Express Pharma

AUGUST 23, 2023

The study was performed to understand whether the immunity gained after vaccination or a prior infection was less effective or “leaky” in situations where people are exposed to high levels of the virus.

Vaccines 86

Vaccines Documentation Immunity Immunization 86

Pharmaceutical Technology

MARCH 28, 2024

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

Documentation 113

Documentation Vaccines 113

European Pharmaceutical Review

DECEMBER 19, 2023

Many of today’s vaccines are produced in ready-to-inject liquid formulations that must be kept cold to maintain stability. However, this greatly complicates both the worldwide distribution and stockpiling of vaccines and other drugs. A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient.

Vaccines 98

Vaccines Communication Immunity Immunization 98

PharmaTech

OCTOBER 24, 2023

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

Vaccines 52

Vaccines Documentation 52

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 130

Vaccines Documentation 130

pharmaphorum

DECEMBER 9, 2020

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The post FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel appeared first on.

Vaccines 111

Vaccines Adverse Reactions Documentation Immunity 111

pharmaphorum

DECEMBER 10, 2020

The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed. Shortly after however BioNTech confirmed that documents submitted as part of its marketing application for coronavirus vaccine BNT-162b had been accessed by the hackers.

Vaccines 111

Vaccines Documentation 111

European Pharmaceutical Review

NOVEMBER 18, 2022

The World Health Organization (WHO)’s Global Vaccine Market Report 2022 , the first report to examine the impact of COVID-19 on the global vaccine market, shows that inequitable distribution is not unique to COVID-19 vaccines, with poorer countries consistently fighting to access vaccines in demand by wealthier countries.

Vaccines 81

Vaccines Immunity Immunization Documentation 81

pharmaphorum

DECEMBER 10, 2020

The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone to serious allergic reactions. Both recovered after appropriate treatment. Both are recovering well.”.

Vaccines 87

Vaccines Documentation 87

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 Drug Pricing Biosimilars Documentation 108

pharmaphorum

DECEMBER 4, 2020

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.

Vaccines 109

Vaccines Documentation 109

pharmaphorum

SEPTEMBER 17, 2020

US medical experts are reportedly concerned that a neurological side effect picked up in AstraZeneca’s closely-watched COVID-19 vaccine trial could compromise the whole project, as the FDA weighs whether to give the go ahead for US studies to resume. The post US experts stress over safety of AZ’s COVID-19 vaccine appeared first on.

Vaccines 105

Vaccines Documentation Immunity Immunization 105

pharmaphorum

JANUARY 13, 2021

Hackers posted stolen confidential information about Pfizer/BioNTech’s COVID-19 vaccine online, the European Medicines Agency has said in an update. The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records.

Vaccines 67

Vaccines Documentation 67

pharmaphorum

JANUARY 28, 2022

The failure of the European Commission to locate text messages between its president Ursula von der Leyen and Pfizer chief executive Albert Bourla on procurement of COVID-19 vaccine has earned a rebuke from the EU Ombudsman. billion doses of Pfizer and BioNTech’s vaccine. billion doses of Pfizer and BioNTech’s vaccine.

Vaccines 64

Vaccines Documentation 64

NY Times

OCTOBER 4, 2021

The findings, which also document a waning of protection against infection, come as officials debate the necessity and timing of booster shots.

Hospitals 98

Hospitals Documentation Vaccines Immunity 98

pharmaphorum

JULY 12, 2022

Researchers in the US have started a clinical trial of a vaccine against Nipah virus, a serious infection caught from animals that has a fatality rate of between 40% and 70%, developed by mRNA specialist Moderna. “The need for a preventive Nipah virus vaccine is significant,” he added.

Vaccines 52

Vaccines Documentation Immunity Immunization 52

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 Immunity 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 80

Vaccines Documentation 80

Express Pharma

JUNE 20, 2023

The vaccine efforts of the COVID-19 pandemic highlighted our knowledge about gaps in the immune system. Institutional support, such as expert consultants, essential document templates, and protocols for regulatory submissions, is also vital. However, the spotlight has shifted to unravelling the complexities of the human immune system.

Immunity 100

Immunity Immunization Vaccines Hospitals 100

Eye on FDA

NOVEMBER 17, 2020

Coincident to COVID-19 case levels in Europe and the United States entering new and serious levels comes welcome news on the development of a vaccine. While vaccination may actually begin in December, the number of doses will be limited. In addition, the process of vaccination takes time.

Communication 81

Communication Vaccines HIPAA Documentation 81

European Pharmaceutical Review

JUNE 29, 2022

As the healthcare sector grows, there is a clear trend towards the expansion of biologic therapeutic drugs and vaccines like the one developed by Novavax. To summarise, bioproduction hurdles include the necessity to be fast, agile and, not to be understated, able to deliver safe and effective vaccines worldwide. _4W2cWlEb439CWlu?startTime=1632749714000

Vaccines 81

Vaccines Documentation 81

pharmaphorum

FEBRUARY 24, 2021

AstraZeneca has said it will be able to meet a target to deliver 180 million COVID-19 vaccines to the EU in the second quarter, by topping up the supply from its global production network. However there is hope that vaccine production will be stepped up later on in the year, according to Reuters.

Vaccines 53

Vaccines Documentation 53

Pharma Pathway

JANUARY 30, 2023

It Specialises in the areas of low-cost Vaccine Production. Manufacturing Vaccines (Drug Substances): Antigen Manufacturing Officer Department: Manufacturing Position: Officer Qualification: B.Sc Execution of documentation activities of liaison with QA & QC for GMP Compliance.

Documentation 66

Documentation Vaccines 66

PharmaTech

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 40

Documentation Vaccines 40

STAT

JUNE 9, 2023

In documents released this week, FDA reviewers appeared receptive to granting full approval to Leqembi. Pfizer developed a vaccine that, if approved, will be given in pregnancy. Track the meeting here and here. The drug was developed by AstraZeneca, and will be marketed in the U.S. Continue to STAT+ to read the full story…

Documentation 191

Documentation Vaccines 191

pharmaphorum

JULY 14, 2022

The European Commission’s failure to reveal text messages between president Ursula von der Leyen and Pfizer chief executive Albert Bourla on COVID-19 vaccine procurement has earned it a formal rebuke from the EU Ombudsman. billion doses of Pfizer and BioNTech’s vaccine. billion doses of Pfizer and BioNTech’s vaccine.

Documentation 52

Documentation Vaccines 52

European Pharmaceutical Review

JULY 7, 2022

In an article published in the Journal of GXP Compliance , Moldenhauer explained what can be learned from the observations for a vaccine production facility published in a redacted FDA 483 Report as an example. One cannot just assume that a repair has no effect on the production,” with the rationale for change and impact decision documented.

Documentation 95

Documentation Vaccines 95

pharmaphorum

MAY 3, 2022

. “From the beginning of the pandemic, we noted inequities in the way the US population was experiencing disease incidence – the cases of COVID and the access to testing, level of clinical services available, and, when the vaccine became available, differential levels of access to the vaccine,” Labrique says.

Vaccines 103

Vaccines Documentation 103

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. S vaccine – developed by J&J’s Janssen Biotech unit – is “consistent” with recommendations in its EUA guidance for COVID-19 vaccines.

Vaccines 59

Vaccines Documentation 59

pharmaphorum

NOVEMBER 10, 2021

After being hailed as a triumph of public-private drug development, Moderna’s partnership with the US government on its COVID-19 vaccine looks like it may descend into acrimony.

Vaccines 96

Vaccines Documentation Drug Development 96

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.

Vaccines 64

Vaccines Documentation 64

Pharma in Brief

SEPTEMBER 22, 2020

On September 16, 2020, the Minister of Health signed an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the Interim Order ) which provides new regulatory pathways to expedite the approval of COVID-19 drugs and vaccines that have not yet been approved for sale in Canada.

Vaccines 98

Vaccines Documentation Labelling 98

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 59

Vaccines Immunity Immunization Documentation 59

Pharma in Brief

JANUARY 19, 2023

Feedback on the Regulatory Amendments and draft guidance documents can be submitted to Health Canada here. We previously reported on the IO here.

Documentation 52

Documentation Labelling 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.

Diabetes 204

Diabetes Biosimilars Documentation Compounding 204

Express Pharma

SEPTEMBER 18, 2023

Our virtual twins have been used to swiftly develop COVID-19 vaccines, optimise surgical procedures, and provide patients with a greater understanding of treatment options.

Documentation 93

Documentation Communication Vaccines 93

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.

Vaccines 89

Vaccines Documentation Diabetes 89