pharmaphorum

JULY 18, 2022

MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, How it works. Regarding the BA.4

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STAT News

JANUARY 19, 2023

Journalist Nathan Vardi joins us to talk about his new book delving into the race to develop the lifesaving cancer drug now called Imbruvica, involving a Scientologist CEO and secretive investor seeking redemption after the worst trade of his life. Read the rest…

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Vaccine Vaccination Life Science RNA 115

pharmaphorum

MARCH 4, 2021

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. This will provide a major incentive to modernise, digitise and grow companies across the country.

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Vaccine Vaccination Development Life Science 105

XTalks

JANUARY 8, 2021

The US Food and Drug Administration (FDA) released a statement this week about dosing schedules for COVID-19 vaccines, saying that any dose changes would be premature. The FDA therefore continues to recommend the two-dose regimens that both the BioNTech/Pfizer and Moderna vaccines require.

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BioSpace

AUGUST 18, 2021

Fueled by the highly contagious delta variant, life science companies have issued policies on COVID-19 vaccines, including verbiage around exemptions or solutions for medical objections.

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Vaccine Vaccination Life Science 97

pharmaphorum

DECEMBER 24, 2020

The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days. Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.

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Vaccine Vaccination Regulation Life Science 126

pharmaphorum

JULY 1, 2021

Miruna Sasu lays out how real-world data is evolving in the post COVID-19 vaccine reality. . Only a year after the emergence of COVID-19, a handful of life science companies started publishing data on the encouragingly high efficacy of their vaccine candidates.

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Vaccine Vaccination Development Life Science 103

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.

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Vaccine Vaccination Life Science Regulation 105

STAT News

FEBRUARY 16, 2023

What does it mean when a vaccine is “free”? We also dive into the latest news in the life sciences, including Moderna’s promise of no-cost Covid-19 vaccines and biotech entrepreneur Vivek Ramaswamy’s potential run for president. Is the pharmaceutical lobby on the ropes? Read the rest…

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Vaccine Vaccination Life Science 98

XTalks

NOVEMBER 23, 2021

Canadian pharma and biotech contract development and manufacturing organization (CDMO) Biovectra has announced plans for building one of the first state-of-the-art mRNA vaccine and biomanufacturing facilities in Canada. Related: Medicago’s Plant-Based COVID-19 Vaccine Enters Human Trials. million, respectively.

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Manufacturing Vaccine Vaccination Drugs 98

XTalks

FEBRUARY 5, 2021

As COVID-19 vaccines continue to be in short supply around the world, pharma giants such as Bayer (Nasdaq: BAYRY ) are stepping up to help fulfill the need. Bayer has agreed to assist in the manufacturing of an mRNA-based coronavirus vaccine, CVnCOV, developed by fellow German biopharma company CureVac (Nasdaq: CVAC ).

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Vaccine Vaccination Production Manufacturing 116

STAT News

JANUARY 26, 2023

We also chat about the latest news in the life sciences, including an FDA advisory meeting debating the necessity for annual Covid vaccinations, and a surprising, but perhaps not, rejection of Eli Lilly’s Alzheimer’s disease treatment. Read the rest…

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Vaccine Vaccination Life Science Drugs 98

XTalks

OCTOBER 12, 2021

Last week, a study that “stumbled upon” a vaccine for rheumatoid arthritis (RA) was published in the Proceedings of the National Academy of Sciences. The vaccine was tested in rats and showed strong, immediate and long-lasting immune responses to confer protection against the disease. With the finding that 14-3-3?

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Vaccine Vaccination Research Immune Response 105

pharmaphorum

JULY 20, 2021

The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. So far the EU has approved four COVID-19 vaccines – two mRNA shots from Pfizer/BioNTech and Moderna, and two based on adenoviral vectors from AstraZeneca and Johnson & Johnson.

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Vaccine Vaccination Protein Immune Response 98

XTalks

FEBRUARY 20, 2024

GlaxoSmithKline’s (GSK) Arexvy and Pfizer’s Abrysvo are the first-ever approved vaccines against respiratory syncytial virus (RSV). The vaccines received approvals from the US Food and Drug Administration (FDA) in May 2023 for the prevention of RSV infection. Arexvy costs $280 per dose while Abrysvo is $295.

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XTalks

SEPTEMBER 1, 2023

GlaxoSmithKline (GSK) has been pumping large sums of cash into expanding its vaccine manufacturing operations and today, it announced an investment of €250 ($272 million) into building a new unit for freeze-drying vaccines at its Wavre campus in Belgium. The British drugmaker expects to produce tens of millions of vaccine doses a year.

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Vaccine Vaccination Manufacturing Production 98

XTalks

AUGUST 16, 2021

The US Food and Drug Administration (FDA) has amended its emergency use authorizations (EUA) for both the Pfizer and Moderna COVID-19 vaccines to incorporate a third dose for immunocompromised individuals. A small study from John Hopkins University has shown that a third dose of a COVID-19 vaccine could indeed help immunocompromised patients.

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XTalks

MARCH 1, 2021

(NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. Related: Could Pfizer and BioNTech’s COVID-19 Vaccine be Stored at Standard Freezer Temperatures?

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XTalks

OCTOBER 28, 2021

BioNTech has announced plans to build a manufacturing facility in Africa to help ramp up production of COVID-19 mRNA vaccines for countries in the continent. With less than ten percent of its population vaccinated, Africa continues to be deeply affected by global vaccine inequities.

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Vaccine Vaccination Production Manufacturing 98

XTalks

DECEMBER 14, 2021

Moderna revealed the first interim results from a small, Phase I study of its mRNA-based influenza vaccine, which showed that the vaccine had no significant safety concerns and elicited immune responses against four strains of the influenza virus. Related: Moderna Unwilling to Share COVID-19 Vaccine Formula Amid Vaccine Inequities.

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Vaccine Vaccination Immune Response Antibody 98

XTalks

JUNE 23, 2021

AstraZeneca scored a major win last week in a lawsuit launched by European Union (EU) officials that accused the drugmaker of failing to deliver on promised supplies of its COVID-19 vaccine. AstraZeneca has been the second largest vaccine supplier to the EU, behind Pfizer, which has provided 233 million doses of its vaccine thus far.

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Vaccine Vaccination Manufacturing Production 97

XTalks

NOVEMBER 16, 2020

Moderna announced today that its highly anticipated COVID-19 vaccine candidate appears to be 94.5 The news comes shortly after Pfizer and BioNTech’s mega announcement last week of their COVID-19 vaccine having shown 90 percent efficacy in an ongoing large-scale Phase III trial. The vaccine is given in two doses.

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XTalks

JULY 2, 2021

There have been growing reports of women experiencing changes in their menstrual cycle after receiving a shot of a COVID-19 vaccine. Some women have said they got their periods early following vaccination, or that their periods were unusually heavy and/or painful. Related: Moderna’s COVID-19 Vaccine Effective Against New Variants.

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Vaccine Vaccination Protein Immune Response 105

XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.

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Vaccine Vaccination Production Manufacturing 105

pharmaphorum

MARCH 7, 2022

The World Health Organization (WHO) announced the opening of a global biomanufacturing hub located in South Korea to provide training to low- and middle-income countries seeking to produce vaccines and other biologics, such as insulin and monoclonal antibodies. . of individuals in low-income countries have received their first dose.

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Vaccine Vaccination Manufacturing Production 98

XTalks

APRIL 18, 2022

Top COVID-19 mRNA vaccine maker BioNTech is setting out to explore new and improved delivery technologies for mRNA vaccines, recently announcing a collaboration with New Jersey-based lipid nanocrystal developer Matinas BioPharma. Related: BioNTech Unveils the BioNTainer, a Modular mRNA Vaccine Factory to Help Production in Africa.

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Vaccine Vaccination Development Immune Response 105

XTalks

JULY 25, 2023

Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). How Does Cyfendus Work? mL for intramuscular injection.

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XTalks

JANUARY 31, 2022

COVID-19 vaccine makers Pfizer/BioNTech and Moderna have both commenced trials for their new variant-specific vaccines targeting omicron. Pfizer and BioNTech have started to enroll participants in a study that will evaluate the new version of their COVID-19 vaccine that targets the omicron variant of SARS-CoV-2.

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Vaccine Vaccination Trials Antibody 98

XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals. What are the major challenges you’re facing right now in vaccine development?

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Vaccine Vaccination Development Clinical Trials 96

XTalks

MAY 27, 2021

To help boost production of its COVID-19 vaccine, Moderna has enlisted the services of Samsung Biologics , a contract development and manufacturing organization (CDMO) based in South Korea. The vaccine doses are intended for countries outside the US, with manufacturing planned to commence in the third quarter of 2021.

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Manufacturing Vaccine Vaccination Production 98

XTalks

MAY 11, 2022

The US Food and Drug Administration (FDA) announced last week that it has limited the authorized use of Janssen/Johnson & Johnson’s COVID-19 vaccine for individuals 18 years of age and older for whom other authorized or approved vaccines are not accessible or clinically appropriate.

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XTalks

JUNE 16, 2021

Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4 Related: Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351

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Vaccine Vaccination Protein Trials 98

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. Vaccine access for a price. Tendayi Achium, labelled the response by the global community as a form of “vaccine apartheid,” a suggestion echoed by the organisation’s director general.

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XTalks

NOVEMBER 29, 2021

Pfizer and vaccine partner BioNTech shared positive long-term data last week that shows their COVID-19 vaccine remains effective for at least four months in adolescents 12 to 15 years of age. The vaccine also maintained a good safety profile with no serious side effects.

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Vaccine Vaccination Trials Clinical Trials 98

XTalks

APRIL 15, 2021

Federal authorities in the US have recommended pausing the administration of J&J’s COVID-19 vaccine as half a dozen cases of rare blood clots reported among women who received the vaccine are under investigation. Related: COVID-19 Vaccine Messaging: Why Vaccine Efficacies Can’t Be Compared and Shopped.

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Vaccine Vaccination Regulation Drugs 98

BioPharma Reporter

SEPTEMBER 14, 2023

Vaxess Technologies, a life sciences company developing a shelf-stable vaccine patch with potential for self-application, has announced an additional $9 million in venture capital funding, with investors including RA Capital, The Engine, and GHIC, and Ulu Ventures.

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Vaccine Vaccination Life Science Engineer 64

XTalks

JULY 14, 2021

In a press briefing on Monday, the World Health Organization (WHO) responded to questions about COVID-19 vaccine boosters that led to a flurry of misleading headlines in the media about the “dangers” of mixing and matching vaccines. Soumya Swaminathan, during the briefing in which she was asked about COVID-19 vaccine boosters.

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