The Pharma Data

NOVEMBER 20, 2020

November 20, 2020 — The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. Source: FDA. Posted: November 2020.

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The Pharma Data

DECEMBER 30, 2020

30 December 2020 — AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. This is the first authorisation for this vaccine.

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The Pharma Data

DECEMBER 11, 2020

11, 2020 – The U.S. Food and Drug Administration is expected to approve emergency use of Pfizer’s coronavirus vaccine as early as Saturday after its advisory panel cleared the way for the start of a national campaign to inoculate Americans and stem the spread of COVID-19. FRIDAY, Dec. Initially, a shipment of 2.9

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The Pharma Data

NOVEMBER 9, 2020

09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate.

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The Pharma Data

NOVEMBER 30, 2020

30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. Novavax will use vaccine material produced at commercial scale for this trial. GAITHERSBURG, Md.,

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The Pharma Data

NOVEMBER 23, 2020

23 November 2020 . Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. .

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The Pharma Data

JANUARY 6, 2021

6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials.

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The Pharma Data

AUGUST 14, 2020

In other news, Genentech’s Evrysdi (risdiplam) has secured FDA approval for the treatment of spinal muscular atrophy and Bristol Myers Squibb has announced positive data from two Phase 3 clinical trials of its drug Opdivo. AstraZeneca seals manufacturing deal to deliver COVID-19 vaccine in China.

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The Pharma Data

DECEMBER 30, 2020

The year 2020 will certainly go down in history as the year of COVID-19. Gilead Sciences Makes Multiple Bets : When Gilead Sciences wasn’t working on remdesivir in COVID-19, the company seemed to be constantly flexing its M&A muscle over the course of 2020. It began in May with the $4.9 But the U.K.-based

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The Pharma Data

DECEMBER 18, 2020

18, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SILVER SPRING, Md. , Hahn , M.D.

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The Pharma Data

NOVEMBER 16, 2020

16, 2020– Moderna, Inc. We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. Room Temperature for Vaccination: Once the vaccine is removed from the refrigerator for administration, it can be kept at room temperature conditions for up to 12 hours. CAMBRIDGE, Mass.–(BUSINESS

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The Pharma Data

DECEMBER 3, 2020

4, 2020 08:00 UTC. The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Janssen Biotech, Inc.

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Codon

NOVEMBER 3, 2024

Even after microbiologists discovered the bacterium that causes the illness in 1882, it wasn’t until the 1920s that researchers were able to develop a vaccine for TB. These breakthroughs have significantly curbed cases, with vaccination reducing the odds of death by 74 percent. tuberculosis , to develop the vaccine.

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EG Life Sciences

FEBRUARY 15, 2023

The US Food and Drug Administration (FDA) approved around 26 novel drugs in 2022. Approval processes were slow in comparison to 2020 and 2021, where 53 and 50 approvals were achieved respectively. Going into the third year of the pandemic, we know that the virus still impacts industry operations.

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The Pharma Data

JANUARY 9, 2021

Reports preliminary 2020 total revenues of $1.55 billion at the midpoint and Adjusted EBITDA of $635 million at the midpoint, both at or above prior guidance given in November 2020. NYSE:EBS) today announced its financial forecast for 2021 and selected preliminary unaudited financial results for 2020.

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The Pharma Data

DECEMBER 13, 2020

14, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. The FDA, an agency within the U.S. .

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The Pharma Data

NOVEMBER 16, 2020

16, 2020– Moderna, Inc. The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. .–(BUSINESS WIRE)–Nov.

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The Pharma Data

DECEMBER 8, 2020

8, 2020– Moderna, Inc., Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 8, 2020– Moderna, Inc.,

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The Pharma Data

NOVEMBER 9, 2020

NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE) November 9, 2020. Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. Pfizer Inc. Today is a great day for science and humanity.

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Codon

AUGUST 26, 2024

He also explains how they could be used to combat pandemics on “day zero,” well before vaccines are developed. After the outbreak ended, it took another three years for the first Ebola vaccine by Merck to be approved. Timelines for vaccine development are shrinking, but can it move even faster?

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The Pharma Data

APRIL 7, 2023

“Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.” The agency’s approval included a requirement that the sponsor conduct a post marketing confirmatory study.

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The Pharma Data

OCTOBER 29, 2020

Data support baricitinib’s ongoing Phase 3 program and potential to be the first approved medicine for people living with alopecia areata (AA). . VACCINATIONS : Avoid use of live vaccines with Olumiant. 1 Olumiant Prescribing Information, 2020. INDIANAPOLIS , Oct. 2 Walker JG and Smith MD. J Rheumatol.

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The Pharma Data

DECEMBER 8, 2020

8 December 2020 — Results of an interim analysis of the Phase III programme conducted by Oxford University with AZD1222, peer-reviewed and published in The Lancet today, demonstrated that the vaccine is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation.

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The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

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The Pharma Data

APRIL 27, 2021

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. due to COVID related stocking in Q1 2020 and low demand for cough and cold brands in Europe. Vaccines delivered growth in its core segments.

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The Pharma Data

DECEMBER 20, 2020

Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. It was approved on December 15, 2020. The FDA completed a class 2 response in July 2020. Here’s a look.

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The Pharma Data

JULY 15, 2021

Interim results from a Phase 1/2a sub-study published in the New England Journal of Medicine (NEJM) demonstrated that both humoral (antibody) and cellular (T-cell) immune responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were strong and stable through eight months after immunization, the length of time evaluated to date.

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The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. Accessed October 2020. Accessed October 2020. Posted: November 2020. NCT identifier: NCT04380688. Available online.

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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

A leader in this critical effort is NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV ) initiative, a public-private partnership involving 20 biopharmaceutical companies, academic experts, and multiple federal agencies. Vaccines Working Group : Accelerates the evaluation of vaccine candidates.

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The Pharma Data

JANUARY 6, 2021

Most recently ( June 2020 ) FUJIFILM Corporation invested 100 billion yen ( 928 million USD ) in FUJIFILM Diosynth Biotechnologies’ Hillerød, Denmark site to double its large-scale cell culture manufacturing capacity and add commercial scale drug product production capabilities. For more information, go to: www.fujifilmdiosynth.com.

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Agency IQ

DECEMBER 1, 2023

BY RACHEL COE, MSC | NOV 27, 2023 8:24 PM CST FDA’s transition away from public health emergency (PHE)-related guidance documents The Covid-19 Public Health Emergency (PHE) was activated on January 31, 2020. supplemental oxygen, mechanical ventilation). Like the first version, the updated guidance was issued as direct-to-final.

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The Pharma Data

DECEMBER 8, 2020

9, 2020 00:15 UTC. During the call, Takeda provided a deep dive into TAK-721, which has the potential to be the first FDA-approved agent for the treatment of eosinophilic esophagitis (EoE), and TAK-003, which is a live attenuated tetravalent vaccine for prevention of dengue disease.

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The Pharma Data

NOVEMBER 17, 2021

For the past year and a half, the COVID-19 pandemic has continued to engulf the globe, fueled in part by novel variants and the uneven distribution of vaccines. In May 2020, they published a study in mice demonstrating that disulfiram reduced inflammation caused by sepsis by blocking a key protein involved in the process.

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Codon

MARCH 24, 2024

MenAfriVac is a meningococcal vaccine that remains active, without refrigeration, for up to four days and has significantly boosted vaccine coverage in parts of sub-Saharan Africa. Mixing the extracts with a bit of water and genetic material then “reboots” the enzymes, which make conjugate vaccines at a cost of about $0.50

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The Pharma Data

JULY 29, 2021

for the same period in 2020. This was primarily driven by the impact of higher in-process research and development (“IPR&D”) expenses in the second quarter 2020 related to the Forty Seven, Inc. billion as of December 31, 2020. billion compared to the same period in 2020. Second Quarter 2021 Financial Results.

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Agency IQ

JANUARY 19, 2024

However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. for the years 2020 to 2022. Conditional approvals and accelerated assessments seem to fluctuate each year, with no clear trend.

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