Pharmaceutical Technology

JANUARY 19, 2023

The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

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pharmaphorum

JANUARY 5, 2021

Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK announced plans to prioritise the first doses of two approved shots. — Sandip Patel MD (@PatelOncology) January 2, 2021.

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pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Pfizer will pay up to $45 million in development related milestone payments and up to $143 million if the vaccine hits early sales targets.

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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.

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BioPharma Reporter

AUGUST 23, 2021

Valneva today commenced rolling submission for initial approval of its COVID-19 vaccine candidate, VLA2001, with the UK health regulator.

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Vaccination Vaccine Regulation Marketing 105

BioPharma Reporter

FEBRUARY 4, 2021

New Zealandâs regulator Medsafe has given the Pfizer/BioNTech vaccine provisional approval, with border workers the first to be offered the vaccine.

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Vaccination Vaccine Regulation Marketing 98

BioPharma Reporter

AUGUST 21, 2022

EMA has begun its review of the conditional marketing authorization application from South Korean developer, SK biosciences, for its COVID-19 vaccine, Skycovion, a recombinant protein-based vaccine with adjuvant from GSK.

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BioPharma Reporter

JANUARY 7, 2021

The World Health Organizationâs vaccine advisory group recommends the two doses of the Pfizer/BioNTech vaccine should be delivered 21 to 28 days apart: although it adds that the maximum time period between doses could be up to six weeks in some situations.

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BioPharma Reporter

FEBRUARY 1, 2022

US government agency, BARDA, is drawing on industry feedback to assist it in understanding the advanced developmental landscape of next-generation COVID-19 vaccines.

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BioPharma Reporter

OCTOBER 5, 2020

The release of the FDA guidance on emergency use authorization (EUA) for vaccines to prevent the spread of COVID-19 would provide regulatory clarity to scientists and strengthen public confidence in any vaccine authorized by the US regulator, says the Biotechnology Innovation Organization (BIO).

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BioPharma Reporter

DECEMBER 17, 2020

New Zealand now has enough COVID-19 vaccines for everyone in the country, says the government, as it announces two new supply agreements with Novavax and AstraZeneca today.

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Vaccination Vaccine Regulation Marketing 142

BioPharma Reporter

FEBRUARY 28, 2022

Medicago and GlaxoSmithKline (GSK) have gained approval for Covifenz, the companiesâ plant-based COVID-19 vaccine, from Health Canada.

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BioPharma Reporter

JANUARY 29, 2024

The global messenger ribonucleic acid (mRNA) vaccine market currently consists entirely of vaccines for COVID-19.

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Vaccination Vaccine Development Marketing 98

pharmaphorum

OCTOBER 5, 2020

As European regulators begin a rolling review of AstraZeneca’s COVID-19 vaccine, the focus in the UK has shifted to the government’s plans to distribute any vaccine that is deemed to be a safe and effective way of preventing the disease. There is going to be no vaccination of people under 18.

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BioPharma Reporter

JULY 25, 2022

The European Commission has extended the marketing authorization for Bavarian Nordicâs smallpox vaccine, Imvanex, to include protection from monkeypox and disease caused by vaccinia virus.

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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.

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BioPharma Reporter

JANUARY 6, 2021

The EMA has recommended granting a conditional marketing authorization for Modernaâs COVID-19 vaccine, mRNA-1273.

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BioPharma Reporter

DECEMBER 20, 2021

The European Commission has granted conditional marketing authorisation to Novavax for its COVID-19 vaccine: making it the first protein-based COVID-19 vaccine in the EU.

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BioPharma Reporter

AUGUST 10, 2020

Moderna Therapeutics reveals it is selling its COVID-19 vaccine for up to $37 a dose, well above the amount charged by some of its rivals.

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BioPharma Reporter

FEBRUARY 9, 2021

Health officials in Azerbaijan have granted approval for a clinical trial to take place in that country combining Russiaâs Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older.

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BioPharma Reporter

JANUARY 25, 2021

The European Ombudsman is investigating the secrecy with which the EU executive is handling COVID-19 vaccine supply contracts.

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BioPharma Reporter

SEPTEMBER 21, 2020

Sanofi and GSK will provide the EU with up to 300 million doses of their COVID-19 vaccine candidate, with the agreement suppporting scale-up of manufacturing capabilities in several European countries.

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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.

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BioPharma Reporter

DECEMBER 13, 2021

Moderna released what it deemed to be positive interim data from the phase 1 study of its quadrivalent flu vaccine, mRNA-1010, on Friday. But the markets were left underwhelmed.

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BioPharma Reporter

DECEMBER 1, 2020

Johnson & Johnson has started a rolling submission with the European Medicines Agency (EMA) for its single-dose COVID-19 vaccine candidate.

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BioPharma Reporter

JANUARY 20, 2022

Valneva announced yesterday that results from a lab study showed three doses of its inactivated COVID-19 vaccine candidate, VLA2001, neutralized the Omicron variant.

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BioPharma Reporter

DECEMBER 8, 2020

The US Food and Drug Administration (FDA) said there are âno specific safety concerns that would preclude issuance of an EUAâ for the investigational COVID-19 vaccine (BNT162b2) from US pharma giant, Pfizer, and its German partner BioNTech.

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BioPharma Reporter

MARCH 22, 2021

Australiaâs Therapeutic Goods Administration (TGA) has approved manufacture of the AstraZeneca COVID-19 vaccine by CSL â Seqirus: reducing the country's dependence on limited supply from abroad and allowing a wider vaccination campaign to begin.

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Pharma in Brief

DECEMBER 3, 2020

Any authorization for drugs, vaccines, and medical devices issued pursuant to the interim orders are also set to terminate when the respective interim order expires or is withdrawn. Drugs and Vaccines. require market authorization holders to meet post-marketing regulatory requirements; and.

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pharmaphorum

FEBRUARY 22, 2021

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults.

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pharmaphorum

SEPTEMBER 15, 2020

As pharmaceutical marketers prepare their brands for the future, there are a number of important ways they can learn from digitally-native brands. This is reinforced by web-focused marketing strategies that give them a highly-targeted approach when it comes to marketing execution.”. Be more agile .

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pharmaphorum

AUGUST 8, 2022

As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.

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BioPharma Reporter

OCTOBER 27, 2020

Thermo Fisher Scientific is seeing âvery, very significant demandâ for its cold storage range as the race to get COVID-19 vaccines to market enters its closing stages.

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BioPharma Reporter

NOVEMBER 3, 2022

The US Food and Drug Administration (FDA) has granted Priority Review to GSKâs respiratory syncytial virus (RSV) older adult vaccine candidate with a decision expected in May 2023: which could make it the first vaccine approved against the virus.

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BioPharma Reporter

JANUARY 22, 2021

The World Health Organizationâs Global Advisory Committee on Vaccine Safety says it has not seen any unexpected or untoward increase in fatalities in frail and elderly individuals who have received the Pfizer/BioNTech vaccine.

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BioPharma Reporter

JANUARY 6, 2021

AstraZeneca officially announced today the Serum Institute of India, had obtained emergency use authorization in India for its COVID-19 vaccine. It also confirmed the vaccine has been granted emergency use authorization in Argentina, Dominican Republic, El Salvador, Mexico and Morocco.

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BioPharma Reporter

JANUARY 5, 2021

The US FDA has emphasized it will not make any changes to the recommended dosing of authorized COVID-19 vaccines: saying any modifications would create a âsignificant riskâ of undermining vaccination efforts.

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