Pharmaceutical Technology

NOVEMBER 17, 2023

million doses of its omicron-adapted mRNA vaccine for Covid-19. Daiichi Sankyo has signed an agreement with Japan's MHLW to deliver 1.4

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Vaccination Vaccine 235

Pharmaceutical Technology

SEPTEMBER 19, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). These antibodies are obtained from B-cells of convalescent Covid-19 patients.

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Pharmaceutical Technology

JUNE 9, 2023

recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta) This marks the world’s first Covid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2. is a Covid-19 vaccine with a broad spectrum to tackle several prevalent subvariants in China and globally. and XBB1.9,

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Pharmaceutical Technology

MARCH 31, 2023

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. It is expected to be as effective as Pfizer /BioNTech’s Comirnaty Covid-19 vaccine. The booster recommendation comes at a time when the future for Covid-19 vaccine rollouts is uncertain.

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Pharmaceutical Technology

SEPTEMBER 6, 2023

The UK MHRA has granted approval for Pfizer and BioNTech’s adapted Covid-19 vaccine (Comirnaty) targeting the Omicron XBB 1.5 subvariant.

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Vaccination Vaccine 246

Pharmaceutical Technology

APRIL 5, 2023

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to InflaRx’s Gohibic (vilobelimab) to treat critically ill hospitalised Covid-19 adult patients. It is a first-in-class monoclonal anti-human complement factor C5a antibody.

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Licensing Licensing Antibody Regulation 246

Pharmaceutical Technology

DECEMBER 7, 2022

Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. The trial is designed to analyse the safety and effectiveness of the vaccine.

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Rethinking Clinical Trials

JANUARY 10, 2024

In this Friday's PCT Grand Rounds, Erin McCreary of the University of Pittsburgh will present "Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce COVID-19 Resources." The Grand Rounds session will be held on Friday, January 12, 2024, at 1:00 pm eastern. Join the online meeting.

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Clinical Trials Clinical Trials Clinical Research Medicine 183

Pharmaceutical Technology

JULY 21, 2022

AstraZeneca has signed a deal with the Federal Office of Public Health (FOPH) of Switzerland to deliver over 1,200 doses of antibody therapy, tixagevimab and cilgavimab combination (AZD7442), for Covid-19 prevention and treatment. 5 variants and can soon be used in Switzerland for the treatment and the prevention of Covid-19.”.

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Pharmaceutical Technology

APRIL 3, 2023

The World Health Organisation (WHO) has revised its recommendations regarding the use of Covid-19 vaccines following a meeting of the agency’s Strategic Advisory Group of Experts on Immunisation (SAGE). SAGE also updated its guidance on bivalent Covid-19 vaccines, now recommending the use of bivalent BA.5-specific

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Vaccination Vaccine 278

BioPharma Reporter

APRIL 2, 2024

The FDA has agreed to permanently remove several social media posts urging people not to take ivermectin for the treatment of COVID-19, after a lawsuit brought by three doctors accused the regulatory body of interfering with their ability to practice medicine.

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Doctors Doctor Medicine Regulation 145

Pharmaceutical Technology

MARCH 28, 2024

Discover the groundbreaking patent by Atea Pharmaceuticals for treating COVID-19 with purine nucleotide phosphoramidates. Learn about the compound's specific configurations and dosing regimens for optimal efficacy.

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Pharmaceutical Technology

SEPTEMBER 16, 2022

Gilead Sciences has received expanded recommendation under the World Health Organization’s (WHO) Therapeutics and COVID-19: living guideline for the use of Veklury (remdesivir) to treat severe Covid-19 patients.

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Allergies RNA Clinical Trials Clinical Trials 277

World of DTC Marketing

APRIL 11, 2021

QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Both Pfizer and Moderna stand to make billions, and even though J&J said they would not make money on the first batch, they are already positioning yearly Covid Vaccine shots that could net them billions in sales.

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Vaccination Vaccine Clinical Trials Clinical Trials 303

Pharmaceutical Technology

JANUARY 26, 2023

Health Canada has accepted for review Valeo Pharma partner Veru’s new drug submission (NDS-CV) for Covid-19 therapy sabizabulin. In September last year, Valeo Pharma and Veru entered into a commercial services agreement in Canada for the agent as Covid-19 treatment. in deaths against placebo.

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Clinical Trials Clinical Trials Trials Antibody 246

Pharmaceutical Technology

NOVEMBER 9, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 In October, Health Canada granted approval for Pfizer Canada and BioNTech’s bivalent Covid-19 vaccine, Comirnaty, as a 30?g

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Vaccination Vaccine Regulation Medicine 264

Pharmaceutical Technology

APRIL 13, 2023

The expanded licence will include the development of vaccines and therapeutic proteins beyond Covid-19 for human and animal health markets in Africa. During the Covid-19 pandemic, vaccination rates of many countries in Africa were significantly trailing the rest of the world.

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Production Vaccination Vaccine Protein 279

Pharmaceutical Technology

JULY 7, 2022

Brii Biosciences and TSB Therapeutics have commercially launched a long-acting neutralising antibody therapy combination, amubarvimab/romlusevimab, for Covid-19 in China. The two non-competing SARS-CoV-2 monoclonal neutralising antibodies, amubarvimab and romlusevimab are obtained from convalesced Covid-19 patients.

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Antibody Clinical Trials Clinical Trials Production 264

Pharmaceutical Technology

NOVEMBER 20, 2022

The UK's National Institute for Health and Care Excellence (NICE) has published a draft guidance that does not recommend the use of five major Covid-19 therapies. Between November 5 and November 12, a total of 20,588 people have reported testing positive for Covid-19 in England, according to government data.

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Drugs Medicine Antibody Clinical Trials 279

Pharmaceutical Technology

NOVEMBER 28, 2023

adapted monovalent mRNA vaccine as a booster for Covid-19. Japan’s MHLW has granted approval for Daiichi Sankyo’s Omicron XBB.1.5-adapted

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Vaccination Vaccine 147

Pharmaceutical Technology

FEBRUARY 21, 2023

Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, had a phenomenal year with forecast sales of $37bn in 2022. Comirnaty is the leading prophylactic vaccine for Covid-19 and is expected to generate an additional $2.8bn in sales in 2022 compared to GlobalData’s H1 2022 forecast.

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Sales Vaccination Vaccine Medicine 246

Pharmaceutical Technology

JULY 28, 2022

The Emergency Task Force (ETF) of the European Medicines Agency (EMA) has commenced the review of Veru’s sabizabulin to treat hospitalised Covid-19 patients at increased acute respiratory distress syndrome (ARDS) risk. The review will facilitate the use of the therapy for emergency usage in countries in the European Union (EU).

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Medicine Regulation Trials Marketing 262

Pharmaceutical Technology

JULY 1, 2022

Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally.

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HR Clinical Development Trials Vaccination 264

Bio Pharma Dive

FEBRUARY 21, 2023

The antiviral Lagevrio did not significantly reduce the risk of getting COVID-19 following household exposure to someone infected by the coronavirus.

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BioSpace

MARCH 25, 2024

The National Institutes of Health claims BioNTech is in default regarding alleged royalty payments the agency contends it is owed in connection with the company’s COVID-19 vaccine Comirnaty.

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Vaccination Vaccine 145

Pharmaceutical Technology

DECEMBER 18, 2022

The 0.25mL dose of the booster vaccine could potentially be used in the European Union (EU) following authorisation in these children a minimum of three months following a previous Covid-19 vaccination. 1273.214, a bivalent Omicron-targeting Covid-19 vaccine of the company. 5), mRNA-1273.

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Gene Therapy Vaccination Vaccine Clinical Trials 304

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.

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Vaccination Vaccine Sales Generic Drugs 272

Bio Pharma Dive

NOVEMBER 16, 2021

Study results released earlier this month showed the pill, when given soon after symptoms start, dramatically reduced the risk of COVID-19 hospitalization or death.

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Pharmaceutical Technology

AUGUST 1, 2022

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. Spikevax is the company’s Covid-19 vaccine intended for active immunisation for disease prevention in people aged 18 years and above. 4/5 strain messenger RNA (mRNA).

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Vaccination Vaccine Gene Therapy RNA 289

Pharmaceutical Technology

OCTOBER 4, 2023

The US FDA has amended the EUA of Novavax’s adjuvanted Covid-19 vaccine (NVX-CoV2601) to incorporate the 2023-2024 formula.

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Vaccination Vaccine 173

Pharmaceutical Technology

DECEMBER 6, 2023

Health Canada has granted expanded authorisation for Novavax’s updated Covid-19 vaccine, Nuvaxovid XBB.1.5.

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Vaccination Vaccine 147

Bio Pharma Dive

SEPTEMBER 1, 2021

Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year.

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Trials Drugs 363

BioSpace

MARCH 24, 2024

The regulator has allowed for emergency use of Invivyd’s monoclonal antibody Pemgarda as a COVID-19 pre-exposure prophylaxis for moderately or severely immunocompromised patients.

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Antibody Regulation 128

BioSpace

APRIL 15, 2024

A federal court in Massachusetts has granted Pfizer and BioNTech’s motion to put on hold Moderna’s lawsuit over alleged patent infringement related to their COVID-19 vaccine Comirnaty.

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Vaccination Vaccine 108

BioSpace

APRIL 3, 2024

A Delaware judge on Wednesday agreed with Roivant subsidiary Arbutus and Genevant’s interpretation of specific patent claims regarding the lipid nanoparticle delivery system used by Moderna’s COVID-19 vaccine.

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Vaccination Vaccine 119

Pharmaceutical Technology

DECEMBER 21, 2023

The FDA released an updated guidance for developing Covid-19 monoclonal antibody treatments for EUAs as variants evolve.

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Antibody Development 130

Pharmaceutical Technology

JANUARY 11, 2024

Expanded patient groups at risk of progression to severe Covid-19 will be eligible for Pfizer’s antiviral pill.

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