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 company began supplying the first consignment to the government of India in February 2022.

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Digital Pharmacist

OCTOBER 26, 2022

On October 7 th , 2022 the U.S. However, administering the Tdap vaccine to the mother during her third trimester of pregnancy, can boost the infant’s immune system by boosting antibodies in the mother, who then transfers the antibodies to the developing fetus. The FDA considered the safety data with the non-U.S.

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European Pharmaceutical Review

JANUARY 23, 2023

The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Evaxion Biotech’s personalised cancer immunotherapy. EVX-01 cancer immunotherapy EVX-01 is a peptide-based cancer immunotherapy generated based on gene analysis of a patient’s tumours and on matching with their immune system. Moderna, Inc.

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PharmaShots

MAY 23, 2023

Was ranked the highest among the list of companies developing Cell & Gene therapy, followed by Novartis with a revenue of $50.54B and Spark Therapeutics with a revenue of $49.27B PharmaShots brings an informative report on the Top 20 Cell and Gene Therapy Companies based on the total Revenue generated in the year 2022 Total Revenue: $0.5M

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. The FDA nod means Rinvoq is now approved for seven indications in gastroenterology, rheumatology and dermatology.

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pharmaphorum

AUGUST 13, 2021

The FDA has cleared the use of third dose of either the Pfizer/BioNTech or Moderna COVID-19 vaccines for people with weakened immune systems, but stopped short of recommending a broader booster campaign. The post FDA authorises COVID-19 booster jabs for at-risk people appeared first on.

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Pharmaceutical Technology

APRIL 26, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). This marks the first-ever designation for genetically modified gamma-delta T cell therapies.

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The FDA Law Blog

APRIL 8, 2024

This year’s report noted that CDER’s Drug Product Catalog contains over 140,000 entries, the same amount as OPQ listed in 2022. Readers also saw that that the Center’s manufacturing Site Catalog remains steady at more than 4,800 entries, the same number we found in the 2022 State of Pharmaceutical Quality report.

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The Checkup by Singlecare

FEBRUARY 20, 2024

Systemic oral and injectable treatments, like methotrexate and biologics , target aspects of the immune system to reduce inflammation. Vtama Approved by the Food and Drug Administration (FDA) in 2022 for use in adults, Vtama (tapinarof) is a topical cream that treats plaque psoriasis by decreasing inflammation.

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pharmaphorum

APRIL 29, 2021

Calliditas Therapeutics could have its first product on the market in the US this autumn, as the FDA has now started a priority review of Nefecon for rare disease primary IgA nephropathy (IgAN). . The EMA has also said it will carry out an accelerated review of the drug, setting up a possible approval date in the first half of 2022.

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European Pharmaceutical Review

MAY 7, 2024

Injectable vaccines activate the immune system to help to prevent infectious conditions such as influenza. Approvals in the injectable drug delivery market In Nov 2023, the US Food and Drug Administration (FDA) approved the first and only obesity medication, Eli and Lilly’s Zepbound injection. Teva Pharmaceuticals Industries Ltd.,

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European Pharmaceutical Review

JANUARY 4, 2024

Immunotherapy drugs like teclistamab can result in potentially fatal side effects, including CRS and immune cell-associated neurotoxicity syndrome (ICANS). An overactive immune response [is] the hallmark of CRS,” Landgren added. In 2022, the drug was approved by the US Food and Drug Administration (FDA) for these patients.

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pharmaphorum

SEPTEMBER 29, 2022

Sanofi and Regeneron have claimed the first approval in the US for a drug for prurigo nodularis, after the FDA gave a green light to Dupixent as a treatment for adults with the rare skin disease following a priority review. Kim (@itchdoctor) September 29, 2022. The suffering he notes from the #itch is 100… [link]. — Brian S.

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pharmaphorum

JULY 19, 2021

The FDA has approved a new pneumococcal vaccine from Merck & Co, just over a month after Pfizer got a green light for a new version of its market leading Prevnar shot. Also in the running is Vaxcyte, which has a 24-valent shot in early development and hopes to have initial clinical data from that programme in late 2022/early 2023.

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European Pharmaceutical Review

MARCH 4, 2024

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 The emergency use approval from the FDA of lipid nanoparticle- (LNP-) based mRNA vaccines during the COVID-19 pandemic attested the significance of LNPs.

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pharmaphorum

JUNE 9, 2021

Pfizer has the FDA approval it was seeking for Prevnar 20, the latest update to its blockbuster pneumococcal vaccination franchise, keeping it one step ahead of a competing shot from Merck & Co. In two phase 3 trials in adults reported last year, V114 stimulated immune responses to all serotypes in the shot.

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The FDA Law Blog

SEPTEMBER 21, 2022

Cato — On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) declared the outbreak of monkeypox virus a public health emergency (see announcement here ). This policy and the EUA templates mirror the approach taken by FDA for COVID-19. By McKenzie E. CDRH has also published templates for EUA requests.

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pharmaphorum

SEPTEMBER 16, 2022

A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”. Verily’s Immune Profiler can, Kim asserted, “generate more than 8 million immune measures across 24 immune cell subsets”.

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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

MAY 4, 2023

According to Research and Markets 8 , the market for bispecific antibodies for cancer is forecasted to grow by $400 million during 2022-2027, due to the increasing prevalence of cancer worldwide. Overall, the mechanisms of action for amivantamab include ligand blocking, receptor degradation, and immune cell-mediated activity.

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The Checkup by Singlecare

APRIL 3, 2024

It is used to control inflammation by suppressing the immune system,” says Jelena Radan, Pharm.D. According to a 2017 study , the beverage acts in an anti-inflammatory manner on different components of the immune system, such as natural killer (NK) cells, monocytes, and neutrophils. Do not take prednisone with certain supplements.

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PharmaShots

APRIL 19, 2023

Shots: The US FDA approved 6 NDAs and 1 BLA in March 2023, leading to treatments for patients and advances in the healthcare industry. The companies launched the patient support program i.e., KevzaraConnect to provide access to patients for Kevzara treatment & offer support from nurses & other specialists 2.

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Pharmaceutical Technology

APRIL 17, 2023

The company will provide regulatory advice to Incannex, and manage clinical trials to develop CannQuit and ReneCann products to treat addiction and immune-disordered skin diseases. In 2022, the company acquired CannQuit and ReneCann products as part of the acquisition of APIRx Pharmaceuticals.

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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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Pharmaceutical Technology

AUGUST 26, 2022

Amid a shortage of monkeypox vaccine doses, the WHO and FDA have declared public health emergencies, and the FDA has granted its first Emergency Use Authorization (EUA) to a monkeypox vaccine and opened the door for more. On the same day, the FDA granted a EUA to Bavarian Nordic’s (Copenhagen, Denmark) Jynneos vaccine.

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The Checkup by Singlecare

JANUARY 4, 2024

In addition, the FDA label for the nighttime forms of Mucinex containing acetaminophen recommends avoiding three or more drinks per day. Effects on the immune system Alcohol may negatively affect your immune system’s ability to fight off infections, especially in people who drink large amounts over time.

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The Checkup by Singlecare

DECEMBER 1, 2023

Vitamin D also supports a healthy immune system and can even help prevent diseases. That is 170% of the daily value (DV) recommended by the US Food and Drug Administration (FDA). Cereal To reduce vitamin D deficiency in America, the FDA now allows more vitamin D to be added to breakfast cereals. How much vitamin D do you need?

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The Checkup by Singlecare

DECEMBER 5, 2023

Known as the “sunshine vitamin,” because the body can produce it after sun exposure, vitamin D is essential for bone health, nerve and muscle function, and immune system function. Levothyroxine (a thyroid hormone) is FDA approved to treat hypothyroidism , a condition in which the body produces less thyroid hormone than your body needs.

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pharmaphorum

APRIL 7, 2022

The official word from the EU authorities is that for now a fourth dose of Pfizer/BioNTech’s Comirnaty or Moderna’s SpikeVax – the preferred booster vaccines in Europe – should only be used in adults aged 80 years and over and people with compromised immunity. FDA gives first thinking on updating vaccines.

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European Pharmaceutical Review

JUNE 27, 2023

difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. This followed results from a large metagenomics study published in November 2022, in which gut microbiome was identified as a key part of Parkinson’s pathogenesis.

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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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Pharmaceutical Technology

MARCH 6, 2023

Adverse events (AEs) were balanced between the arms, except for immune-related AEs, which were more frequent in the Tuoyi arm (grade ≥ 3, 8.9% Tuoyi also enjoys an FDA breakthrough therapy designation. Following this, an FDA approval is far from certain, despite the very promising OS data. versus 1.4%).

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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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PharmaShots

MARCH 29, 2023

PharmaShots has prepared a list of the top 20 drugs with patent expiry in 2023 Company: Eisai Generic Name: Rufinamide First Approval Date: Nov 17, 2008 Patent Expiration: Apr 2023 2022 Sales: $52M Indication: Lennox-Gastaut syndrome (LGS) Banzel is a prescription add-on drug for the treatment of seizures linked with LGS.

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The Checkup by Singlecare

APRIL 16, 2024

Stelara works by blocking proteins in the immune system that cause inflammation. Stelara as a treatment for psoriasis People with psoriasis have an overactive immune system. Be aware that non-live vaccines may not elicit an immune response strong enough to prevent disease. How much does Stelara cost? every eight weeks.

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BuzzRx

SEPTEMBER 2, 2022

On July 23, 2022, the World Health Organization declared monkeypox a public health emergency of international concern. As of August 1, 2022, the Centers for Disease Control and Prevention (CDC) website reported over 5,800 confirmed cases of monkeypox in the United States. What is monkeypox? Monkeypox is not related to chickenpox.

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pharmaphorum

APRIL 20, 2022

Regeneron has agreed an all-cash deal to acquire CheckMate Pharmaceuticals, adding immune activator vidutolimod to its cancer immunotherapy pipeline and ending a barren spell for M&A in the biotech sector. Readouts from phase 2 studies in head and neck and non-melanoma skin cancer patients are due in the second half of 2022.

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