Digital Pharmacist

OCTOBER 24, 2022

Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials. . following data from the CENTAUR Phase 2 Clinical Trials. . This indication was approved under accelerated approval based on the response and duration of the response. Date of Approval: 9/22/2022.

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Pharmaceutical Technology

FEBRUARY 27, 2023

The regulatory approval is based on the data obtained from the open-label, head-to-head, randomised, international Phase III DESTINY-Breast03 clinical trial. In the study, Enhertu showed a 72% reduction in the risk of disease progression or death compared to T-DM1 and a consistent safety profile with previous clinical trials.

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pharmaphorum

NOVEMBER 25, 2022

In review documents published ahead of the ODAC meeting, the agency took issue with what it described as marginal efficacy in clinical trials of the drug, high toxicity rates, and concerns about the dose selected for study. The post FDA rejects Spectrum’s lung cancer drug poziotinib appeared first on.

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Pharmaceutical Technology

DECEMBER 11, 2022

Due to the rarity of the disease, no FDA-approved therapy exists specifically for RT, and these patients are treated using regimens derived from the DLBCL treatment paradigm and other small-scale clinical trials. The most common Grade ≥3 treatment-related adverse events were neutropenia at 20%, hypertension at 3%, and hemorrhage.

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Hospital Pharmacy Europe

DECEMBER 20, 2022

Enhertu clinical efficacy. The press release adds how the safety profile of Enhertu was consistent with previous clinical trials with the most common Grade 3 or higher treatment-emergent adverse events were neutropenia (13.7%), anaemia (8.1%), fatigue (7.5%), leukopenia (6.5%), thrombocytopenia (5.1%) and nausea (4.6%).

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PharmaShots

FEBRUARY 17, 2023

Difficile Infection Date: Feb 15, 2023 | Tags: Seres Therapeutics, SER-109, Recurrent C. to go Public via Austin Biosciences SPAC Merger for ~$166.3M to go Public via Austin Biosciences SPAC Merger for ~$166.3M

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European Pharmaceutical Review

JANUARY 5, 2023

The clinical study for the telomerase inhibitor met its primary efficacy endpoint of eight-week TI and a key secondary endpoint of 24-week TI. Patients also experienced a statistically significant (p=0.042) and clinically meaningful mean reduction in red blood cell (RBC) transfusion units compared to placebo. dL for placebo.

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Hospital Pharmacy Europe

JANUARY 5, 2023

The first-line treatment consists of intensive chemotherapy with autologous stem cell transplant for the fit or less intensive chemotherapy for less fit and transplant-ineligible individuals, although many eventually relapse with a progressive clinical course. Neurologic adverse events occurred in 15.4%

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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, (..)

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Pharmaceutical Technology

FEBRUARY 5, 2023

months of statistically significant and clinically meaningful overall survival (OS) compared with single-agent chemotherapy and a 34% reduction in risk of disease progression or death. Trodelvy showed 3.2 We thank the physicians, patients and their families who put their trust in the TROPiCS-02 study and helped make this milestone possible.”

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pharmaphorum

SEPTEMBER 8, 2020

For example, clinical decision support systems, driven by AI tech, are starting to help physicians sift through data and diagnose diseases as early as possible – a key goal for any system hoping to reduce the burden of disease. Much of this was being driven by digital innovation even before COVID-19.

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PharmaShots

FEBRUARY 17, 2023

Shots: The company reported the commercial availability of Stimufend, a biosimilar to Neulasta in the US for patients who are at risk for febrile neutropenia. Stimufend is commercially available in a 6mg/0.6

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Pharmaceutical Technology

SEPTEMBER 19, 2022

The latest development is based on findings from the single-arm, open-label Phase II/III ALD-102 (Starbeam) and Phase III ALD-104 clinical trials. Mucositis, vomiting, nausea, febrile neutropenia, alopecia and reduced appetite among others were reported to be the most prevalent non-laboratory adverse reactions reported.

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PharmaShots

MARCH 1, 2023

The proposed biosimilar is currently in the advanced clinical stage Fresenius Kabi will get exclusive commercialization right to FYB202, a proposed biosimilar referencing Stelara in key global markets after successful approval by respective health agencies, incl. The company provides a patient support program i.e., AMJEVITA SupportPlus incl.

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European Pharmaceutical Review

DECEMBER 8, 2022

Safety data of the non-squamous NSCLC clinical trial . The most common TEAEs were anaemia, asthenia, nausea, constipation, cough, dyspnoea, vomiting, decreased appetite, and neutropenia. PERLA Phase II study. The key secondary endpoint of mPFS showed 8.8 months (95 percent CI: 6.7 in the dostarlimab treatment arm compared to 6.7

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Hospital Pharmacy Europe

FEBRUARY 1, 2024

He added: ’The decision by NICE will be welcomed by both patients and the clinical community.’ In the Phase 1/2 NHL-1 clinical trial, epcoritamab prevented growth or spread of the cancer for an average of 15.6 months, and the patients lived for an average of 19.4 months from the start of epcoritamab therapy.

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PharmaShots

MAY 17, 2023

Shots: The company launch Fylnetra, a biosimilar referencing Neulasta in the US making it the sixth biosimilar for febrile neutropenia. The biosimilar was developed in collaboration with Kashiv Biosciences The company focuses to provide high-quality biosimilars to the global markets over the coming years.

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PharmaShots

MAY 17, 2023

Shots: The company launch Fylnetra, a biosimilar referencing Neulasta in the US making it the sixth biosimilar for febrile neutropenia. The biosimilar was developed in collaboration with Kashiv Biosciences The company focuses to provide high-quality biosimilars to the global markets over the coming years.

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European Pharmaceutical Review

AUGUST 18, 2022

The safety and effectiveness of Zynteglo were established in two multi-centre clinical studies that included adult and paediatric patients with beta-thalassemia requiring regular transfusions. Of 41 patients receiving Zynteglo, 89 percent achieved transfusion independence. .

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PharmaShots

APRIL 5, 2023

The company's main goal is to advance the most diverse pipelines in neuroscience, which will revolutionize patient care in a no. of new active lesions was similar b/w treatment groups @24wk.

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Hospital Pharmacy Europe

OCTOBER 23, 2023

Anna Sureda, head of clinical hematology department, Institut Català d’Oncologia – L’Hospitalet in Barcelona, Spain, said: ‘R/R DLBCL is an aggressive cancer and patients can face a difficult and emotional treatment journey.

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PharmaShots

MARCH 10, 2023

Vertex Receives the US FDA’s IND Clearance of VX-264 for the Treatment of Type 1 Diabetes Date: Mar 10, 2023 | Tags: Vertex, VX-264, Type 1 Diabetes, Regulatory, US, FDA, IND Alnylam Expands its Collaboration with Medison Pharma to Commercialize RNAi Therapies Date: Mar 10, 2023 | Tags: Alnylam, Medison Pharma, RNAi Therapies, Onpattro, patisiran, (..)

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PharmaShots

JUNE 7, 2023

based on change from baseline on a standardized DAS28-CRP which evaluates the severity of RA using clinical and laboratory data Additionally, the company initiates PK study for AVT05 in Jan 2023. rheumatoid arthritis The primary outcome measures will be to show the comparative efficacy of AVT05 vs Simponi @16wks. 84% vs 64%) & 2yr. (60%

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