pharmaphorum

DECEMBER 16, 2022

The Japanese pharma says it will now start talking to regulatory authorities around the world about potential marketing applications for zolbetuximab as a first-line treatment for patients with locally advanced unresectable or metastatic gastric and gastro-oesophageal (GEJ) cancer. Claudin 18.2 Claudin 18.2 cancers appeared first on.

Leads 57

Leads Biopharma Prospecting Patients 57

Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. A clinical outcome assessment is a measure that describes or reflects how a patient feels, functions or survives.

Patients 52

Patients Food and Drug Administration FDA Safety 52

PM360

SEPTEMBER 15, 2022

The term “patient centricity” has been around for over a decade, and since its first utterance the buzzword has been praised, dissected, criticized, and everything in between. The concept has always been worthwhile, but people within and outside of the industry have wondered whether the industry was truly becoming more patient centric?

Patients 98

Patients Healthcare Healthcare Marketing 98

Pharmaceutical Technology

MAY 15, 2023

The US FDA database has 95 approved pyridine derivatives, including isoniazid and ethionamide (tuberculosis), delavirdine (HIV/AIDS), abiraterone acetate (prostate cancer), and tacrine (Alzheimer’s). Its primary focus is on oncology, cardiovascular, immunology, and fibrotic therapeutic projects.

Pharmaceutical 52

Pharmaceutical Leads Pharmacology Medicine 52

Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

Patients 52

Patients Food and Drug Administration FDA Safety 52

pharmaphorum

JULY 1, 2022

billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. Those changes haven’t been enough to prevent the FDA from taking action, although outside the US the studies will continue as planned with the tighter safety monitoring.

Side effects 87

Side effects Safety Biopharma Recruitment 87

pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease. billion or more.

Sales 108

Sales Biopharma Medicine Patients 108

pharmaphorum

SEPTEMBER 6, 2022

Pleco Therapeutics has closed a first-round financing, raising just over €17 million that it says will fund the development of its lead therapy for acute myeloid leukaemia (AML) through to regulatory filings in the US and EU. million in equity and R&D funding from Belgian biopharma company Hyloris, which was first announced last year.

Leads 84

Leads Biopharma Government Patients 84

pharmaphorum

JANUARY 9, 2023

Biopharma and healthcare group Chiesi Farmaceutici S.p.A. Supported by voting agreements from leading Amryt shareholders and directors, and unanimously approved and recommended by the boards of both companies, the total transaction is worth up to $1.48 is to acquire the 2015-established Amryt Pharma Plc. on 6 th January.

Pharma 88

Pharma Biopharma Management Medicine 88

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

Food and Drug Administration 77

Food and Drug Administration Manufacturing Safety Transportation 77

PM360

JUNE 11, 2022

Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. But 71% also want publicly shared information about how patients’ perspectives were incorporated into the development of products and services. Noël Moossa.

Patients 59

Patients Pharma Education Media 59

Pharmaceutical Technology

APRIL 4, 2023

of NSCLC patients with exon 19 and 21 mutations develop resistance mutations at C797S. While Scorpion will lead the development of STX-721, Pierre Fabre will handle STX-241. The biopharma aims to start the study as soon as the IND is cleared by the FDA. Up to 12.5%

Food and Drug Administration 52

Food and Drug Administration Biopharma FDA Pharmaceutical 52

PM360

MAY 2, 2023

We are fortunate to work with innovative startup and mid-stage biopharma companies that are developing vaccines and medicines for rare diseases, cancer, specialty therapeutic areas, and other patient needs, as well as partnering with diagnostic and medical device companies.

Food and Drug Administration 52

Food and Drug Administration Healthcare Healthcare Biopharma 52

Pharmaceutical Technology

SEPTEMBER 5, 2022

On 23 August, at a Reuters Newsmakers online forum, Soriot announced his interest in increasing AstraZeneca’s portfolio of bolt-on acquisitions leading up to 2025. The FDA has granted the drug an orphan drug designation, and Phase III trials with eplontersen were completed In June. In 2019, AstraZeneca entered a $6.9

FDA 114

FDA Pharmaceutical Biopharma Pharma 114

PM360

DECEMBER 14, 2023

A New Online Destination for HCPs HealthCentral Corporation , operator of leading digital platforms that serve patients living with chronic illness, their care partners, and health professionals, has announced the newest addition to its suite of HCP support sites: MedCentral.

Physicians 52

Physicians Pharma Medical Patients 52

pharmaphorum

SEPTEMBER 13, 2022

The HARMONY study compared two doses of Akero’s FGF21 mimic efruxifermin to placebo over 24 weeks in 128 adult patients with biopsy-confirmed NASH, a serious form of non-alcoholic fatty liver disease (NAFLD) that affects millions of people and which for several years has been billed as one of pharma’s next big growth areas.

Biopharma 52

Biopharma Patients FDA Pharma 52

Clarivate

AUGUST 2, 2022

Four major trends came to light from CIRS’ most recent analysis of new active substance (NAS) approvals for the European Medicines Agency (EMA), US Food and Drug Administration (FDA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA).

Medicine 98

Medicine Food and Drug Administration FDA Healthcare 98

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

European Pharmaceutical Review

MARCH 7, 2024

Last month, construction began on Europe’s first industrial-scale facility dedicated to the production of lead-212 based radioligand therapies. percent for the gastroenteropancreatic neuroendocrine tumours (GEP-NET) patients who had never received radioligand therapy).

Manufacturing 52

Manufacturing Food and Drug Administration Marketing Management 52

pharmaphorum

SEPTEMBER 30, 2022

Perhaps more interestingly, similar signals have also emerged from traditional biopharma heavyweights, such as Novartis and Lilly, which one would typically associate with more conservative approaches to pricing. New manufacturers, such as EQRx, have been vocal in their desire to bring new PD-1/PD-L1 checkpoint inhibitors (e.g.

Consulting 86

Consulting Marketing Pharma Manufacturing 86

Clarivate

OCTOBER 30, 2022

Half of the psychiatrists surveyed reported having prescribed or recommended DTx to patients within the three studied indications, while the remainder indicated they expect or are open to prescribing them. As a result, few products have FDA clearance. Payers and providers embrace evidence-based DTx. What’s next?

Insurance 52

Insurance FDA Prescription Marketing 52

Zymewire

FEBRUARY 8, 2024

Skip to a topic Axonis' journey and purpose The impact of the economic client on emerging biopharma The place of Artificial Intelligence in drug development & discovery Working with NASA Relationships with CROs, CDMOs, and other service providers What made you want to start Axonis? What unmet needs are you hoping to address for patients?

Competition 52

Competition Leads Patients Marketing 52

European Pharmaceutical Review

JULY 20, 2023

In June 2023, an array of leading voices in AAV development for cell and gene therapies articulated the current challenges and their optimism for the rapidly advancing sector at the Cell and Gene Therapy Summit event in London. More recently, the FDA granted approval of Roctavian in June 2023.

Consulting 57

Consulting Side effects Manufacturing Safety 57

Pharmaceutical Technology

DECEMBER 20, 2022

Companies are recognizing the importance of working together to advance science, improve solutions, and best serve patients. Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety. Free Whitepaper.

Biopharma 52

Biopharma Manufacturing FDA Pharmaceutical 52

Clarivate

OCTOBER 19, 2023

The most important benefit is that it can deliver efficacious therapeutics to patients awaiting treatment much faster. the FDA offers a period of 3 years of data exclusivity for a new application of a previously approved drug. For example, in the U.S.,

Networking 59

Networking Consulting Safety Side effects 59

Clarivate

OCTOBER 10, 2022

Clarivate oncology experts share key takeaways from the 2022 ESMO Congress and their expected impact on the drug treatment landscape and patients. Positive outcomes in a key patient segment could broaden TRODELVY’s uptake in metastatic breast cancer. Market impact.

Marketing 52

Marketing Safety Patients Competition 52

pharmaphorum

SEPTEMBER 12, 2022

Dr Prasanth Reddy, head of oncology at LabCorp, tells us how the company works with cancer care teams, biopharma partners, and patients as an integral part of the patient journey from testing to treatment. The test is conducted in a care provider’s office or our patient service centres (PSC).

Patients 102

Patients Medicine FDA Healthcare 102

European Pharmaceutical Review

APRIL 30, 2024

What are the top three trends that you are seeing in the biopharma manufacturing space? Let’s talk about continuous biopharma manufacturing. Speaking of your biopharma clients, what are you hearing about their main priorities? I believe this is going to be an emerging trend in the market.

Manufacturing 77

Manufacturing Food and Drug Administration Biopharma Marketing 77

pharmaphorum

JANUARY 6, 2023

From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. Patient choice will push sponsors toward operational excellence.

Safety 106

Safety Management Patients Biopharma 106

PM360

JULY 13, 2023

However, due to conjugation instability and unfavorable safety profiles of currently available ADCs, we can still do more to ensure ADCs are more broadly available and amenable options for the patients who need them. Cellectis is pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients.

Patients 98

Patients Engineering Side effects Leads 98

Clarify Health

MAY 19, 2020

The time-consuming and resource-intensive path from the lab bench to the patient bedside starts with drug discovery, progresses to pre-clinical and clinical research, and then enters regulatory review. After FDA-approval comes the last critical mile of this journey: bringing the product to market. Which physicians see these patients?

Biopharma 52

Biopharma Physicians Marketing Prescription 52

European Pharmaceutical Review

OCTOBER 19, 2023

billion deal, in which Eli Lilly agreed to acquire two of POINT Biopharma Global’s late-stage radioligand therapies for oncological indications. These diagnostics have significantly progressed based on rigorous Phase III trial designs and because of the impact these diagnostics have had on patient management.

Food and Drug Administration 87

Food and Drug Administration Side effects Manufacturing Doctors 87

Pharmaceutical Technology

MAY 24, 2023

The ability to modify or introduce genetic material in human cells in such a precise and patient-centered manner clearly constitutes a breakthrough in personalized medicine. Allogeneic therapies begin with healthy donor samples to develop the eventual therapeutic product which can be administered to multiple patients.

Manufacturing 98

Manufacturing Transportation Specialization Patients 98

Legacy MEDSearch

MAY 19, 2023

PaceMate ® announced today its collaboration with AliveCor ® , the global leader in FDA-cleared personal electrocardiogram technology and remote patient management solutions for the cardiovascular industry. We are proud to be the pioneer in remote cardiac management.”

Healthcare Provider 52

Healthcare Provider Management Healthcare Healthcare 52

Clarivate

NOVEMBER 8, 2022

We feel that a cure for cancer or to changing cancer patients’ lives is in our grasp,” Tureci said in the BBC interview. . RNA therapeutics actually burst onto the scene prior to the COVID-19 pandemic, with the FDA approval of Ionis/Biogen’s SPINRAZA®, for the treatment of spinal muscular atrophy, in 2016. Cargene Biopharma Inc.,

Pharma 52

Pharma Biopharma FDA Marketing 52

Medgadget

FEBRUARY 17, 2023

All of these systems operate under the “master-slave” concept, which involves a surgeon sitting behind a console, away from the patient, who manipulates the mechanical arms of the robot via some kind of joystick-like device.

Physicians 80

Physicians Engineering Side effects Leads 80

Medgadget

MARCH 2, 2023

This leads to substantial damage to healthy tissues and too often results in poor outcomes. The rest of the patients had partial responses. The FDA looked at the data, saw it promising, and asked for a small feasibility study in the U.S. with ten patients to try to duplicate the results.

Manufacturing 83

Manufacturing Leads Patients Medicine 83