Get Into Politics or Get Out of Pharmacy
Drug Topics
AUGUST 12, 2024
Our congressional representatives have plenty of interaction with PBM lobbyists. It’s time they hear from patients as well.
Mon.Aug 12, 2024
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What’s in a drink? U.S. regulators consider new alcohol label, but health advocates want even more
STAT
AUGUST 12, 2024
If you twirl a bottle of alcohol and squint, you might see a text box with a warning. Usually in black and white, with letters two to three millimeters high, it reads: GOVERNMENT WARNING: (1) According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects. (2) Consumption of alcoholic beverages impairs your ability to drive a car or operate machinery, and may cause health problems.
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Merck Discontinues Study Evaluating Vibostolimab/Pembrolizumab Combination for SCLC
Pharmacy Times
AUGUST 12, 2024
The trial evaluated a fixed-dose combination of vibostolimab and pembrolizumab in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer.
Opinion: The FDA should withdraw approval of more than 400 tainted medicines
STAT
AUGUST 12, 2024
When the FDA learned that a testing facility in India had submitted fraudulent data for more than 400 drugs (most of them generics), the agency should have withdrawn them from the market. Instead, it has allowed these drugs to continue to be prescribed and distributed for at least a year as the pharmaceutical companies retest them for equivalency to the original brand-name drugs.
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
23andMe to launch GLP-1 telehealth offering, shuts down internal drug development business
Fierce Healthcare
AUGUST 12, 2024
Consumer genetic testing company 23andMe sees an opportunity to get in on the weight loss boom. | 23andMe plans to launch a GLP-1 weight loss telehealth membership through its Lemonaid Health platform by the end of the month.
Opinion: Some ‘inconvenient’ truths about pharmacy benefit managers
STAT
AUGUST 12, 2024
Pharmacy benefit managers have been in the crosshairs of late, as the focus of media scrutiny, government investigations and reports, and proposed federal legislation. A few recent examples make the point: A New York Times story in June 2024 bore the headline, “Pharmacy benefit managers are driving up drug costs for millions of people, employers and the government.
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The politics of health: How elections will impact life sciences
pharmaphorum
AUGUST 12, 2024
Explore how the recent and upcoming elections may impact the field of life sciences and medical technology. Stay informed about the intersection of politics and health advancements.
A tough week for MDMA-assisted psychotherapy
STAT
AUGUST 12, 2024
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. A hard weekend for those backing MDMA-assisted psychotherapy: First, the FDA rejects a treatment from Lykos Therapeutics. Now a journal is retracting three MDMA papers, citing data integrity issues. Also, a nasal epinephrine spray gets an FDA approval, and more.
Ajinomoto will lay off 71 staffers in CA to streamline CDMO business following $620M Forge Biologics buy
Fierce Pharma
AUGUST 12, 2024
Following last year’s acquisition of viral vector and plasmid specialist Forge Biologics, Japan’s Ajinomoto Bio-Pharma Services is streamlining its business in San Diego. | Following last year’s acquisition of viral vector and plasmid specialist Forge Biologics, Japan’s Ajinomoto Bio-Pharma Services is streamlining its business in San Diego. As a result, 71 California-based staffers—or 13% of the company’s overall workforce—are set to lose their jobs, Ajinomoto said in a memo shared with Fierce
STAT+: Pharmalittle: We’re reading about FDA rejecting MDMA; a nasal spray for allergic reactions, and more
STAT
AUGUST 12, 2024
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of phone calls, online meetings, and deadlines has predictably returned. But you knew this would happen, yes? After all, we can only move forward. So what better way to cope than with a refreshing cup or two of stimulation?
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.
Pfizer, looking to expand RSV vaccine's reach, touts its benefits in immunocompromised adults
Fierce Pharma
AUGUST 12, 2024
Locked in a closely watched respiratory syncytial virus (RSV) vaccine competition, Pfizer aims to expand the reach of its offering Abrysvo. | Locked in a closely watched RSV vaccine competition, Pfizer aims to expand the reach of its offering Abrysvo. Monday, Pfizer said Abrysvo elicited a strong response in adults with compromised immune systems.
Maintaining a Specialty Medication Regimen
Pharmaceutical Commerce
AUGUST 12, 2024
In this part of his Pharma Commerce video interview, Josh Marsh, Vice President and General Manager of Cardinal Health Sonexus Access and Patient Support, discusses the impact technology has in relation to patients sticking to their medication plan.
After icodec rejection, Novo Nordisk plots 2024 FDA filing for once-weekly insulin and semaglutide combo
Fierce Pharma
AUGUST 12, 2024
Despite hitting a roadblock on the path to approval for its once-weekly insulin icodec in the U.S., Novo Nordisk is continuing to move full speed ahead with a combo treatment pairing the drug with | Despite hitting a roadblock on the path to approval for its once-weekly insulin icodec in the United States, Novo Nordisk is continuing to move full speed ahead with a combo treatment pairing the drug with its unstoppable GLP-1 semaglutide.
Morning Rounds: Getting healthier in the checkout aisle and the alcohol aisle
STAT
AUGUST 12, 2024
Want to stay on top of health news? Sign up to get our Morning Rounds newsletter in your inbox. It’s Brittany subbing for Theresa this fine Monday. Thank you for all of the excellent song recommendations over the weekend. If you want to check out my road trip playlist, you can find it here.
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.
Daxxify maker Revance agrees to $924M buyout by private skin care company Crown Laboratories
Fierce Pharma
AUGUST 12, 2024
After treading the commercial path alone for the past year and change, Revance Therapeutics, maker of the Botox rival Daxxify, has agreed to fly the Crown Laboratories flag. | Revance and Crown Laboratories—a privately held skin care company with multiple marketed products of its own—are merging, the companies said in a release Monday. Under the deal, which has won the unanimous blessing of Revance’s board of directors, Crown will enter a tender offer to acquire all outstanding Revance stock for
MSD adds bispecific cancer antibody via $1.3bn Curon deal
pharmaphorum
AUGUST 12, 2024
MSD adds a bispecific antibody for blood cancers and autoimmune diseases to its pipeline via a $1.3bn licensing deal with Curon Biopharma.
Era of ADCs: Pharma companies innovate to stand out in a buzzing market
Pharmaceutical Technology
AUGUST 12, 2024
As antibody drug conjugate (ADC)-centred deals dominate the oncology space, biotechs are using newer targets and linkers to differentiate themselves.
PLAIO raises €4.3M to revolutionize pharma supply chains with AI-driven planning platform
Outsourcing Pharma
AUGUST 12, 2024
In a landmark move for the pharmaceutical industry, PLAIO, a pioneering Icelandic tech firm, has secured â4.3 million in an oversubscribed funding round to accelerate its AI-driven sales and operations planning platform designed specifically for the pharmaceutical sector.
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.
FDA clears first anaphylaxis nasal spray at second attempt
pharmaphorum
AUGUST 12, 2024
ARS Pharma gets FDA approval for epinephrine nasal spray neffy, the first needle-free alternative to EpiPen-style autoinjectors for serious allergic reactions.
FDA Approves First Treatment for Hypoparathyroidism in Adults
Drug Topics
AUGUST 12, 2024
Ascendis Pharma said it is currently completing manufacturing of commercial product, which it anticipates will be available in the US in the first quarter of 2025.
FDA Approves Palopegteriparatide for Treatment of Hypoparathyroidism
Pharmacy Times
AUGUST 12, 2024
Palopegteriparatide is a prodrug of parathyroid hormone designed to provide continuous exposure of the hormone over a 24-hour dosing period.
NICE updates on controversial multiple myeloma decisions
pharmaphorum
AUGUST 12, 2024
Three controversial decisions by NICE on NHS use of new multiple myeloma therapies are heading for the end of comment and appeals processes.
Lykos’ heartache over FDA setback as new trial for groundbreaking PTSD treatment ordered
Outsourcing Pharma
AUGUST 12, 2024
In a blow to millions of Americans battling post-traumatic stress disorder (PTSD), Lykos Therapeutics announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its new drug application (NDA) for midomafetamine capsules.
Article retractions muddy MDMA waters after FDA denial
pharmaphorum
AUGUST 12, 2024
Journal retracts three articles on MDMA-assisted psychotherapy, shortly after FDA blocks approval of @Lykos_PBC's therapy for PTSD
FDA Grants RMAT Designation for KYV-101 to Treat Patients With Progressive Myasthenia Gravis
Pharmacy Times
AUGUST 12, 2024
The autologous, fully human CD19 chimeric antigen receptor T-cell product, KYV-101, is being studied for the treatment of patients with progressive myasthenia gravis.
Another AIM defection as BiVictriX plans to delist
pharmaphorum
AUGUST 12, 2024
BiVictriX is the latest UK biotech to say it wants to cancel its AIM-listed shares and go private in pursuit of better financing opportunities.
New Finding for Diabetic Wounds Has Potential for Use in Developing New Therapeutics
Pharmacy Times
AUGUST 12, 2024
Many patients are unaware of wound complication, so it is valuable for pharmacists to communicate prevention methods with all patients with diabetes.
KFF: A look at prior authorization trends in Medicare Advantage
Fierce Healthcare
AUGUST 12, 2024
Prior authorization denials in Medicare Advantage jumped between 2021 and 2022, according to a new analysis from KFF.
Potential Role for IVIG in Treating Systemic Sclerosis With Muscular, Digestive Manifestations
Pharmacy Times
AUGUST 12, 2024
The systematic review summarized all available evidence on the subject, finding that intravenous immunoglobulin could have a role in treatment.
Pharmacy Deserts are Becoming a National Problem
Pharmaceutical Commerce
AUGUST 12, 2024
A lack of access could shut out patients in need of maintenance drugs for complex conditions.
Study Finds Increased Risk of Mental Health Disorders Following Cardiovascular Hospitalization
Pharmacy Times
AUGUST 12, 2024
Risk of developing anxiety or depression is highest within the first year after cardiovascular hospitalization.
J.D. Power: Brick-and-mortar pharmacies ceding ground to mail order options on consumer satisfaction
Fierce Healthcare
AUGUST 12, 2024
While customer satisfaction with mail order pharmacies is continuing to grow, brick-and-mortar pharmacies are falling behind, according to a new survey from J.D. Power. | While customer satisfaction with mail order pharmacies is continuing to grow, brick-and-mortar pharmacies are falling behind, according to a new survey from J.D. Power.
Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious
The FDA Law Blog
AUGUST 12, 2024
By Sara W. Koblitz — In the world of patent term extensions, every day considered part of the regulatory review period is important, as that day—either in whole or in part—gets added back to the patent upon approval of the product. In the veterinary world, where rolling applications are common, the testing phase is usually particularly important because the review phase, which starts only when the last component of the rolling New Animal Drug Application (NADA)—called the Administrative NADA—is
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