Pharmaceutical Technology

MAY 4, 2023

After a winter marked by a rise in hospitalisations due to the RSV, the FDA has granted its first approval for an Respiratory Syncytial Virus (RSV) vaccine to GSK’s Arexvy for adults ages 60 years and above. This vaccine specifically prevents RSV-related lower respiratory tract disease (LRTD).

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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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Pharmaceutical Technology

APRIL 24, 2023

Since then, the field of nanomedicine has steadily progressed to reach high points such as the successful use of nanotechnology to deliver messenger RNA (mRNA)-based Covid-19 vaccines. In the case of most mRNA vaccines, a lipid nanoparticle-based approach was chosen due to its ability to protect the mRNA in the body and prevent degradation.

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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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Pharmaceutical Technology

MAY 1, 2023

After a long period of inactivity in RSV vaccine development , two pharmaceutical companies are now approaching regulatory decisions for their RSV vaccines. Both Pfizer and GSK have major approval decisions regarding the use of their RSV vaccines for older adults this May. What incentivises a country to cover a vaccine?

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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

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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Pharma Marketing Network

MAY 11, 2025

The Pharma Marketing Network (PMN), hosted at www.pharma-mkting.com , is an online publication and digital hub built specifically for professionals in pharmaceutical marketing, healthcare advertising, and life sciences communications. PMN delivers timely updates on these changes, often before they impact your next campaign.

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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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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). Non-muscle invasive bladder cancer is characterised by cancer cells that remain only in the lining of the bladder.

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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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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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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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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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Pharmaceutical Technology

MARCH 22, 2023

Among other things, supply chain optimisation, maintaining access to affordable vaccines, and supporting innovation for unmet clinical needs will be the discussion topics, she adds. “The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says.

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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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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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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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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

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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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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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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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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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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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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Pharmaceutical Technology

MARCH 21, 2023

FDA and EMA decisions In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older. Regulatory decisions by the FDA and EMA for select therapies from late January to late February and the CMOs contracted to manufacture the therapies.

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Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. The ABPI points to the FDA in the US as an example. The FDA’s Modernization Act 2.0 This approach to more pragmatic regulation is also trending globally.

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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

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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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

JUNE 6, 2023

In a 2022 annual report, the US Food and Drug Administration’s (FDA) Office of Generic Drugs stated it had approved 106 first generics— the introductory generic competitors of branded drugs. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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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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Pharmaceutical Technology

MAY 26, 2023

Tripling its production capacity, Touchlight can now manufacture 8kg plasmid DNA, a key component for mRNA gene therapies and vaccines. Research into genetic medicines like mRNA vaccines and gene therapies, as well as gene-editing treatments and novel cancer therapies, have driven increased demand for DNA.

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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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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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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