Pharmaceutical Technology
JULY 15, 2022
Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. In a budget change proposed in February and confirmed in May , California’s Department of Health Care Access and Information (HCAI) requested a one-time investment of $100 million for Newsom’s CalRx Biosimilar Insulin initiative.
Bio Pharma Dive
JULY 15, 2022
In exchange for $500 million, the fund, called OMERS, will get a 30% royalty on future sales of Ultragenyx’s drug Crysvita in the U.S. and Canada, where it’s approved to treat two rare conditions.
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Pharmaceutical Technology
JULY 15, 2022
Despite entering its fourth decade of availability, in vitro fertilization (IVF), a medical technique used to facilitate the conception of a baby for those facing fertility problems, remains an elusive dream for many. Artificial intelligence (AI) could change this, with many researchers looking to harness the technology to increase IVF’s reliability, affordability, and availability.
Bio Pharma Dive
JULY 15, 2022
The regulator said there have been “a few” spontaneous severe allergic reactions following administration of the vaccine, which was this week authorized in the U.S.
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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
Pharmaceutical Technology
JULY 15, 2022
Health Canada has granted approval for the usage of Moderna’s messenger RNA (mRNA) Covid-19 vaccine, Spikevax, in a 25µg two-dose regimen for active immunisation to prevent Covid-19 in children aged six months to five years. So far, children aged below five years were not eligible to receive the Covid-19 vaccine in Canada. The two-dose initial vaccine regimen in children of this age group is completed in one month, which is the same dosing schedule in adults, adolescents and children aged above
World of DTC Marketing
JULY 15, 2022
To address the “retention” problem, pharma companies are paying employees exorbitant salaries. The problem with that system is that people do whatever they need to to “hold onto” their high-paying jobs and become employees who are content not to excel. This is NOT what pharma needs. Last week I briefly chatted with someone in the industry evaluating another job offer.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 15, 2022
The Brazilian Health Regulatory Agency (Anvisa) has granted emergency use authorization for Sinovac Biotech’s Covid-19 vaccine, CoronaVac, in children aged three to five years. Subjects in this age group can receive the same vaccine dosage authorised in patients aged six to 17 years, as well as adults. Furthermore, there exists no restriction on vaccine usage in immunosuppressed children aged three to five years.
Bio Pharma Dive
JULY 15, 2022
The initiative aims to address inflationary pressures and prevent worse health outcomes down the line, CEO Andrew Witty told investors Friday.
Pharmaceutical Technology
JULY 15, 2022
The UK National Institute for Health and Care Excellence (NICE) has recommended Novartis Pharmaceuticals UK’s Piqray (alpelisib) along with hormonal therapy fulvestrant to treat hormone receptor+, HER2-, PIK3CA-mutated locally advanced or metastatic breast cancer. In the final draft guidance, NICE noted that the combination treatment is intended for such patients with tumour growth following the usage of combined hormonal therapy and a cancer growth inhibitor.
NPR Health - Shots
JULY 15, 2022
Mental health advocates hope the new hotline will make it much easier to get support if you're in crisis or helping someone who is. Here's how it works and what could stand in its way.
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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
BioPharma Reporter
JULY 15, 2022
Amazon is partnering with the Fred Hutchinson Cancer Research Center on a Phase I trial for a cancer vaccine targeting metastatic melanoma and breast cancer.
STAT News
JULY 15, 2022
New York City’s Health Department announced Friday it will speed up the delivery of first doses of monkeypox vaccine to people in the city at high risk of contracting the disease. The move, it warned, may delay the city’s ability to dole out second doses to those who’ve been vaccinated — which would run counter to advice from the Food and Drug Administration and the Centers for Disease Control and Prevention.
NPR Health - Shots
JULY 15, 2022
Nearly 5,000 NPR readers told us how they dealt with COVID on a trip. Did they respect the CDC guidance to wait 10 days before flying? Or did they travel anyway? What lessons do they have to share?
STAT News
JULY 15, 2022
Next year, UnitedHealthcare will offer employer health plans that have no copays or out-of-pocket costs for five vital drugs — insulin, epinephrine, glucagon, naloxone, and albuterol — but those discounts will only be a guaranteed for less than a quarter of UnitedHealthcare’s membership for now. The news of the plans comes right as UnitedHealthcare’s parent company, UnitedHealth Group, reported revenue and profits in the second quarter that blew away Wall Streetȁ
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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.
pharmaphorum
JULY 15, 2022
Pfizer’s tyrosine kinase inhibitor Xalkori has picked up a fourth approval from the FDA, adding a new use in the treatment of a rare form of benign tumour that typically affects children and young adults. Xalkori (crizotinib) has been cleared for inflammatory myofibroblastic tumours (IMT), which appear in organs like the lung, stomach, bladder or liver.
STAT News
JULY 15, 2022
WASHINGTON – GenBioPro, which sells the generic version of the abortion pill mifepristone, hired its own team of lobbyists for the first time this summer, according to new federal disclosures. GenBioPro has hired two lobbyists from the firm Emergent Strategies to advocate on “Issues related to medication abortion … abortion access [and] FDA Approval of Mifepristone,” its filing states.
pharmaphorum
JULY 15, 2022
Akili looks like it could bring another digital therapeutic (DTx) to market after a clinical trial backed the efficacy of its AKL-T01 in patients with the autoimmune disorder systemic lupus erythematosus (SLE). The PureTech group company – which scored the first FDA and EMA approvals for a DTx for attention-deficit hyperactivity disorder (ADHD) – is developing AKL-T01 to tackle cognitive impairments that can affect people with SLE.
STAT News
JULY 15, 2022
Andy couldn’t sleep more than a couple fitful hours a night because it felt like a hot fork was stabbing him in the butt. He had excruciating internal and external lesions around his anus. It was the weekend: his doctor wasn’t available, an emergency department provider told him he might have anal cancer, and an urgent care provider sent him home with Tylenol and no diagnosis.
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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.
pharmaphorum
JULY 15, 2022
In the final piece of a three-part series, Ben Hargreaves explores how manufacturing infrastructure was rapidly built up to the required capacity to ensure sufficient supply of COVID-19 vaccines, and what still remains to be done to improve vaccine equity globally. During the early stages of the current pandemic, much of the focus was taken by the possibility of developing a successful vaccine and around the R&D efforts required to achieve this.
STAT News
JULY 15, 2022
The problems started early on. The young girl from a Denver suburb — identified in a recent lawsuit only as “I.” — had problems interacting with the kids at school. She got bullied. The oldest of three children, it wasn’t uncommon for I. to fly into a rage once she got home, explaining in graphic detail how she’d kill herself or her siblings.
NPR Health - Shots
JULY 15, 2022
A report from WHO and UNICEF states that last year, 25 million children missed out on one or more "lifesaving vaccines" — for diseases like tuberculosis, diphtheria, tetanus, polio and yellow fever.
STAT News
JULY 15, 2022
During surges of Covid-19, providing hospital-level care in the home was a good alternative to receiving care in hospitals strained by historic staffing shortages and populated by people infected with SARS-CoV-2, the virus that causes the disease. Rather than fading away with the pandemic, this form of care needs to be seen as an integral part of health care in the United States.
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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.
pharmaphorum
JULY 15, 2022
Health technology assessment (HTA) agency NICE has finalised its guidance on Amarin’s Vazkepa, clearing the path for GPs to start prescribing the drug in up to 425,000 NHS patients at high cardiovascular risk because of raised triglyceride levels. The just-published final technology appraisal document recommends that Vazkepa (icosapent ethyl) can be prescribed to people in England and Wales for adult patients with high-risk cardiovascular disease and elevated levels of triglycerides (1.7 m
STAT News
JULY 15, 2022
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.
Pharma Times
JULY 15, 2022
Data from APHINITY study shows Roche’s Perjeta-based regimen reduces the risk of disease returning for people with HER2-positive early breast cancer
STAT News
JULY 15, 2022
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, quite modest. We plan to catch up on our reading, take a few naps, and hang with Mrs. Pharmalot. Perhaps a listening party is in order. And what about you? This is, of course, a delightful time to enjoy the great outdoors — drives in the country, blankets on the beach, or long walks in the park all come to
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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.
Scienmag
JULY 15, 2022
Raman spectroscopy, an optical microscopy technique, is a non-destructive chemical analysis technique that provides rich molecular fingerprint information about chemical structure, phase, crystallinity, and molecular interactions. The technique relies on the interaction of light with chemical bonds within a material. However, since light is a wave, optical microscopes are unable to resolve distances less than […].
Drug Channels
JULY 15, 2022
Today’s guest post comes from Carolyn Zele, Senior Manager of Solution Enablement at MMIT. Carolyn explains the advantages of alternative payment models (APM) for measuring and rewarding value and outcomes in our healthcare system. For more on how APMs measure value, click here to learn about MMIT’s Pulse Analytics Solution. Read on for Carolyn’s insights.
Scienmag
JULY 15, 2022
After the Centers for Disease Control and Prevention released a guideline for prescribing opioids to patients experiencing chronic pain in 2016, the prescribing rate of non-opioid pain medication increased each year above and beyond what would be expected based on the preexisting trends, a new study finds. The 2016 guideline aimed to help U.S. clinicians […].
NPR Health - Shots
JULY 15, 2022
NPR's Ari Shapiro speaks with CDC Director Rochelle Walensky about the monkeypox outbreak in the United States and the steps the federal government is taking to manage it.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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