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.
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 Just a few months later, the study was retracted because there had been no formal process for those parents to consent to the study.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
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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.
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.
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.
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
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 Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
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.
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.
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.
Drug Topics
SEPTEMBER 18, 2024
The Eversense 365 is the world’s first long-term CGM that provides 1 year of use and should be available by the fourth quarter of 2024.
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.
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.
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.
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
Drug Topics
SEPTEMBER 18, 2024
This approval offers an additional treatment option for a disease that can commonly return.
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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 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
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.
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
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
Fierce Pharma
SEPTEMBER 18, 2024
This summer, GSK cut its yearly vaccine sales projection o | In the study, co-administration of GSK's RSV vaccine Arexvy and shingles shot Shingrix elicited non-inferior immune responses compared with separate administration of the vaccines.
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 Pharma
SEPTEMBER 18, 2024
Since GSK’s Nucala and AstraZeneca’s Fasenra were approved two years apart to treat patients with severe asthma, the IL-5 inhibitors have engaged in a spirited market battle, with one key differenc | Locked in a spirited market battle with GSK's Nucala, AstraZeneca's Fasenra is catching up with its IL-5 inhibitor rival as the FDA signed off on its use to treat the rare autoimmune condition of eosinophilic granulomatosis with polyangiitis.
STAT
SEPTEMBER 18, 2024
Hello, everyone, and how are you today? We are muddling along, but the middle of the week is upon us, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy. So we are digging about the pantry and firing up our coffee kettle to get things started.
Pharmacy Times
SEPTEMBER 18, 2024
In a patient with long-shedding SARS-CoV-2, transfusion-related acute lung injury developed after intravenous immunoglobulin, emphasizing careful treatment considerations.
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
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.
Fierce Pharma
SEPTEMBER 18, 2024
Theratechnologies' reliance on a small pool of contract manufacturers has come back to bite the Quebecois biopharma, which announced Tuesday that supplies of its HIV med Egrifta SV could | Theratechnologies' reliance on a small pool of contract manufacturers has come back to bite the Quebecois biopharma, which announced Tuesday that supplies of its HIV med Egrifta SV could soon run short.
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.
Fierce Healthcare
SEPTEMBER 18, 2024
Ascension’s finances were on track for strong recovery until cybersecurity issues threw a wrench in its operations and revenues. | The Catholic giant logged a $1.8 billion operating loss for its most recent fiscal year, but was trending much closer to even prior to May, according to its latest financial filings.
Pharmacy Times
SEPTEMBER 18, 2024
The combination of amivantamab and lazertinib showed improved intracranial efficacy, progression-free survival, and overall survival for non-small cell lung cancer.
The FDA Law Blog
SEPTEMBER 18, 2024
By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients. Specifically, FDC Act 201(ff)(3)(B) provides that a dietary supplement does not include: (i) an article that is approved as a new drug under section 355 of [the FDC Act], certified as an antibiotic under section 357 of [the FD
Pharmacy Times
SEPTEMBER 18, 2024
In 2 studies, durvalumab improved overall survival for those with unresectable hepatocellular carcinoma and event-free survival for muscle-invasive bladder cancer.
pharmaphorum
SEPTEMBER 18, 2024
Digital health company Noom has launched a compound pharmacy-made version of Novo Nordisk's obesity drug semaglutide to make the drug more accessible to consumers in the US.The bold move has been accompanied by a full-page ad in the Wall Street Journal explaining its reasoning, and claiming that the prices of GLP-1 drugs for weight loss are five times too high and need to be brought in line with levels in other countries.
Pharmacy Times
SEPTEMBER 18, 2024
The approval is based on positive results from the phase 2/3 IND.227/KEYNOTE-483 trial.
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