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Xtalks Vitals covers a variety of news stories in the life sciences industry – including pharmaceutical, medical device, and disease research news – to keep you up to date on everything happening in the industry.


Hormel Issues Price Increase for Meat Products Amid Increasing Demand for Bacon

The current demand for bacon is so high that farmers cannot raise pigs fast enough to meet it.

Cancer-Detecting Pen to Help Guide Surgeons in Tumor Resection

Researchers at The University of Texas at Austin have developed a disposable cancer identification pen capable of rapidly identifying malignant tissue during surgery.

AstraZeneca Posts Favourable Results for First-in-Class Asthma Drug

Results from AstraZeneca’s Phase IIb PATHWAY clinical trial suggest that the antibody drug tezepelumab could offer a new treatment option for patients with severe, uncontrolled asthma.

Earth Fare Introduces New Low-Price ‘Clean Food Security’ Meals

Earth Fare unveils a new “Clean Food Security” program that can feed a family of four for under ten dollars per meal.

Approved Alzheimer’s Drug Could Reduce Inflammation in Patients with Metabolic Syndrome

A recent report published in the journal JCI Insight suggests that an existing Alzheimer’s drug could also be used to treat patients with metabolic syndrome, a condition characterized by high blood pressure, elevated glucose levels, high cholesterol and excess fat around the midline.

FDA-Approved Fentanyl Drug Screening Assay to Help Identify Opioid Abuse

For the first time, the US Food and Drug Administration (FDA) has approved a urine-based immunoassay to detect fentanyl in living patients.

Additional Insulin Injection May Reduce Heart Disease Risk in Patients with Type 1 Diabetes

A small clinical trial conducted by researchers at the NIHR Newcastle Clinical Research Facility has found that patients with type 1 diabetes who were given an additional insulin injection three hours after consuming a meal may have a decreased risk of developing cardiovascular disease.

Samsung Bioepis Receives First FDA Drug Approval for Remicade Biosimilar

South Korea-based biopharmaceutical company, Samsung Bioepsis, has received its first product approval for the US market.

Researchers Urge FDA to Update Guidance for Alzheimer’s Drug Approvals

Alzheimer’s disease drugs are notoriously difficult to develop, as they often show efficacy in early stage clinical trials but fail to meet critical endpoints when it comes to the pivotal Phase III study.

Drugs Ratings Online Database for Physicians Launched by Sermo

Physicians’ social media network, Sermo, has launched a new database for prescription drugs featuring ratings, reviews and comments.

Medeor to Start Late-Stage Clinical Trial of Immunotherapy for Transplant Patients

Medeor Therapeutics has just received the FDA go-ahead to start a clinical trial of its cell-based immunotherapy, MDR-101. The personalized therapeutic could replace immune-suppressing drugs in patients who have received an organ transplant.

Saturated Fat Does Not Clog Arteries, According to Researchers

The researchers cited a systematic review and meta-analysis of observation studies that found no link between saturated fat consumption, coronary heart disease, and death.

New Medici App Has Big Implications for Future of Doctor-Patient Relationship

A new healthcare messaging app, Medici, promises to connect patients with all of their doctors through a single platform.

FDA Approves VivaLnk’s Wearable Device for Continuous Temperature Monitoring

Digital health startup, VivaLnk, has just received FDA clearance for their continuous temperature monitoring medical device, Fever Scout.

Observational Study Finds Sanofi’s Diabetes Drug Lowers Incidence of Hypoglycemia

Data from a recent real-world observational study has found that that Sanofi’s type 2 diabetes drug, Toujeo (insulin glargine 300 Units/mL), was associated with a lower risk of hypoglycemia, compared to other basal insulins.

Teva’s New Treatment for Huntington’s Disease Approved by FDA

Teva Pharmaceuticals’ Huntington’s Disease drug, Austedo (deutetrabenazine), has been approved by the FDA in the treatment of involuntary movements associated with the disorder, known as chorea.

Women with Unexplained Clots May Now be Advised to Stop Taking Blood Thinners

Researchers at the University of Ottawa have developed and validated a rule which may help physicians decide whether some women can stop taking blood thinners after a venous thrombosis.

New PARP Inhibitor Drug Approved to Treat Women with Recurrent Ovarian Cancer

The US Food and Drug Administration (FDA) has approved Zejula (niraparib) as a maintenance treatment for women with certain types of recurrent cancers, including epithelial ovarian, fallopian tube, and primary peritoneal cancer.

Nektar’s Opioid Analgesic Meets Endpoints in Phase III Clinical Trial

Nektar Therapeutics has announced that their opioid analgesic has met both its primary and secondary endpoint in a recent Phase III efficacy study.

European Pharmaceutical Associations Urge Physicians to Exercise Caution When Prescribing Biosimilars

Three pharmaceutical industry groups in the EU have published a document aimed at helping physicians decide when it’s medically appropriate to switch a patient from a biologic to a biosimilar.

New Zika Virus Research Sheds Light on Tissues Infected with the Pathogen

Researchers at Oregon Health and Science University (OHSU), have identified multiple tissue types infected by the mosquito-borne Zika virus.

Genomic Diagnostic Could Use Nasal Swab to Detect Lung Cancer

A non-invasive nasal swab could improve lung cancer diagnosis, according to genomic diagnostics company, Veracyte.

Merck’s Antiviral Drug Meets Primary Endpoint in Phase III Clinical Trial

Merck’s investigational antiviral medicine, letermovir, has met its primary endpoint of reducing the incidence of cytomegalovirus (CMV) infection in adults following a bone marrow transplant.

Some Online Pharmacies in UK Dispensing Antibiotics Without Prescription

A new study suggests that online pharmacies in the UK could be contributing to the global health issue of antibiotic resistance by allowing patients to obtain antibiotics without a prescription.

CDC: Interim Results Suggest Flu Vaccine 48 Percent Effective This Season

This year’s influenza vaccine has reduced the risk of contracting the virus by approximately 50 percent, according to an interim report released by the Centers for Disease Control and Prevention (CDC).

Brain-Computer Interface Allows Late-Stage ALS Patients to Communicate

Researchers at The Wyss Center at Campus Biotech in Geneva, Switzerland, have found that a non-invasive brain-computer interface could facilitate communication for patients with ALS.

Amgen’s Repatha Cholesterol Drug Cuts Risk of Cardiovascular Events in Clinical Trial

Initial results from Amgen’s FOURIER clinical trial show that Repatha reduces the risk of cardiovascular events in patients with heart disease.

Asthma Misdiagnosis Could Mean Many are Unnecessarily Medicated

Though asthma is one of the most common respiratory conditions around the world, a new study suggests it may be overdiagnosed.

Ebola Blood Biomarker Could Help Healthcare Workers Predict Patient Outcomes

A team of researchers at the University of Liverpool have identified a transcriptomic biomarker in the blood of patients infected with the Ebola virus, which may be a predictor of survival.

Stable Synthetic Stem Cells Could Reduce Risks and Improve Benefits

Synthetic cardiac stem cells have been developed by researchers at North Carolina (NC) State University, in collaboration with the University of North Carolina (UNC) at Chapel Hill and First Affiliated Hospital of Zhengzhou University.

Fluorescent Skin Dye Offers Temporary Option for Skin Cancer Management

A team of researchers at the University of California, Los Angeles, have developed a novel fluorescent ink to temporarily tag the skin cancer lesion.

Food Additive Could Contribute To Development of Colon Cancer

Lab-grown lungs could help researchers develop more effective therapeutics to treat lung cancer, among other lung diseases, by providing an accurate model with which to screen drug candidates.

Lab-Grown Lungs Survive Transplant into Mice

Lab-grown lungs could help researchers develop more effective therapeutics to treat lung cancer, among other lung diseases, by providing an accurate model with which to screen drug candidates.

Pfizer Fined Nearly £90 Million for Epilepsy Drug Price Hike in UK

Yesterday, pharmaceutical company Pfizer, and their UK distributer, Flynn Pharma, were fined £89.4 million by British regulators in response to the increasing cost of an epilepsy drug.

High Blood Pressure Identified As Biomarker for PTSD Drug Response

New findings suggest that soldiers with high blood pressure before taking medication for post-traumatic stress disorder (PTSD), may respond better to the treatment.

Diagnosing Concussions Based on High-Resolution Brain Imaging and Machine Learning

According to Canadian researchers, high-resolution brain scans could be paired with machine learning algorithms to improve the diagnosis of mild traumatic brain injury.

Study Finds Most People Don’t Read Pharmaceutical Risk Disclosures

Despite the fact that consumers claim to read the risk disclosures on websites for branded pharmaceuticals, research conducted at the University of Tennessee suggests that this isn’t always true.

New Company Aims To Prevent Food Allergies In Children Through Exposure

A new company, Before Brands, is hoping to prevent food allergies in children before they develop. With $13.1 million in initial funding, the company could develop topical and edible products aimed at exposing children ages six months and older to potential food allergens.

Unvaccinated Adults Place $7 Billion Burden on US Healthcare System

According to a study conducted by researchers at the University of North Carolina in 2015 the US economy spent $8.95 billion treating vaccine-preventable diseases in adults. Unvaccinated adults are responsible for the bulk of this cost, placing a $7.1 billion burden on the healthcare system.

Study Finds Most People Don’t Read Pharmaceutical Risk Disclosures

Despite the fact that consumers claim to read the risk disclosures on websites for branded pharmaceuticals, research conducted at the University of Tennessee suggests that this isn’t always true. What does this mean for pharmaceutical companies?

New Study Supports Transposon Theory Of Aging

A recent study has contributed further evidence that transposons – DNA elements capable of moving around the genome – could play a role in deteriorating health associated with advanced age. Could the research help in the development of life-extending treatments capable of counteracting the effects of transposons on health?

Cempra Releases Promising Phase II Clinical Trial Results For Anti-NASH Drug

Antibiotics developer Cempra Inc. has released positive interim results from a Phase II clinical trial for their drug, solithromycin, in the treatment of non-alcoholic steatohepatitis. Could the drug offer a new treatment option for patients?

Is Codeine Still The Best Choice For Pediatric Pain Management?

Is codeine still the best choice for pediatric pain management? According to the American Academy of Pediatrics, the answer to this question is a resounding “no.”

Bayer Seeks To Buy Monsanto in $66 Billion Deal

German pharmaceutical company Bayer has announced its intention to acquire the US-based agribusiness company Monsanto in a $66 billion deal. Best known for the discovery of aspirin, Bayer’s acquisition of Monsanto would make it the world’s largest seed and crop spray supplier.

CRISPR Gene Editing Could Be Used To Treat Sickle Cell Disease

Researchers at St. Jude’s Children’s Research Hospital have pioneered the use of CRISPR gene editing as a therapeutic for sickle cell disease and other blood disorders. This is just the latest of many potential therapeutic applications of gene editing.

Chemical Used In Plastic Manufacturing Could Be Harmful To Fertility

A chemical used in the production of plastic products – called BPS – could be just as harmful to reproductive health as its chemically-related compound, BPA. BPS was introduced as a substitute to BPA, however a new study on fertility suggests it may not be as harmless as previously thought.

Nanorobots Could Redefine Targeted Cancer Therapies

Targeting tumors using nanorobots could be the future of cancer treatment thanks to research performed at McGill University. These researchers have designed nanorobots capable of being injected into a patient’s bloodstream, and delivering a drug directly into cancerous cells.

FDA Grants Fast Track To Eli Lilly And AstraZeneca’s Alzheimer’s Drug

A drug designed to treat patients in the early stages of Alzheimer’s disease has been granted a fast track designation by the FDA. Will the drug become the first new therapy for Alzheimer’s to be approved in over a decade?

New Drug Could Treat Trio Of Deadly Parasitic Infectious Diseases

A new proteasome inhibitor drug could effectively treat three parasitic infections including, Chagas disease, leishmaniasis and sleeping sickness. The researchers screened three million compounds made by pharmaceutical company Novartis, to identify the most effective, broad-spectrum antiparasitic drug.

Biochip Blood Test Could Identify Those With An Increased Risk Of Alzheimer’s Disease

A new blood test developed by researchers at Randox Laboratories could help identify patients who face a higher risk of developing Alzheimer’s disease. Could the biochip test improve early diagnosis?

Roche’s Home Healthcare Medical Device For Anticoagulant Therapy Launches In Europe

Roche has launched a new blood clotting testing device for European patients taking anticoagulant drugs. Could the medical device improve out-of-hospital care for patients?

FDA Approves First Medical Device Implant For Opioid Dependence

The FDA has approved the first buprenorphine implantable medical device – marketed as Probuphine - for patients with opioid dependence. Will the new drug delivery method improve patient outcomes?

FDA Urges Food Industry To Reduce Sodium In Processed Products

The FDA has issued draft guidance aimed at encouraging the food industry to voluntarily reduce sodium levels in processed and commercially prepared foods. The regulator’s two-year and 10-year goals are aimed at helping the average US citizen reduce their daily sodium intake from 3,400 to 2,300 mg/day.

Diagnostic Device Rapidly Diagnoses Heart Attack

A new diagnostic device designed by Philips is able to quickly diagnose patients who have experienced a heart attack, at the point-of-care. Will the medical device help physicians make faster treatment decisions?

What Brexit Means for UK Pharmaceutical Industry

After the results of the close vote were announced, the country’s trade organization known as the Association of the British Pharmaceutical Industry warned its members of “immediate challenges” for the pharmaceutical industry.

Trump, Sanders and Clinton: Pharmaceutical Industry’s Friends Or Foe?

Pharmaceutical industry issues surrounding drug pricing, patient access and affordable healthcare, have all become important points of debate in the 2016 US general election. So What do Bernie Sanders, Hillary Clinton and Donald Trump have planned for the pharmaceutical industry, if they are elected to office?

Wolbachia Bacteria Could Help Prevent Spread Of Zika And Dengue

A study conducted by Brazil’s Oswaldo Cruz Foundation and Eliminate Dengue, has confirmed that Wolbachia bacteria can reduce Zika virus transmission by the Aedes aegypti mosquito. The bacterial genus is currently used in regions like Australia, to control the spread of dengue.

FDA To Track Sales Of Antibiotics To Livestock Farmers

The FDA has recently released its final rule requiring pharmaceutical companies to report sales data for all antibiotics used in various types of food-producing livestock. The rule – which goes into effect in 60 days – could help the agency understand how the drugs are used to raise hogs, cattle, chickens, or turkeys destined for human consumption.

Injectable Multiple Sclerosis Drug Passes EMA Regulatory Review

The European Medicines Agency has recommended Biogen and AbbVie’s injectable multiple sclerosis drug for marketing approval. The drug – a monoclonal antibody called Zinbryta – could be a new treatment option for patients with relapsing forms of the autoimmune disorder.

CAR-T Cell Immunotherapy Could Be Viable Treatment For Some Brain Cancers

A Phase I clinical trial has found that CAR-T cell immunotherapy could be a viable treatment for a type of brain cancer known as glioblastoma. The study provides further evidence that the therapy could be effective against solid tumors.

FDA Requires Additional Trials For Catalyst Pharmaceuticals’ Rare Disease Drug

Just two months after Catalyst Pharmaceuticals received a rarely-issued Refuse to File letter from the FDA, the biotech has faced more hurdles with the regulatory agency. The FDA is now requiring that the company conduct more trials to test the safety of its rare disease drug candidate, Firdapse.

AstraZeneca Partners With Human Longevity To Sequence Two Million Genomes

AstraZeneca is launching a project aimed at sequencing two million genomes, in an effort to harness the power of genomics data in directing drug development. The company plans to use the data to identify new drug targets based on a patient’s genetic information.

Startup Looks To Improve Patient Charting Using Google Glass

San Francisco-based startup Augmedix has raised $17 million to help physicians use Google Glass to create and review patient charts. Could the tool help physicians see more patients?

Extended-Release Pill Attaches To GI Lining For Prolonged Drug Delivery

Researchers have developed a new pill designed to adhere to the lining of the gastrointestinal tract and steadily release its drug load. Once swallowed, one side of the tablet binds to the intestinal tissue, while the other resists passing food and liquids which could dislodge it from its point of attachment.

EMA Approves First Gene Therapy For Pediatric Rare Disease

A new gene therapy developed by GlaxoSmithKline has been approved by the European Medicines Agency (EMA) for use in children with the ultra-rare genetic disease, ADA severe combined immune deficiency. Could this decision pave the way for gene therapy in the US?

Breast Cancer Pill Illuminates Tumors, Leading To More Accurate Screening

A new oral pill could help clinicians more accurately identify cancerous breast tissue during routine screening. Could the pill improve early detection rates?

Bioengineered Skin Displays Characteristics Of Integumentary Organ System

Japanese scientists have performed a skin transplant on mice using 3-D bioengineered tissue generated from pluripotent stem cells. These cells – which consisted of multiple layers, including sweat glands and hair follicles – were successfully integrated into the animal transplant recipient.

Exposure To Peanuts Builds Tolerance In Children, Potentially Preventing Allergy

A new study suggests that feeding infants peanut products can prevent them from developing serious allergies to the food during childhood. What’s more, early exposure to peanuts is sufficient to elicit prolonged tolerance, despite extended periods of ceased consumption.

Regular Consumption Of High Glycemic Index Foods Could Increase Lung Cancer Risk

Individuals whose diet consists of high glycemic index foods could have a significantly higher risk of developing lung cancer, compared to those with a healthier diet. Could your diet be putting you at risk?

5 Ways To Increase Patient-Centricity In Your Clinical Trial Operations

Patient-centricity has become a much-used buzzword by those in the clinical trials industry, but practically-speaking, how can the concept be applied to the average clinical trial site?

Celldex Therapeutics Terminates Phase III Clinical Trial For Brain Cancer Vaccine

Biotech company Celldex Therapeutics announced they would be prematurely ending the Phase III clinical trial for their glioblastoma vaccine, Rintega.

Developing The Zika Vaccine

Meet the top 6 companies in the race to develop a Zika vaccine. Since the companies are in various stages of development, will a Zika vaccine be available anytime soon?

GlaxoSmithKline Receives $54.4 Million Fine In UK For Pay-For-Delay Deal

The UK’s Competition and Markets Authority has fined GlaxoSmithKline for a pay-for-delay deal made over 10 years ago. How will the decision affect the availability of generics in the future?

Is The Food You Eat Affecting Your Genes?

According to a new study published in the journal, Nature Microbiology, while genetic factors influence our metabolism, the food we consume may be also be affecting our genes. How is your diet affecting your DNA?

Prenatal Exposure To Acetaminophen Linked To Asthma Risk

A new study conducted by the Norwegian Institute of Public Health has confirmed a link between prenatal exposure to acetaminophen and an increased risk of developing asthma in early childhood. What does this risk mean for pregnant women taking the drug?

FDA: Celltrion’s Remicade Biosimilar “Highly Similar” To Branded Drug

An FDA advisory panel is strongly recommending that the agency approve Celltrion’s biosimilar of Johnson & Johnson’s Remicade. What would the approval mean for sales of the inflammation drug?

Study Finds Pfizer’s Smoking Cessation Drug, Chantix, Is No More Effective Than Nicotine Patches

A new study published in the Journal of the American Medical Association, found that there was no statistically significant difference in quit smoking rates between individuals using nicotine patches, lozenges or taking Pfizer’s Chantix. What will these results mean for sales of the quit smoking drug?

Gene Editing Approved For Research On Human Embryos In UK

The Human Fertilisation and Embryology Authority in the UK has approved a research proposal to use gene editing in human embryos to further understand the genetic basis of inherited diseases. While the research could provide valuable insight into mutations causing genetic disease, some are concerned about the ethics of the gene editing technique.

Pfizer’s Lyrica Recalled Due To Heat Damage

Pfizer has recalled almost 150,000 bottles of Lyrica – a best-seller used to treat nerve pain – after learning that the pharmaceuticals may have been exposed to extreme heat during transportation, leading to damage. The recalled pharmaceuticals include three lots, with each bottle containing 90 capsules.

Replacement Pancreatic Cells Could Be Treatment For Type 1 Diabetes

Researchers at MIT and Boston Children’s Hospital, have designed a novel material for encapsulation of pancreatic cells, which may allow the cells to be transplanted into patients with type 1 diabetes. Could the cell therapy be a cure for the disease?

Double Approval For Amgen’s Kyprolis and Repatha

Amgen has started 2016 on a strong note, with two regulatory approvals for the company’s drugs Kyprolis and Repatha.

Over 80 Pharmaceutical Companies Join Forces For Antibiotics R&D

During the World Economic Forum in Switzerland last week, over 80 pharmaceutical companies pledged to devote more resources to the development of new antibiotics. What will the alliance mean for the future of antibiotic development?

New Drug May Stop Cancer-Causing Epstein-Barr Virus

A new purpose for an old drug may stop the cancer-causing Epstein-Barr virus. Cellular senescence could be the key to getting Epstein-Barr under control.

Dissolvable Brain Sensor Developed To Monitor Patients With Traumatic Brain Injury

A dissolvable brain sensor is in development to monitor patients with traumatic brain injury. Could a less invasive sensor lead to better patient outcomes?

Diabetes Drug Metformin Could Inhibit Progression of Pancreatic Cancer

The diabetes drug metformin could inhibit progression of pancreatic cancer. New research has identified the mechanism behind the drug’s inhibitory action on pancreatic tumors.

Illumina To Develop Blood Test For Early Detection Of Cancer

Sequencing giant Illumina plans to develop a blood test for early cancer detection. Could the company be developing the holy grail of oncology?

Arthritis Drug Could Prove Useful In Treating BRCA-1 Postive Ovarian Cancer

An arthritis drug could prove useful in treating BRCA1-positive ovarian cancer. Repurposing an already-approved drug could reduce regulatory hurdles.

90% Of Americans Consume An Excess Of Salt

According to the CDC, 90 percent of Americans are consuming too much salt. How much sodium is in your diet?

Research Deactivate Cancer-Causing Protein

Researchers at the University of Toronto, Canada have developed an inhibitor drug for the cancer-causing protein, Ras. What will this discovery mean for the future of cancer medicine?

Evolution Of Gut Bacteria Affected By Host Immune System

New research suggests that the evolution of beneficial bacteria in the human gut may be influenced by the immune system. The study points to the importance of personalized medicine when treating diseases of the gastrointestinal tract.

Gene Editing Mosquitos May Stop Spread Of Malaria

Thanks to research performed at the University of California, we may be one step closer to stopping the transmission of malaria by mosquito vectors.

Common Ingredient In Sunscreen May Be An Effective Antibacterial Coating For Medical Devices

A common ingredient in sunscreen could prevent medical implants from harboring antibiotic-resistant bacteria. Could a nanoparticle coating protect your medical device?

Ingestible Sensor Monitors Vital Signs

Doctors may soon be able to measure a patient’s vital signs from inside their gastrointestinal tract. Researchers at MIT have developed an ingestible sensor the size of a multivitamin capable of measuring heart and breathing rates.

Cholesterol-Lowering Vaccine May Be More Effective Treatment For High Levels Of LDL

Could you lower your cholesterol levels by getting vaccinated? New research suggests a cholesterol vaccine may be even more effective than treatment with statins.

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