uses and effectiveness of female fertility drugs, they come with multiple risks that must be considered before prescribing or administering them. Continue Reading
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05 Feb 2024
Exploring Challenges, Successes in Solid Tumor Cell and Gene Therapy
Despite the ongoing difficulty of developing cell and gene therapies for solid tumors, some early developments have laid the foundation for future successes. Continue Reading
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01 Feb 2024
Mislabeled Packaging Results in Recalled ADHD Medication
Last week, Azurity Pharmaceuticals issued a voluntary recall of Zenzedi, an ADHD and narcolepsy medication, due to mislabeled packaging. Continue Reading
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30 Jan 2024
Digitizing the Biopharmaceutical Supply Chain Improves Resilience
Deloitte researchers evaluate the importance of digitizing the biopharmaceutical supply chain in establishing the industry’s future. Continue Reading
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29 Jan 2024
Overlapping Genomic and Clinical Data Through Real-World Data Insights
Flatiron Health collaborates with Caris Life Sciences on real-world data offering that combines genomic data with clinical insights. Continue Reading
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25 Jan 2024
Eli Lilly Gene Therapy Restores Hearing Within 30 Days
Eli Lilly recently announced the success of their gene therapy for genetic hearing loss, noting it had restored hearing in a pediatric patient within 30 days. Continue Reading
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19 Jan 2024
FDA Expands Approval of CASGEVY for Beta Thalassemia
Following its revolutionary approval as the first CRISPR-based gene therapy, the FDA expanded the indications for CASGEVY, approving it for beta thalassemia. Continue Reading
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17 Jan 2024
Exploring Facets of the Cell and Gene Therapy Market
LifeSciencesIntelligence explores the cell and gene therapy market, noting how it evolved in the past year. Continue Reading
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16 Jan 2024
Evaluating the Series of Infant Formula Recalls in the US
PharmaNewsIntelligence explores the various stages of infant formula recalls in the US and how the FDA has adapted to minimize contamination. Continue Reading
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09 Jan 2024
10 Ways CRISPR Advancements Are Reshaping Healthcare
Recent CRISPR technology advancements are crucial in healthcare as they enable precise gene editing and offer new treatments for genetic diseases. Continue Reading
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19 Dec 2023
Combating Specialty Drug Challenges in the Pharmaceutical Industry
Rising specialty drug use demands cost and experience considerations for optimal patient outcomes. Continue Reading
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18 Dec 2023
AllianceRx Walgreens Selected to Distribute XDEMVY
Along with BlinkRx, Carepoint, and CVS, AllianceRx Walgreens Pharmacy was selected to distribute XDEMVY (lotilaner ophthalmic solution) 0.25%. Continue Reading
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30 Nov 2023
FDA Investigates Safety of CAR T-Cell Therapy
After identifying T-cell malignancies in some patients treated with CAR T-cell therapy, the FDA is launching an investigation into the safety of the treatment. Continue Reading
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29 Nov 2023
Biden Leverages DPA to Strengthen Pharmaceutical Supply Chain
Among almost 30 other proposed plans, the Biden administration announced its intention to strengthen the pharmaceutical supply chain through the DPA. Continue Reading
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16 Nov 2023
Gene Editing Technology Could Treat Hypercholesterolemia
An announcement from Verve Therapeutics revealed data from a proof-of-concept study suggesting that gene editing could treat familial hypercholesterolemia. Continue Reading
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18 Oct 2023
HHS and Pfizer Reach Paxlovid Agreement to Improve Access
An announcement from the HHS highlighted collaborative efforts by the department and Pfizer to improve access to Paxlovid. Continue Reading
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10 Oct 2023
FDA Updates Infant Formula Compliance Program
The FDA has updated its infant formula compliance program after multiple infant formula recalls in the past year. Continue Reading
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27 Sep 2023
Pediatric Amoxicillin Shortage Persists as Winter Approaches
Public health experts are concerned that the shortage may impact pediatric healthcare as infections continue. Continue Reading
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27 Sep 2023
Five Ways That Genetic Research and Advancements Inform Healthcare
As genetic research advances, healthcare professionals, patients, and other stakeholders must determine how new data and tools will inform care. Continue Reading
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18 Sep 2023
National Blood Supply Dropped 25%, Causing Critical Shortage
An announcement by the American Red Cross expresses an urgent need for blood donations amidst climate crises. Continue Reading
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14 Sep 2023
NIH Will Allocate $50.3 Million to Multi-Omics Research Over 5 Years
The institute will fund six different sites across the US, with $11 million of initial funding. Continue Reading
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06 Sep 2023
Researchers Identify Multidrug Chemotherapy Resistant Genes
A study published in Molecular Cancer identified multidrug chemoresistant genes in squamous cell carcinoma cells from the head and neck. Continue Reading
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25 Aug 2023
Are African Individuals at Higher Risk of Parkinson’s Disease?
A recent study of African American and Afro-Caribbean individuals identified genetic risk factors for Parkinson’s disease. Continue Reading
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24 Aug 2023
Researchers Identify a Completed Sequence of the Y Chromosome
The completed sequence of the Y chromosome is the final human chromosome to be sequenced. Continue Reading
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23 Aug 2023
More Eyedrops Recalled Due to Bacterial, Fungal Contamination
A recent recall of MSM eye drops cites bacterial contamination, fungal contamination, or both as justifications. Continue Reading
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15 Aug 2023
Over 99% of US Hospital Pharmacists Reported Drug Shortages
A survey published by the ASHP notes that ongoing drug shortages in hospital pharmacies are moderately or critically impactful. Continue Reading
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09 Aug 2023
Gene Therapy Restores Sight in a Pediatric Patient with DEB
After two surgical treatments, gene therapy restored sight in a 14-year-old boy with severe vision loss from DEB. Continue Reading
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04 Aug 2023
Lupin Pharmaceuticals Recalls Two Lots of Birth Control
The company explained that the low ascorbic acid levels in Tydemy, a prescription oral contraceptive, can reduce effectiveness. Continue Reading
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02 Aug 2023
ADHD Medication Shortages Prompt Response from the FDA and DEA
The organizations issued a joint statement detailing efforts to strengthen the ADHD medication supply chain. Continue Reading
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21 Jul 2023
Pfizer Plant Damage May Cause Pharmaceutical Supply Chain Shortages
Damage from a tornado at the Pfizer Rocky Mount, NC, plant may cause pharmaceutical supply chain shortages. Continue Reading
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12 Jun 2023
Top Challenges Facing Biosimilar Adoption and Manufacturing
Although biosimilars can decrease prescription drug spending and increase patient access, there are challenges and concerns regarding biosimilar adoption and manufacturing. Continue Reading
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07 Jun 2023
FDA Turns to China for Chemotherapy Drug Imports Amidst Shortage
With never-ending shortages of multiple chemotherapy and oncology drugs, the FDA has turned to China to import cisplatin. Continue Reading
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01 Jun 2023
FDA Issues Warning on Compounded Semaglutide Products
On May 30, 2023, the FDA issued a warning on multiple compounded semaglutide products marketed for type 2 diabetes and weight loss. Continue Reading
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24 May 2023
The Top 5 Most Expensive FDA-Approved Gene Therapies
Hemgenix, Skysona, Zynteglo, Zolgensma, and Luxturna comprise the top 5 most expensive gene therapies approved by the FDA. Continue Reading
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22 May 2023
CDC Update Identifies Fourth Death Linked to Eyedrop Recall
In an update published last week, the CDC identified a fourth death linked to a series of eyedrop recalls earlier this year, bringing the infection total to 81. Continue Reading
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16 May 2023
NIH Spends $140 Million to Accelerate Research on Genetic Variations
Last week, the NIH spent $140 million launching a new program, the Common Fund’s Somatic Mosaicism Across Human Tissues, to accelerate research on genetic variations. Continue Reading
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15 May 2023
Syphilis Rates Continue to Rise as Penicillin Availability Falls
Recent alerts from the FDA have identified a shortage of penicillin injections, causing alarm as syphilis rates continue to rise across the United States. Continue Reading
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11 May 2023
Designing Next-Generation Cell and Gene Therapies
Researchers at Cedars-Sinai are working on a new method to treat ALS and retinitis pigmentosa using engineered stem cells, potentially paving the way for personalized treatments. Continue Reading
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03 May 2023
Strategies for Sustainability in the Global Pharmaceutical Supply Chain
Sustainable strategies are essential for the global pharmaceutical industry's supply chain to minimize its environmental impact, reduce greenhouse gas emissions, preserve natural resources, and address growing concerns about climate change. Continue Reading
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03 May 2023
CRISPR Gene Editing and Antiretroviral Therapy Eliminates HIV in Mice
A recent study by researchers at the University of Nebraska and Temple University found that CRISPR gene editing of the CCR5 and HIV-1 genes alongside antiretroviral therapy eliminates HIV in humanized mice. Continue Reading
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27 Apr 2023
Understanding the Pharmaceutical Drug Development Life Cycle
Collaborative efforts among the stakeholders in the pharmaceutical industry and a robust understanding of the drug development life cycle are critical for producing safe and effective treatments. Continue Reading
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27 Apr 2023
US Continues to Increase Its Reliance on Chinese Pharma Supply Chain
The United States is growing its import of Chinese pharmaceuticals regardless of supply chain consequences. Continue Reading
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26 Apr 2023
Drug Shortages: A Growing Concern for the Healthcare Industry Worldwide
Drug shortages pose a significant challenge for healthcare providers worldwide, leaving patients without essential medications and healthcare providers struggling to find alternative treatment options. Continue Reading
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20 Apr 2023
Greater Pharmacist Role Improves Pharma Supply Chain Management
Empowering pharmacists to become more involved in pharma supply chain management gives patients and caregivers a more personalized and proactive approach to care. Continue Reading
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19 Apr 2023
How to Properly Dispose of Unused Drugs, Understanding Key Roles
All members of the healthcare system, including manufacturers, providers, and patients, may play a role in properly disposing of unused or expired drugs and medicines. Continue Reading
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03 Apr 2023
Canadian Province Restricts Ozempic Sales to United States Citizens
After data revealed that many Americans are crossing borders for Ozempic, British Columbia, a Canadian Provence, restricts sales to United States Citizens. Continue Reading
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31 Mar 2023
Researchers Discover Anxiety Biomarkers, Developing a Blood Test
In a study published in Molecular Psychiatry, researchers discovered anxiety biomarkers using a four-step approach, allowing them to develop a blood test. Continue Reading
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27 Mar 2023
Using Genomic Profiling in Oncology Advances Precision Medicine
In the era of precision medicine, genomic profiling may be a critical tool in oncology to assess a patient’s response to treatment or advance oncological research. Continue Reading
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23 Mar 2023
Fundamentals of the Pharmaceutical Supply Chain
The complex pharmaceutical supply chain poses challenges requiring efficient solutions to deliver vital medications. Continue Reading
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22 Mar 2023
The Policy Problem Behind Adderall's Pharmaceutical Supply Chain Crisis
Drugs used to treat ADHD have been lacking for months now, leading to problems with access to prescription amphetamines and creating questions about the cause of the massive shortage. Continue Reading
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07 Mar 2023
Liquid Albuterol Shortages Exacerbated by Supply Chain Issues
Liquid albuterol shortages, exacerbated by supply chain issues, have left pediatric hospitals struggling amidst rising asthma rates. Continue Reading
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07 Mar 2023
Finding Solutions for Drug Shortages: Short and Long-Term Management
The impact of drug shortages on patients, providers, and healthcare spending has left industry leaders looking for short- and long-term management solutions. Continue Reading
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27 Feb 2023
Ohio Train Derailment and Chemical Spill Causes Health Hazards
An Ohio train derailment caused a chemical spill of vinyl chloride and butyl acetate, leading to various health hazards for humans and animals in the area. Continue Reading
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17 Feb 2023
Genetic Analysis Identifies microRNAs Associated with Diabetes
Results of a genetic analysis published in the Proceedings of the National Academy of the Sciences identified microRNAs in the pancreas associated with type 2 diabetes. Continue Reading
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12 Jan 2023
NIH Study Supports Genomic Approach to Addressing Genetic Conditions
A National Institutes of Health study examined past research into genotype-first approaches in medicine, finding new links to genetic conditions. Continue Reading
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23 Dec 2022
Pharmacies Limit Children’s Pain Medication Purchases
Amidst extremely high COVID, flu, and RSV infection rates, many pharmacies have begun to limit the sale of children’s pain relief medications to minimize the effects of the ongoing shortage. Continue Reading
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22 Dec 2022
Colorectal Cancer Study Identifies New Genetic Links to Disease
A multi-omic analysis of 200,000+ people with cancer and non-cancerous controls identified hundreds of risk associations and revealed 50 undiscovered genetic associations with colorectal cancer. Continue Reading
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19 Dec 2022
Projected Shortage of Non-Human Primates May Impact Drug Development
After an indictment of officials for smuggling endangered species into the US, a projected shortage of non-human primates may impact domestic drug development. Continue Reading
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13 Dec 2022
Navigating Cold and Flu Medication Shortages
With the rise of cold, flu, and other viral infection rates, patients, parents, and providers struggle to navigate the ongoing cold and flu medication shortages. Continue Reading
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08 Dec 2022
Pfizer Invests $750M in Michigan Pharmaceutical Manufacturing Expansion
Company officials plan to expand the Western Michigan plant responsible for mass-producing the first COVID-19 vaccines. Continue Reading
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29 Nov 2022
Adderall Withdrawal Exacerbated by Pharmaceutical Supply Chain Issues
The recent Adderall shortages in the United States have exacerbated withdrawal symptoms and contributed to medication rationing. Continue Reading
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08 Nov 2022
Genetic Testing May Predict Heart Disease for Women with Lupus
In a recent press release, a biosolutions company announced a genetic test for women with lupus that can predict heart disease risk and offer providers support for choosing therapies. Continue Reading
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26 Oct 2022
Most People with Spinal Muscular Atrophy Utilize Gene Therapy
In a recent press release, Health Union announced that the Spinal Muscular Atrophy in America survey found that most people with spinal muscular atrophy utilize gene therapy. Continue Reading
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26 Oct 2022
Understanding the Impacts of Newborn Whole Genome Sequencing
Newborn whole genome sequencing may have many impacts, including reduced patient and family exhaustion, provider anxiety, and improved education. Continue Reading
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11 Oct 2022
Understanding Differences between Generic, Brand Name, Biosimilars
Knowledge of and understanding the differences between generics, brand names, and biosimilars is essential for patients, payers, and providers to make informed decisions about care. Continue Reading
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21 Sep 2022
Bluebird’s Gene Therapy Costs $3 Million per Treatment
Bluebird’s newly approved gene therapy, Skysona, costs $3 million per treatment, making it the most expensive therapeutic intervention worldwide. Continue Reading
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25 Aug 2022
Biden Administration Secures COVID-19 Booster Shots for Use This Fall
Pharmaceutical companies have submitted variant-specific COVID-19 boosters for FDA approval and are expecting another coronavirus surge this fall. Continue Reading
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02 Aug 2022
HHS Statement on FDA Approval of Bavarian Nordic Monkeypox Vaccine
HHS secretary Xavier Becerra recently issued a statement regarding the FDA approval of the Bavarian Nordic Monkeypox Vaccine. Continue Reading
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14 Jul 2022
$354M BARDA Contract for Pharmaceutical Manufacturing Goes Unfulfilled
A massive BARDA contract granted to Phlow Corp. promised cheap manufacturing of generic medications, but the company has yet to meet expectations and is unlikely to comply with future deadlines. Continue Reading
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21 Jun 2022
CRISPR Treatment in Clinical Trial for Pediatric Sickle Cell Disease
Recently, the European Hematology Association released clinical trial research with implications for using CRISPR treatment for pediatric sickle cell disease. Continue Reading
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06 Jun 2022
Nephron Pharmaceuticals Recalls 2.1 Million Doses of Medicine, Medical Equipment
Nephron Pharmaceuticals recalls 2.1 million doses of medicine and medical equipment because of a lack of assurance of sterility. Continue Reading
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31 May 2022
Eli Lilly Invest $2.1B in Indiana Pharmaceutical Manufacturing
Eli Lilly is building their US pharmaceutical manufacturing base and expanding the domestic pharmaceutical supply chain with this significant Indiana investment. Continue Reading
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25 May 2022
Hospital Contrast Dye Shortage Results in Rationed Medical Imaging Care
Hospitals worldwide are navigating a COVID-related iodinated contrast dye shortage, resulting in rationed medical imaging care. Continue Reading
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19 May 2022
Study Finds Genetic Links to Common Mental Illnesses
Shared genes were found across several major mental disorders, expanding the understanding of genetic links to mental illness. Continue Reading
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13 May 2022
Magellan Healthcare, Concert Genetics to Improve Genetic Testing
The companies will combine genetic tests and unique ID systems with updated medical policies, test-specific coding standards, and lab-quality information to improve genetic testing. Continue Reading
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11 May 2022
Tempus, VA Expand Next-Generation Sequencing for Cancer Treatment
The agreement allows providers across the VA’s 171 Medical Centers to leverage Tempus’ next-generation sequencing tests for personalized cancer treatments. Continue Reading
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04 May 2022
Pfizer Opens First US Phase 3 Study Evaluating Gene Therapy
After FDA placed a clinical hold on the gene therapy study in December 2021, the agency noted that Pfizer has addressed its request related to the potency assay and will open the first US sites. Continue Reading
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21 Apr 2022
Veterans Affairs Study Produces Genotype Assay for Major Diseases
Using genomic testing, researchers created an assay to assist with disease detection and workflow optimization. Continue Reading
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20 Apr 2022
Thermo Fisher Launches Cas-9 Protein to Support Genome Editing
The GMP-manufactured Gibco CTS TrueCut Cas9 Protein provides consistent high-editing efficiency in all tested cell lines and greater than 90% efficiency in human primary T-cells. Continue Reading
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13 Apr 2022
Defining Precision Medicine and Evaluating Its Healthcare Impacts
Precision medicine is a change from the one-size-fits-all treatment and prevention approach traditionally used in healthcare by examining a person’s genes, behaviors, and environment. Continue Reading
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12 Apr 2022
Thermo Fisher Launches Next-Generation Sequencing Platform for Labs
The next-generation sequencing platform is designed for clinical laboratories and enables users to perform diagnostic testing and clinical research on a single instrument. Continue Reading
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12 Apr 2022
Sandoz Expands Collaboration in Antimicrobial Resistance Fight
Sandoz and Ares Genetics will fight antibiotic resistance by enabling genomic surveillance for resistant pathogens using next-generation sequencing (NGS) and bioinformatics technology. Continue Reading