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.

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Drug Discovery World

MARCH 7, 2023

In 2023, the company revealed data from a Phase III trial which showed that its vaccine candidate DCVax-L more than doubled overall survival in glioblastoma patients. Here at FAB our proprietary approach aims to overcome this fundamental challenge to human health as we work to discover and develop new drugs for age-associated diseases.”

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The Pharma Data

MARCH 2, 2021

Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. The terms of the EUA allow use of the vaccine while more data are gathered.

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The Pharma Data

JANUARY 12, 2021

Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients to meet the federal government’s Operation Warp Speed goals. Have chronic kidney disease. cardiovascular disease, OR.

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The Pharma Data

NOVEMBER 9, 2020

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. government. GAITHERSBURG, Md.,

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The Pharma Data

NOVEMBER 30, 2020

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. Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrollment of volunteers.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration advisory panel will vote on Thursday whether to recommend emergency approval of Pfizer’s coronavirus vaccine, a decision that will come not a moment too soon as the country reported more than 3,000 new COVID-19 deaths on Wednesday. THURSDAY, Dec. 10, 2020 – A U.S. Meanwhile, U.S.

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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]

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The Pharma Data

DECEMBER 11, 2020

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. Centers for Disease Control and Prevention. Who is first in line?

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The Pharma Data

MAY 7, 2021

. Pfizer-BioNTech files for US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) ( Politico ) ( Press ). Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ). Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ).

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The Pharma Data

DECEMBER 8, 2020

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 against COVID-19 and 100% efficacy against severe disease.

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The Pharma Data

NOVEMBER 16, 2020

We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We

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The Pharma Data

DECEMBER 10, 2020

–( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. 11, 2020 02:48 UTC. CULVER CITY, Calif.–(

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The Pharma Data

FEBRUARY 23, 2022

Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Pfizer’s TicoVac TM (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older, in the following U.S. Global President, Vaccines, Pfizer. “We

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The Pharma Data

NOVEMBER 16, 2020

and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S.

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The Pharma Data

DECEMBER 11, 2020

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. Government to supply doses in 2020 & 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. immediately.

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The Pharma Data

NOVEMBER 20, 2020

billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date. by the middle to end of December 2020. participants are 56-85 years of age.

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The Pharma Data

FEBRUARY 25, 2022

Pfizer is a leader in this vital healthcare segment with more than 14 years of global in-market experience, the first FDA approved biosimilar for the treatment of certain autoimmune conditions and nine approved biosimilars in the U.S.

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Drug Discovery World

APRIL 27, 2023

Today, North Carolina ranks among the top three states in bioscience employment and has become a world leader in vaccine research and manufacturing 5. Dr Vaessen says that local government and business development partners work closely within the industry to attract companies like FUJIFILM Irvine Scientific to the region.

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The Pharma Data

DECEMBER 10, 2020

. Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. Jansen, Ph.D.,

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The Pharma Data

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. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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The Pharma Data

APRIL 8, 2022

“Since its first-line approval based on the initial groundbreaking CROWN trial results, LORBRENA has solidified its place as a practice-changing medicine, and these updated data add to the growing body of evidence supporting its use from the onset of metastatic disease.”. LORBRENA is approved in the U.S. Source link: [link].

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The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S.

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The Pharma Data

JULY 29, 2021

The FDA grants emergency use authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available. Vaccinations: Avoid use of live vaccines with baricitinib. Wesley Ely, M.D.,

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The Pharma Data

APRIL 27, 2021

In April 2020, mobocertinib received Breakthrough Therapy Designation from the FDA for patients with EGFR Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines.

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The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

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The Pharma Data

MAY 4, 2021

Lilly will donate both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together – providing options to treat COVID-19 patients at different stages of the disease. ” The allocation of therapies will be based on the disease burden and hospitalization rates in each country.

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Agency IQ

NOVEMBER 3, 2023

So what about all of the “biotic” terms that pop up in the news, on products labels and even in FDA warning letters? Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community.

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The Pharma Data

JUNE 18, 2021

4,5 Between 20 and 46 percent of adults with atopic dermatitis have moderate to severe disease. 6 The range of symptoms pose significant physical, psychological and economic burden on individuals impacted by the disease. The approved dose for RINVOQ is 15 mg. Have recently received or are scheduled to receive a vaccine.

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The Pharma Data

APRIL 28, 2021

European Commission approves second indication of Sarclisa ® (isatuximab) for relapsed multiple myeloma. This marks the second EC approval of Sarclisa in combination with a standard of care regimen in less than 12 months. “ This EC approval closely follows the U.S. The ORR remained similar for each arm at 86.6%

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The Pharma Data

JUNE 18, 2021

1 At week 56, 29 percent of patients treated with continuous RINVOQ 15 mg achieved minimal disease activity a (MDA). PtGA-Disease Activity NRS ?2.0; RINVOQ can be an important treatment option to help rheumatologists provide their patients with long-term maintenance of improvements in disease activity.” 1 or BSA-Ps ?3

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The Pharma Data

JULY 29, 2021

HCV product sales increased 23% to $549 million for the second quarter 2021 compared to the same period in 2020, driven primarily by improved market starts in the United States and Europe as well as an unfavorable change in estimate of government rebates in the second quarter 2020. Viral Diseases.

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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

JUNE 18, 2021

“We are dedicated to helping more people living with rheumatoid arthritis reach their treatment goals aimed at remission or low disease activity,” said Mudra Kapoor, M.D., Low Disease Activity per DAS28-CRP?3.2 Low Disease Activity per CDAI?10 Low Disease Activity per CDAI is defined as CDAI less than or equal to 10.

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The Pharma Data

JULY 29, 2021

Food & Drug Administration (FDA) has extended the shelf life for the Johnson & Johnson single-shot COVID-19 vaccine to six months. Expiration dates will be updated on www.vaxcheck.jnj , where vaccine providers can confirm the latest expiration dates of our vaccine. We continue to work with the U.S.

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The Pharma Data

MAY 6, 2022

Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. In the trial, a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective (95% confidence interval [CI, 87.5,

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