Pharmacy Times
DECEMBER 8, 2023
Psychological safety substantially contributes to team effectiveness, learning, employee retention, and—most critically—better decisions and better performance.
STAT
DECEMBER 8, 2023
The Food and Drug Administration on Friday approved the world’s first medicine based on CRISPR gene-editing technology, a groundbreaking treatment for sickle cell disease that delivers a potential cure for people born with the chronic and life-shortening blood disorder. The new medicine , called Casgevy, is made by Vertex Pharmaceuticals and CRISPR Therapeutics.
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Pharmacy Times
DECEMBER 8, 2023
The approval marks isavuconazonium sulfate as the only granted azole antifungal therapy for pediatric individuals AI and IM that are as young as 1 years old.
STAT
DECEMBER 8, 2023
For 39 years, I have lived with sickle cell disease. As of late, the sickle cell community has heard a lot of excitement about gene therapy’s potential to be the cure we’ve all been waiting for. That potential took a step toward fulfillment Friday when the Food and Drug Administration approved Casgevy from Vertex Pharmaceuticals’ and Lyfgenia from Bluebird Bio, both gene therapy treatments for people with sickle cell.
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.
Pharmacy Times
DECEMBER 8, 2023
As the use of sequencing, proteomics, and immunopeptidomics increases, more targets will also be discovered, as well as more biomarkers that predict responses to treatments.
Fierce Pharma
DECEMBER 8, 2023
Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell | Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell disease (SCD).
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
STAT
DECEMBER 8, 2023
Editas Medicine, CRISPR Therapeutics, and Intellia Therapeutics were all started in the 2013-2014 time frame with the same goal of turning the nascent CRISPR gene-editing technology into medicines. With the approval of Casgevy , the world’s first gene-edited therapy and a potential cure for sickle cell disease, CRISPR Therapeutics won the race.
Fierce Pharma
DECEMBER 8, 2023
Groundbreaking? Game-changing? Transformational? Historic? | Vertex Pharmaceuticals and CRISPR Therapeutics have won an historic FDA approval for their sickle cell disease gene therapy Casgevy. The transformational treatment is a potential cure for the debilitating and life-threatening disease which affects more than 100,000 in the United States, most of them Black.
STAT
DECEMBER 8, 2023
The Food and Drug Administration’s approval on Friday of two gene therapies for sickle cell disease sets up what could be an intense competition between Bluebird Bio, maker of Lyfgenia, and the partnership of Vertex Pharmaceuticals and CRISPR Therapeutics, whose drug is Casgevy. For the first time, physicians and patients will have a choice of potentially curative treatments for an inherited disease that affects nearly 100,000 Americans.
Fierce Pharma
DECEMBER 8, 2023
Three years on, Bristol Myers Squibb is bidding adieu to its top dealmaker. | Three years on, Bristol Myers Squibb is bidding adieu to its top dealmaker. Elizabeth Mily, who replaced BMS’ former M&A czar Paul Biondi back in 2020, is headed for the exit, the company confirmed Friday.
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.
Pharmacy Times
DECEMBER 8, 2023
Tera Moore, PharmD, BCACP, discusses how the integration of pharmacists into team-based models could benefit patient access to care in rural populations.
Drug Topics
DECEMBER 8, 2023
The analysis revealed deeper issues created by payer and manufacturer lockouts placed on Integrated Health System Specialty Pharmacies.
Pharmacy Times
DECEMBER 8, 2023
Study results indicate insignificant differences between PFS and OS in patients with HR[+]/HER2[-] breast cancer who received either palbociclib-letrozole or palbociclib-fulvestrant treatment.
STAT
DECEMBER 8, 2023
Research universities are voicing concerns over some proposed changes to the process for reviewing scientific misconduct allegations, citing worries that new government requirements would hobble their own independent procedures and constitute a huge administrative burden. Nearly two decades since it last released research misconduct rules, the U.S. Office of Research Integrity (ORI) is ready to update its requirements for ensuring the scientific standards of projects funded by the U.S.
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Drug Topics
DECEMBER 8, 2023
Two posters presented at ASHP Midyear 2023 looked at how the two medications differed and how clinical pharmacy services improved transitions.
STAT
DECEMBER 8, 2023
In a win for Vertex Pharmaceuticals, a Colorado state board voted not to place the company’s best-selling cystic fibrosis medication on a list of drugs for which payment limits will be set for most residents, including those whose insurance is covered by a government agency or a commercial health plan. The Colorado Prescription Drug Affordability Board voted unanimously that the expensive medicine, which carries a wholesale price of about $310,000 in the U.S. before any rebates or discoun
Fierce Healthcare
DECEMBER 8, 2023
A House vote on transparency regulations in healthcare could occur next week, potentially having substantial ramifications on how PBMs and hospitals operate. | Bipartisan anticipation is in the air for a potential vote in the House this week that would bring transparency to PBMs and ban spread pricing in Medicaid, but hospital groups are firmly opposed to provisions enacting site-neutral payment.
STAT
DECEMBER 8, 2023
Health officials on Friday released the first nationally representative estimate of how many U.S. adults have chronic fatigue syndrome: 3.3 million. The Centers for Disease Control and Prevention’s number is larger than previous studies have suggested, and is likely boosted by some of the patients with long COVID. The condition clearly “is not a rare illness,” said the CDC’s Dr.
PharmExec
DECEMBER 8, 2023
FDA approval of bluebird bio’s Lyfgenia and Vertex Pharmaceuticals' and CRISPR Therapeutics’ Casgevy marks significant milestone in the treatment of sickle cell disease.
STAT
DECEMBER 8, 2023
“Can I tell you what I really think about what’s going on?” she asks, looking down and clutching her coffee, her right sneaker tapping. I had been fairly sure about two things ahead of our session: one, that she would talk about the Conflict, and two, that I would dislike what she was going to say. I gulp what I hope is a hidden gulp, every inch of me wanting to tell her no actually, can we please not go there and just stick with your relationship unhappiness?
Fierce Pharma
DECEMBER 8, 2023
Merck and Eisai’s combo of Keytruda and Lenvima has missed the mark yet again, rounding out a year of multiple trial flops for the pairing. | The combo missed both endpoints in a phase 3 study in certain patients with advanced or recurrent endometrial carcinoma, adding yet another entry to a long list of recent trial failures.
STAT
DECEMBER 8, 2023
On Thursday, the Medicare Payment Advisory Commission reviewed Medicare performance data and concluded that despite doctors’ protests that their pay hasn’t kept up with inflation over the last 20 years, doctors shouldn’t get more than a minor raise for 2025. On the other hand, the committee admitted hospitals could use a larger increase in payment rates.
Pharmacy Times
DECEMBER 8, 2023
Cole Daniels, PharmD, BCPS, discusses a quality improvement initiative for glycemic outcomes with pharmacist management of insulin.
STAT
DECEMBER 8, 2023
Understand how science, health policy, and medicine shape the world everyday. Sign up for our Morning Rounds newsletter here. Institutions push back on scientific misconduct rules Investigating scientific research misconduct is necessarily a heavy lift for universities and other institutions. Many are now saying that proposed changes from the U.S.
Pharmacy Times
DECEMBER 8, 2023
Influenza, COVID-19, and respiratory syncytial virus will all peak in the coming months.
Drug Topics
DECEMBER 8, 2023
A Q&A with Kevin Malloy, PharmD, BCPS, on how diabetes technology has improved and how it can help pregnant people manage their disease.
STAT
DECEMBER 8, 2023
Research universities are voicing concerns over some proposed changes to the process for reviewing scientific misconduct allegations, citing worries that new government requirements would hobble their own independent procedures and constitute a huge administrative burden. Nearly two decades since it last released research misconduct rules, the U.S. Office of Research Integrity (ORI) is ready to update its requirements for ensuring the scientific standards of projects funded by the U.S.
Fierce Healthcare
DECEMBER 8, 2023
The role of primary care physician has been evolving – along with our understanding of medicine and the social drivers of whole health. | From reactive to proactive, and symptom-focused to holistic, primary care physicians are engaging more deeply with patients in four key ways.
STAT
DECEMBER 8, 2023
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.
The Checkup by Singlecare
DECEMBER 8, 2023
The start of a new year provides an opportunity to refresh and renew—to turn your attention to neglected areas of life. Self-improvement is a common goal, with 48.5% of Americans making New Year’s resolutions to lose weight, eat healthier, and more. SingleCare is here to help with your 2024 wellness goals. Whether you want to learn new ways to manage your anxiety , log more sleep , eat more protein , or stay adequately hydrated , you’ll find a wealth of health and wellness tips and
BioPharm
DECEMBER 8, 2023
MilliporeSigma’s new platform combines generative AI, machine learning, and computer-aided drug-design aimed at increasing the success rate of new drugs and therapies.
Drug Store News
DECEMBER 8, 2023
The software's capabilities include archiving all the training an organization has taken to meet regulatory requirements and assigning, tracking and reporting on CE.
European Pharmaceutical Review
DECEMBER 8, 2023
AbbVie has signed a definitive agreement to acquire Cerevel Therapeutics and its neuroscience pipeline – including antipsychotic emraclidine – for approximately $8.7 billion. Cerevel’s pipeline includes multiple clinical-stage and preclinical candidates with potential across several diseases including schizophrenia, Parkinson’s disease, and mood disorders.
Drug Store News
DECEMBER 8, 2023
The software's capabilities include archiving all the training an organization has taken to meet regulatory requirements and assigning, tracking and reporting on CE.
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