BioPharma Drive: Drug Pricing

JULY 11, 2023

While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the US regulator in its current review cycle.

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Drugs.com

SEPTEMBER 7, 2023

7, 2023 -- New COVID-19 booster shots could soon pass the needed hurdles for vaccinations to begin next week. Food and Drug Administration plans say boosters could be approved as soon as Friday, NBC News. THURSDAY, Sept. Sources familiar with U.S.

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BioPharma Drive: Drug Pricing

AUGUST 21, 2023

The expanded approval follows the FDA’s May clearance of the shot, called Abrysvo, in older adults.

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Drugs.com

AUGUST 22, 2023

22, 2023 -- Women may soon have a vaccine they can take during a pregnancy to help protect their newborn from respiratory syncytial virus (RSV), following U.S. Food and Drug Administration approval of the shot, called Abrysvo, on. TUESDAY, Aug.

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Drugs.com

AUGUST 22, 2023

22, 2023 -- Women may soon have a vaccine they can take during a pregnancy to help protect their newborn from respiratory syncytial virus (RSV), following U.S. Food and Drug Administration approval of the shot, called Abrysvo, on. TUESDAY, Aug.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S. 45 years ago.

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The Pharma Data

OCTOBER 30, 2020

Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

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The Pharma Data

APRIL 26, 2022

Before now, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with COVID-19. “As director of the FDA’s Center for Drug Evaluation and Research. The FDA urges the public to get vaccinated and receive a booster when eligible.

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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

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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BioPharma Drive: Drug Pricing

AUGUST 30, 2024

Elsewhere, the FDA approved a vaccine for mpox and a biotech planned layoffs. A new analysis showed semaglutide reduced the risk of worsening heart failure.

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The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. ” Other authors on the paper include Sydney A.

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The Pharma Data

NOVEMBER 29, 2021

National Cancer Institute: Ovarian, Fallopian Tube, and Primary Peritoneal Cancer FDA Approved Drugs: Questions and Answers. ###. The FDA, an agency within the U.S.

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The Pharma Data

JANUARY 17, 2021

FDA approval this year. We plan to do so by proceeding the projects to cope with COVID-19 including development of diagnostics, vaccines, and treatments. by obtaining FDA approval for new drugs as well as accelerating clinical progress to increase the value of various pipelines.” ” .

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The Pharma Data

NOVEMBER 18, 2020

” COVID Vaccines Move Closer to Emergency Use Approval. Pfizer and the German firm BioNTech announced Thursday that their vaccine is 95 percent effective and they will apply for emergency use approval “within days.” announced earlier this week that early results show its coronavirus vaccine is 94.5

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The Pharma Data

JULY 12, 2021

Rare cases of the neurological disorder, Guillain-Barré syndrome have been reported following vaccination with the Janssen COVID-19 vaccine. Most occurred within 42 days after vaccination. For further information on the safety of authorized COVID-19 vaccines, please visit: [link]. What Is the Janssen COVID-19 Vaccine?

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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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The Pharma Data

SEPTEMBER 23, 2020

The FDA is set to release new guidelines that would raise safety and efficacy requirements required for a COVID-19 vaccine to be granted Emergency Use Authorization. . The FDA will also assess at least five severe coronavirus patients in the placebo group of each trial. This has been revealed by The Washington Post.

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The Pharma Data

MARCH 29, 2022

Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series.

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. The interim analysis comprised 95 cases of symptomatic COVID-19 among volunteers.

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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. billion in damages were brought between 1980 and 1986.

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Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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The Pharma Data

NOVEMBER 21, 2021

The FDA approved Voxzogo under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need, based on a surrogate or intermediate clinical endpoint. The FDA, an agency within the U.S.

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The Pharma Data

NOVEMBER 20, 2020

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. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) advisory panel in regard to the COVID-19 vaccine from Moderna. The Vaccines and Related Biological Products Advisory Committee will be determining whether the product should be authorized for emergency use, according to CNBC. The vote itself is not slated to take place until after 3 p.m.

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

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The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * efficacy against any symptomatic COVID-19 disease, in line with expected vaccine effectiveness in today’s environment dominated by variants of concern.

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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

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. These real-world studies also have shown that PAXLOVID is effective amongst both vaccinated and unvaccinated high-risk patients.(6,7,8,9,10) NYSE: PFE) announced today that the U.S. Source link: [link]

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The Pharma Data

NOVEMBER 23, 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

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School. The vaccine currently being tested stimulates the body’s immune system to produce antibodies to oxycodone.

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The Pharma Data

MAY 13, 2021

CDC Advisers Endorse Pfizer Vaccine for Children Ages 12 to 15 ( NYTimes ) ( Reuters ) ( STAT ). US CDC finds more clotting cases after J&J vaccine, sees causal link ( Reuters ) ( NBC ) ( NYTimes ). Covid vaccines may not protect people with immune disorders. In Focus: US.

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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. and Australia.

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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

NOVEMBER 12, 2021

Treatment is First FDA-Approved Option Patients Can Take Regardless of Previous Therapies. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. The FDA, an agency within theU.S.

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