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 111

Safety Management Patients Training 111

European Pharmaceutical Review

JANUARY 13, 2025

Updated clinical findings from the ongoing Phase I/Ib StrateGIST 1 clinical trial of IDRX-42 in patients with advanced GIST, showed promising anti-tumour activity alongside a manageable safety profile. These capabilities make it a potential best-in-class candidate, according to GSK.

Biopharma 59

Biopharma Safety Patients Management 59

Clarivate

JUNE 29, 2023

We’re mindful of some challenges that life science and healthcare organizations must work through before this technology is mature enough for use in critical business decisions that may impact patient health. Our customers entrust our products and services to help them improve patient health, and we will not jeopardize that mission.

Patients 98

Patients Safety Healthcare Healthcare 98

World of DTC Marketing

JUNE 8, 2021

The Financial Times said , “Michael Carome, director of the health research group at Public Citizen, said, “these costs to patients, to their families, are just not justified based upon what we know about this drug”. There are no efficacy data to clearly demonstrate this drug helps patients. Nowhere to be seen.

FDA 207

FDA Food and Drug Administration Patients Biopharma 207

European Pharmaceutical Review

NOVEMBER 18, 2022

The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over. Upstaza is administered through a minimally invasive neurosurgical stereotactic procedure used to treat several neurological disorders in paediatric and adult patients. Upstaza clinical trials.

Side effects 126

Side effects Biopharma Safety Marketing 126

Veeva

APRIL 22, 2024

A robust pharmacovigilance and safety strategy is crucial, regardless of a company’s scale. Solutions like Veeva Vault Safety enable life sciences companies to bring management of safety processes in-house, with global end-to-end adverse event management on a unified platform, enabling access to real-time information.

Safety 52

Safety Management Biopharma Patients 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 98

Side effects Safety Biopharma Recruitment 98

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

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 97

Food and Drug Administration Manufacturing Safety Transportation 97

PharmaTech

NOVEMBER 20, 2024

Elevate your viral screening with Eurofins BioPharma Product Testing’s qPCR- based assays. Our advanced testing goes beyond standard screenings to detect even dormant and hard-to-detect pathogens, ensuring comprehensive safety in every stage of the allogeneic therapy pipeline.

Safety 40

Safety Biopharma Leads Patients 40

European Pharmaceutical Review

DECEMBER 20, 2022

FINTEPLA ® ▼ (fenfluramine) oral solution has been recommended for marketing authorisation by the Committee for Medicinal Products for Human Use (CHMP) for treating seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients over two years old in the European Union (EU).

Safety 98

Safety Medicine Biopharma Patients 98

European Pharmaceutical Review

NOVEMBER 23, 2022

Patients with severe Haemophilia B typically need routine intravenous (IV) infusions of Factor IX replacement products to sustain sufficient clotting factor levels to prevent bleeding episodes. Patients should be monitored for adverse infusion reactions and transaminitis in their blood. Haemophilia B clinical trial.

FDA 128

FDA Food and Drug Administration Biopharma Food 128

pharmaphorum

AUGUST 23, 2022

France’s BrainVectis, a subsidiary of Bayer’s Asklepios BioPharma (AskBio) unit, has been given the green light by regulators in France to start dosing patients with its gene therapy candidate for devastating neurodegenerative disorder Huntington’s disease.

Safety 106

Safety Biopharma Patients 106

European Pharmaceutical Review

NOVEMBER 16, 2022

Beyond adapting existing sites or engineering new facilities geared to modern drug production, biopharma companies also need to be more cost-conscious than ever before, in how they run and monitor their manufacturing and supply chain operations. Embracing the spirit rather than the letter of regulations.

Manufacturing 119

Manufacturing Pharma Biopharma Management 119

European Pharmaceutical Review

AUGUST 23, 2023

Retevmo’s potential in oncology The Phase III study LIBRETTO-531 enrolled 291 patients and is the first randomised trial to compare the safety and efficacy of a highly selective RET -kinase inhibitor with multikinase inhibitors in this patient population. More than 800 patients from 16 countries were included in the trial.

Biopharma 98

Biopharma Safety Medical Patients 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.

Sales 112

Sales Patients Medicine Biopharma 112

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 98

Food and Drug Administration Safety Biopharma Patients 98

European Pharmaceutical Review

DECEMBER 7, 2022

Biopharma Akeso Inc. state the therapy could help reduce side effects and safety concerns. At the American Society of Clinical Oncology (ASCO) 2022, Phase II study results showed ivonescimab demonstrated an overall response rate (ORR) for patients with NSCLC who failed EGFR-TKI’s of 68.4 Under the agreement, Akeso Inc.

Pharma 98

Pharma Side effects Safety Patients 98

pharmaphorum

JANUARY 3, 2023

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. in the evenamide group.

Side effects 106

Side effects Biopharma Patients Medical 106

European Pharmaceutical Review

JANUARY 8, 2024

The European Commission (EC) has now granted a marketing authorisation for biopharma company UCB’s treatment, as an add-on to standard therapy in patients who have this rare autoimmune condition. It is indicated as a subcutaneous, add-on to standard therapy in these patients.

Biopharma 98

Biopharma Medicine Healthcare Healthcare 98

PharmaTech

NOVEMBER 7, 2024

Can biopharma manufacturers avoid extra costs, potential problems and wasted production time by designing a fully compliant (cGMP) manufacturing process early on?

Biopharma 52

Biopharma Manufacturing Safety Patients 52

European Pharmaceutical Review

DECEMBER 14, 2023

I’m happy to see…that my patients will soon have this new nonhormonal treatment option available to better control their moderate to severe VMS,” commented Prof. These studies (SKYLIGHT 1, SKYLIGHT 2 and SKYLIGHT 4) enrolled some 3,000 patients across Europe, the United States and Canada.

Food and Drug Administration 96

Food and Drug Administration Biopharma Medicine Food 96

European Pharmaceutical Review

NOVEMBER 20, 2023

. “This state-of-the-art parenteral site with the latest technology will enable us to continue to deliver medicines with safety first and quality always around the world,” stated Edgardo Hernandez, Executive Vice President and President of Eli Lilly’s manufacturing operations.

Manufacturing 98

Manufacturing Medicine Biopharma Engineering 98

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. It’s heartening.

Biopharma 52

Biopharma Manufacturing Pharmaceutical FDA 52

European Pharmaceutical Review

JUNE 28, 2024

Data integrity and AI: how pharma can build a data-driven future LabVantage Solutions explains that data integrity remains a core responsibility – and challenge – as pharmaceutical organisations seek to leverage AI and data lakes to grow, innovate and serve patients.

Biopharma 52

Biopharma Manufacturing Safety Pharmaceutical 52

PM360

DECEMBER 20, 2023

With 2024 on the horizon, many in the biopharma space are taking stock of 2023 and what the current environment means for their potential success next year. Evaluate’s VC data show quarter-over-quarter drops in the number of biopharma companies raising private cash and in the amount of money raised.

Biopharma 111

Biopharma Pharma Marketing Management 111

PM360

JUNE 24, 2024

This fuels an enormous need for effective patient communication and education as new therapies move through the biopharma pipeline. Marketing to rare disease patient populations is equal parts opportunity and responsibility. audiences (direct-to-patient advertising rules are fundamentally different overseas).

Marketing 52

Marketing Patients Food and Drug Administration Digital Media 52

Clarivate

OCTOBER 17, 2024

In-licensing and acquisitions are fast tracks for pharmaceutical companies to access groundbreaking technologies and assets that will drive the next generation of transformative patient treatments. Dealmaking is not a trivial process.

Pharma 59

Pharma Competition Marketing Healthcare 59

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 106

Patients Medicine FDA Healthcare 106

European Pharmaceutical Review

DECEMBER 26, 2023

The increasing adoption of technologies promoting safety, efficacy and reduced production costs has been a persistent trend that will continue to benefit the industry and help to treat a broader patient population. These challenges predominantly surround scalability, stability, regulatory compliance and access to patients.

Manufacturing 98

Manufacturing Safety Patients Competition 98

PM360

SEPTEMBER 28, 2022

Now, as the President of Accord BioPharma , the U.S. The entire premise was that because biosimilars were so new, and there was not a lot of information on the safety and efficacy of those products, customers should be a bit leery prior to jumping on the biosimilar bandwagon. specialty division of Intas Pharmaceuticals, Ltd.,

Competition 98

Competition Marketing Manufacturing Biopharma 98

PM360

JUNE 24, 2024

Patients can look forward to electronic assistance that can return their voice or other lost abilities. It provides guidance and acts as a safety net for prescribers. When entering a patient’s conditions into the chatbot, it responds with a list of recommended drugs. In the patient engagement space, the potential is immense.

Healthcare 52

Healthcare Healthcare Patients Side effects 52

European Pharmaceutical Review

DECEMBER 12, 2023

As a biotech, what work does Innate Pharma do in the biopharma industry? IPH5201 is being investigated in a Phase II trial, MATISSE, in combination with durvalumab (anti-PD-L1) and chemotherapy, in patients with resectable early-stage NSCLC. A favorable safety profile was also observed. An ORR of 46.4 percent in the blood.

Pharma 124

Pharma Engineering Safety Patients 124

pharmaphorum

JULY 4, 2022

Two weeks after reporting disappointing results for its lead coeliac disease therapy, 9 Meters Biopharma will draw some comfort from a mid-stage trial of its candidate for short bowel syndrome (SBS), although its share price remains under pressure.

Leads 98

Leads Biopharma Food Safety 98

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

Pharmaceutical Technology

FEBRUARY 15, 2023

Kinnate Biopharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its pan-FGFR inhibitor, KIN-3248, to treat unresectable, locally advanced or metastatic cholangiocarcinoma (CCA). Kinnate Biopharma expects to receive initial dose escalation data in the second half of this year.

Food and Drug Administration 52

Food and Drug Administration FDA Biopharma Safety 52

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. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. Sunny White.

Pharma 98

Pharma Education Training Transportation 98