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 102

Vaccines Communication Immunization Documentation 102

BioPharm

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 FDA 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 131

Vaccines Documentation 131

Drug Topics

NOVEMBER 3, 2023

By way of natural immunity, vaccination, and behavior change, the majority of the 30,861 documented cases and 54 deaths were confined to 2022, and the epidemic curve portrays a picture of success.

Documentation 98

Documentation Immunization Vaccines 98

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 FDA Adverse Reactions Documentation 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 85

Vaccines Immunization Documentation 85

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 88

Vaccines Documentation FDA 88

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 110

Vaccines Documentation FDA 110

STAT

JANUARY 23, 2023

Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. For people who are older or immunocompromised, the FDA would recommend two annual doses of the revised shot.

FDA 133

FDA Documentation Vaccines 133

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

Pharma Times

JULY 27, 2023

New HSCC document deems the UK’s vaccination position to be at risk - News - PharmaTimes

Vaccines 47

Vaccines Documentation 47

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 FDA Documentation Immunization 105

Omnicell

JANUARY 10, 2023

Howard Montgomery, MS, RPh Director, Clinical Consulting, Omnicell The biggest vaccination campaign in history is now underway and scaling fast. The vaccine rollout brings unique logistical challenges, especially for health system pharmacy as they need to manage inventory across multiple, diverse locations.

Vaccines 52

Vaccines Omnicell Documentation Compounding 52

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

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 81

Vaccines Documentation FDA 81

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 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 FDA Immunization Documentation 52

Omnicell

SEPTEMBER 5, 2022

Danny Sanchez VP and General Manager, EnlivenHealth® As news emerged about the positive COVID-19 vaccine trial results from Pfizer and its German partner BioNTech, the attention turned to how the vaccine would be distributed and administered to 330 million Americans.

Vaccines 52

Vaccines Documentation Communication 52

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 85

Vaccines Documentation 85

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

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

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

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

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 97

Documentation Vaccines FDA 97

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 97

Vaccines Documentation 97

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.

FDA 59

FDA Vaccines Documentation 59

PQA

MARCH 3, 2023

The second edition of the guide documents real-world SDOH services that are promising for improving the quality and safety of medication use. The appendix documents a host of characteristics and subcategories for the initiatives to aid in ease of identification.

Vaccines 52

Vaccines Documentation Community Pharmacies 52

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 64

FDA Vaccines Documentation 64

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 FDA Immunization Documentation 59

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.

FDA 90

FDA Vaccines Documentation 90

Pharmaceutical Technology

MARCH 10, 2023

Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity. The process eliminates the disadvantages of conventional drying methods or freezing.

Documentation 59

Documentation Packaging Vaccines 59

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 72

Vaccines Immunization Documentation FDA 72

pharmaphorum

NOVEMBER 10, 2020

The UK’s NHS is ready to start rolling out a coronavirus vaccine, likely beginning in the new year, according to health secretary Matt Hancock. In an interview with the BBC Hancock said that the vaccine could be available by Christmas, but he expected a mass roll out “in the first part of the new year”.

Vaccines 59

Vaccines Documentation 59

pharmaphorum

JUNE 2, 2021

The first batch of EU countries have started recognising the vaccination status of travellers using digital vaccine certificates as the bloc moves towards freeing up travel ahead of the summer period. Europeans should enjoy a safe and relaxing summer.

Vaccines 81

Vaccines Documentation 81