pharmaphorum

DECEMBER 1, 2021

In a complete response letter (CRL), the FDA said that it would need a second clinical trial of plinabulin before it could consider approving the drug, setting up what looks like a lengthy delay for the programme. of patients taking plinabulin plus pegfilgrastim and 13.6% of the pegfilgrastim-only arm.

Chemotherapy 52

Chemotherapy Immunity Immunization 52

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.

Adverse Reactions 75

Adverse Reactions Labelling Pharmacy Management Immunity 75

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.

Adverse Reactions 52

Adverse Reactions Labelling 52

Pharmacy Joe

MARCH 26, 2023

Future studies evaluating clinical outcomes between IVP and IVPB administration may be of benefit. The reconstitution instructions used in the study were: Ceftriaxone 1g per 10 mL normal saline or 2 g per 20 mL NS Cefepime 1g per 10 mL normal saline or 2 g per 20 mL NS Meropenem 0.5g

Inpatient 52

Inpatient 52

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.

Documentation 98

Documentation 98

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.

Labelling 59

Labelling 59

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

Biosimilars 40

Biosimilars Vaccines 40

RX Note

JUNE 5, 2023

vinblastine, vincristine, vindesine, vinorelbine) Dactinomycin Mitomycin # For the complete list of vesicants and irritants, you may refer to Ministry of Health Systemic Therapy Protocol page 131 or Management of Chemotherapy Extravasation: ESMO Clinical Practice Guidelines, 2012. Common vesicants should include Anthracyclines (e.g.

Chemotherapy 52

Chemotherapy Diabetes Hospitals 52

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.

52

52

Pharmacy Joe

MAY 10, 2020

Future studies evaluating clinical outcomes between IVP and IVPB administration may be of benefit. The reconstitution instructions used in the study were: Ceftriaxone 1g per 10 mL normal saline or 2 g per 20 mL NS Cefepime 1g per 10 mL normal saline or 2 g per 20 mL NS Meropenem 0.5g

Inpatient 40

Inpatient 40

Pharmacy Joe

NOVEMBER 3, 2021

The way forward that has the most chance of applicability to clinical practice is likely to combine risk factor analysis with biomarkers for candida infection , although the optimal strategy for this approach has not been identified. Receipt of blood transfusion (odds ratio 4.9) Candida colonization (odds ratio 4.7)

Inpatient 40

Inpatient Diabetes 40

Pharmacy Joe

DECEMBER 21, 2022

With the long duration of therapy needed for CNS infections, adverse events like elevated serum transaminases, neutropenia, and interstitial nephritis can frequently complicate therapy. In addition, nafcillin requires administration every 4 hours which adds to the burden of care.

Hospitals 52

Hospitals Inpatient 52

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 Biosimilars Immunity Immunization 40

Pharmacy Joe

NOVEMBER 21, 2021

The authors concluded that: Calculating subcutaneous filgrastim doses using actual body weight appears to produce similar systemic exposure in morbidly obese and non-obese patients with severe neutropenia. In addition, no clinical efficacy factors could be assessed due to the small sample size of the study.

Inpatient 40

Inpatient 40

Pharmacy Joe

DECEMBER 21, 2022

With the long duration of therapy needed for CNS infections, adverse events like elevated serum transaminases, neutropenia, and interstitial nephritis can frequently complicate therapy. In addition, nafcillin requires administration every 4 hours which adds to the burden of care.

Hospitals 40

Hospitals Inpatient 40

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.”

Adverse Reactions 105

Adverse Reactions Chemotherapy Labelling 105

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.

Biosimilars 97

Biosimilars Drug Pricing Chemotherapy Vaccines 97

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

Biosimilars 40

Biosimilars 40

RX Note

JUNE 3, 2023

A colleague told me that not all pharmacists are professionally trained to perform their clinical service. Is Good Clinical Practice a requirement prior to starts research? Chemotherapy induced emesis Febrile neutropenia Secondary malignancies Tumour lysis syndrome Which agent is approved to treat doxorubicin-induced cardiomyopathy?

Health and Personal Care Stores 40

Health and Personal Care Stores Chemotherapy Compounding Dosage 40

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.

Adverse Reactions 98

Adverse Reactions Labelling 98

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.

Biosimilars 40

Biosimilars Packaging Labelling 40

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

Chemotherapy 103

Chemotherapy 103

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.

Biosimilars 40

Biosimilars 40

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.

Biosimilars 40

Biosimilars 40

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. .

Adverse Reactions 85

Adverse Reactions 85

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.

Biosimilars 49

Biosimilars Packaging Labelling Hospitals 49

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, (..)

Diabetes 40

Diabetes Biosimilars Vaccines 40

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%

Biosimilars 40

Biosimilars Packaging Diabetes Pharmaceutical Companies 40

LifeProNow

APRIL 19, 2023

The increase in myeloma cells and M protein causes a variety of clinical manifestations, including hematopoietic disorders (mainly anemia), kidney damage, and osteolytic lesions. Identify CRS based on clinical presentation. Monitor and treat for CMV reactivation in accordance with clinical guidelines.

Adverse Reactions 100

Adverse Reactions Vaccines Immunity Immunization 100