BioPharma Drive: Drug Pricing

SEPTEMBER 11, 2023

Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.

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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

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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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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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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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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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. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target.

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The Pharma Data

OCTOBER 30, 2020

To increase demand for products during the novel coronavirus pandemic, the US Food and Drug Administration (FDA) has already approved at-home testing and investigated the effectiveness of malaria pills and other antiviral drugs to treat Covid-19 9. FDA approves first treatment for Covid-19.

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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

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. “Today marks a monumental milestone as PAXLOVID became the first COVID-19 oral treatment to be approved by the U.S. NYSE: PFE) announced today that the U.S. 11) At this time, the U.S.

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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 are pleased to confirm the U.S.

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The Pharma Data

NOVEMBER 29, 2021

Cytalux is used with a Near-Infrared fluorescence imaging system cleared by the FDA for specific use with pafolacianine. The FDA previously granted Cytalux orphan-drug , priority and fast track designations. The FDA granted the approval to On Target Laboratories, LLC. The FDA, an agency within the U.S.

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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

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

JANUARY 17, 2021

are expected to be approved by the U.S. FDA this year. as a treatment for metastatic breast cancer, under priority review by FDA are about to announce the results of their BLA/NDA approval (biologics license application; BLA), respectively. FDA approval this year. 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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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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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

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. These comments will be reviewed by the FDA. The week of Nov.

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Eye on FDA

AUGUST 4, 2021

As more drugs are being approved, is FDA getting less advice than in the past? FDA maintains a vast network of outside advisors to provide input and counsel to the agency related to decisions on policy as well as product approvals. But for that, it needs to be utilized.

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The Pharma Data

NOVEMBER 18, 2020

The simple nasal swab test, developed by Lucira Health, requires a prescription and people under the age of 14 can’t perform the test on themselves, the FDA said in a statement. ” COVID Vaccines Move Closer to Emergency Use Approval. Food and Drug Administration on Tuesday.

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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 granted the approval of Voxzogo to BioMarin. Related Information.

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The Pharma Data

MARCH 15, 2022

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, Ph.D.,

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The Pharma Data

FEBRUARY 24, 2022

Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Related Information.

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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

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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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

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. The emergency approval comes not a moment too soon.

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The Pharma Data

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. SILVER SPRING, Md. , 18, 2020 /PRNewswire/ — Today, the U.S.

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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. GAITHERSBURG, Md., Glenn, M.D., and globally.”.

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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

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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The Pharma Data

DECEMBER 13, 2020

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 determined that food from GalSafe pigs is safe for the general population to eat. SILVER SPRING, Md. ,

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The Pharma Data

APRIL 7, 2023

This drug was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. The decision was issued jointly by the FDA Commissioner and Chief Scientist. Based on that review, they have decided to withdraw approval of Makena and generic versions of Makena.

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The Pharma Data

NOVEMBER 23, 2021

Priority Review designation directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. The FDA, an agency within theU.S.

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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. Boumen Japet/Shutterstock. The meeting is slated to run from 9 a.m.

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