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Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.
The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.
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.
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.
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.
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.
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.
It is an industry-wide challenge to control [host cell proteins] HCPs to ensure the safety and quality of biopharmaceutical products” stated Derrick Zhang , Senior Scientist, US Pharmacopeia. This follows an announcement by USP about its intent to revise General Chapter <1132.1>
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.
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?
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.
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.
Neurogene’s Rett syndrome gene therapy has preliminary data supporting safety and efficacy of the one-time treatment. But a late-breaking report of a serious complication in a patient who received the high dose sent shares of the biotech downward.
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).
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.
Gene therapy can offer hope to patients with previously untreatable diseases, but there’s more work to be done to improve both the safety and efficacy of this therapeutic modality.
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.
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.
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.
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.
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.
The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.
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.
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.
Can biopharma manufacturers avoid extra costs, potential problems and wasted production time by designing a fully compliant (cGMP) manufacturing process early on?
. “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.
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.
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.
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).
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).
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.
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.
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.,
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.
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.
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.
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.
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.
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.
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.
They are there to do a job and ultimately to keep patients safe. This knowledge enables companies [in this sector] to accelerate drug discovery and development programmes, with a significant amount of safety, toxicity and efficacy data already known and on which we can build. What are your future predictions for the industry?
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.
An international team of scientific, regulatory, and safety and compliance (GxP) specialists, PharmaLex is based in Germany. The company provides strategic assistance and regulatory support to biopharma firms across the lifecycle of the product.
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