Specialty Pharmacist Transforms HIV Care Outside of the Pharmacy
Drug Topics
NOVEMBER 14, 2024
Cassandra Esperant, PharmD, AAHIVP, discussed the ups and downs of her career journey as a clinical HIV pharmacist.
Thu.Nov 14, 2024
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Measles cases rose 20% worldwide in 2023, per new report
STAT
NOVEMBER 14, 2024
Measles vaccination coverage globally has still not recovered to pre-Covid levels, a fact that contributed to a 20% increase in measles cases in 2023 over the previous year, according to a new report from the World Health Organization and the Centers for Disease Control and Prevention that was released Thursday. The pandemic backsliding is hindering efforts to eliminate measles globally, and subjecting children — generally children under the age of 5 — to a health threat that can b
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FDA Approves Eladocagene Exuparvovec-Tneq for Treatment of AADC Deficiency
Pharmacy Times
NOVEMBER 14, 2024
Eladocagene exuparvovec-tneq is the first FDA-approved gene therapy for with aromatic L-amino acid decarboxylase deficiency.
Facing a dialogue with RFK Jr., a top FDA official mounts a public defense of vaccines
STAT
NOVEMBER 14, 2024
WASHINGTON — Peter Marks wants to keep his job. A top Food and Drug Administration official, Marks arrived Wednesday at the five-star hotel where the Milken Institute was hosting its Future of Health Summit via bicycle, having flown back to D.C. from Boston, where he spoke earlier in the day. In a black suit jacket and moccasins, he looked slightly nervous on a six-person panel.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Amazon One Medical rolls out telehealth treatment services in competition with Ro, Hims & Hers
Fierce Healthcare
NOVEMBER 14, 2024
Amazon One Medical is rolling out a new service to provide Prime members access to clinical treatments for common health and lifestyle conditions like men's hair loss and anti-aging skin care. | Amazon One Medical is rolling out a new service to provide Prime members access to clinical treatments for common health and lifestyle conditions like men's hair loss and anti-aging skin care.
STAT+: Vertex’s upcoming sciatica trial readout is a high-stakes moment in its quest to quell pain
STAT
NOVEMBER 14, 2024
After turning cystic fibrosis from a death sentence into a manageable condition for many patients, Vertex Pharmaceuticals is now looking to transform the treatment of pain, and a pivotal point in this quest is fast approaching. The Boston biotech plans to announce results by the end of the year from a mid-stage trial of an experimental treatment for patients with lumbosacral radiculopathy, or LSR, more commonly known as sciatica.
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STAT+: Neurogene and the race to the bottom of gene therapy
STAT
NOVEMBER 14, 2024
This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. Call me cranky or old-fashioned, but I believe companies developing genetic medicines for even the rarest and most severe diseases should be conducting randomized, placebo-controlled clinical trials.
How the Inflation Reduction Act Will Impact Pharmacy Reimbursement | ASPL 2024
Drug Topics
NOVEMBER 14, 2024
Pharmacy experts from AON Pharmacy in Florida discussed the Inflation Reduction Act and how it affects reimbursement for Medicare Part D drugs.
PTC wins FDA approval for first brain-delivered gene therapy Kebilidi
Fierce Pharma
NOVEMBER 14, 2024
The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.
Community Pharmacists Play Key Role in Diabetes Prevention, Management
Drug Topics
NOVEMBER 14, 2024
Jennifer Goldman, PharmD, CDCES, BC-ADM, FCCP, discusses how pharmacists can help with diabetes prevention and early detection in the community.
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.
In boost to GSK's £3B plan for Blenrep, myeloma ADC shows survival edge over J&J's Darzalex
Fierce Pharma
NOVEMBER 14, 2024
GSK’s 3 billion pounds sterling peak sales goal for its multiple myeloma drug Blenrep appears increasingly attainable thanks to a key patient survival win.
STAT+: Changing course, European regulators now say Alzheimer’s treatment Leqembi should be approved
STAT
NOVEMBER 14, 2024
LONDON — Reversing an earlier decision, European regulators on Thursday recommended that an Alzheimer’s therapy from Eisai and Biogen should be approved, saying that the benefits of the treatment outweigh the risks in a select group of patients. A European Medicines Agency committee had said in July that the medicine, called Leqembi, should be rejected, citing the modest benefits seen in trials and the potentially dangerous side effects that accompany the drug.
Citing 'capacity constraints,' Novo Nordisk plots global wind-down of human insulin pen production
Fierce Pharma
NOVEMBER 14, 2024
As sales of Novo Nordisk’s GLP-1 drugs for diabetes and obesity continue to soar, the Danish drugmaker is once again adjusting its insulin production priorities. | Citing 'capacity constraints,' Novo Nordisk plans to transition its human insulin—which is currently sold in pens and vials—to vials only. The decision is playing a part in a broader discussion around equitable access to diabetes treatments in less-wealthy countries.
STAT+: FDA scolds Merz over ‘misleading’ Instagram posts featuring interior designer Nate Berkus
STAT
NOVEMBER 14, 2024
The Food and Drug Administration has scolded Merz Pharmaceutical for making misleading claims on Instagram about the safety and effectiveness of an injectable treatment for smoothing facial lines, the fifth time this year the agency has taken a pharmaceutical company to task for its marketing. The regulator criticized Merz for a few reasons concerning Xeomin, which is promoted as an alternative to Botox for combating wrinkle and frown lines.
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.
Allergic Diseases Potentially Increase Risk of Select Mental Health Conditions
Pharmacy Times
NOVEMBER 14, 2024
The strongest association is found between asthma and the risk of attention deficit/hyperactivity disorder, though these links do not equate to causality.
Opinion: Tech and social media bans alone cannot fix teen mental health
STAT
NOVEMBER 14, 2024
You’re probably not worried about the role that Strava is playing in the teen mental health crisis. But you should be. Strava seems extremely benign — especially compared to an app like Instagram or TikTok. It simply “lets you track your running and riding with GPS, join Challenges, share photos from your activities, and follow friends,” in the company’s own words.
BioNTech signs agreement to acquire Biotheus
Pharmaceutical Technology
NOVEMBER 14, 2024
BioNTech has signed a definitive agreement to acquire Biotheus to obtain complete worldwide rights to BNT327/PM8002, a programmed death-ligand 1 and vascular endothelial growth factor A-targeting bispecific antibody.
Opinion: How chaplains can help the fractured U.S. health care system
STAT
NOVEMBER 14, 2024
As a medical intern in the late 1980s, I’d occasionally see priests and rabbis on hospital wards, but we basically ignored one another. When we doctors walked into a patient’s room, they’d quickly leave, and when we exited, they’d enter. They seemed to operate in a wholly different realm. After all, we were scientific.
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.
Pharmacist-Led CGM Workflow Could Help Improve Diabetes Outcomes
Drug Topics
NOVEMBER 14, 2024
A study found that a continuous glucose monitor workflow led by a pharmacist led to reduced HbA1c levels.
STAT+: Merck licenses Chinese cancer drug, searching for next Keytruda blockbuster
STAT
NOVEMBER 14, 2024
In a move to safeguard the company’s dominant position in cancer, Merck said Thursday it will license a new cancer drug from LaNova Medicines, a Shanghai-based firm, for $588 million upfront and as much as $2.7 billion in potential milestone payments. The cancer immunotherapy Keytruda, Merck’s most important product and the best-selling drug in the world with $23 billion in annual sales, is set to lose patent protection and face competition from generic drugmakers as early as 2028,
MSD joins PD-1/VEGF push in cancer with LaNova deal
pharmaphorum
NOVEMBER 14, 2024
There has been a lot of talk about drugs targeting both PD-1 and VEGF stealing the crown held by MSD's Keytruda in cancer immunotherapy. Now, the company has made a move to try to make sure it isn't left behind. Its solution is a licensing deal with Chinese biotech LaNova Medicines for LM-299, which consists of an anti-VEGF antibody joined to the functional parts of a pair of anti-PD-1 antibodies.
Amgen defends obesity drug amid bone concerns
STAT
NOVEMBER 14, 2024
This story first appeared in The Readout newsletter. Sign up for The Readout and receive STAT’s award-winning biotech news delivered straight to your inbox. Good morning, my dear subscribers. This is my last Readout newsletter — just kidding! It’s just my last Readout for the next few weeks. I’m going off on a three-week vacation and so you won’t see my name here for a while.
EMA changes tack, endorses Eisai and Biogen's Leqembi in restricted Alzheimer's population
Fierce Pharma
NOVEMBER 14, 2024
Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | Upon reexamination, the EMA has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. But the recommendation for approval has a restriction.
STAT+: Mild Alzheimer’s patients won’t save Cassava Sciences
STAT
NOVEMBER 14, 2024
This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. As we count down toward the December readout of Cassava Sciences’ simufilam Phase 3 clinical trial in Alzheimer’s disease, it’s a good time to correct one of the more egregious misconceptions regarding the handling of patient subgroup data that has been floating persistently around the internet.
GLP-1 Receptor Agonists Show Promise in Treating Obesity-Related Heart Failure
Pharmacy Times
NOVEMBER 14, 2024
These therapies represent an encouraging advancement in cardiovascular care.
GSK hails survival data with revived myeloma drug Blenrep
pharmaphorum
NOVEMBER 14, 2024
GSK's multiple myeloma therapy Blenrep's increase in overall survival in the DREAMM-7 trial has achieved statistical significance
FDA Adds Delayed Gastric Emptying as Adverse Event on Semaglutide Label
Pharmacy Times
NOVEMBER 14, 2024
The label includes postmarking reports showing rare instances of pulmonary aspiration for patients undergoing procedures that require general anesthesia or deep sedation.
Threats to children from anti-vax views, Plan B with higher BMI, a dim view of tech bans for teen mental health
STAT
NOVEMBER 14, 2024
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Good morning. I’m back on the newsletter beat today while Theresa’s on holiday, but I’m off to Chicago soon to cover the American Heart Association’s scientific sessions. Ping me if you’ll be following the conference, too.
Syncona aims Slingshot at biotech's 'translational gap'
pharmaphorum
NOVEMBER 14, 2024
Syncona launches Slingshot Therapeutics with a mission to find promising projects in academia and translate them into development projects.
STAT+: Pharmalittle: We’re reading about a Merck deal, GSK cancer drug data, and more
STAT
NOVEMBER 14, 2024
Rise and shine, everyone, another busy day is on the way. We can tell by the sound of the motor vehicles passing by our window and the furious panting of the official mascots as they forage for breakfast on the campus grounds. Even Mrs. Pharmalot is up and about earlier than usual thanks to her own hectic agenda. As for us, we are engaged in the usual ritual of brewing cups of stimulation.
Metsera gets $215m for obesity trials, and other financings
pharmaphorum
NOVEMBER 14, 2024
If any further evidence were needed for the insatiable investor appetite for companies with obesity assets, look no further than New York startup Metsera.After emerging from stealth with a $290 million first round in April, the biotech has added another $215 million to its coffers via a Series B led by Wellington Management and Venrock Healthcare Capital Partners, taking the total raised by the company over $500 million in just seven months.
Evaluating the Safety of Tetracycline Use During the First Trimester of Pregnancy
Drug Topics
NOVEMBER 14, 2024
As “therapeutic orphans,” pregnant women and their health care providers must balance the benefits of treatment with the risk of fetal harm.
Overcoming nonspecific binding challenges in pharmacokinetic assays
Outsourcing Pharma
NOVEMBER 14, 2024
Pharmacokinetic (PK) tests form an integral part of the drug development process, helping to ensure the safety and efficacy of new drugs.
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