Vertex, Verve team up to develop a gene editing drug for liver disease
Bio Pharma Dive
JULY 20, 2022
The deal, which is worth $60 million upfront, broadens Vertex’s reach into gene editing and expands Verve’s research beyond heart disease.
Wed.Jul 20, 2022
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Prescribing shift for Pfizer’s Paxlovid expands access but draws questions
Pharmaceutical Technology
JULY 20, 2022
A key factor of Pfizer’s Covid-19 antiviral Paxlovid efficacy has been early intervention, but getting it in time has proven to be a challenge. On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. Previously, only licensed and authorised physicians, advanced practice registered nurses, and physician assistants could prescribe the drug. .
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Roche digs deeper into gene therapy for the eye
Bio Pharma Dive
JULY 20, 2022
The Swiss drugmaker, which already owns rights to a marketed gene therapy for inherited vision loss, will work with startup Avista Therapeutics to develop better delivery tools for the complex treatments.
Gladstone and UCSF scientists discover BET protein role in Covid-19
Pharmaceutical Technology
JULY 20, 2022
Researchers at Gladstone Institutes and UC San Francisco (UCSF) have discovered in a study that bromodomain and extraterminal (BET) proteins are vital for the body to fight Covid-19 infection. . The research also found that BET proteins play two distinct roles in affecting how the SARS-CoV-2 virus interacts with human cells. . They provide the virus with a pathway into cells while aiding cells to defend themselves.
With Aduhelm sidelined, Wall Street turns to Biogen's next Alzheimer's drug
Bio Pharma Dive
JULY 20, 2022
On the company’s latest earnings call, analysts pressed for more details about the drug, called lecanemab, including its odds for approval and how that could reshape Biogen.
Healthcare doesn’t give a damn about patients
World of DTC Marketing
JULY 20, 2022
A new analysis released Wednesday by Patients for Affordable Drugs estimates that pharmaceutical companies in the U.S. have raised drug prices 1,186 times so far this year. But they’re not alone. Health insurers in individual marketplaces across 13 states and Washington D.C. will raise rates an average of 10% next year, according to a review of rate filings by the Kaiser Family Foundation.
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TSB and CR Pharma partner for Covid-19 antibody therapy in China
Pharmaceutical Technology
JULY 20, 2022
TSB Therapeutics, a joint venture (JV) majority-owned by Brii Biosciences (Brii Bio), has entered a collaboration with China Resources Pharmaceutical Commercial Group (CR Pharma) for the commercialisation of an antibody therapy, amubarvimab/romlusevimab combination, for Covid-19 in China. . Brii Bio developed the combination therapy in partnership with Tsinghua University and the 3rd People’s Hospital of Shenzhen.
Inovio to lay off 18% of staff after COVID shot struggles
Bio Pharma Dive
JULY 20, 2022
The cuts are meant to conserve cash as the biotech attempts to position its coronavirus vaccine as a potential booster.
July 20, 2022: ACTIV-6 Reaches 1 Year, Will Share Results in COVID-19 Grand Rounds
Rethinking Clinical Trials
JULY 20, 2022
In this Friday’s COVID-19 Grand Rounds, Dr. Susanna Naggie of Duke University will present “ACTIV-6: One Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone.”. ACTIV-6 is a nationwide, double-blind study evaluating the effectiveness of repurposed medications in reducing symptoms of mild to moderate COVID-19 in outpatients. The Grand Rounds session will be held on Friday, July 22, at 1:00 pm eastern.
Internet of things hiring levels in the pharmaceutical industry rose to a year-high in June 2022
Pharmaceutical Technology
JULY 20, 2022
The proportion of pharmaceutical companies hiring for internet of things related positions rose in June 2022 compared with the equivalent month last year, with 19.8% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 15.8% of companies who were hiring for internet of things related jobs a year ago and an increase compared to the figure of 19% in May 2022.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Eggs can survive decades without signs of aging. Now, scientists may know why
STAT News
JULY 20, 2022
In a high-stakes evolutionary gambit, female mammals are born with a finite supply of immature eggs. Propagating future generations depends on this reserve of pre-egg cells, or “primordial oocytes,” staying alive and out of the way of harmful, mutation-causing molecules — sometimes for decades — so they can give rise to mature eggs capable of producing healthy offspring.
U.S. death toll from drug overdoses is rising fast among Black and Indigenous people
NPR Health - Shots
JULY 20, 2022
Drug overdoses are killing more people than ever in the U.S., and a new CDC report finds growing racial disparities among those who have died — with the largest increase among Black Americans.
STAT+: Biogen agrees to pay $900 million to settle whistleblower case alleging kickbacks and sham speaking events
STAT News
JULY 20, 2022
After a decade of legal squabbling, Biogen has agreed in principle to pay $900 million to settle a lawsuit filed by a former employee who alleged the company paid kickbacks to hundreds of physicians to boost sales of its multiple sclerosis drugs. The settlement ends a long-running battle that began in 2012, when a former Biogen sales manager named Michael Bawduniak filed a whistleblower lawsuit claiming the company ran thousands of speaker and consulting programs that were not educational sessio
'Time bomb' lead pipes will be removed. But first water utilities have to find them
NPR Health - Shots
JULY 20, 2022
Health experts warn problems with these "underground poisonous straws" can strike suddenly, and states are getting cash to replace them. But no one knows how many lines exist or where they are.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
UK scientists say they have found cancer driver in junk DNA
pharmaphorum
JULY 20, 2022
It has suspected for many years that some diseases may be linked to non-coding or ‘junk’ DNA, but the mechanism behind the pathology hasn’t been worked out. Now, scientists in the UK think they have found a culprit implicated in cancer. Junk DNA is a term used to describe the 97% of the genetic sequence in human cells found between the 3% coding for our 20,000 genes, once thought to be inert.
This goat is all ears. REALLY! They may be the longest in goat history
NPR Health - Shots
JULY 20, 2022
How long are they? Reportedly an astonishing 23 inches, which might qualify the kid for a Guinness World Record. But some goat gurus say the floppy ears should be trimmed for the animal's well-being.
How does the brain decide what memories are good and bad? A new mouse study offers clues
STAT News
JULY 20, 2022
SAN DIEGO — Your first kiss. The blissful cool of ice cream. That time you smashed your finger while shutting the car door. Life is full of memories that we instinctively and instantly label as good or bad. In a new study, scientists took a key step toward unraveling how our brain assigns positive or negative emotions to our experiences. Researchers at the Salk Institute working in mice found that a signaling molecule called neurotensin profoundly shaped whether the animals associated cue
With no textbooks or antibiotics, this WWI surgeon pioneered facial reconstruction
NPR Health - Shots
JULY 20, 2022
Medical historian Lindsey Fitzharris tells the story Dr. Harold Gillies, a military surgeon who spent WWI reconstructing the faces of soldiers and sailors who'd suffered horrific facial injuries. (Image credit: Sgt Adrian C.
The New Age of Decentralized Clinical Trials
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Opinion: STAT+: 10 tips for vendors seeking to create or expand digital health and virtual health solutions
STAT News
JULY 20, 2022
Virtual and digital care expanded dramatically during the pandemic as patients, providers, employers, and regulators sought to limit the risk of contracting Covid-19 during hospital and medical visits. Even so, digital health care and virtual health still account for under 2% of all medical expenses, so there is plenty of opportunity for growth. Patient acceptance, provider shortages, and improved technologies will further increase the attractiveness of virtual and digital care going forward.
Construction Underway on BioVectra’s mRNA Biomanufacturing Facility
XTalks
JULY 20, 2022
Construction is well underway on BioVectra’s new mRNA biomanufacturing facility in Charlottetown, Prince Edward Island (PEI) in Canada. The Canadian pharma and biotech contract development and manufacturing organization (CDMO) with global services had announced plans for the $79.6 million state-of-the-art mRNA vaccine and biomanufacturing facility, making it one of the first in the country.
At a 988 call center, volunteers embrace a new number while providing familiar hope
STAT News
JULY 20, 2022
FRAMINGHAM, Mass. — Don smiled when he saw who was calling. He usually works the overnight shift at a suicide hotline call center outside Boston, so he knew she’d be surprised to hear his voice on a Saturday afternoon. When he said hello, the caller answered the mandatory first question before he could even ask it: No, she wasn’t feeling suicidal today.
What is Quark Cheese and Why is it Rare to Find in the US?
XTalks
JULY 20, 2022
Quark cheese is a high-protein, low-fat alternative to soft cheese and yogurt that can be used for baking, cooking and blending. Quark, the white cow’s milk cheese, is like smooth cottage cheese, equally reminiscent of yogurt and has a mild, but versatile flavor. If the menu calls for sweet or savory, hot or cold, quark cheese works well in place of almost any dairy.
Roles and Responsibilities of Specialized Clinical Supply Experts
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
As diabetes during pregnancy grows more common, experts point to a need for preventive care
STAT News
JULY 20, 2022
Gestational diabetes is on the rise, climbing 30% between 2016 and 2020, according to a new study published Tuesday by the Centers for Disease Control and Prevention. “There is a growing maternal health crisis in the United States, and gestational diabetes is an important and common complication that requires new focus,” said Sadiya Khan, an assistant professor of medicine and preventive medicine at the Northwestern University Feinberg School of Medicine, who was not involved in th
Collaboration Aims to Address Clinical Trial Patient Diversity Shortcomings
ACRP blog
JULY 20, 2022
Addressing “clinical trial diversity is an issue of fairness and the first step in achieving health equity,” Dr. Valerie Montgomery Rice, MD, FACOG, president and CEO of the Morehouse School of Medicine (MSM), told attendees at a July 19 press event announcing a new collaboration aimed at fostering greater participation in clinical trials among more diverse populations of volunteers.
Opinion: Safe surrender of newborns is just the beginning of post-Roe journeys
STAT News
JULY 20, 2022
With abortion now restricted or even penalized in nearly half of U.S. states, there’s likely to be an increase in the number of mothers using safe haven laws to anonymously relinquish their newborn babies. Parents who choose this option bring their newborn baby to a safe location, typically an emergency room or fire station, and state their intention to “surrender” their baby to personnel at the location.
Introducing a protocol for using robotic pets in memory care
Scienmag
JULY 20, 2022
You might think it was a typical therapy session at a long-term care facility. In a quiet room, a therapist sets down a pet carrier, brings out a cat, and sets it on a resident’s lap. As the resident gently strokes the cat’s fur, it purrs, and the therapist asks the resident questions about their […].
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
STAT+: Medicare offers financial perks for rural hospitals that convert to its new provider type. Will they bite?
STAT News
JULY 20, 2022
The federal government is hashing out the details on a new type of rural hospital, and new developments suggest regulators want to make it an attractive option. So-called Rural Emergency Hospitals (REH) will run emergency rooms, but won’t offer inpatient care. On top of bumped-up Medicare reimbursement, they’ll get facility payments north of $3 million annually, which is nothing to sneeze at for small hospitals.
New discovery in cancer progression paves way to combat cancer
Scienmag
JULY 20, 2022
Scientists from A*STAR’s Institute of Molecular and Cell Biology (IMCB) and Genome Institute of Singapore (GIS), as well as the NUS Cancer Science Institute of Singapore (CSI Singapore), National Cancer Centre Singapore (NCCS) and Nanyang Technological University (NTU), have identified an important cancer progression mechanism that is observed in 90 per cent of cancer cells. […].
STAT+: Pharmalittle: Pharma and advocacy groups differ on vaccine equity; EC says Illumina-Grail deal breached merger rules
STAT News
JULY 20, 2022
Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation, especially since it appears there may be a benefit in doing so.
Improving serious illness communication for patients with advanced cancer
Scienmag
JULY 20, 2022
LEBANON, NH – Patients with advanced cancer want and need to partner with their care team to make treatment decisions that reflect their own values and align with what matters most. “Serious illness conversations” include two equally important parts: clinicians sharing information on prognosis and treatment options, and patients and their loved ones sharing their […].
Accelerating Clinical Supply Through Integrated Drug Development
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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