Sunscreen Safety: What Every Pharmacist Needs to Know
Drug Topics
MAY 14, 2024
Warm weather means one thing: People are eager to be outdoors. Although sun protection is paramount, sunscreen options can be daunting. How can pharmacists help?
Tue.May 14, 2024
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USDA, FDA turf battles hamper responses to outbreaks like H5N1 bird flu
STAT
MAY 14, 2024
WASHINGTON — On a bright June day in 2018, one of the nation’s top regulators waved groceries in the air, quizzing the secretary of agriculture on which agency is charged with monitoring different types of food. Scott Gottlieb, the commissioner of the Food and Drug Administration at the time, grinned widely as he held liquid egg whites and a carton of eggs.
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COVID-19 Vaccine Booster Dose Beneficial to Immunocompromised Patients
Drug Topics
MAY 14, 2024
A recent study found that, of 423 participants who were initially low responders, 90% increased their antibody concentrations to more than 400 AU/mL.
STAT+: CVS is willing to dump 10% of its Medicare Advantage members next year
STAT
MAY 14, 2024
CVS Health is preparing to make significant changes to its 2025 Medicare Advantage plans, which could potentially drive away 10% of its membership, the company’s chief financial officer said at an investment banking conference Tuesday. “The goal for next year is margin over membership,” CVS CFO Tom Cowhey said at the conference, hosted by Bank of America.
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.
Pharmacists Need Additional Training to Combat Corticophobia for Patients With Atopic Dermatitis
Pharmacy Times
MAY 14, 2024
Corticophobia is defined as a phobia of topical corticosteroids due to negative feelings or beliefs, which can come from misinformation about the long-term effects.
FDA Issues CRL for Heplisav-B in Adults With ESRD on Hemodialyis
Drug Topics
MAY 14, 2024
Dynavax plans to meet with the FDA to discuss how the company can provide additional data to support the approval of its 4-dose Heplisav-B regimen and expand protection for adults with end-stage renal disease (ESRD) on hemodialysis.
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Survey: 1 in 8 Adults Have Utilized a GLP-1 Medication, 6% Currently Are
Pharmacy Times
MAY 14, 2024
According to the results, approximately 82% of adults said they have heard at least a little about GLP-1 medications and 32% said they have heard a lot.
What we know about extreme heat’s health impacts after the hottest summer on record
STAT
MAY 14, 2024
Last summer’s heat waves demonstrated all the ways that extreme heat takes a toll on the human body. In cities across the U.S. from Phoenix to New York, people suffered from heat exhaustion, heat stroke, heat cramps, and more. In Texas, more than 300 people died from heat last year — the highest number since the state started tracking the deaths in 1989.
ICER raps conduct of Lykos’ psychedelic trial for PTSD
pharmaphorum
MAY 14, 2024
The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).
STAT+: Lawmaker accuses Amgen of placing profits above patients with dosing for a cancer drug
STAT
MAY 14, 2024
A U.S. lawmaker is accusing Amgen of “putting profits before patients” over its decision to continue marketing a high dose of a pricey cancer treatment instead of a lower dose that is less expensive and not as toxic to patients. At issue is a medication called Lumakras, which is used to treat non-small cell lung cancer and which won conditional regulatory approval three years ago.
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.
With 4-year data, Novo bolsters star power of obesity blockbuster Wegovy
Fierce Pharma
MAY 14, 2024
With new four-year data in hand, Novo Nordisk can make a case for its popular obesity med Wegovy to be used as a long-term treatment. | An analysis unveiled at the European Congress on Obesity showed that Wegovy patients lost 10% of their weight, on average, over a 4-year span.
STAT+: Novo to test Wegovy and other obesity drugs against alcohol-related liver disease
STAT
MAY 14, 2024
Novo Nordisk will test whether its GLP-1 drugs can help people with alcohol-associated liver disease, and, as part of that, will study if the treatments will change the amount of alcohol people drink. This appears to be the first time the company is getting involved in research to see if the booming class of GLP-1 diabetes and obesity drugs can affect substance consumption, a question that academic researchers have been probing but the pharmaceutical industry has so far avoided.
Bayer cutbacks start to be felt with 1,500 jobs shed in Q1
pharmaphorum
MAY 14, 2024
Bayer's first-quarter results update shows its headcount has shrunk by around 1,500 since the start of the year, suggesting promised job cuts are starting to take hold
Study Finds AI Models May Help Accurately Assess PTSD in Women After a Traumatic Childbirth
Pharmacy Times
MAY 14, 2024
The authors note that this finding may have promise for use in assessing mental health conditions and improving patient outcomes.
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.
In vitro gametogenesis: the science has to be right, and it has to be safe
pharmaphorum
MAY 14, 2024
Today’s podcast sees web editor Nicole Raleigh speak with Dr Mark Leondires, founder and medical director at Illume Fertility, who shares his own journey and insights on In vitro gametogenesis (IVG).
When is the best time to take metformin?
The Checkup by Singlecare
MAY 14, 2024
Metformin is an FDA-approved prescription drug for treating Type 2 diabetes. It is also sold under brand names like Glucophage, Fortamet, and Glumetza and belongs to a class of medications called biguanides. It is sometimes used off-label to prevent weight gain, manage polycystic ovary syndrome (PCOS), and treat or prevent gestational diabetes. “ Metformin has a variety of actions on the body that help the body regulate blood sugar (glucose),” says Emily Dornblaser , Pharm.D., an associate profe
Lonza, busy with capacity upgrades and exec turnover, hints at CDMO industry rebound
Fierce Pharma
MAY 14, 2024
A tough biotech funding environment and a downturn in COVID-related contracts has weighed heavily on CDMOs of all stripes in recent years. | With a new CEO waiting in the wings, Swiss manufacturing juggernaut Lonza is attempting to reassure the market that a CDMO industry stabilization is playing out.
After traumatic brain injury, life support decisions can use more time
STAT
MAY 14, 2024
Deciding whether to withdraw life support after a severe traumatic brain injury is extremely difficult. Loved ones are faced with balancing their hopes for recovery with the desire not to prolong suffering, and clinician insight is essential. With the support of critical care physicians, most decisions on whether to end life support are made within 72 hours of hospitalization.
Bayer slashed 1,500 roles in Q1 as simpler organization takes shape
Fierce Pharma
MAY 14, 2024
When Bayer unveiled a restructuring in January, the company didn’t provide specifics on the number of planned job cuts. | When Bayer unveiled a restructuring in January, the company didn't provide specifics on the number of planned job cuts. Now, the size of the initial round of cuts shows that CEO Bill Anderson means business.
12 Questions with Michael Stevinson
pharmaphorum
MAY 14, 2024
Get to know Michael Stevinson from IPG Health Medical Communications with these 12 insightful questions. Learn more about his background, experiences, and perspectives.
Another delay for Ascendis' hormone therapy as FDA extends review by 3 months
Fierce Pharma
MAY 14, 2024
It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). | It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). And now, it’ll take another three months for the United States regulator to decide on the treatment for the endocrine disease hypoparathyroidism.
Private equity firm off the hook in FTC's antitrust case against portfolio anesthesia provider
Fierce Healthcare
MAY 14, 2024
Private equity firm Welsh, Carson, Anderson & Stowe will not be scrutinized in court for the potentially anticompetitive practices of its portfolio anesthesia group U.S. | A federal judge ruled Monday that Welsh Carson's minority, noncontrolling stake in U.S. Anesthesia Partners does not make it liable for the provider's potential anticompetitive practices.
Opinion: Health care needs a new profession: neuroimaging counseling
STAT
MAY 14, 2024
Until recently, getting an MRI meant traveling to the hospital. But a new generation of more affordable and highly portable MRI (pMRI) devices are rapidly reshaping neuroimaging research and clinical care. The scanner will now come to you. That means the time is ripe for a related innovation: neuroimaging counseling. While portable MRI is emerging for many body parts, scanning brains with pMRI raises unique ethical concerns.
Cytokinetics prepares to take on BMS’ Camzyos in HCM
pharmaphorum
MAY 14, 2024
Cytokinetics has revealed the results from a phase 3 trial of its hypertrophic cardiomyopathy (HCM) drug aficamten that it hopes will allow it to compete with Bristol-Myers Squibb’s first-to-market Camzyos.
Watch: Restaurant workers can serve your food, bring your drinks, and maybe save your life
STAT
MAY 14, 2024
BOSTON — The tables set up near the entrance of the Big Night Live concert venue looked like a typical merch spread. But instead of band T-shirts and buttons, there were plastic models of human noses and a handful of naloxone nasal sprays. This unusual display was part of a medical training for bar and restaurant workers — who are often the first to encounter people experiencing a drug overdose.
Real-life data highlights need for patient-centered management of unhealthy cholesterol
Outsourcing Pharma
MAY 14, 2024
The Global Heart Hub, an international alliance of heart patient organizations based in Ireland, has unveiled the first findings from their patient-led Insights from Patients living with Elevated Cholesterol (IPEC) data generation program.
Sanofi adds to biomanufacturing investment in France
European Pharmaceutical Review
MAY 14, 2024
Using an investment of over €1 billion, Sanofi plans to generate new bioproduction capacity at three sites in France, focusing on biologic medicines. The sites are in Vitry-sur-Seine (Val de Marne), Le Trait (Seine-Maritime) and Lyon Gerland (Rhône). This cash injection will create more than 500 jobs and “significantly strengthen” France’s present and future ability to control the full production process of essential medicines, the company stated.
After filing hitch, Eisai and Biogen begin rolling FDA submission for subcutaneous Leqembi
Fierce Pharma
MAY 14, 2024
After suffering a setback with U.S. regulators last month, Eisai and Biogen’s effort to deploy a more convenient version of their Alzheimer’s disease drug Leqembi appears to be back on track. | Late Tuesday, Biogen and Eisai said they kicked off a rolling FDA submission for the subcutaneous version of Leqembi—which is currently infused—after winning a fast track tag from the agency.
Takeda agrees to develop active immunotherapy for Alzheimer’s
European Pharmaceutical Review
MAY 14, 2024
Takeda and AC Immune SA have agreed a global option and license agreement for a potential first-in-class Abeta-targeting active immunotherapy for Alzheimer’s. AC Immune’s related immunotherapies targeting Abeta are part of the deal, including the Alzheimer’s treatment ACI-24.060. According to Takeda, based on blinded data, immunogenicity of this immunotherapy is “very encouraging with clear evidence of anti-Abeta antibody responses”.
STAT+: Element Biosciences, an Illumina rival, on its genomics ambitions — and why it hasn’t gone public
STAT
MAY 14, 2024
SAN DIEGO — Companies racing to read the genome accurately, quickly, and affordably have hit a snag recently, with several firms reporting that their growth has slowed, stalled, or reversed. Upstart Element Biosciences is hoping it can succeed despite the challenging market conditions. The San Diego firm launched a $290,000 sequencer, dubbed Aviti, in March 2022 and now has 150 instruments installed in more than 25 countries, according to a sales update Element shared with STAT.
First oral treatment for chronic kidney disease launched in China by Everest Medicine
Outsourcing Pharma
MAY 14, 2024
Today (May 14) Everest Medicines, a biopharmaceutical company focused on progressive medicines and vaccines, announced the successful launch of small molecule Nefecon, a delayed-release capsule, in China, with the first prescription issued.
Is Novavax a new meme stock?
STAT
MAY 14, 2024
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. I’m making another plea to please fill out our brief survey ! We want to know how to make this newsletter more informative and helpful for you.
Roquette solving toughest drug development challenges with new capsules
Outsourcing Pharma
MAY 14, 2024
Roquette, a global leader in plant-based ingredients and a key provider of pharmaceutical and nutraceutical excipients, announced today (May 14) the launch of its innovative Lycagel Flex hydroxypropyl pea starch premix for softgel capsules.
Babyscripts teams up with Lyft to provide transportation to maternal health services
Fierce Healthcare
MAY 14, 2024
Digital maternal health company Babyscripts announced a partnership Tuesday with Lyft Healthcare to offer sponsored rides for people who are pregnant or postpartum and face barriers to transportati | Babyscripts hopes to increase utilization of prenatal and postpartum care through a new ridesharing pilot program with Lyft Healthcare.
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