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.

Vaccines 105

Vaccines Immunization FDA 105

European Pharmaceutical Review

OCTOBER 14, 2022

RemeGen has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its proprietary novel fusion protein Telitacicept (RC18) for the treatment of myasthenia gravis (MG). Telitacicept is a proprietary novel fusion protein from RemeGen to treat autoimmune diseases.

FDA 108

FDA Immunization 108

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.

FDA 40

FDA Immunization 40

Pharmaceutical Technology

MARCH 6, 2023

While the data will be presented at an upcoming meeting, a previous analysis of the two arms for OS showed an HR of 0.59, which could lead to a modest but clinically meaningful improvement in OS. 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%

Chemotherapy 52

Chemotherapy FDA Labelling Immunization 52

PharmaShots

JUNE 13, 2023

Adcetris received marketing authorization in 70+ countries for r/r HL and systemic ALCL Ref: Businesswire | Image: Seagen Related News:- Seagen’s Adcetris (brentuximab vedotin) Receives the US FDA’s Approval for High-Risk Hodgkin Lymphoma PharmaShots! Your go-to media platform for customized news ranging for multiple indications.

Immunization 40

Immunization FDA 40

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. Oral Presentation JGN-75414.

Immunization 89

Immunization Chemotherapy FDA 89

European Pharmaceutical Review

DECEMBER 28, 2023

As well as presenting recent findings from the pivotal AFM13-104 study, Andreas also reflects on the challenges encountered and conquered in developing Affimed’s innate cell engager, Acimtamig, which targets CD30 on lymphoma cells and CD16A on NK cells. Can you share some highlights from the data presented at ASH 2023?

Immunization 84

Immunization Chemotherapy Medical Schools FDA 84

pharmaphorum

OCTOBER 28, 2021

FDA advisors gave a green light to Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for children in that younger age bracket earlier this week and the Centre for Disease Control and Prevention (CDC) looks set to follow suit next week. Both recommendations now have to be ratified by the FDA and CDC.

Vaccines 98

Vaccines FDA Immunization 98

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.

FDA 86

FDA Vaccines Immunization Compounding 86

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.

Vaccines 105

Vaccines Immunization Pharmacy Program Director Chemotherapy 105

The FDA Law Blog

FEBRUARY 19, 2023

Hyman, Phelps & McNamara (“HPM”) Director Larry Houck will present “Prescribing Red Flags, Corresponding Responsibility and DEA Investigations: What’s a Pharmacist To Do?” at this year’s American Pharmacists Association’s (“APhA’s”) Annual Meeting in Phoenix, March 24-27.

Controlled Substances 59

Controlled Substances Immunization 59

PharmaShots

MARCH 24, 2023

PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)

FDA 64

FDA Immunization 64

pharmaphorum

SEPTEMBER 20, 2022

Dr Furie has also lead other clinical trials resulting in FDA approval of new therapies for SLE, including Saphnelo (anifrolumab), as well as Benlysta (belimumab) for lupus nephritis – the first therapy approved for treatment of that form of lupus. is presently enrolling two phase studies in 31 countries worldwide. Dr Kevin J.

Immunization 111

Immunization FDA 111

pharmaphorum

JULY 9, 2021

The FDA updated labelling for both shots to reflect the possible link to heart inflammation towards the end of last month, while cardiologists in the US have said that the benefits of the vaccines “enormously outweigh” any risk of heart-related complications. The therapy hasn’t yet been approved by the FDA.

Vaccines 105

Vaccines Labelling FDA Immunization 105

Hospital Pharmacy Europe

AUGUST 24, 2023

Multiple myeloma is a malignancy of terminally differentiated plasma cells that typically presents with bone marrow infiltration of clonal plasma cells and monoclonal protein in the serum and/or urine. The EC approval follows a similar FDA approval in the US in August 2023. mg/kg or biweekly 0.8

Hospitals 93

Hospitals Dosage Immunization FDA 93

PharmaShots

MAY 19, 2023

Alimera Acquires Rights from EyePoint Pharmaceuticals to Commercialise Yutiq in the US Date: May 19, 2023 | Tags: Alimera, EyePoint Pharmaceuticals, Yutiq, Iluvien, chronic non-infectious uveitis, US, Pharma Sobi Reports EMA’s Validation of MAA for Efanesoctocog Alfa to Treat Haemophilia A Date: May 19, 2023 | Tags: Sobi, Efanesoctocog Alfa, (..)

Medical Schools 40

Medical Schools FDA Immunization Vaccines 40

PharmaShots

MAY 12, 2023

Sanofi Reports P-IIIb Trial (HARMONIE) Results of Nirsevimab for the Prevention of Hospitalizations due to RSV-Related LRTD Date: May 12, 2023 | Tags: Sanofi, Nirsevimab, RSV-Related LRTD, Clinical Trial, P-IIIb, HARMONIE Trial G1 Therapeutics Presents Preliminary Results from P-II Trial of Trilaciclib for Triple-Negative Breast Cancer at ESMO 2023 (..)

FDA 40

FDA Chemotherapy Immunization Hospitals 40

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.

FDA 52

FDA Immunization 52

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.

Chemotherapy 59

Chemotherapy Immunization FDA 59

pharmaphorum

NOVEMBER 30, 2020

Neutralising antibodies (NAbs) present a unique challenge to researchers looking to treat patients with AAV treatment. As AAV is a virus derived from the common cold, the immune system can easily have levels of pre-existing NAbs that will recognise and neutralise AAV, rendering it ineffective.

Immunization 105

Immunization FDA 105

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

Labelling 91

Labelling Immunization FDA 91

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

Labelling 91

Labelling Immunization FDA 91

PharmaShots

JANUARY 27, 2023

Magenta Therapeutics Pauses the P-I/II Study in AML Patients Date: Jan 27, 2023 | Tags: Magenta Therapeutics, MGTA-117, AML, Clinical Trial, P-I/II Ipsen Receives CHMP Negative Opinion for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva Date: Jan 27, 2023 | Tags: Ipsen, Palovarotene, Fibrodysplasia Ossificans Progressiva, Regulatory, CHMP, (..)

FDA 40

FDA Immunization 40

pharmaphorum

MARCH 3, 2021

Convalescent plasma taken from recovered COVID-19 patients is laden with antibodies against SARS-CoV-2, and the hope was this could be used to confer a form of passive immunity to individuals still battling the infection. Last year, the PLACID trial found no benefit of the therapy in patients hospitalised with moderate COVID-19.

Immunization 52

Immunization FDA Hospitals 52

European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. A two-dose version of the vaccine was approved by the US Food and Drug Administration (FDA) in 2017.

Vaccines 71

Vaccines Immunization FDA 71

European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

Pharmaceutical Companies 102

Pharmaceutical Companies Pharmaceutical Companies Immunization Process Improvement 102

pharmaphorum

SEPTEMBER 27, 2021

Initial results from the 20-patient HOPE-2 trial reported last year showed signs of activity in older boys and young men with advanced DMD , prompting Capricor to ask the FDA about the possibility of filing for approval based on the mid-stage trial. point improvement over placebo at 12 months.

FDA 86

FDA Immunization 86

pharmaphorum

DECEMBER 9, 2022

There was also encouraging safety data observed within a wider group of 92 patients: 3% of patients experienced Grade 3 or higher cytokine release syndrome (CRS) and 8% experienced Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS).

Immunization 97

Immunization FDA 97

pharmaphorum

FEBRUARY 8, 2022

With the safety of gene therapies thrown into the spotlight by a series of FDA clinical holds, Astellas has said that an interim readout in a phase 1/2 trial of its Pompe disease candidate AT845 hasn’t found any cause for concern. The post Astellas says Pompe gene therapy clears safety hurdle appeared first on.

Immunization 52

Immunization FDA 52

BuzzRx

SEPTEMBER 2, 2022

Monkeypox skin lesions can also be present in the mouth and on the face, chest, hands, and feet. A new vaccine called JYNNEOS (Imvanex or Imvamune) has been approved by the United States Food and Drug Administration (FDA) to prevent monkeypox virus infection. A monkeypox infection causes symptoms similar to smallpox but milder.

Vaccines 52

Vaccines Immunization FDA 52

PharmaShots

MARCH 24, 2023

PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)

FDA 40

FDA Immunization 40

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.

Chemotherapy 96

Chemotherapy Immunization FDA Vaccines 96

The Checkup by Singlecare

DECEMBER 15, 2022

Suppressing your own immune system by taking medication is naturally frightening but is absolutely necessary to control many autoimmune conditions. Remicade is also FDA approved for use in pediatric patients ages six and older for the treatment of Crohn’s and ulcerative colitis. .

Immunization 52

Immunization Dosage Labelling FDA 52

Roots Analysis

JANUARY 14, 2024

Given the ongoing scientific advancements and the rise of FDA-approved biologics, the pharmaceutical industry seems to be approaching the era of biologics. Like all drugs, biologics are regulated by the FDA. They are different from small molecules in terms of their size and complexity.

Immunization 40

Immunization Vaccines FDA 40

PharmaShots

JUNE 27, 2023

We saw Biogen presented multiple results for different biosimilar molecules. Can you please talk about the trial and the results which were presented at ACR’22? Dr. Mourad Farouk Rezk: The “PROPER” study is a pan-European real-world non-interventional study of patients with immune-mediated inflammatory disease.

Immunization 40

Immunization FDA 40

pharmaphorum

NOVEMBER 9, 2021

Some cancer cells contain large amounts of PD-L1, which helps them to evade the body’s immune system. Also, Bristol-Myers Squibb was recently successful in gaining FDA approval for Opdivo to be used as an earlier line treatment for post-surgical treatment of invasive bladder cancer.

Chemotherapy 59

Chemotherapy Immunization FDA 59

PharmaShots

MARCH 9, 2023

We are esteemed and elated to present a list of the 20 women who have excelled in reaching the summit of excellence, arranged alphabetically Total experience: 16 yrs. Present company and time period: Pfizer (2 yrs.) Present company and time period: Sensium Healthcare (6 yrs. Present company and time period: Pfizer (26 yrs.)

FDA 40

FDA Pharmaceutical Companies Pharmaceutical Companies Immunization 40