Pharmafile

APRIL 28, 2023

Pfizer has announced that the US Food and Drug Administration (FDA) has approved its PREVNAR 20 (20-valent pneumococcal conjugate vaccine) for the prevention of invasive pneumococcal disease (IPD) in infants and children from six weeks to 17 years of age. read more

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Pharmafile

APRIL 19, 2023

The FDA has announced its amendment of the emergency use authorisations (EUAs) for the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines in an attempt to simplify the vaccination programme. These amendments mean that: read more

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The FDA Law Blog

JUNE 12, 2024

We are looking forward to seeing the START pilot program chart a path for a broader application of this more enhanced communication approach and FDA’s continued collaboration to facilitate development of new drugs for rare diseases, as we know there are many programs that would benefit from this approach, not just those included in the pilot.

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Communication FDA Vaccines 59

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.

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pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford-AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

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pharmaphorum

SEPTEMBER 27, 2021

As the vaccines were developed and rolled out, the disparity in their take up among different sections of the community highlighted how excluded some minority communities felt from areas of healthcare. And then the COVID-19 pandemic really brought it into sharp relief.

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Vaccines Communication FDA 122

pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

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Vaccines Immunization Medical Schools FDA 59

pharmaphorum

JULY 5, 2021

vaccine effectiveness rates, reading the latest updates on local infection rates and cautiously deciding whether it’s safe or not to see their friends again. we have found macro, population-wide trends that largely echo those that have been reported by the CDC and vaccine manufacturers themselves. As the U.S.

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Pharmaceutical Technology

JANUARY 20, 2023

In 2020, Moderna made a net loss of $747 million while its investigational mRNA vaccines were under development. However, during the Covid-19 pandemic, the US-based biotech rose to prominence as it was one of the first companies to develop Covid-19 vaccines with its mRNA technology. billion in Covid-19 vaccine sales.

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Vaccines Communication FDA 98

Pharma Marketing Network

DECEMBER 5, 2024

Consider Pfizer’s Science Will Win campaign, which highlighted the companys dedication to vaccine development. Overcoming Challenges in Marketing Networks While the benefits of marketing networks are clear, challenges abound: Regulatory constraints : Ensure compliance with FDA and EMA guidelines.

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Digital Pharmacist

NOVEMBER 21, 2022

Food and Drug Administration (FDA) announced its approval of the Boostrix vaccine, commonly known as Tdap (combination of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis) for immunization administration during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age.

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pharmaphorum

DECEMBER 21, 2021

In early 2020, health officials were cautious about forecasting a COVID-19 vaccine timeline to the public, as vaccine discovery was a historically laborious process that took years (if not decades). Yet a successful COVID-19 vaccine gained emergency approval in just 11 months, a blistering pace that likely saved millions of lives.

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European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. The facility aims to support vaccination efforts at both national and international levels.

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European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

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ISPE

NOVEMBER 2, 2022

He shared Pfizer’s approach to reinventing to be able to develop medicines and vaccines faster, an approach that is helping pave the way to future development. Pfizer “cleared runway to allow for large-scale vaccine manufacturing before we had a product!” while clinical trials were still underway, he said.

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ISPE

NOVEMBER 3, 2022

The regulatory keynote was delivered by Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research (CBER), US FDA. Marks outlined some concepts that the FDA is thinking about that could help move in this direction, such as developing a “cookbook” to standardize bespoke product development and manufacturing.

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The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. But we digress.

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Pharma Marketing Network

JANUARY 7, 2025

Because the way your company communicates its value to patients, healthcare providers, and stakeholders can mean the difference between success and failure. For instance, oncology drugs may require unique outreach compared to vaccines like Pfizers Comirnaty. Patients and healthcare providers alike expect clear, honest communication.

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The Checkup by Singlecare

OCTOBER 17, 2023

Certain vaccines interact with clindamycin , which can cause a diminished vaccine effect. The cholera vaccine (Vaxchora) should be avoided in people receiving antibiotics and for another 14 days following oral antibiotics. Another vaccine affected by a drug interaction with clindamycin is the oral typhoid vaccine , Vivotif.

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Vaccines Documentation FDA Dosage 52

The Checkup by Singlecare

OCTOBER 6, 2023

The interaction is severe enough that prescribing information for many NSAIDs warns against the concomitant use of corticosteroids in a Food and Drug Administration (FDA) issued Medication Guide. Still, they are independently associated with many significant side effects, much so that the FDA has issued guidance regarding their use.

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The Checkup by Singlecare

SEPTEMBER 27, 2023

Nitrofurantoin can interact with certain antacids, gout medications, anesthetics, and travel vaccines. This includes some antacids, gout medications, anesthetics, and travel vaccines, as well as methotrexate and fluconazole. However, sulfinpyrazone has been discontinued by the Food and Drug Administration (FDA).

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ISPE

OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , Complete Data Gathering.

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ISPE

JUNE 27, 2023

The session included regulators from the European Medicines Agency (EMA), the UK Medicines & Healthcare Products, Regulatory Agency (MHRA), the Spanish Agency of Medicines and Medical Products (AEMPS) and the US Food and Drug Administration (FDA). In answer to the question, what does the industry have to do?

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Communication FDA Vaccines 52

ISPE

AUGUST 16, 2023

Food and Drug Administration (FDA). “By For example, for product and inspection types included under the MRA with the US, this resulted in a reduction of inspections conducted by EU authorities in the USA by 70%, as inspections conducted by the FDA could be relied on. View Past Event Quality Regulatory GMP Lifcyc Mgmt Regulatory

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PQA

DECEMBER 15, 2022

To support pharmacists’ ability to assess patients’ immunization needs and successfully close gaps in care related to vaccinations, immunization authority should be consistent across states and pharmacy practice sites.

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The Checkup by Singlecare

SEPTEMBER 13, 2024

Choosing between Fasenra and Nucala to manage severe asthma requires complex decision-making and communication with your healthcare provider, but having an understanding of how the drugs work can help you understand why they may prescribe one over the other. Nonetheless, there are some matters of concern.

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ISPE

MARCH 8, 2023

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.

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ISPE

SEPTEMBER 11, 2023

Nature Communications 12, no. Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” www.fiercepharma.com/manufacturing/sanofi-pumps-554m-into-new-vaccine-manufacturing-facility-eastern-france 41 Boccard. New Project: Evolutive Vaccines Facility for Sanofi.” Biotechnology Progress 36, no.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

Viseven

DECEMBER 4, 2024

It ensures compliance The Food and Drug Administration (FDA) in the U.S. This type of validation is particularly useful for fast product launches (think the COVID-19 vaccine) when there is no time for prospective validation. The FDA suggests using measurable data to monitor performance accurately.

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ISPE

MAY 9, 2023

Jaguar Gene Therapy is building a $125 million facility in RTP to manufacture adeno-associated virus (AAV)-based gene therapies, Beam Therapeutics is constructing an $83 million plant to develop precision medicines, and IQVIA, a CRO, opened an innovation lab in the park in 2021, focusing on bioanalytics, vaccines, biomarkers, and genomics.

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ISPE

AUGUST 29, 2022

In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The FDA has also offered both early dialogue and training to share knowledge and experience with the industry, providing an excellent example for other regulators to follow.

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PharmaShots

APRIL 3, 2023

of the newly combined company The combined companies’ focus is to advance Elicio’s lymph node-targeting amphiphile technology to develop immunotherapies & also focus on ELI-002, a therapeutic cancer vaccine targeting mKRAS-driven tumors is currently being evaluated in the P-I trial (AMPLIFY-201) for PDAC and CRC. ORR (41.8%

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The Checkup by Singlecare

NOVEMBER 13, 2023

To help decrease the risk of shingles, Shingrix vaccine is FDA-approved for adults 50 and older. It is a two-vaccine series and significantly decreases the risk of a shingles outbreak. Asthma is a non-communicable disease that causes difficulty in breathing, and it may cause sharp pain on the right side of the chest.

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ISPE

AUGUST 30, 2022

Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). It is considered a moderate change by the FDA (CBE30) and NMPA. This change ranges from a moderate change (CBE-30) by the FDA to a minor change not requiring prior approval by the WHO.

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Documentation FDA Packaging Communication 52

pharmaphorum

AUGUST 27, 2020

Already under fire for what some view as a premature authorisation of convalescent plasma for COVID-19, the FDA is now being accused of a blunder that could render current supplies unusable. Now, tragically, there is zero credibility for the upcoming @US_FDA review of #SARSCoV2 vaccines in the months ahead. .

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pharmaphorum

DECEMBER 15, 2022

Back in 2015, the influencer-of-influencers, Kim Kardashian, was slammed for failing to mention the potential side effects of an anti-nausea drug, leading to the US FDA getting involved. This approach has not been free from controversy, however. Nonetheless, it does show that care needs to be taken when designing similar campaigns.

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The Checkup by Singlecare

MARCH 28, 2024

Food and Drug Administration (FDA) to treat many bacterial infections. Amoxicillin is FDA-approved for treating nose, throat, ear, lung, skin, and urinary tract infections. This can be done in several ways, including abstaining from sexual activity, vaccination, and mutual monogamy. Can amoxicillin treat STDs?

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