Marketing, Medicine, Regulation and Vaccination

UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine

pharmaphorum

JANUARY 7, 2021

The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. As things stand, the two rival mRNA-based vaccines from Pfizer/BioNTech and Moderna are now approved for use in the EU.

Vaccination

FDA starts speedy review of Takeda’s dengue vaccine

pharmaphorum

NOVEMBER 23, 2022

The US regulator has started a priority, six-month review of Takeda’s dengue fever vaccine TAK-003 – tipped as a potential blockbuster product – making a decision likely in the first half of 2023. It was recommended for approval by the EMA’s human medicines committee, the CHMP, last month. billion in peak sales.

Vaccination

Vaccination Vaccine Marketing Sales

Breaking through the forecasting fog – 3 trends that will impact critical medicine supply in 2023

pharmaphorum

JANUARY 27, 2023

So, here are three “best guesses” for what 2023 will hold for the off-patent medicines segment — which accounts for roughly 70% of medicines prescribed worldwide (including the vast majority of system-critical antibiotics and ICU therapies), but only about 20% of the total cost.

Medicine

Medicine Production Marketing Packaging

Germany and Canada restrict AZ vaccine again over blood clot fears

pharmaphorum

MARCH 31, 2021

Germany and Canada have both slapped restrictions on the AstraZeneca vaccine, recommending its use only in older patients, because of concerns over a link with blood clots. According to STIKO the side effect occurred four to 16 days after vaccination and was predominantly seen in people under 60 years of age.

Vaccination

Regulation optimisation could save thousands of life years

pharmaphorum

DECEMBER 14, 2021

The first publication focused on market and patient access, whereas the new report concentrates on the final part of the route to marketing authorisation: from the final scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) to the final decision of the European Commission (EC). Tide of change.

Regulation

Regulation Marketing Life Science Medicine

Moderna Works With International Regulators to Speed Up COVID-19 Vaccine Review Process

The Pharma Data

OCTOBER 15, 2020

Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson. The Cambridge, Mass.-based

Regulation

Regulation Vaccination Vaccine Trials

Takeda dengue vaccine receives positive CHMP opinion

pharmaphorum

OCTOBER 17, 2022

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Takeda GmbH’s live, attenuated dengue tetravalent vaccine, Qdenga ( TAK-003 ). Medicines submitted under EU-M4all are assessed by the CHMP in collaboration with the WHO and target countries.

Vaccination

Deep Dive: Market Access

pharmaphorum

APRIL 30, 2021

It’s fair to say this is the most interesting time ever for market access. Not only has COVID forced companies, governments and healthcare systems to work towards approving drugs and vaccines in record times, the sector is also facing an influx of digital therapeutics and advanced drugs that don’t fit neatly into existing access frameworks.

Marketing

Marketing Sales Regulation Pharma Companies

mRNA Cancer Vaccines and Therapies: An Overview

Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. Personalized medicine using genetic resequencing techniques, such as cell and gene therapies, enables researchers to create more customized therapies for combatting cancer.

Vaccination

Vaccination Vaccine Protein Antibody

EU orders 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine

pharmaphorum

NOVEMBER 12, 2020

The European Union has ordered 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine following this week’s landmark announcement that it was effective in more than 90% of patients. Vaccine doses for Europe will be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium.

Vaccination

Vaccination Vaccine Manufacturing Regulation

Scottish regulator approves first chronic hepatitis delta virus drug

Drug Discovery World

MARCH 17, 2023

The Scottish Medicines Consortium (SMC) has become the first UK health authority to permit routine NHS use of Gilead Sciences’ Hepcludex (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection. The conditional marketing authorisation was granted based on the results of two Phase II studies, MYR202 and MYR 203.

Regulation

Regulation Drugs Licensing Licensing

EMA panel backs COVID-19 vaccines targeting Omicron BA.1

pharmaphorum

SEPTEMBER 2, 2022

The EMA’s human medicines committee (CHMP) has recommended authorisation of two COVID-19 vaccines from Moderna and Pfizer/BioNTech that include sequences coding for Omicron spike protein as booster shots. The FDA has just authorised vaccines from the two companies that will specifically target the BA.4 Moderna’s BA.1

Vaccination

Vaccination Vaccine Protein Regulation

Pfizer/BioNTech to deliver COVID-19 vaccine to UK after approval

pharmaphorum

DECEMBER 2, 2020

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. Distribution will be prioritised – the Joint Committee on Vaccine and Immunisation has already set out priority groups who will receive the vaccine.

Vaccination

Vaccination Vaccine Regulation RNA

Pfizer and Moderna apply for European COVID-19 vaccine authorization

BioPharma Reporter

DECEMBER 1, 2020

Pfizer/BioNTech and Moderna have each submitted formal applications for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their COVID-19 vaccines: completing the rolling review process.

Vaccination

Biosimilars: a rapidly maturing market

pharmaphorum

FEBRUARY 23, 2022

Ben Hargreaves takes a look at why uptake began slowly in both the EU and the US, and then began to accelerate to see biosimilars take a large portion of market share away from originator products. One way in which the pharmaceutical industry and regulators have reacted is by developing or facilitating the development of biosimilars.

Marketing

Marketing Production Development Medicine

Innovation across the healthcare system is needed to realise the value of medicines

pharmaphorum

APRIL 11, 2022

Janssen’s Catherine Taylor, vice-president, EMEA medical affairs, therapy area strategy, discusses the importance of systemic innovation across the healthcare system to realise the full value of medicines. Medicines and vaccines are among the most powerful interventions that can help improve quality of life for people across the world.

Medicine

Medicine Clinical Trials Clinical Trials Development

Pfizer/BioNTech say COVID-19 vaccine could be approved in Europe by year-end

pharmaphorum

DECEMBER 1, 2020

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. The filing for a conditional marketing authorisation completed the rolling submission process that began on October 6.

Vaccination

Vaccination Vaccine RNA Clinical Trials

Russia’s COVID-19 vaccine filed with WHO, as MHRA reviews Moderna shot

pharmaphorum

OCTOBER 27, 2020

Russia’s sovereign wealth fund has filed applications with the World Health Organization (WHO) that if approved could see the Sputnik V coronavirus vaccine backed for use in many countries around the world. The vaccine is based on two adenovirus vectors (Ad5 and Ad26) fused with the spike protein from the SARS-CoV-2 coronavirus.

Vaccination

Vaccination Vaccine Medicine Manufacturing

EMA finds possible link to AstraZeneca vaccine and very rare cases of unusual blood clots: Regulator not recommending age or gender restrictions

BioPharma Reporter

APRIL 7, 2021

The European Medicines Agencyâs safety committee, PRAC, has concluded there is a possible link between the use of AstraZenecaâs COVID-19 vaccine and rare side effects of unusual blood clots and low blood platelets in individuals who received the shot.

Vaccination

Cyberattack targets EMA, hacks COVID-19 vaccine data

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.

Vaccination

Vaccination Vaccine Pharma Companies Medicine

The Pandemic Treaty and the opportunity to end ‘vaccine apartheid’

pharmaphorum

DECEMBER 16, 2022

Ben Hargreaves discovers why some have referred to the distribution of COVID-19 vaccines and treatments as a form of apartheid. There are already rules that dictate how countries should react against public health events that have the potential to traverse country borders, through the International Health Regulations. Reacting faster.

Vaccination

Vaccination Vaccine Production Licensing

Valneva focuses its sights on the EU for its inactivated COVID-19 vaccine candidate

BioPharma Reporter

DECEMBER 6, 2021

The European Medicines Agency (EMA) has started a rolling review of VLA2001, Valnevaâs COVID-19 vaccine candidate, with the company set to supply up to 60 million doses to the European Union.

Vaccination

WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines

The Pharma Data

NOVEMBER 6, 2020

In their joint statement, international medicines regulators and WHO reiterate that therapeutics and vaccines against COVID-19 can only be rapidly approved if applications are supported by robust and sound scientific evidence that allows medicine regulators to conclude on a positive benefit-risk balance for these products.

Medicine

Medicine Vaccination Vaccine Clinical Trials

Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

Manufacturing

Manufacturing Vaccination Vaccine Packaging

UK appoints COVID-19 vaccine rollout minister as country preps for launch

pharmaphorum

NOVEMBER 30, 2020

The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine. The vaccines can only be kept in a fridge for up to five days before being administered, although Pfizer has designed a “pizza box” style transportation container.

Vaccination

Vaccination Vaccine Medicine Production

Complex Medicines: A multi-billion-pound addition to the UK life sciences industry

pharmaphorum

JULY 19, 2021

A new report published by Medicines Discovery Catapult and CPI details the huge medical and market potential for complex medicines in the UK. A complex medicine applies novel technologies that deliver or target drugs, by modification of a pharmaceutical ingredient, formulation or using a new delivery route.

Life Science

Life Science Medicine RNA Vaccination

UK faces “V-Day” and largest ever vaccination programme

pharmaphorum

DECEMBER 7, 2020

Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial. Health secretary Matt Hancock reportedly came up with the wartime analogy to describe what will be the largest scale vaccination programme in the country’s history.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

UK gives Moderna's COVID-19 vaccine the green light

BioPharma Reporter

JANUARY 8, 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorized Moderna's COVID-19 vaccine for people aged 18+ in the UK: marking the fifth jurisdiction to give the vaccine the green light.

Vaccination

Vaccination Vaccine Medicine Production

Moderna seeks CMA for COVID-19 vaccine booster shot in the EU

BioPharma Reporter

SEPTEMBER 6, 2021

Moderna has submitted data for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of its COVID-19 vaccine.

Vaccination

Brexit could hinder access to coronavirus vaccines, says pharma group

pharmaphorum

NOVEMBER 26, 2020

The UK’s pharma industry trade body has warned that Brexit could derail the government’s efforts to get coronavirus vaccines to the population, but welcomed other measures in this week’s spending review aimed at reviving the economy after the pandemic.

Vaccination

Vaccination Vaccine Life Science Regulation

Data shows antibody persistence for Moderna COVID-19 vaccine

BioPharma Reporter

APRIL 8, 2021

Moderna today highlighted the publication of antibody persistence data out to six months following the second dose of its COVID-19 vaccine in The New England Journal of Medicine.

Antibody

Antibody Vaccination Vaccine Medicine

EMA recommends authorization for Pfizer/BioNTech COVID-19 vaccine

BioPharma Reporter

DECEMBER 21, 2020

The European Medicines Agency (EMA) has recommended authorization of the Pfizer/ BioNTech COVID-19 vaccine: paving the way for the first marketing authorization of a COVID-19 vaccine in Europe.

Vaccination

CureVac starts rolling review in Europe for COVID-19 vaccine

BioPharma Reporter

FEBRUARY 12, 2021

CureVac has initiated a rolling review with the European Medicines Agency, working towards authorization for its mRNA COVID-19 vaccine in the European Union.

Vaccination

EU regulators back uses for AZ’s Lynparza in prostate and ovarian cancer

pharmaphorum

SEPTEMBER 21, 2020

AstraZeneca may have had a rough ride following a safety scare with its COVID-19 vaccine, but the company’s busy pipeline is producing successes in other areas. Lynparza was the first PARP (poly (ADP-ribose) polymerase) drug on the market in 2014, first approved in the US for ovarian cancer.

Regulation

Regulation Marketing Gene Trials

EMA review of AZ’s COVID-19 vaccine imminent; report

pharmaphorum

OCTOBER 1, 2020

The EU regulator is poised to start a review of AstraZeneca and Oxford University’s COVID-19 vaccine, but the FDA is widening its investigation into the shot’s safety, according to reports citing people close to the project. The post EMA review of AZ’s COVID-19 vaccine imminent; report appeared first on.

Vaccination

Vaccination Vaccine Trials Clinical Trials

Tackling virus variants: EMA publishes guidelines for modified COVID-19 vaccines

BioPharma Reporter

MARCH 3, 2021

The European Medicines Agency (EMA) has published guidance outlining the regulatory requirements for manufacturers planning to modify their COVID-19 vaccines against SARS-CoV-2 variants.

Vaccination

Vaccination Vaccine Manufacturing Medicine

Belgium halts dosing of J&J COVID vaccine in under 41s after death

pharmaphorum

MAY 26, 2021

Belgium’s Ministry of Health has paused dosing of people under the age of 41 with Johnson & Johnson’s one-shot COVID-19 vaccine, following the death of a woman from what appeared to be a blood clot-related condition. . Last month, the EU regulator concluded that the benefits of the vaccine still outweigh any risks.

Vaccination

European decision on Pfizer/BioNTech COVID-19 vaccine moves closer

BioPharma Reporter

DECEMBER 15, 2020

The European Medicines Agency has brought forward a key meeting to assess the Pfizer/BioNTech COVID-19 vaccine: with its committee now convening a week earlier than scheduled.

Vaccination