pharmaphorum

AUGUST 18, 2022

Astellas remains on course to be the first drugmaker to bring a new non-hormonal therapy for symptoms of menopause to market, after the FDA started a review of its orally-active neurokinin-3 (NK3) receptor antagonist fezolinetant. It acquired elinzanetant as part of its takeover of UK biotech KaNDy Therapeutics in 2020.

FDA 52

FDA Safety Marketing Pharma 52

pharmaphorum

SEPTEMBER 14, 2022

The French biotech said the cash injection – which follows a €45 million Series A in 2020 – will also help it bring forward the first development candidate in a collaboration signed with gene-editing specialist Intellia Therapeutics last year, currently in the early-discovery stage.

Safety 52

Safety Leads Patients FDA 52

European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). 2020; 19(10): 2044–56. Personalized medicine at FDA. References 1. Garrido P et al.

Food and Drug Administration 89

Food and Drug Administration Safety Patients Medicine 89

Legacy MEDSearch

AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. The SkyWalker System has the technical advantages of precise operation and efficient coordination, while prioritizing safety.

Food and Drug Administration 98

Food and Drug Administration Recruitment Medical Food 98

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 83

Manufacturing Pharma Food and Drug Administration Safety 83

European Pharmaceutical Review

JUNE 29, 2023

A reduced global inspections rate in a post-pandemic world further augment the challenge; in 2022 the US Food and Drug Administration (FDA) inspected only six percent of approximately 2,800 overseas manufacturers. But with the spate of recalls, the FDA developed a Guidance for Industry on Control of Nitrosamine Impurities in Human Drugs.

Food and Drug Administration 83

Food and Drug Administration Manufacturing Food Medicine 83

European Pharmaceutical Review

DECEMBER 28, 2023

We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval. These efficacy results, combined with the safety profile that allows patients to complete their treatment regimen, are extremely encouraging.

Food and Drug Administration 84

Food and Drug Administration Patients Safety Medical science 84

European Pharmaceutical Review

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. The plant is set to be operational before the end of 2023.

Food and Drug Administration 96

Food and Drug Administration Manufacturing Medicine Pharma 96

Pharmaceutical Technology

AUGUST 16, 2022

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn. overall response rate (ORR), with a median duration of response (DOR) of 8.7

Food and Drug Administration 59

Food and Drug Administration Sales Patients Food 59

pharmaphorum

DECEMBER 20, 2022

The condition is largely associated with obesity and an unhealthy diet and lifestyle, and is on the rise in industrialised nations, leading to estimates it could present a market opportunity worth tens of billions of dollars worldwide.

Pharmacology 52

Pharmacology Pharma Marketing Biopharma 52

Pharmaceutical Technology

JANUARY 10, 2023

Many of the current existing therapies are often viewed by physicians as not optimal to addressing the needs of patients, and challenges remain such as improving patient compliance, safety profile, and addressing comorbidities of T2D. billion in 2029, although its sales growth is likely to continue beyond 2029.

Marketing 52

Marketing Physicians Leads Sales 52

pharmaphorum

OCTOBER 26, 2022

There are many challenges in the development of therapies for rare diseases due to several unique factors, including small target patient populations, lack of long-term safety and efficacy data or natural history data, and often complex administration, dosing, and patient monitoring requirements,” Chiesi says. About the author.

Patients 77

Patients Pharma Consulting Transportation 77

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

FDA 105

FDA Pharmacology Patients Pharmaceutical 105

Pharmaceutical Technology

APRIL 13, 2023

Lower DCT usage for Phase I studies may be accounted for due to the heavier focus on safety and efficacy, and increased monitoring of trial participants in-person. Metabolic disorders have remained the leading therapy area for DCT adoption for over five years, mainly due to the use of wearables, such as glucometers, and other smart devices.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 52

European Pharmaceutical Review

MAY 4, 2023

Adjuvanted vaccine Arexvy has been approved by the US Food and Drug Administration (FDA). The agency’s approval is important, because according to the US Centers for Disease Control and Prevention, RSV leads to around 60,000-120,000 hospitalisations and 6,000-10,000 deaths in adults 65 years of age and older every year in the US.

Food and Drug Administration 84

Food and Drug Administration Safety FDA Food 84

European Pharmaceutical Review

MAY 8, 2024

2 Driven by the success of FMTs with clinical efficacy in several indications 3-6 and the first two FDA-approved donor-derived products on the market for recurrent Clostridioides difficile infections, 7,8 a new and promising trend is emerging that combines the ‘whole ecosystem’ of FMTs with rational consortia design. Microbiome.

Manufacturing 88

Manufacturing Safety FDA Patients 88

PM360

SEPTEMBER 15, 2022

Quantitative survey results can often lead to a false sense of security around pre-selected response options, therefore missing critical contextual information that helps someone truly understand the patient’s perspective. This sub-set of office personnel is valuable and often leads to rich insights if marketers can spend the time/money.

Patients 98

Patients Healthcare Healthcare Marketing 98

pharmaphorum

SEPTEMBER 27, 2022

It comes after Johnson & Johnson’s Janssen Biotech division signed up to access the bispecific antibody technology in 2020, without revealing any financial details. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022. 2 T cells, which have potent tumour-killing activity.

Safety 100

Safety FDA Sales Leads 100

European Pharmaceutical Review

JULY 13, 2023

A new therapeutic antibody class, bispecific antibodies, was engineered to build on the classic antibody design and bind to two different proteins, demonstrating how incremental changes in protein design can lead to entirely new therapies. 3 The CARs recognise and bind to proteins on the surface of cancer cells, effectively killing them.

Engineering 85

Engineering Food and Drug Administration Safety Patients 85

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry. This places a continued reliance upon plate reading and the limitations of human vision.

Pharmaceutical 125

Pharmaceutical Food and Drug Administration Manufacturing FDA 125

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

Food and Drug Administration 75

Food and Drug Administration Safety Patients Leads 75

Pharmaceutical Technology

NOVEMBER 22, 2022

The live attenuated vaccine was authorized by the EMA and FDA five years later in 2019 — half the time than normal. Devex’s global COVID-19 funding dashboard recorded $172 million invested in vaccine research between 1 January 2020 and 27 June 2020. With the world watching, the biopharmaceutical community got to work.

Manufacturing 52

Manufacturing Government FDA Safety 52

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Biologics represent an increasingly large part of the pharmaceutical industry.

Food and Drug Administration 87

Food and Drug Administration Manufacturing Safety Pharmaceutical 87

PM360

SEPTEMBER 7, 2023

Since 2020, diversity, equity, and inclusion (DE&I) has been a prime area of attention within healthcare and the life sciences. For one, the pandemic put a spotlight on the disparity within clinical trials—in 2020 the FDA found that 75% of trial participants were white, 11% were Hispanic, 8% were Black, and 6% were Asian.

Healthcare 111

Healthcare Healthcare Patients Education 111

Pharma Marketing Network

APRIL 30, 2021

The release in November of FDA’s final guidance on strategies to increase participation of underrepresented populations in trials ( “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry” ) has given added impetus to these efforts.

Patients 52

Patients Pharma Recruitment Distribution 52

Pharmaceutical Technology

FEBRUARY 6, 2023

Leading up to 2023, experts have said a company’s financial wellbeing may depend on its economic position when the market shifted. In 2020, the company had raised $165.6 The FDA approved both drugs in 2014. On February 2, the FDA cleared an Investigational New Drug Application for PLN-101095.

Marketing 59

Marketing Pharmaceutical FDA Prospecting 59

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. This was higher than the number of approvals in 2019 and 2020. FirstLine was developed with a zero-defect philosophy,” explains Santambrogio. “It

Pharma 52

Pharma Manufacturing Key account management Marketing 52