pharmaphorum

JULY 13, 2021

The FDA has added a new warning on the Johnson & Johnson COVID-19 vaccine, saying the shot has been linked to a serious but rare side effect – Guillain-Barré syndrome – that can cause muscle weakness. The cases have mostly been recorded two weeks after vaccination and seem to be more common in men aged 50 and older.

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The Checkup by Singlecare

MAY 8, 2024

The role of Remicade for ulcerative colitis Infliximab is an antibody that intercepts one of the key messengers of the immune system’s signaling pathway. With the immune system not using resources to fight a war on its own body, our systems can devote more proteins and energy to daily living.

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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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PharmaShots

FEBRUARY 21, 2023

In Aug’21, the US FDA cleared QSam’s IND application for CycloSam. Nordic is advancing the development of CD37-targeted therapies for hematological cancers and immune diseases. In Jun’21, the company initiated the evaluation of FAP-2286 in a P-I/II clinical trial (LuMIERE) following the US FDA’s IND clearance.

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The Checkup by Singlecare

NOVEMBER 30, 2023

Acetaminophen may also blunt the effects of other medications that impact the immune system, including some medicines used to manage cancer diagnoses and even the immune response following vaccinations. In some cases, metyrapone is used off-label in the treatment of Cushing syndrome.

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European Pharmaceutical Review

AUGUST 10, 2022

countries with manufacturing capacity for diagnostics, vaccines and therapeutics. Monkeypox is a disease caused by a zoonotic orthopoxvirus (the monkeypox virus) with similar but less severe symptoms to smallpox – a related disease eradicated through vaccination campaigns by May 1980 – including a rash and fever. But what is monkeypox?

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PharmaShots

MARCH 9, 2023

Birthplace: Belén was born in Almansa (Spain) Additional Information: Merck became a significant international participant in immunology, oncology, and immune oncology under her leadership of the Healthcare business. Designation: Global Head Previous company: Merck Global Vaccines (2 yrs. and Banco Bilbao Vizcaya Argentaria S.A

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pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford-AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

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pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

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Vaccines Immunization Medical Schools FDA 59

pharmaphorum

SEPTEMBER 7, 2021

The EU regulator has started to review a marketing application filed by Pfizer and BioNTech for a third, booster dose of their Comirnaty COVID-19 vaccine given six months after the first course to people aged 16 and over. The two companies said they would also file the dossier with other regulators “in the coming weeks.”

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The FDA Law Blog

JUNE 2, 2023

“All In” Manufacturer Definition CMS believes that the National Rebate Agreement (NRA) requires a “manufacturer” to report to Medicaid all of its covered outpatient drugs, under all of its labeler codes. This includes newly acquired labeler codes and newly formed subsidiaries. 42 U.S.C. §§ 1396r-8(k)(3) and 1396r-8(g)(1)(B)(i).

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The Checkup by Singlecare

DECEMBER 5, 2022

There are seven FDA-approved prescription medications for weight loss. Finding the cause of your sleepless nights can be tiresome, but sometimes it’s as easy as reading the labels on your prescriptions. Usually, it’s best to get your vaccination before the end of October, but if you haven’t received yours yet, it’s not too late.

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The Checkup by Singlecare

MARCH 28, 2024

Food and Drug Administration (FDA) to treat many bacterial infections. Amoxicillin is FDA-approved for treating nose, throat, ear, lung, skin, and urinary tract infections. It may also be prescribed off-label to treat other bacterial infections, including certain STDs. Amoxicillin is an antibiotic approved by the U.S.

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European Pharmaceutical Review

SEPTEMBER 12, 2022

The first aims to explore whether intradermal delivery of the Jynneos monkeypox vaccine is efficacious, and could thereby be used to expand the limited vaccine supply ; while the second aims to establish the efficacy of SIGA’s antiviral tecovirimat (TPOXX). Intradermal vaccine delivery.

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Pharmaceutical Technology

APRIL 24, 2023

Since then, the field of nanomedicine has steadily progressed to reach high points such as the successful use of nanotechnology to deliver messenger RNA (mRNA)-based Covid-19 vaccines. In the case of most mRNA vaccines, a lipid nanoparticle-based approach was chosen due to its ability to protect the mRNA in the body and prevent degradation.

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Pharmaceutical Technology

MARCH 21, 2023

FDA and EMA decisions In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older. A few weeks later, the EC extended the approval label of AstraZeneca’s Forxiga (dapagliflozin) to include the treatment of symptomatic hearth failure.

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