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Fennec’s hearing loss drug for cancer patients wins breakthrough FDA nod

Pharmaceutical Technology

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. The current standard of care for many cancers is cisplatin chemotherapy or platinum therapy.

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Cymbalta generic availability, cost, and dosage

The Checkup by Singlecare

Food and Drug Administration (FDA) in 2004 , Cymbalta has become a widely used antidepressant to treat various mental health and pain-related conditions. What Are the Off-Label Uses for Cymbalta? Cymbalta may have several off-label uses in addition to its FDA-approved uses. Approved by the U.S.

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Amoxicillin-potassium clavulanate interactions to avoid

The Checkup by Singlecare

How to minimize amoxicillin-potassium clavulanate interactions Your best bet to avoid drug-drug interactions involving amoxicillin-potassium clavulanate is to communicate well with your medical providers.

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SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies

ISPE

Mexican Governor: Cancer Children Given Water Instead of Chemotherapy.” 3M explores New Label-As-A-Service Concept with Blockchain on Azure to Stop Counterfeit Pharmaceuticals.” You may unsubscribe from these ISPE communications at any time. 30 June 2016. link] 6 BBC News. Published 19 January 2017. link] 7 He, J., Cai, and X.

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MSD’s Keytruda use in adenocarcinoma could be limited based on biomarker

Pharmaceutical Technology

Merck ( MSD ) has announced updated results with Keytruda (pembrolizumab) in the Phase III Keynote-811 trial, which opens up the possibility of changing the checkpoint inhibitor’s label in HER2-positive gastric or GEJ adenocarcinoma so it’s based on the tumour’s PD-L1 biomarker status. Please check your email to download the Report.

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FDA approves Biostar’s Phase II/III plans with utidelone injectable for NSCLC

Pharmaceutical Technology

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. as the secondary endpoints. ORR, 81.0% DCR (disease control rate), 4.37

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CMO Moves: Regulatory catalysts for drug manufacturing- February

Pharmaceutical Technology

The ADC is already approved in the metastatic setting after chemotherapy or in the case of disease recurrence during or in six months after adjuvant chemotherapy. Regulatory decisions by the US FDA for select therapies from late December to late January, and the CMOs contracted to manufacture them.