Pharmacy Times

JUNE 20, 2025

It’s also helpful to hear from managed care experts—understanding their concerns and what documentation is needed to ensure patients can get coverage for the latest treatments. I love that OPC is positioned so close to ASCO because pharmacists often can’t attend large meetings due to travel restrictions and limited funding.

Compounding Pharmacies

The Checkup by Singlecare

JUNE 12, 2025

That gives patients enough time to get any vaccines or medications they may need (depending on their destination), and plenty of time to refill routine medications. Depending on the country they’re headed to, certain travel vaccines, such as hepatitis B, typhoid, chikungunya, or yellow fever, may be recommended or even required.

Vaccines

Pharmacy Times

JULY 22, 2025

Artificial intelligence (AI) platforms such as PGxAI are now automating literature review, guideline development, and reimbursement documentation, enabling pharmacogenetic innovation to move from discovery to clinical application in months rather than decades.

Compounding Pharmacies

Pharmacy Times

JULY 2, 2025

They can collect documentation on prior preventive therapies, baseline MMDs, and follow-up outcomes to support prior authorization, including site-of-care arrangements. of participants discontinued due to adverse effects.

Compounding Pharmacies

PharmTech

JUNE 23, 2025

It builds on drug calculations topics previously described (1), including guidance documents (2–5). FDA guidance documents illustrate labeling salt drugs and associated active moieties. Discussion topics Part two of this series ( click here for part one ) addresses numeric calculations for types of bulk drugs.

Compounding

Pharmacy Times

JULY 2, 2025

The manufacturer reported that, as part of the NDA review, they have not highlighted any technical concerns related to the submitted documentation or testing of OLC. The CRL was received after OLC’s initial Prescription Drug User Fee Act date of June 28, 2025, and cited for deficiencies that are unrelated to OLC itself.

FDA

Drug Topics

JULY 7, 2025

The study cohort included 136 patients with a confirmed HAE type 1 or 2 diagnosis who had at least 2 documented HAE attacks within 3 months prior to screening. Patients received either 300 mg or 600 mg sebetralstat or placebo. The study found patients who received sebetralstat had a beginning of symptom relief of 1.61 hours for 300 mg and 1.79

FDA

Drug Topics

JULY 8, 2025

TCSs are the first-line anti-inflammatory treatment and their effectiveness and safety have been well documented.” “The next step consists of treatment with topical anti-inflammatory therapies. Above all other medication classes and formulations, TCSs have been deemed as the most important pharmacotherapy in the treatment of AD. J Clin Med.

Vaccines

Pharmacy Times

JULY 1, 2025

We all share the same electronic health record and document every patient interaction in the health record, and we have very easy access to reach out to the patient's provider to let them know of any questions or concerns that the patient has regarding their medication.

Specialty Pharmacies

Pharmacy Times

JUNE 22, 2025

Sayer: The most documented, most significant benefits If you take a look at the trials we've run, first of all, you always see an A1c reduction, because average glucose values go down and A1c follows. Even just glucose numbers, that's way more than they've had before.

Compounding Pharmacies

PharmTech

JULY 24, 2025

Waite further emphasizes the need for pharmaceutical companies to quickly build internal capabilities in customs compliance, including tariff classification, country of origin documentation, and accurate customs valuation. Subscribe Now! Related Videos Related Content Advertisement July 24th 2025 Opposing Reactions as RFK Jr.

Dosage

Pharmacy Times

JULY 17, 2025

Patients were excluded if they had a primary mental health diagnosis of a substance use disorder or no documented Behavioral Health Initial Assessment Form in the electronic medical record. Due to incomplete documentation, the MARS score could not be calculated for all the patients.

HIV Treatment and Prevention Agents

Drug Topics

JUNE 25, 2025

In a new CDC report, investigators found that there was no connection between thimerosal in vaccines and autism or other neurodevelopmental conditions. The properties of thimerosal were documented to contribute to the safe use of multidose vials and packaging of vaccines, such as seasonal and pandemic influenza vaccines.

Vaccines

Pharmacy Times

JULY 18, 2025

Compliance with FDA guidelines, including documenting clinical differences and avoiding investigational GLP-1s, is essential for compounders. It would also be expected that the reason would be documented in the patient’s chart. In other words, the pharmacist can take that determination verbally but must document it.

Compounding

Pharmacy Times

JULY 9, 2025

2 Evidence Supporting Supplementation A randomized controlled trial involving high-dose vitamin D (300 IU/kg/day, up to 5000 IU/day) in children with ASD documented meaningful improvements in Childhood Autism Rating Scale (CARS) scores, repetitive behaviors, eye contact, and attention after 4 months, without toxicity.

Compounding Pharmacies

Pharmacy Times

JUNE 23, 2025

We just must do a good job of documenting them and develop that clinical evidence base that supports it. In our state of type 2 paper that we published in conjunction with this meeting, one of the things that was very interesting to me was that there were like 111 health care professional surveys.

Insurance Coverage

European Pharmaceutical Review

JULY 9, 2025

Many pharmaceutical companies, particularly those developing innovative biologics or vaccines, lack the specialised facilities, expertise, or economic justification to build their own aseptic manufacturing capabilities. Equally important is the CDMO’s capacity for genuine partnership.

Documentation

PharmTech

JULY 17, 2025

Finalize documentation with full traceability and ensure preparations are quarantined until verified. Stage 5: independent verification before release Engage an independent observer to verify formulation integrity, test results, documentation, and labeling accuracy. antineoplastics, allergens).

Compounding

Pharmaceutical Technology

JULY 11, 2025

How will RFK Jr’s American dream for vaccines play out? To learn more about the solutions provided by Paradigm Health, download the document below. To serve both science and patients, the industry must embrace transformation before inefficiency puts progress out of reach. Sign up for our daily news round-up!

Hospitals

Pharmaceutical Technology

JULY 2, 2025

How will RFK Jr’s American dream for vaccines play out? In addition, documentation of the material is required, along with clearly defined next steps for modification and expansion. Such logistics requires specialists in cold chain logistics, who need to maintain a full chain of custody and ensure traceability.

Packaging

Pharmacy Times

JULY 29, 2025

Geison’s findings, which draw on Pasteur’s previously inaccessible laboratory notebooks, offer detailed documentation of how public scientific claims may be shaped by selective presentation of data.

Department of Veterans Affairs

Pharmaceutical Technology

JULY 16, 2025

How will RFK Jr’s American dream for vaccines play out? Robert Barrie July 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Shares in London-listed GSK closed 1.19% down following the document release. following the document release compared to the market open on 15 July. 1take1shot via Shutterstock.

Documentation

Pharmaceutical Technology

JULY 15, 2025

How will RFK Jr’s American dream for vaccines play out? The net payment made by Sino to acquire LaNova will be approximately $500.9m, a figure that excludes the estimated cash and bank deposits, according to a company document outlining the terms of the transaction.

Packaging

Pharmaceutical Technology

JULY 18, 2025

How will RFK Jr’s American dream for vaccines play out? Comstock said it is not yet clear if the report will be turned into an official agency guidance document, but it will be made publicly available.

FDA

STAT

APRIL 24, 2025

Servicemembers dismissed for refusal to take Covid vaccine are reinstated. Trump orders federal funding be withheld from schools requiring Covid vaccination. CDC vaccine advisory board meeting postponed. ” FDA cancels an advisory committee meeting on flu strains for the upcoming season’s vaccine.

Vaccines

Pharmaceutical Technology

JULY 18, 2025

How will RFK Jr’s American dream for vaccines play out? The concern of ocular toxicity was first highlighted in a document published ahead of the ODAC meeting that took place on 17 July. The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the 23 July PDUFA date.

FDA

PharmD Live

JULY 7, 2025

This aligns with CMS’s push for greater transparency and accurate service documentation. Documentation: The Foundation of Compliance CMS now expects bulletproof documentation for every TCM claim. Proper documentation not only validates services for reimbursement but also shields organizations from costly audits and denials.

Documentation

STAT

APRIL 11, 2025

Judges for the award, one of the highest in American journalism, specifically wrote that STAT “uncovered the ongoing tragedy of sickle-cell patients pressured into sterilization; relentlessly documented the way UnitedHealth Group gobbled up healthcare providers to create a vast network of profit-maximizing patient mills; and showcased a life-saving (..)

Vaccines

Pharmaceutical Technology

JULY 3, 2025

How will RFK Jr’s American dream for vaccines play out? Real-world roadblocks (and how to remove them) When you start implementing these requirements, you’ll face practical challenges that don’t appear in regulatory guidance documents. Or distribute responsibility across existing quality, IT, and operations teams?

Packaging

The FDA Law Blog

JUNE 4, 2025

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. That leaves us to speculate what the implications of this Assessment will be.

Labelling

Drug Topics

JANUARY 10, 2024

The estimated efficacy of the vaccine against documented infection for children and adolescents during the Omicron wave was 74.3% and 85.5%, respectively.

Vaccines

Drug Topics

JANUARY 16, 2023

In the 3 cases documented by researchers, hepatitis B surface antigen (HBsAG) levels were reduced by more than 50% after Japan began its COVID-19 vaccination program.

Vaccines

STAT

NOVEMBER 15, 2022

As the Covid-19 pandemic spread across the world two years ago, one of India’s leading biotech companies was racing to develop a vaccine with crucial backing from the Indian government. Read the rest…

Documentation

STAT

JULY 9, 2025

WASHINGTON — The Department of Health and Human Services is sitting on information about new vaccine advisers’ conflicts of interest, and seemingly backtracking on its vow to make key disclosure documents public. 

Vaccines

STAT

MAY 16, 2023

An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the Food and Drug Administration said Tuesday in an analysis of the data generated to support licensure of the vaccine.

Vaccines

pharmaphorum

MARCH 16, 2021

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. As it conducted its analysis of the vaccine in December, the European Medicines Agency’s systems were targeted by unknown hackers.

Vaccines

STAT

OCTOBER 4, 2023

It’s the end of an era for a once-critical pandemic document: The ubiquitous white Covid-19 vaccination cards are being phased out. Now that Covid-19 vaccines are not being distributed by the federal government, the Centers for Disease Control and Prevention has stopped printing new cards. Read the rest…

Vaccines