Walking at Faster Speeds Could Significantly Reduce Type 2 Diabetes Risk
Drug Topics
NOVEMBER 29, 2023
A new systematic review and meta-analysis found that the risk of type 2 diabetes decreased significantly at walking speeds of 4 km/h or above.
Wed.Nov 29, 2023
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FDA Grants 510(k) Clearance for CARE Oral Appliances to Treat Adults with Severe OSA
Pharmacy Times
NOVEMBER 29, 2023
This FDA clearance comes about 11 months after another clearance for appliances to treat mild-to-moderate obstructive sleep apnea (OSA)—the first clearance for oral appliances to treat OSA with supplemental therapies.
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FDA: Roflumilast Cream sNDA Accepted for Atopic Dermatitis
Drug Topics
NOVEMBER 29, 2023
The treatment from Arcutis Biotherapeutics has a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2024.
STAT+: Colon cancer prevention paradox: Higher-risk patients pay more for colonoscopy
STAT
NOVEMBER 29, 2023
Ashley Conway-Anderson was prepared for a lot of things when it came to her first colonoscopy. She sought out tips to make the daylong prep more bearable. She braced herself mentally for what the doctors would find; her mother, after all, was just a couple years out of recovery from colorectal cancer. When she awoke from the procedure, she said, things seemed relatively fine.
Position Your Pharmacy for Expansion
Speaker: Chris Antypas and Josh Halladay
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
2022-2023 Influenza Season Classified as High Severity by CDC
Drug Topics
NOVEMBER 29, 2023
This season marks the fourth to be classified as high severity since the 2009 influenza A(H1N1) pandemic.
With latest tranche, U.K. Biobank has genome sequences from 500,000 people available for research
STAT
NOVEMBER 29, 2023
LONDON — Data from half a million people’s whole genome sequences are now available to researchers worldwide, as the U.K. Biobank on Thursday debuted the latest addition to what it aims to be the world’s most comprehensive health data resource. The Biobank has been building its collection over 20 years, with 500,000 volunteers recruited to provide survey responses about their health, medical records, tests of molecular markers, and imaging scans.
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STAT+: UnitedHealth Group now employs or is affiliated with 10% of all physicians in the U.S.
STAT
NOVEMBER 29, 2023
UnitedHealth Group has about 90,000 employed or affiliated doctors, approximately 10% of all physicians in the U.S. The number — disclosed Wednesday at the company’s investor day by Amar Desai, the CEO of UnitedHealth’s Optum Health division — means the company acquired or hired 20,000 doctors in the past year alone. The rapid growth of UnitedHealth’s physician base underscores how the company, which already is the country’s largest private health insure
Pharmacy Focus: Conversations On Reproductive Health - Episode 2
Pharmacy Times
NOVEMBER 29, 2023
In this episode, we spoke with Dr. Christina Madison, founder and CEO of The Public Health Pharmacist, about why abortion access and reproductive care are public health issues.
Opinion: Neuroscience has to grapple with a long legacy of racism if it wants to move into the future
STAT
NOVEMBER 29, 2023
Many parts of neuroscience research have a race problem. Black people are often excluded from studies due to the texture of their hair , receive erroneous and inaccurate readings due to the melanin content of their skin , and are severely underrepresented in neuroimaging datasets. Now neurotechnology is undergoing a moment of tremendous change, as Elon Musk’s Neuralink has obtained independent review board approval to conduct its first human trials for the R1 robot and N1 brain implant.
Amgen expands pact with Amazon to usher drug manufacturing into the AI era
Fierce Pharma
NOVEMBER 29, 2023
Seeking to identify ways to improve the discovery and production of medicines, Amgen is expanding its partnership with tech giant Amazon. | Amgen is growing its decade-old collaboration with Amazon Web Services—a widely used cloud platform—to create generative artificial intelligence that the companies aim to use to increase the manufacturing throughput of pharmaceuticals.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Melanoma LIMS, Algorithmic-Based Classification Achieves Specificity, Precision in Skin Cancer Diagnosis
Pharmacy Times
NOVEMBER 29, 2023
The study authors are encouraged by the findings, noting that LIMS with algorithmic-based classification can aid in early and accurate diagnosis of skin cancer, improving patient prognosis.
STAT+: Cigna, Humana in talks to merge into health insurance giant, per report
STAT
NOVEMBER 29, 2023
Cigna and Humana are in discussions to merge, a potential move that would create a health insurance and prescription drug benefits titan with approximately $300 billion of annual revenue. A proposed transaction would almost certainly prompt a close review from antitrust enforcers at the Department of Justice and the Federal Trade Commission. A merged Cigna-Humana would further consolidate the market for pharmacy benefit managers.
Case study: The pinnacle of person-centred care in hospital pharmacy
Hospital Pharmacy Europe
NOVEMBER 29, 2023
In November 2022, London North West University Healthcare NHS Trust embarked on a person-centred care pilot that has changed the face of their pharmacy practice for the better. Helena Beer speaks to four of the key players about how they went about the ground-breaking project, the impact it’s having on patients, staff and the wider healthcare community, and their top tips for success.
Gene Therapy in Hemophilia A: Safety, Efficacy, and the Changing Landscape
Pharmacy Times
NOVEMBER 29, 2023
Atta Chowdhry, RPh, and Robert Sidonio Jr, MD, MSc, discuss the safety and efficacy of gene therapy for hemophilia A, highlighting recent approvals, with insights into adverse effects, immunosuppression, and the evolving treatment landscape.
5 Reasons to Upgrade Your Pharmacy Management Software
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Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.
Texas abortion case puts doctors’ agency in treating pregnancy complications in the spotlight
STAT
NOVEMBER 29, 2023
The Texas Supreme Court on Tuesday heard a case that could end up deciding whether abortion in the state should be protected under its constitution when it’s provided for medical reasons. Also at stake is the issue of how much agency doctors have to exercise their medical judgment in the treatment of the most complicated pregnancies — a power that the case’s plaintiffs claim has been lost under Texas’s current abortion laws.
WSJ: Cigna, Humana exploring insurance mega-merger
Fierce Healthcare
NOVEMBER 29, 2023
A health insurance megamerger is reportedly brewing. | The Wall Street Journal, citing people familiar with the matter, reported on Wednesday that payer giants Cigna and Humana are exploring a combination that could shake up the power dynamics of the industry.
STAT+: FDA chief scientist to replace Woodcock
STAT
NOVEMBER 29, 2023
WASHINGTON — The Food and Drug Administration’s chief scientist will replace retiring Janet Woodcock as principal deputy commissioner of the agency next year, the FDA commissioner announced Wednesday. Namandjé N. Bumpus was named chief scientist in June of last year. The chief scientist works closely with the FDA’s product centers, and Bumpus played a big role in the expansion of the agency’s regulation of cosmetics.
ACOs not shown to improve mental health outcomes: study
Fierce Healthcare
NOVEMBER 29, 2023
Accountable care organizations do not positively influence treatment and outcomes for chronic mental health conditions for Medicare patients, according to a study in Health Affairs. | A new study pours water on the belief that ACOs are well-suited to handle chronic mental health conditions its patients experience.
STAT+: Blood cancers may arise from CAR-T cells, but experts think only in very rare cases
STAT
NOVEMBER 29, 2023
The announcement on Tuesday that the Food and Drug Administration was investigating whether CAR-T immunotherapy had itself caused blood cancers initially appeared to be a significant blow to one of the brightest spots in cancer care. But experts quickly cautioned that risk of this complication is probably minuscule compared to the known risk of secondary cancers from other cancer therapies like chemotherapy and radiation.
Mayo Clinic unveils $5B, 6-year renovation of its flagship Rochester campus
Fierce Healthcare
NOVEMBER 29, 2023
This week Mayo Clinic pulled back the curtain on a $5 billion, six-year plan to overhaul its flagship campus located in downtown Rochester, Minnesota. | The nonprofit will add five new buildings spanning 2.4 million square feet, two of which will be clinical facilities with designs intended to support continuous, tech-enabled care.
Are Predetermined Change Control Plans on the road to Global Harmonization?
The FDA Law Blog
NOVEMBER 29, 2023
By Lisa M. Baumhardt, Senior Medical Device Regulation Expert — In October 2021, FDA and MHRA (United Kingdom’s Medicines and Healthcare products Regulatory Agency) jointly developed 10 guiding principles for the development of Good Machine Learning Practice (GMLP) with the goal of promoting “safe, effective, and high-quality medical devices” that are based on Artificial Intelligence/Machine Learning (AI/ML) technologies.
As FDA probes CAR-T safety, expert meeting for Bristol's Abecma could serve as key guidepost
Fierce Pharma
NOVEMBER 29, 2023
The revelation of an FDA investigation< | As industry watchers deliberate the implications from the FDA's investigation into secondary cancer risks from CAR-T medicines, an upcoming expert meeting could offer precious clarity from drug regulators.
CSL, Arcturus get first approval for self-assembling RNA jab
pharmaphorum
NOVEMBER 29, 2023
Japan’s medicines regulator has approved the first vaccine based on self-assembling RNA, a spin on the mRNA technology used in current shots, which is designed to deliver greater efficacy with a lower dose.
How long does it take for MiraLAX to work?
The Checkup by Singlecare
NOVEMBER 29, 2023
If it’s been days since you’ve been able to go, you may visit your pharmacy looking for an over-the-counter (OTC) treatment to help move things along. One common OTC option is MiraLAX , an osmotic laxative used to treat occasional constipation. It works by drawing water into the colon, which softens the stool and makes it easier to pass, while also increasing the colon’s contents to trigger a bowel movement.
FDA Investigating Risk of Secondary Cancers in Patients Administered CAR T-Cell Therapy
PharmExec
NOVEMBER 29, 2023
The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies.
FIP report: Pharmacy-based point-of-care testing is expanding worldwide, but challenges remain
Drug Store News
NOVEMBER 29, 2023
The report highlights obstacles to pharmacy POCT, such as lack of reimbursement, inadequate collaborative practice models, legislative barriers and more.
Opinion: Listen: What we take for granted after 30 years of Prozac
STAT
NOVEMBER 29, 2023
When Prozac first entered the psychiatry scene in in the late ’80s, the profession was still Freud’s territory. Many considered taking medication to treat depression a failure. But that was all about to change, as early stewards like psychiatrist Peter Kramer refused to shy away from the new drug’s potential. These days, he says that people take for granted all of the progress that’s been made with antidepressant treatment in the past three decades.
The beauty of purpose
Drug Store News
NOVEMBER 29, 2023
Being a purposeful brand can mean anything from donating profits from one SKU, reworking packaging to be more sustainable or creating campaigns to address mental health.
AbbVie cues up filing for c-Met ADC in lung cancer
pharmaphorum
NOVEMBER 29, 2023
AbbVie is preparing to file for accelerated approval of telisotuzumab vedotin (Teliso-V) as a treatment for some patients with lung cancer after the drug hit the mark in a pivotal phase 2 trial.
Missouri nonprofit systems BJC HealthCare, Saint Luke's $10B merger will close Jan. 1
Fierce Healthcare
NOVEMBER 29, 2023
BJC HealthCare of St. | The cross-market deal has satisfied "all regulatory reviews" and will yield an integrated, academic nonprofit system comprised of 28 hospitals, according to a Wednesday announcement of the organizations' definitive agreement.
U.S. life expectancy rose in 2022, but it remains below its pre-pandemic level
STAT
NOVEMBER 29, 2023
NEW YORK — U.S. life expectancy rose last year — by more than a year — but still isn’t close to what it was before the Covid-19 pandemic. The 2022 rise was mainly due to the waning pandemic, Centers for Disease Control and Prevention researchers said Wednesday. But even with the large increase, U.S. life expectancy is only back to 77 years, 6 months — about what it was two decades ago.
FDA kicks off review of Karuna’s schizophrenia drug KarXT
pharmaphorum
NOVEMBER 29, 2023
Karuna Therapeutics said this morning that the FDA has formally started its review of KarXT, aiming to become the first drug to reach the market for schizophrenia with a new mechanism of action in decades.
STAT+: Saudi VC loops Novo Nordisk, other biotech VCs into new longevity incubator
STAT
NOVEMBER 29, 2023
The Hevolution Foundation, a Saudi investment firm focused on aging science, said Wednesday that it is launching an incubator that will bring together experts from the scientific community, pharma, and multiple biotech VCs. The incubator, called the Breakthrough Innovation Alliance, will give up to $1 million apiece to 10 different research initiatives over the next three years, allowing scientists and entrepreneurs to run preclinical research to determine whether the ideas hold any promise.
Ferring reveals long-term data for cancer gene therapy
European Pharmaceutical Review
NOVEMBER 29, 2023
Following the US Food and Drug Administration (FDA)’s approval of Ferring Pharmaceuticals’ gene therapy Adstiladrin ® (nadofaragene firadenovec-vncg) in December 2022, new long-term follow up data has been revealed. Adstiladrin is the first FDA-approved intravesical gene therapy to be authorised for adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
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