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

DECEMBER 10, 2020

11, 2020 02:48 UTC. –( 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. CULVER CITY, Calif.–(

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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

JANUARY 12, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland. million doses of the COVID-19 Vaccine Moderna. About the COVID-19 Vaccine Moderna.

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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

NOVEMBER 20, 2020

. Based on current projections, the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. by the middle to end of December 2020. participants are 56-85 years of age.

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The Pharma Data

DECEMBER 11, 2020

Friday, 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.

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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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The Pharma Data

DECEMBER 12, 2020

12, 2020 – The U.S. Food and Drug Administration approved Pfizer’s coronavirus vaccine for emergency use on Friday, clearing the way for the launch of a national campaign to inoculate enough Americans to stem the spread of COVID-19. ” Who is first in line to be vaccinated? SATURDAY, Dec.

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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. Jansen, Ph.D.,

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The Pharma Data

DECEMBER 10, 2020

Thursday, 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.

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The Pharma Data

JANUARY 21, 2021

.” The once-monthly rilpivirine and cabotegravir injectable treatment was approved by Health Canada on March 20, 2020, and the European Commission approved a once-monthly and once every two-month version of the injectable treatment on December 21, 2020.

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The Pharma Data

JANUARY 17, 2021

FDA also designated LAPS Triple Agonist (HM15211) as an orphan drug for the treatment of primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC) in 2020, and the indications will be expanded to include idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD) as well.

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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

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

NOVEMBER 30, 2020

30, 2020– Moderna, Inc. The data analysis indicates a vaccine efficacy of 94.1%. 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. CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Nov.

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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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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. That requirement would only be fulfilled if FDA agreed to such a change. But we digress. And indeed, after Pliva v.

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The Pharma Data

JULY 29, 2021

It is approved for paediatric use in SEA from ages six to 17 in Europe, the US and several other markets. In the US, Japan, Canada and a number of other markets, it is approved for use in adult patients with EGPA. It is not currently approved for use in COPD anywhere in the world. Consider vaccination if medically appropriate.

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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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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

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

OCTOBER 14, 2020

15, 2020 10:00 UTC. 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

DECEMBER 10, 2020

10, 2020 – A U.S. 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. Meanwhile, U.S.

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The Pharma Data

MAY 15, 2021

It is manufactured in the USA with an FDA approved facility under the strictest of standards and under clean sterile conditions. Copyright 2020 vitalityburn.com. Rest assured you are buying something that is doctor backed, research verified, natural, and will stimulate your fat loss the moment you start.

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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

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

FEBRUARY 1, 2021

This approval expands Biogen’s industry-leading portfolio of MS treatments, which also includes the subcutaneous (SC) administration of Plegridy, and follows the European Commission’s marketing authorization for the IM administration in December 2020. “At MS, the coronavirus and vaccines – updated global advice. Source link.

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The Pharma Data

APRIL 27, 2021

FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with HER2 mutations or EGFR mutations including Exon20 insertion mutations. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines.

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The Pharma Data

JANUARY 12, 2021

“Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

NOVEMBER 20, 2020

November 21, 2020 – Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA). We are also very encouraged by recently announced promising vaccine results; however, there remains a need to treat patients who develop COVID-19, especially as some may not have had access to or were not protected by vaccination.

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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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Eye on FDA

APRIL 15, 2020

Bristol Myers Squibb stated in its press release announcing FDA approval of the company’s treatment for multiple sclerosis that the commercial launch would be delayed due to the COVID-19 situation. And each day we are without a vaccine means these effects are going to linger. Why would COVID-19 affect a drug launch?

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The Pharma Data

APRIL 4, 2022

The safety results of these trials were generally consistent with the known safety profile of Dupixent in its approved indications. In September 2020, the U.S. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. Source link: [link].

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