Pharmacy Times

JANUARY 5, 2024

Adalimumab-aqvh (Yusimry; Coherus Biosciences) entered the market in July 2023, following approval by the FDA in December 2021.

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Immunization FDA 65

The FDA Law Blog

APRIL 30, 2023

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub.

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Immunization FDA Labelling 59

pharmaphorum

JULY 27, 2022

The vaccine, codenamed BNT162b5, codes for “enhanced” prefusion spike proteins from the original wild-type strain of the virus and the Omicron variant that are designed to increase “the magnitude and breadth of the immune response.” 1 subvariant of Omicron. 1, but with less activity against the fast-emerging BA.4

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Vaccines Immunization FDA 122

pharmaphorum

JUNE 7, 2021

It was filed for the adult ALL indication in the US in April, and has a priority review from the FDA, with a verdict due in October. Around a quarter of patients treated with Tecartus had a severe immune reaction, and there were two deaths in the trial. Novartis eyes Yescarta challenge in follicular lymphoma.

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FDA Labelling Immunization 105

Pharmaceutical Technology

NOVEMBER 14, 2022

Such developments, including a 2021 approval of AstraZeneca’s Saphnelo (anifrolumab) , prompted The Lancet Rheumatology to posit that 2022 could be a “banner year” for the condition. In lupus, the body’s immune system starts to attack its own cells. MSCs and CAR-Ts for lupus.

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Immunization FDA 144

Pharmaceutical Technology

APRIL 14, 2023

This will suppress the effector characteristics in multiple immune cell subsets. Tiziana Life Sciences chief medical officer Matthew Davis said: “We anticipate entering into a Phase 2a placebo-controlled clinical trial upon successful feedback from the FDA.

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Immunization FDA 98

Pharmaceutical Technology

JUNE 12, 2023

Addiction affects an estimated three million US citizens and claimed over 100,000 lives in 2021 alone. In 2022, the FDA awarded VX-548 breakthrough therapy and fast-track designations for post-operative pain, and the drug is forecast to reach sales of $416m by 2029.

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Immunization FDA 143

The Checkup by Singlecare

SEPTEMBER 22, 2023

Here’s what you need to know about the new FDA-approved RSV vaccine. But young children, older adults, and individuals with weakened immune systems are at high risk of severe, potentially life-threatening RSV illness. The RSV vaccines are not mRNA immunizations, and “they are not live vaccines,” explains Blair Gingerich , Pharm.D.,

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Vaccines Immunization Insurance FDA 105

pharmaphorum

JANUARY 10, 2023

Other IgG proteases are being developed to tackle the issue of pre-existing immunity against AAV, but according to Selecta chief executive Carsten Brun these tend to be derived from common human pathogens – which means they themselves can be the target of existing antibodies. .”

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Immunization FDA 119

Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Children between the ages of five and 36 months are at highest risk of death from malaria.

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Vaccines Immunization FDA 111

European Pharmaceutical Review

APRIL 25, 2023

Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months. R21/Matrix-M contains Novavax’s saponin-based adjuvant Matrix-M, which enhances immune response, making it more potent and more durable. This age group is at highest risk of death from malaria.

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Vaccines Immunization FDA 111

pharmaphorum

DECEMBER 17, 2020

The vaccine is based of inactivated viruses grown in culture and includes an adjuvant used to boost the immune response. Valneva plans to include more than 4,000 participants in additional trials, which it believes could support an initial regulatory approval in the fourth quarter of 2021.

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Vaccines FDA Immunization Hospitals 105

European Pharmaceutical Review

DECEMBER 7, 2022

In October 2021, The EMA concluded that a booster dose of the Comirnaty ® COVID-19 vaccine can be given to people with severely weakened immune systems, at least 28 days after their second dose. Additional authorisations and recommendations of Comirnaty ®.

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Vaccines Immunization FDA 98

European Pharmaceutical Review

JULY 13, 2023

The field of immunotherapy is constantly evolving with the ultimate goal to develop new treatments that help the body’s immune system fight cancer. Immune cells, such as T cells and natural killer (NK) cells, have the inherent ability to combat diseases, including cancer, but are often inhibited by the body’s own suppressive mechanisms.

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Immunization Hospitals FDA 98

pharmaphorum

APRIL 9, 2021

Founded in 1999, Marseille-based company Innate Pharma is on a mission to develop immunotherapies that take advantage of the body’s innate immune system. The cytokine release prompts T-cells so they can translate that first innate immune response into a long-lasting adaptive immune response.

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Immunization Packaging FDA 122

Pharmaceutical Technology

APRIL 11, 2023

The US Food and Drug Administration (FDA) has granted final approval to India-based Zydus Lifesciences ‘ 500mg azithromycin tablets for the treatment of bacterial infections. The vaccine, which generates the SARS-CoV-2 viral spike protein on administration, induces the immune system’s cellular and humoral arm-mediated immune response.

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FDA Immunization Vaccines 52

STAT

MARCH 6, 2023

“I’m slowly running out of options,” said Young, 62, who in November began   receiving   a five-month series of shots at a clinic near her San Francisco home; the vaccine is designed to teach her immune cells to recognize and combat tumors. “People come to this thinking they will be cured.”

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Vaccines FDA Immunization Chemotherapy 98

pharmaphorum

MARCH 17, 2021

A readout from the phase 3 section is expected later this year, lining up a potential launch midway through 2021. The US FDA granted Fast Track designation for the vaccine midway through last month, granting a faster development and review. Two doses of 3.75 micrograms of the vaccine are administered 21 days apart.

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Vaccines Immunization FDA 105

pharmaphorum

MAY 25, 2022

Shares in US biotech Verrica Pharma lost half their value today after the FDA declined to approve its candidate treatment for viral skin infection molluscum contagiosum for a third time. Sterling was classified by the FDA as voluntary action indicated (VAI) last November.

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Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir).

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FDA Labelling Immunization 59

pharmaphorum

APRIL 26, 2022

PubMed cites 1,822 pieces of research relating to the microbiome in 2011, which grew to 25,153 published in 2021. As more research has been conducted, closer and unexpected links have been found between the microbiome of the gut, as one example, and other areas of the body, such as brain health and the immune system.

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Immunization FDA 115

Hospital Pharmacy Europe

AUGUST 24, 2023

The the first and only treatment indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, budesonide was approved by the FDA in 2021 under the accelerated approval scheme. IgA nephropathy is a chronic immune-mediated kidney disease characterised by IgA deposition in the glomeruli.

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Immunization FDA Hospitals 91

pharmaphorum

FEBRUARY 28, 2021

The FDA has approved emergency use of a third COVID-19 vaccine from Johnson & Johnson’s Janssen Biotech unit, the day after an advisory committee concluded it was safe and effective. Today, FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of #COVID19 caused by SARS-CoV-2. Janssen’s Ad26.COV2.S

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Vaccines FDA Immunization 59

pharmaphorum

OCTOBER 4, 2020

However it requires high-dose chemotherapy to destroy the bone marrow, and that poses significant risks to patients in its own right, and can also lead to graft-versus-host disease, a potentially life-threatening complication in which the bone marrow donor’s immune cells attack the recipient’s cells and tissues.

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Immunization Chemotherapy FDA 98

European Pharmaceutical Review

JUNE 27, 2023

Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies.

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Chemotherapy Immunization FDA Vaccines 105

pharmaphorum

NOVEMBER 23, 2020

ADC Therapeutics could claim its first product approval in the US next May, after the FDA started a priority review of lead drug Lonca for diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin’s lymphoma. The post FDA sets May date for verdict on ADC’s lymphoma drug Lonca appeared first on.

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pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.

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FDA Immunization 52

Pharma Mirror

OCTOBER 16, 2023

The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021. The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021.

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Immunization Vaccines FDA 52

European Pharmaceutical Review

MAY 4, 2023

Overall, the mechanisms of action for amivantamab include ligand blocking, receptor degradation, and immune cell-mediated activity. 4 BsMAb amivantamab was designed to enhance adherence of tumour cells to macrophages and natural killer cells, to improve immune-cell mediated killing of cancer cells. Personalized medicine at FDA.

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Immunization Chemotherapy FDA 98

The Checkup by Singlecare

SEPTEMBER 12, 2023

The Shingrix vaccine triggers the immune system to respond to the varicella virus and suppress the outbreak of shingles,” says David Cutler , MD, a family medicine physician at Providence Saint John’s Health Center in Santa Monica, California. This is a typical immunization response as your body builds a defense against possible infection.

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Vaccines Immunization Pharmacy Program Director Chemotherapy 105

The Checkup by Singlecare

MARCH 8, 2024

While nonbiologic drugs are made with chemicals and have a known structure, most biologics are complex mixtures and cannot be easily identified or characterized, according to the Food & Drug Administration (FDA). Continue reading to learn more about FDA approved Humira biosimilars, which are made by various drug companies.

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Dosage Pharmaceutical Companies Pharmaceutical Companies FDA 97

pharmaphorum

MARCH 27, 2022

The decision comes less than a month after Carvykti was approved by the FDA as a fifth-line therapy for multiple myeloma, teeing up a tussle in the market with Bristol-Myers Squibb and bluebird bio spinout 2seventy’s Abecma (idecabtagene autoleucel) which was approved for a similar indication last year.

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Labelling Immunization FDA 98

pharmaphorum

MARCH 28, 2022

GlaxoSmithKline and Vir’s Xevudy has become the latest COVID-19 antibody therapy to have its use restricted by the FDA as a result of waning activity against new variants of the virus. 2 is emerging as the dominant strain of SARS-CoV-2, said the FDA. The post FDA restricts GSK’s Xevudy due to lower efficacy against BA.2

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European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

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Immunization Vaccines Communication Labelling 97

pharmaphorum

APRIL 30, 2021

Shares in the company nevertheless fell 3% in the wake of the announcement, even though the company maintained its 2021 guidance for revenues and earnings. It’s Merck’s last remaining COVID-19 programme after it scrapped development of its vaccine candidate and immune modulator MK-7110.

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The Checkup by Singlecare

OCTOBER 11, 2023

Phenylephrine In September 2023, the FDA announced that a common decongestant found on shelves, phenylephrine, is not actually effective to decrease congestion. Fruits and vegetables are full of vitamins and nutrients (like vitamin C and beta carotene ) that can boost the immune system when you’re sick. Here’s what to skip.

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Mayo Clinic Immunization FDA Compounding 106

PharmaShots

MARCH 21, 2023

In patients with persistent partial response, where daratumumab interference is suspected, consider using an FDA-approved daratumumab-specific IFE assay to distinguish daratumumab from any remaining endogenous M protein in the patient’s serum, to facilitate the determination of a complete response. The portfolio sales grew 9.9%

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