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 89

Side effects Safety Biopharma Recruitment 89

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 79

Food and Drug Administration Manufacturing Safety Transportation 79

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

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. billion buyout of Principia Biopharma.

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FDA Side effects Biopharma Prospecting 72

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

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.

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Sales Biopharma Medicine Patients 108

Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

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FDA Prescription Medicine Biopharma 52

pharmaphorum

DECEMBER 9, 2022

Nasdaq: AUTL), a clinical-stage biopharma and a portfolio company of Syncona Ltd., has announced that the pivotal phase 2 FELIX clinical trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukaemia (ALL) patients has met its primary endpoint of overall remission rate (ORR) at interim analysis.

Food and Drug Administration 91

Food and Drug Administration Safety Biopharma Patients 91

Clarivate

APRIL 4, 2024

Greater awareness among clinicians could improve early diagnosis and disease management in patients. Because misdiagnoses are relatively frequent for patients with IMIDs, awareness of racial and ethnic variations in IMIDs could aid early diagnosis and improve disease management,” the paper concluded. You can read about the study here.

Electronics 52

Electronics Patients Medical FDA 52

European Pharmaceutical Review

DECEMBER 21, 2022

Despite the tidal wave of renewed interest in psychedelic therapies, there is still much to be learned about them, including their precise mechanisms of action, their long- and short-term safety profiles, the durability of their effect, and their adverse effects—which can be severe. Authorisation under exceptional circumstances.

Food and Drug Administration 109

Food and Drug Administration Medicine Food Government 109

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

JULY 7, 2022

While just two gene therapy products have been approved by the FDA, a number of companies are nearing the market with therapies targeting rare diseases, including 14 candidates in Phase III plus three in the pre-registration phase, according to GlobalData. The industry is moving at an unprecedented speed.

Medicine 98

Medicine Transportation Manufacturing Biopharma 98

Pharma Marketing Network

MARCH 25, 2022

Although the caregiver is seen as an extension of the patient and their role is not strictly defined, they are informal members of the front-line care team. The FDA has studied the importance of caregivers to drug development and regulatory decision-making. What Can Pharma Do? Sunny White. Reach out at swhite@xaviercreative.com.

Pharma 98

Pharma Education Transportation Training 98

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

European Pharmaceutical Review

JULY 20, 2023

Dr Baghirzade continued, highlighting that since a particular defining moment for the industry in the late 90s, which resulted in an unfortunate patient fatality, “there is a lot more focus on safety” in gene therapy clinical trials today. More recently, the FDA granted approval of Roctavian in June 2023.

Consulting 59

Consulting Manufacturing Side effects Safety 59

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

DECEMBER 20, 2022

Earlier this year, Madrigal reported positive results in another phase 3 trial of resmetirom called MAESTRO-NAFLD-1, including some patients with NASH, and said a filing in the lead indication of non-cirrhotic NASH with liver fibrosis hinged on a positive readout in MAESTRO-NASH.

Pharmacology 52

Pharmacology Pharma Marketing Biopharma 52

World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. Where to start? Nowhere to be seen.

FDA 207

FDA Food and Drug Administration Patients Biopharma 207

Clarivate

OCTOBER 19, 2023

Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects). 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

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

MARCH 17, 2022

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? Experts at a November 2021 Food and Drug Administration (FDA) meeting also wrestled with this theme of clinical trials and pregnancy. Medicine use during pregnancy: balancing risks.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10

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 108

Safety Management Patients Biopharma 108

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).

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Patients Medicine FDA Healthcare 103

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

Clarivate

OCTOBER 7, 2021

Clarivate oncology experts share major takeaways from ESMO and their expected impact on the treatment landscape and patients. Introduced earlier in the treatment paradigm, Keytruda could substantially reduce risk of recurrence in high-risk early-stage melanoma patients. Context: In August 2021, Merck & Co. in the placebo group.

Patients 91

Patients Safety Marketing Physicians 91

Medgadget

MARCH 2, 2023

Moreover, due to the different nature of healthy and cancerous tissue, alpha radiation produced by Alpha DaRT sources diffuses about a millimeter into healthy tissue while penetrating at a diameter up to about five millimeters into tumors, providing an automatic safety mechanism. The rest of the patients had partial responses.

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Manufacturing Leads Patients Medicine 83