Eye on FDA

JULY 19, 2021

But here is what we see looking at the first 6 months 2021, and comparing it to mid-years past. Last year the agency issued over 400 releases on a range of topics (65 percent of releases were related to COVID-190. Last year the agency issued over 400 releases on a range of topics (65 percent of releases were related to COVID-190.

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Eye on FDA

NOVEMBER 17, 2020

Coincident to COVID-19 case levels in Europe and the United States entering new and serious levels comes welcome news on the development of a vaccine. While vaccination may actually begin in December, the number of doses will be limited. In addition, the process of vaccination takes time.

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Eye on FDA

JANUARY 12, 2022

During nearly all of 2021, FDA has been under the direction of an acting commissioner. COVID – 144 announcements were COVID-related in 2021, compared to 274 such announcements during 2020; Approvals – there were 77 announcements related to approvals this year, 22 of which were COVID-related announcements.

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The Pharma Data

SEPTEMBER 30, 2021

As one among the leading global vaccines companies, we still bring options which help protect people’s health round the world,” said Michael Greenberg, MD, MPH, Medical Head, Sanofi Pasteur North America. “As 4,5 The CDC recommends a primary dose of the MenACWY vaccine at 11-12 years old and a second dose at 16 years old. In the U.S.,

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The Pharma Data

JULY 29, 2021

Second-Quarter 2021 Revenues of $19.0 Billion The 10% Operational Growth Excluding BNT162b2(1) in Second-Quarter 2021 Builds on the 6% Operational Growth Delivered by the Comparable Business in Second-Quarter 2020 Second-Quarter 2021 Reported Diluted EPS(2) of $0.98, Adjusted Diluted EPS(3) of $1.07

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The Pharma Data

MAY 4, 2021

Posted 04 May 2021 | By Kari Oakes . The European Medicines Agency (EMA) has added Sinovac’s COVID-19 vaccine to its portfolio of vaccines under rolling review. . CureVac’s CVnCoV COVID-19 vaccine and NVX-CoV2372, the Novavax candidate, have been under review since February 2021. EMA. . . . . .

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The Pharma Data

JULY 8, 2021

People who receive mRNA COVID-19 vaccines are up to 91 percent less likely to develop the disease than those who are unvaccinated, according to a new nationwide study of eight sites, including Salt Lake City. Those who unfortunately got COVID-19 despite being vaccinated were still better off than those who didn’t.”

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The Pharma Data

MAY 3, 2021

Posted 03 May 2021 | By Kari Oakes . The European Medicines Agency (EMA) is evaluating an application submitted by Pfizer and BioNTech for use of their COVID-19 vaccine in children aged 12 to 15 years. . The vaccine has been authorized by the EU for use in people 16 years and up since December 2020. . EMA. . . .

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The Pharma Data

SEPTEMBER 5, 2021

AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the Advance Purchase Agreement for the delivery of the COVID-19 vaccine Vaxzevria (ChAdOx1-S [Recombinant]). Legal proceedings by the European Commission against AstraZeneca were initiated in Brussels on 21 April 2021.

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The Pharma Data

NOVEMBER 17, 2021

AstraZeneca and its partners have released for supply two billion doses of their COVID-19 vaccine to more than 170 countries across every continent on the planet in the last 11 months. 2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7).

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The Pharma Data

OCTOBER 14, 2021

Biogen today announced results of a new analysis of immune response to the COVID-19 vaccine among people with multiple sclerosis (MS). Germany and Spain, researchers evaluated blood samples from 322 participants 28-90 days after their last COVID-19 vaccine dose. Using data from the MS PATHS network in the U.S.,

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The Pharma Data

APRIL 20, 2022

Results of a new multicenter study published in the New England Journal of Medicine found that vaccination with a primary series of the Pfizer-BioNTech mRNA COVID-19 vaccine reduced the risk of COVID-19-associated hospitalizations in children ages 5-11 years by two-thirds during the Omicron period.

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The Pharma Data

MAY 5, 2022

The Fact Sheet for Healthcare Providers Administering Vaccine now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS.

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The Pharma Data

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Sanofi continued its growth trajectory.

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The Pharma Data

MAY 16, 2022

The profound health and economic impact of the Pfizer-BioNTech vaccine during its first year of rollout in the US is described in detail in a new study in the peer-reviewed Journal of Medical Economics. It is estimated that in 2021 the vaccine, the most widely used against COVID-19 in the US, prevented 8.7

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The Pharma Data

JULY 28, 2021

There are many reasons that an intranasal vaccine against the SARS-CoV-2 virus would be helpful in the fight against COVID-19 infections, University of Alabama at Birmingham immunologists Fran Lund, Ph.D., The seventh vaccine candidate is an inert protein subunit. and Troy Randall, Ph.D., ” Frances E Lund, Troy D Randall. .

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The Pharma Data

SEPTEMBER 5, 2021

million patients found no serious health effects that could be linked to the 2 mRNA COVID-19 vaccines. “The world is relying on safe and effective vaccines to bring an end to the COVID-19 pandemic. The study reported findings from mid-December 2020 through June 26, 2021. The total number of people evaluated was 6.2

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National Drug & Alcohol Research Centre Blog

FEBRUARY 24, 2022

Olivia Price It has been one year since the COVID-19 vaccine rollout commenced in Australia, and while vaccination rates initially lagged behind other countries, over 95% of Australians aged 12 years and older are now fully vaccinated. We tend to consider the remaining unvaccinated people a homogenous ‘anti-vax’ group.

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The Pharma Data

JUNE 30, 2021

For their remarkable scientific contributions, doctoral student Julia Klaus, Zurich University VetSuisse Faculty, and Dr Yasmin Parr from the MRC-University of Glasgow, Centre for Virus Research, have received the 2021 ABCD Young Scientist Award. To foster young talent development in the feline health research community.

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The Pharma Data

MAY 14, 2021

Product Name: My Cellulite Solution – Updated April 2021. Click here to get My Cellulite Solution – Updated April 2021 at discounted price while it’s still available… All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors.

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The Pharma Data

NOVEMBER 22, 2021

Company Welcomes Leadership Shown by the European Commission and EU Member States, plus Norway and Iceland to Help Advance Equitable Access to Our Vaccine. As a practical rapid response to the urgent need to scale up equitable access to vaccines, these doses will be utilized to help protect individuals in lower-income countries.

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The Pharma Data

MARCH 11, 2021

Expected to enroll 415 participants; interim results expected in Q3 2021. The Companies expect interim results from this trial in the third quarter of 2021. the vaccines global business unit of Sanofi, to develop mRNA vaccines for up to five infectious disease pathogens.

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The Pharma Data

OCTOBER 7, 2021

COVID-19 vaccines are highly effective in preventing symptomatic illness among health care workers in real-world settings. For those who received the two-dose regimen of the Moderna vaccine, the risk was reduced by 96%. The vaccines’ effectiveness was, however, lower in immunocompromised people.

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. JUNE 22 , 2021. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus.

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The Pharma Data

JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We Second Quarter 2021 Financial Results. Total second quarter 2021 revenue of $6.2 As of June 30, 2021, Gilead had $7.4

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The Pharma Data

SEPTEMBER 30, 2021

Anderson Professor of Chemical and Biomolecular Engineering, and his colleagues, are reporting in iScience the event of an intranasal subunit vaccine that gives durable local immunity against inhaled pathogens. A fundamental limitation of intramuscular vaccines is that they’re not designed to elicit mucosal immunity.

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The Pharma Data

MARCH 25, 2021

European Medicines Agency to Conduct First-Ever Parallel Assessment of a Medicinal Product, Takeda’s Dengue Vaccine Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the EU-M4all (Previously Article 58) Procedure. About TAK-003. 4,5 Efficacy varied by serotype.

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The Pharma Data

JULY 15, 2021

FreVAX is an innovative intramuscular needle free vaccine injection device for pigs around weaning until the end of nursery. to provide improved vaccination compliance and data management,” added Marius Leyhausen, Senior Global Brand Manager, Integrated Health Management at Boehringer Ingelheim Animal Health. The FreVAX app 2.0

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Broad Institute

OCTOBER 16, 2024

William Studier receives the 2024 Merkin Prize in ceremony at the Broad Institute for developing technology used to produce millions of doses of COVID-19 vaccines By Corie Lok October 16, 2024 Breadcrumb Home F. It was also in 2021 that, in recognition of Merkin’s partnership, the Broad named its building at 415 Main Street the Richard N.

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The Pharma Data

FEBRUARY 18, 2022

Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia to establish mRNA vaccine production. At the European Union – African Union summit in Brussels today WHO Director-General, Dr Tedros Adhanom Ghebreyesus, announced the first six countries that will receive the technology needed to produce mRNA vaccines on the African continent.

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BioPharma Drive: Drug Pricing

APRIL 24, 2024

The mRNA vaccine maker, which has lost most of its value since early 2021, is undergoing an “organizational redesign” that will involve the elimination of 150 positions.

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The Pharma Data

AUGUST 15, 2021

Even as several safe and effective COVID-19 vaccines are being administered to people worldwide, scientists are still hard at work developing different vaccine strategies that could provide even stronger or longer-lasting immunity against SARS-CoV-2 and its variants. 2021 Apr 8:2021.04.08.438884. bioRxiv [Preprint].

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The Pharma Data

AUGUST 9, 2021

Research by Lancaster University scientists to create a COVID-19 vaccine which can be administered through the nose has taken a significant step forward. The pre-clinical animal trials of the intranasal vaccine showed a reduction in both the impact of the disease itself and transmission of the virus.

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The Pharma Data

AUGUST 3, 2021

Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology.

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The Pharma Data

JUNE 25, 2021

In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. About CVnCoV. About CureVac.

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The Pharma Data

APRIL 1, 2021

Sanofi to build new facility in Canada to increase global availability of high-dose influenza vaccine. Sanofi announces investment of more than €600 million to build a new vaccine facility in Toronto to increase supply of its differentiated influenza vaccines in Canada, the United States and Europe.

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The Pharma Data

MAY 4, 2021

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has banned the trade in unapproved COVID-19 vaccines for a year to prevent the use of vaccines that may not be safe or effective. . The public could also import personal supplies of vaccines. © 2021 Regulatory Affairs Professionals Society.

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