Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. weight reduction in obese individuals, as per its label.

Insurance Coverage and Processing 105

Insurance Coverage and Processing Diabetes Labelling Communication 105

Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. weight reduction in obese individuals, as per its label.

Insurance Coverage and Processing 98

Insurance Coverage and Processing Diabetes Labelling Communication 98

pharmaphorum

JULY 1, 2021

The only reason for the change is that the FDA-approved labelling for the drug requires fewer MRI scans per patient than were carried out during clinical trials of the anti-amyloid antibody.

Labelling 59

Labelling Drug Development 59

FDA Law Blog: Biosimilars

JANUARY 12, 2025

The new draft guidance , Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics , is intended to replace much of the 2014 Guidances discussion of the topic.

Drug Development 64

Drug Development Communication Labelling 64

Pharmaceutical Technology

AUGUST 17, 2008

Yes there has been some slowing in the approval of drugs from the FDA, in part due to legitimate concerns in relation to drug safety. In that regard the FDA has been somewhat more cautions in its approach in moving many drugs forward to ensure there are no cardiac events. NB: What about issues such as reimportation?

Labelling 40

Labelling Pharmaceutical Companies Pharmaceutical Companies Drug Development 40

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

Moreover, the letter noted that whether Pepaxto was safe and effective for a narrower indication was outside the scope of the statutory basis for withdrawing accelerated approval; the question was whether it should remain on the market as currently approved and labeled.

Documentation 59

Documentation Labelling Drug Development 59

ID Stewardship

JUNE 6, 2023

Streamlined Prescription Filling : AI systems can automate prescription filling processes by extracting relevant information from electronic prescriptions, verifying insurance coverage, and generating labels. This reduces manual errors, saves time, and allows pharmacists to focus on patient care.

Insurance Coverage and Processing 52

Insurance Coverage and Processing Prescription Filling Hospitals Medication Dispensing 52

Pharmaceutical Technology

MAY 23, 2023

In February, Centessa presented additional data from the Phase IIa Serpin PC study (NCT04073498) at the 16th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), showing that there were no treatment-related adverse events observed.

Labelling 59

Labelling Communication Drug Development 59

Putting Patients First Blog

APRIL 7, 2025

14 In addition, sponsors should ensure that the datasets used to develop AI models reflect the intended patient population and disease variations. 15 ,16 Failure to do so risks overlooking meaningful variability and could reinforce historical limitations in drug development.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

STAT

MAY 16, 2023

In any event, the to-do list is growing so we are passing along the latest laundry list of interesting items for you to peruse. billion deal would hamper innovation and slow the pace of drug development. So we will celebrate our good fortune with a delightful cup of stimulation. Our choice today is toasted hazelnut.

Labelling 202

Labelling Drug Development 202

PharmaTech

JUNE 6, 2025

In these instances, gas phase sequencing of purified peptides (also known as Edman sequencing) can be performed to sequentially identify amino acids based on their chromatographic elution positions following specific, sequential chemical labeling. MS provides mass information allowing identification of N-glycan compositions.

Dosage 52

Dosage Drug Development Documentation Biosimilars 52

LifeProNow

MARCH 27, 2023

President, Global Drug Development and Chief Medical Officer, Novartis. iDFS is a composite endpoint in EBC adjuvant trials, which incorporates locoregional relapse, ipsilateral and contralateral invasive breast cancer, distant recurrence, and types of new cancer events or death from any cause.

Chemotherapy 130

Chemotherapy Labelling Drug Development 130

FDA Law Blog: Biosimilars

JULY 9, 2024

DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. Would any such failure to meet DAP goals be reflected in labeling?

Drug Development 59

Drug Development Communication Documentation Labelling 59

PharmaShots

APRIL 3, 2023

events/100 patient-yrs.) The results also showed a reduction in risk of hospitalization for any cause with 14% relative risk reduction (24.8 vs 10%) The companies will discuss the findings with regulatory authorities, initiate a P-III study in adjuvant melanoma in 2023 & expand to additional tumor types, incl.

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

BioPharma Dive

JUNE 5, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from FDA’s AI tool ‘Elsa’ is here, and the industry has questions The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool’s rollout.

Drug Pricing 52

Drug Pricing Drug Development Vaccines Pharmaceutical Manufacturing 52