Digital Pharmacist

OCTOBER 26, 2022

Food and Drug Administration (FDA) announced its approval of the Boostrix vaccine, commonly known as Tdap (combination of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis) for immunization administration during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age.

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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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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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pharmaphorum

JUNE 11, 2021

Sanofi’s hopes of a speedy approval of first-in-class C1s inhibitor sutimlimab in rare disorder cold agglutinin disease (CAD) were dashed by the FDA, but new phase 3 data keep the drugmaker on track for a resubmission before year-end. Sutimlimab, which Sanofi acquired via its $11.6

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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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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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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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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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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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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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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

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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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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PharmaShots

JUNE 15, 2023

In Nov 2021, the clinical results showed that TIL cell therapy + pembrolizumab in immune-checkpoint inhibitor naïve patients showed ORR (57%) in Cervical Cancer, 60% in Melanoma with 30% CR & 39% in Head & Neck Cancer The Iovance TIL platform showed promising clinical data across multiple solid tumors.

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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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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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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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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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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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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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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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Hospital Pharmacy Europe

AUGUST 24, 2023

IgA nephropathy is a chronic immune-mediated kidney disease characterised by IgA deposition in the glomeruli. In June 2023, Calliditas submitted a supplemental new drug application (sNDA) to the US FDA seeking full approval based on the full NefIgArd study data.

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The People's Pharmacy

MAY 1, 2023

The FDA has approved three prescription medicines for treating influenza , but one is reserved for hospitalized patients. It is considered an adaptogen that has antiviral, anti-inflammatory and immune modulating effects ( Pharmaceuticals , Sep. But the question remains: what can you do if you catch the flu? 8, 2020 ). 28, 2022 ).

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Immunization Hospitals FDA 56

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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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

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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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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The People's Pharmacy

APRIL 3, 2023

A review in the journal BMC Complementary Medicine and Therapies (April 7, 2021 ) concluded that elderberry may reduce the severity and duration of colds. Studies have confirmed that adequate zinc is essential for good antiviral immune response ( Advances in Nutrition , July 1, 2019 ). Don’t forget the zinc lozenges.

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The Checkup by Singlecare

DECEMBER 12, 2023

Plus, they’re not immune to regular old headaches. Sources 8 non-invasive pain relief techniques that really work , Harvard Health (2017) ACOG response to consensus statement on paracetamol use during pregnancy , American College of Obstetricians and Gynecologists (2021). Harvard Health (2021) Is massage safe during pregnancy?

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pharmaphorum

MAY 18, 2021

Incyte has made further progress with its ruxolitinib cream, notching up a phase 3 trial showing it can re-pigment skin in vitiligo ahead of a key FDA decision in atopic dermatitis. Filings with the FDA and the European Medicines Agency are planned for the second half of this year.

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pharmaphorum

FEBRUARY 2, 2022

The Netherlands biotech is developing leniolisib (formerly CDZ173) under license from Novartis for activated PI3K delta syndrome (APDS), an ultra-rare disease with no approved therapies that causes severe immune deficiency and a risk of blood cancers.

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PharmaShots

MAY 23, 2023

The company first received the US FDA approval for its gene therapy Zynteglo in Aug 2022 for treating adult and pediatric patients with ß-thalassemia. Later in Sep 2022, the company also received approval from the US FDA for its gene therapy, Skysona, to treat boys aged between 4 and 17 with active cerebral adrenoleukodystrophy (CALD).

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The Checkup by Singlecare

NOVEMBER 30, 2023

Being pregnant doesn’t make you immune from allergies—and, in some cases, many find that their allergy symptoms actually get worse during pregnancy. The FDA is beginning to move away from that rating system, says Alyssa Dweck , MD, an OB-GYN and medical adviser for INTIMINA. appeared first on The Checkup.

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pharmaphorum

JANUARY 26, 2023

The cancer is particularly challenging for immunotherapy, as it tends to have fewer mutations than other cancers, presenting fewer targets for immune cells, and tends to be immunologically ‘cold’, with few immune cells infiltrating the tumour.

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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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pharmaphorum

DECEMBER 18, 2020

MacroGenics’ HER2-targeted breast cancer drug Margenza has been approved by the FDA, challenging several recently approved drugs with a narrow efficacy edge over Roche’s Herceptin in data gathered so far in advanced disease. A final overall survival analysis is expected in the second half of 2021, after a planned launch in March next year.

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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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