STAT

JUNE 9, 2023

At the meeting, the FDA is asking six independent experts to review a subsequent and larger Phase 3 clinical trial and vote on whether the results confirm Leqembi’s benefit. In documents released this week, FDA reviewers appeared receptive to granting full approval to Leqembi. Track the meeting here and here.

FDA 73

FDA Documentation Vaccines 73

Pharmaceutical Technology

SEPTEMBER 15, 2022

Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. YoY revenue growth.

Vaccines 108

Vaccines Documentation Compounding FDA 108

pharmaphorum

DECEMBER 16, 2020

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%. Both vaccines will be provided free of charge to recipients. The overall 94.5%

FDA 88

FDA Vaccines Documentation 88

pharmaphorum

JUNE 29, 2022

Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). They are however both based on the original BA.1 1 will be “already somewhat outdated.”

Vaccines 52

Vaccines FDA Immunization Documentation 52

pharmaphorum

NOVEMBER 20, 2020

Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end. On the efficacy side, the filing will highlight a vaccine efficacy rate of 95% in a phase 3 study testing patients with and without previous infection with SARS-CoV-2.

Vaccines 79

Vaccines Documentation FDA 79

pharmaphorum

FEBRUARY 25, 2021

Johnson & Johnson’s one-shot coronavirus vaccine is due to be reviewed by an FDA advisory committee on Friday, and according to the regulator meets the requirements for emergency use authorisation. According to the document, clinical trials filed to support the EUA show that Ad26.COV2.S S (JNJ-78436735) was 66.9%

FDA 57

FDA Vaccines Documentation 57

pharmaphorum

DECEMBER 18, 2020

The FDA is looking to quickly approve Moderna’s COVID-19 vaccine after it was unanimously backed by a panel of experts. Pfizer’s vaccine was approved within a day of a positive vote from the Vaccines and Related Biological Products Advisory Committee.

FDA 62

FDA Vaccines Documentation 62

BioPharm

MAY 18, 2023

The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.

Documentation 52

Documentation FDA Vaccines 52

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. As of 2019, about 1.9 million people have type 1 diabetes in the U.S.,

FDA 78

FDA Documentation Compounding Pharmaceutical Companies 78

European Pharmaceutical Review

JULY 7, 2022

However, she notes that useful information for assessing risks in your facility and preparing for upcoming inspections can be gleaned from other’s warning letters and regulatory inspection observation reports, such as FDA 483.

Documentation 97

Documentation Vaccines FDA 97

The FDA Law Blog

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

FDA 108

FDA Documentation Vaccines 108

pharmaphorum

APRIL 7, 2022

It is too early to consider widespread use of a second COVID-19 vaccine booster dose, according to the European Centre for Disease Prevention and Control (ECDC) and EMA’s COVID-19 task force (ETF). FDA gives first thinking on updating vaccines.

Vaccines 57

Vaccines FDA Immunization Documentation 57

pharmaphorum

FEBRUARY 19, 2021

Two researchers have suggested that the second dose of Pfizer and BioNTech’s COVID-19 vaccine could be delayed, as this would increase the number of people that can be protected while supplies are limited without compromising its efficacy. . Feature image copyright BioNTech SE 2020, all rights reserved.

Vaccines 70

Vaccines Immunization Documentation FDA 70

The FDA Law Blog

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For post-approval pregnancy studies, it most certainly does.

FDA 59

FDA Documentation Vaccines 59

ISPE

SEPTEMBER 8, 2023

Attendees were invited to submit questions to the FDA representatives. A highlight of the session was the mutual praise from industry and regulators on how well the two parties worked together during the pandemic to bring vaccines and drugs to the patients in record time. How will the FDA use Annex 1 in its final version?

FDA 52

FDA Vaccines Documentation 52

The Checkup by Singlecare

OCTOBER 17, 2023

Although this infection has been documented with almost all antibiotics, the most frequent offenders include clindamycin , ampicillin, amoxicillin, and cephalosporins. Certain vaccines interact with clindamycin , which can cause a diminished vaccine effect. Antibiotics can increase the risk of an infection called C.

Vaccines 52

Vaccines Dosage Documentation FDA 52

pharmaphorum

JULY 28, 2022

That means maintaining regulatory readiness – because having cGMP compliance problems with the FDA can significantly exacerbate the problem. The extraordinary scenario of producing vaccines for a global pandemic led to a well-documented shortage of vials, stoppers, and syringes, and finding a solution is no easy task.

FDA 99

FDA Dosage Documentation Compounding 99

ISPE

OCTOBER 28, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Dr Gouws added that WHO was the only regulatory authority to have performed inspections of Chinese manufacturers of Covid-19 vaccines during the pandemic.

FDA 97

FDA Vaccines Dosage Documentation 97

pharmaphorum

JANUARY 18, 2022

The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience.

Packaging 52

Packaging FDA Documentation Vaccines 52

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.

Communication 98

Communication FDA Documentation Vaccines 98

ISPE

NOVEMBER 21, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Dr Gouws added that WHO was the only regulatory authority to have performed inspections of Chinese manufacturers of Covid-19 vaccines during the pandemic.

FDA 52

FDA Vaccines Dosage Documentation 52

Pharmaceutical Technology

OCTOBER 28, 2022

QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). For example, the Covid-19 pandemic brought messenger ribonucleic acid (mRNA) vaccines into international prominence.

Vaccines 52

Vaccines Documentation FDA 52

pharmaphorum

JANUARY 29, 2021

The EMA has approved AstraZeneca’s COVID-19 vaccine for use in the EU in all adults aged over 18, despite assertions in Germany this week that it shouldn’t be used in elderly people. That’s in line with the conclusions of the MHRA, which approved the vaccine at the end of last year. Janssen shot 66% effective.

Vaccines 62

Vaccines Documentation FDA 62

pharmaphorum

APRIL 16, 2021

Even with the vaccine roll-out, further waves of COVID infection and lockdowns mean these vital drivers of launch performance remain impacted in 2021, and even beyond. Approval by regulators such as the FDA or EMA, as reported by the regulators themselves. We measured the pandemic impact on the launch of NAS at four levels.

Pharmaceutical Companies 77

Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 77

European Pharmaceutical Review

JANUARY 16, 2023

He warned, “Implementation of a CCS will require more than writing documents.”. This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry.

Vaccines 127

Vaccines FDA Research Laboratories Documentation 127

ISPE

NOVEMBER 22, 2022

Have all requested documents ready and easily accessible. Regulatory authorities participating in this initiative included EMA, US FDA, TGA, Health Canada and WHO. The panel was asked about some of the challenges that inspectors had found when inspecting manufacturers of mRNA vaccines or cell-based medicines.

Documentation 52

Documentation FDA Vaccines 52

Pharmaceutical Technology

FEBRUARY 1, 2023

Pharmaceutical companies have been working on developing vaccines and other prophylactics for respiratory syncytial virus (RSV) since its discovery in 1956. Despite strong efforts and scientific advances, a safe and effective vaccine for RSV has yet to be approved for any patient population.

Vaccines 64

Vaccines Documentation Pharmaceutical Companies Pharmaceutical Companies 64

Pharmaceutical Technology

NOVEMBER 15, 2022

Paxlovid first hit the shelves in the US last December after the Food and Drug Administration (FDA) granted the treatment an emergency use authorisation (EUA). Within Pfizer’s Covid-19 pipeline, Pfizer and BioNtech’s vaccine Comirnaty is also being used to fight the pandemic. 7)) and the other one in common between the BA.4

Vaccines 64

Vaccines Documentation FDA 64

ISPE

OCTOBER 27, 2022

You will get answers to the following questions: How were the fill-finish processes for the SARS CoV-2 vaccines developed and qualified, and how did the manufacturers manage to provide vaccine doses in such large quantities in such a short time? SARS CoV-2 vaccines have been formulated in lipid nanoparticles.

Dosage 98

Dosage Vaccines FDA Documentation 98

European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

Packaging 99

Packaging Vaccines Documentation FDA 99

pharmaphorum

AUGUST 16, 2021

Nearly every element of the clinical trial design, data collection, analysis and approvals has been shortened and this helped ensure the swift rollout of safe and effective vaccines.”. Thankfully, paper-based studies are becoming a thing of the past, but spreadsheets and Word documents are still commonly used to design and build trials.

Documentation 98

Documentation Vaccines Packaging Pharmaceutical Companies 98

pharmaphorum

JANUARY 9, 2023

1 Kenya, for example, entered the pandemic with no human vaccines manufacturing facility and established the BioVax institute for local vaccine manufacture with a major plant investment starting in 2023. For pharma, the impact in critical areas such as the performance of newly marketed innovation has already been documented.

Vaccines 90

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 90

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.

Communication 98

Communication Documentation Immunization Vaccines 98

ISPE

SEPTEMBER 11, 2023

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.” www.boccard.com/evolutive-vaccines-facility-for-sanofi/ 42 Amgen.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

pharmaphorum

SEPTEMBER 16, 2021

Pfizer and Moderna have both reported data that they say backs up the need for booster shots of their COVID-19 vaccines ahead of an FDA advisory committee meeting tomorrow, although the regulator seems less convinced. Administering a third dose restores protective efficacy back up to 95% or more, it said.

FDA 89

FDA Vaccines Documentation 89

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

Documentation 52

Documentation FDA Communication Packaging 52

pharmaphorum

OCTOBER 7, 2020

The FDA may have been blocked from issuing stricter guidelines for emergency approval of COVID-19 vaccines by the Trump administration, but it has still managed to make its new approach public. These standards have been broadly communicated for months and they were well understood across the industry.

Vaccines 57

Vaccines FDA Documentation Communication 57