Drug Topics
SEPTEMBER 18, 2024
A co-administration option for both vaccinations can increase the likelihood of older adults completing the vaccination series and improve health outcomes for the patient population.
PharmaVoice
SEPTEMBER 18, 2024
Overpromising, overcommitting and neglecting CMC are a few of the pitfalls that cause sponsors to stumble when submitting a new drug application.
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Drug Topics
SEPTEMBER 18, 2024
The health care giant’s pharmacy benefit manager subsidiary filed a lawsuit claiming that the FTC’s recent 6(b) report was false and misleading.
Pharmacy Times
SEPTEMBER 18, 2024
The authors also found that there was a higher frequency of miscarriages compared with women who did not have asthma.
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
Drug Topics
SEPTEMBER 18, 2024
This approval offers an additional treatment option for a disease that can commonly return.
Pharmacy Times
SEPTEMBER 18, 2024
Reasons include fear of adverse effects, lack of education, polypharmacy, and others
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
PharmaVoice
SEPTEMBER 18, 2024
The FDA’s backlog of overseas drug manufacturer inspections is still mounting — and new drugs could be delayed as a result.
Drug Topics
SEPTEMBER 18, 2024
The approval was based on data from the phase 3 MANDARA trial, where the therapy met the primary endpoint of proportion of patients in remission at weeks 36 and 48.
STAT
SEPTEMBER 18, 2024
At the recent annual International AIDS Conference, a startling presentation about the newest wonder drug in HIV prevention brought a raucous standing ovation. Lenacapavir, a novel drug given as an injection under the skin every six months, was 100% successful in preventing HIV in adolescent girls and young women in two countries in Africa. It felt to many like a generational moment.
Drug Topics
SEPTEMBER 18, 2024
In an installment of Drug Topics’ 5 Questions With a Pharmacist, Michael and Joan Kim of Grubb’s Pharmacy in Washington, DC, discussed their practice and the community it serves.
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.
STAT
SEPTEMBER 18, 2024
Last year, a Springer Nature journal published a study surveying 1,700 parents of adolescents and young adults with gender dysphoria. Just a few months later, the study was retracted because there had been no formal process for those parents to consent to the study. But the story didn’t end there. Ongoing fallout from the paper and its retraction has opened up an internal rift among academic editors and journal staff that led to one editor’s resignation, as first reported by Retrac
Drug Topics
SEPTEMBER 18, 2024
The MVA-BN vaccine is manufactured by Bavarian Nordic and has shown strong efficacy against mpox infection in real-world studies.
Pharmacy Times
SEPTEMBER 18, 2024
The Drug Supply Chain Security Act (DSCSA) will soon mandate end-to-end tracking of pharmaceuticals throughout the supply chain, with numerous benefits for health systems.
STAT
SEPTEMBER 18, 2024
The cyberattack that forced Ascension to shut off access to its electronic health records cost the nonprofit hospital system roughly $1.3 billion, according to STAT’s analysis of financial documents the health system released Tuesday evening.
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
SEPTEMBER 18, 2024
Analyzing consolidation of 8 drug pump libraries into 1 IV infusion library in a 9-hospital system: from standardization to implementation.
STAT
SEPTEMBER 18, 2024
Amid debate over potential abuse of the U.S. patent system by the pharmaceutical industry, moves by some drugmakers to expand their patent claims appear to be delaying the arrival of lower-cost generic medicines to the marketplace, according to a STAT analysis. At issue are use codes, which are brief descriptions of a type of patent claim that focuses on the specific use of a medicine, or the “method of use” in legal vernacular.
Pharmacy Times
SEPTEMBER 18, 2024
The approval is based on positive results from the phase 2/3 IND.227/KEYNOTE-483 trial.
STAT
SEPTEMBER 18, 2024
A long-running race to develop a gene therapy for the most common cause of age-related blindness is heating up. On Wednesday, 4D Molecular Therapeutics announced new data from its program for the disease, known as wet age-related macular degeneration, or wet-AMD. In one 30-person Phase 2 study, patients’ need for standard-of-care injections fell by 89% after receiving gene therapy, and 73% did not need another standard-of-care shot for at least 32 weeks.
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Fierce Healthcare
SEPTEMBER 18, 2024
CVS' Oak Street Health unit has agreed to pay a $60 million settlement to resolve kickback allegations, the Justice Department announced on Wednesday. | CVS' Oak Street Health unit has agreed to pay a $60 million settlement to resolve kickback allegations, the Justice Department announced on Wednesday.
STAT
SEPTEMBER 18, 2024
Biotech companies routinely compete to develop and commercialize products. But these rivalries are seldom as publicly heated as what has played out on social media this week between two firms racing to develop new ways to screen for colon cancer. Over the weekend, during the leadup to Exact Sciences announcing data from a blood-based colon cancer test, Guardant Health co-CEO AmirAli Talasaz challenged Exact’s CEO, Kevin Conroy, in a LinkedIn post that was unusually confrontational.
Pharmacy Times
SEPTEMBER 18, 2024
Eosinophilic granulomatosis with polyangiitis is a rare and immune-mediate vasculitis that can damage multiple organs and be fatal if left untreated.
STAT
SEPTEMBER 18, 2024
A House committee on Wednesday passed a bill to renew a program aimed at aiding development of drugs for rare diseases in children , putting it in a better position to be added to government funding legislation. The pediatric rare disease priority review voucher program is set to end on Sept. 30. The legislation would extend the program until Sept. 30, 2029.
Fierce Healthcare
SEPTEMBER 18, 2024
A critical telehealth extension bill passed in a House markup hearing Wednesday, but it's far from the only activity in Congress this week.
STAT
SEPTEMBER 18, 2024
In 2017, at the age of 42, Susan Whitehead was diagnosed with an early form of breast cancer after discovering a lump in her breast. She embarked on a challenging path of treatment, including a recurrence with stage 2 cancer four years later. Susan underwent two lumpectomies, a mastectomy, radiation, and chemotherapy. Throughout this process, she was steadfast in her resolve to seek the best possible care, which included demanding a controversial full-body scan that led to an unexpected discover
Fierce Pharma
SEPTEMBER 18, 2024
With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow. | Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis, which is looking at a major expansion opportunity in eczema.
Fierce Healthcare
SEPTEMBER 18, 2024
Healthy.
pharmaphorum
SEPTEMBER 18, 2024
PBM Express Scripts has sued the FTC, claiming its recent report on the sector's role in drug pricing is defamatory and should be retracted
STAT
SEPTEMBER 18, 2024
A House committee on Wednesday advanced legislation that would extend Medicare telehealth flexibilities and a home hospital program adopted during the pandemic, the final step before the bills face a vote by the full House of Representatives. Congress in 2022 extended pandemic-era flexibilities about where and what kinds of care Medicare enrollees could receive over telehealth.
pharmaphorum
SEPTEMBER 18, 2024
In a new solution spotlight, learn more about the Aktiia Medical Grade Wearable, a clinically validated device engineered to deliver precise blood pressure readings passively, irrespective of the user's position—be it sitting, lying down, or standing.
STAT
SEPTEMBER 18, 2024
Roivant Sciences continues its dealmaking hot streak, announcing Wednesday that it would sell one of its subsidiaries to pharma company Organon in a deal worth $1.2 billion. Organon is buying Roivant subsidiary Dermavant and its topical treatment Vtama. The drug is currently approved to treat various forms of the skin condition plaque psoriasis. But analysts and Organon see the real potential in Dermavant’s standing application with the Food and Drug Administration to expand the drug
pharmaphorum
SEPTEMBER 18, 2024
Organon has agreed a $1.
STAT
SEPTEMBER 18, 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. My colleague Ed Silverman, who I view as the foremost expert on drug patents (and coffee flavors), has been taking a closer look at patent claims to bring us an exclusive analysis. We get into all of that today.
Pharmacy Times
SEPTEMBER 18, 2024
The humanized anti-butyrophilin 3A monoclonal antibody selectively activates Vγ9Vδ2 T-cells.
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