Express Pharma

MAY 22, 2023

The addition of India to this important study will help to accelerate the development of this drug,” said Mickey Mikitani, Co-CEO, Rakuten Medical. ASP-1929 is a conjugation of antibody cetuximab and IRDye 700DX, a light activatable dye, and is Rakuten Medical’s first pipeline drug developed on its Alluminox platform.

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Labelling Drug Development 91

pharmaphorum

DECEMBER 5, 2022

The findings will be presented at an upcoming medical meeting and submitted to the FDA for regulatory approval in 2023. A vast majority of patients diagnosed with CRPC already present with metastases at the time of diagnosis. Those with metastatic prostate cancer have an estimated 30% chance of surviving five years.

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Chemotherapy Compounding Labelling Drug Development 59

pharmaphorum

SEPTEMBER 30, 2022

An open-label extension revealed that ALS patients had around six more months before being hospitalised, requiring a ventilator or dying compared to the control group and, according to Amylyx, patients who continued taking the drug survived about 10 months longer. .” Bad news for Biohaven.

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Specialty Pharmacies Labelling Hospitals Drug Development 98

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. The worldwide trend of using botanical drugs and strategies for developing global drugs.

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Drug Development Biosimilars Documentation Compounding 103

PharmaShots

APRIL 3, 2023

Shots: The first quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Date - Jan 04, 2023 Product – N/A The acquisition is completed from a shareholder group led by Nordic Capital, in an all-cash transaction valued at $2.8B per ADS up front & CVR of ~$2.50

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

Packaging 59

Packaging Documentation Labelling Communication 59

European Pharmaceutical Review

FEBRUARY 14, 2024

Clinical success will then obviously drive future investment in process optimisation throughout the drug substance and drug product processes to engineer a reduction in variation through enhanced process characterisation. He is an inventor of six patents and serves as a Visiting Lecturer at Manchester University on Product Development.

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Dosage Packaging Compounding Labelling 97

PharmaShots

FEBRUARY 21, 2023

Market Cap: $10.67M Founded Year: 2009 Total Employees: ~410 Headquarters: Colorado, United States Stock Exchange: OTCMKTS Clovis Oncology is a biopharma company that develops and delivers anti-cancer agents to the US, EU, and other international markets.

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Dosage Labelling Immunity Immunization 56

Pharmaceutical Technology

JUNE 14, 2023

Biologics form 51% of the current global drugs pipeline (highest stage of development as pipeline) according to GlobalData’s Drugs database (as of February 7, 2023). Tamper proofing and security may also require inner seals and labels, shrink wrap around removable lids, and/or unique IDs.

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Packaging Labelling Drug Development 52

European Pharmaceutical Review

FEBRUARY 7, 2023

RMAT designation will provide the benefits of added intensive FDA guidance and expedited review through the programme’s development. RMAT designation RMAT designation is designed to expedite the drug development and review processes for promising pipeline products, including gene therapies.

Labelling 105

Labelling Drug Development 105

ID Stewardship

JUNE 6, 2023

BCPS, BCIDP Article Posted 7 June 2023 With the exception of the questions in bold, this entire text was written by ChatGPT. Streamlined Prescription Filling : AI systems can automate prescription filling processes by extracting relevant information from electronic prescriptions, verifying insurance coverage, and generating labels.

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Insurance Coverage and Processing Prescription Filling Hospitals Medication Dispensing 52

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Notably, this decision marks the first use of the new expedited procedures for withdrawal of an accelerated approval that were enacted in the Food and Drug Omnibus Reform Act of 2022 (FDORA).

Documentation 59

Documentation Labelling Drug Development 59

Putting Patients First Blog

JULY 10, 2023

NHC Comments on PFDD: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making (PDF) July 5, 2023 Robert M. MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. Califf M.D.,

Communication 40

Communication Drug Development Packaging Labelling 40

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. The guidance’s second warning reminds drug developers that FDA regulations (i.e.,

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Drug Development Documentation Labelling Medical Records 64

European Pharmaceutical Review

FEBRUARY 23, 2023

7 Raman imaging in pharmaceutical research – an overview The application of Raman spectroscopy in the medical field led to its use in pathogen screening; in turn, this has led to a role in drug development, such as time‑lapse experiments to better understand the bacterial growth‑dependent phenomena and metabolic response to novel antimicrobials.

Labelling 121

Labelling Packaging Drug Development 121

FDA Law Blog: Biosimilars

JULY 9, 2024

The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. Would any such failure to meet DAP goals be reflected in labeling? The statute and Draft Guidance do not provide for penalties or consequences.

Drug Development 59

Drug Development Communication Documentation Labelling 59

Pharmaceutical Technology

MAY 23, 2023

The multicentre, first-in-human study also investigated the the drug’s actions in the body and how drug levels vary in the blood over time. In its Q1 report , Centessa stated plans to present more data from part five of the open-label expansion of the Phase IIa study, subject to completion, at an undisclosed scientific meeting in 2023.

Labelling 59

Labelling Communication Drug Development 59