Pharmaceutical Technology

JUNE 9, 2023

WestVac Biopharma has announced that the Chinese authorities have granted emergency use authorisation (EUA) for coviccine trivalent XBB.1.5-recombinant The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University. recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta) 5 subvariants.

Biopharma 107

Biopharma Safety Medical 107

European Pharmaceutical Review

DECEMBER 2, 2024

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>

Biopharma 52

Biopharma Manufacturing Consulting Safety 52

MedCity News

JUNE 11, 2023

Human tissues, coupled with AI that can deal with terabytes of data will blow mice models out of the water. With animal testing requirements finally removed, the pharma industry and its constituents can hope for faster innovation.

Safety 105

Safety Medical Pharma Biopharma 105

MedCity News

FEBRUARY 7, 2024

Gilead Sciences said an independent review of interim Phase 3 data found the immunotherapy, magrolimab, led to a higher risk of death. Though Gilead is discontinuing further development of the drug in blood cancers, a review is ongoing in solid tumors.

Safety 119

Safety Leads FDA Biopharma 119

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

JANUARY 6, 2023

Veeva’s industry experts share their predictions about how breaking down silos across clinical, regulatory, safety, and quality teams will benefit patients. This will enable biopharmas to create a more streamlined drug development process rooted in lean process execution and higher-quality data.”.

Safety 111

Safety Management Patients Training 111

PharmaTech

DECEMBER 5, 2022

For all stages throughout the development, manufacturing and release of your biological product, Eurofins BioPharma Product Testing offers comprehensive, fully cGMP-compliant Viral Safety Services, including characterization of cell banks, unprocessed bulk testing, end of production cells, and raw materials testing.

Safety 40

Safety Biopharma Manufacturing 40

MedCity News

APRIL 11, 2023

Risk-based quality management, or RBQM, is the process by which pharmaceutical organizations monitor and manage quality throughout clinical trials.

Management 105

Management Safety Patients Pharmaceutical 105

MedCity News

JANUARY 1, 2024

Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies.

Electronics 142

Electronics Media Safety Biopharma 142

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

MedCity News

NOVEMBER 30, 2022

Eisai has presented and published full data from the Phase 3 clinical trial for its Alzheimer’s disease drug lecanemab, with results showing a statistically significant slowing decline associated with the neurodegenerative disorder.

Safety 98

Safety FDA Biopharma Pharma 98

Clarivate

OCTOBER 25, 2021

The move further expands and integrates drug toxicity data and translational safety intelligence from OFF-X into all aspects of the life science cycle.

Safety 110

Safety Biopharma Competition Management 110

MedCity News

MARCH 31, 2024

Approval of Akebia Therapeutics’ Vafseo is based on additional post-marketing safety data from Japan, where the drug has been used since 2020. The FDA rejected the drug two years ago due to concerns about cardiovascular safety.

FDA 116

FDA Safety Marketing Biopharma 116

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

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

MedCity News

JANUARY 2, 2024

Longboard Pharmaceuticals’ epilepsy drug candidate bexicaserin met the main efficacy goal of its Phase 1b/2a study along with safety data suggesting a potential edge over current treatments. With Longboard now preparing to advance to Phase 3 testing, its stock price soared more than 300%.

Safety 130

Safety Pharma Pharmaceutical Biopharma 130

MedCity News

JANUARY 22, 2023

A collaboration between Nvidia and startup Evozyne was able to produce novel versions of a human protein never before seen in nature but with enhanced function and the same safety as native protein. The research lays the groundwork for potential new therapies for a rare inherited disorder.

Safety 143

Safety Biopharma 143

European Pharmaceutical Review

NOVEMBER 18, 2022

The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over. The efficacy and safety profile of Upstaza has been shown across clinical trials and compassionate use programmes. In addition, Upstaza reduced symptoms that can cause potentially life-threatening complications.

Side effects 126

Side effects Biopharma Safety Marketing 126

MedCity News

JULY 29, 2024

As the FDA stakes its claim as the primary regulator of AI in healthcare, it must navigate the delicate balance between fostering innovation and ensuring safety and responsibility. The post Enabling Clinical Trial Innovation Through AI Regulation at FDA appeared first on MedCity News.

FDA 126

FDA Safety Healthcare Healthcare 126

MedCity News

APRIL 30, 2024

With cancer as its initial focus, the startup contends its approach could offer safety and efficacy advantages compared to currently available targeted therapies. Enlaza Therapeutics’ drugs form covalent bonds that lock the therapy onto its target. The post J.P.

Leads 128

Leads Safety Biopharma Pharma 128

MedCity News

NOVEMBER 10, 2024

While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability. Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia.

FDA 126

FDA Engineering Safety Biopharma 126

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 105

Safety Biopharma Patients 105

MedCity News

DECEMBER 2, 2024

Last year, Novartis discontinued its Huntington’s program after safety issues emerged in Phase 2 testing. Novartis is securing global rights to a PTC Therapeutics Huntington’s disease drug candidate that has encouraging Phase 2 data that will be discussed with the FDA to plan a pivotal study.

Safety 119

Safety FDA Biopharma Pharma 119

European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent.

Food and Drug Administration 97

Food and Drug Administration Manufacturing Safety Transportation 97

European Pharmaceutical Review

AUGUST 22, 2022

However, the biopharma industries realised that traditional vaccine development and manufacturing techniques, which take around five to 10 years for initial development to large-scale distribution, 1 were inadequate to meet the growing demand for COVID-19 vaccines. Novel biotechnology platforms for vaccine development.

Manufacturing 98

Manufacturing Biopharma Engineering Safety 98

MedCity News

NOVEMBER 16, 2022

Risk-based quality management is a data monitoring approach that accelerates the drug development pathway without compromising on safety – and one that is enhanced by the use of technologies such as artificial intelligence.

Management 128

Management Safety Biopharma 128

MedCity News

SEPTEMBER 27, 2024

Bristol Myers Squibb’s Cobenfy treats schizophrenia by going after a different target than currently available antipsychotic drugs, which is intended to offer better efficacy and safety. The drug came from the pharma giant’s $14 billion acquisition of Karuna Therapeutics.

FDA 124

FDA Safety Pharma Biopharma 124

European Pharmaceutical Review

DECEMBER 20, 2022

Commenting on fenfluramine, an oral solution developed by biopharma UCB, this “positive CHMP opinion is a significant regulatory milestone towards providing a new treatment option [for] this rare epilepsy in the EU,” explained Mike Davis, Head of Global Epilepsy & Rare Syndromes, UCB.

Safety 98

Safety Medicine Biopharma Patients 98

MedCity News

OCTOBER 15, 2024

In addition to meeting the main safety and tolerability goal, MieraGTx Holdings’ gene therapy for Parkinson’s disease also showed signs of efficacy. The one-time treatment is intended to reprogram dysfunctional brain circuits.

Safety 122

Safety Biopharma Pharma 122

MedCity News

NOVEMBER 12, 2024

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.

Safety 110

Safety Patients Biopharma 110

MedCity News

FEBRUARY 20, 2024

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. The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug.

FDA 115

FDA Patients Safety Biopharma 115

European Pharmaceutical Review

NOVEMBER 23, 2022

Sponsorship of the clinical trials transitioned to Australian biopharma company CSL after it acquired global rights to commercialise the treatment in May 2021. The safety and effectiveness of Hemgenix was evaluated in two studies of 57 adult males between 18 to 75 years old with severe or moderately severe Haemophilia B.

FDA 128

FDA Food and Drug Administration Biopharma Food 128

World of DTC Marketing

JUNE 8, 2021

Instead of pulling away from the amyloid theory, or going past it, they are now giving it a tremendous boost, despite a mountain of data that proves it’s the wrong path — at least on its own” Ultimately, this is a disaster that will once again create a serious atmosphere of financial toxicity, for everyone in biopharma.

FDA 207

FDA Food and Drug Administration Patients Biopharma 207

MedCity News

SEPTEMBER 29, 2023

Preliminary weight loss and safety data for Structure Therapeutics’ drug candidate suggest it’s competitive with other oral GLP-1 targeting contenders from big pharma companies.

Competition 124

Competition Safety Pharma Biopharma 124

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. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Biopharma 98

Biopharma Medicine Healthcare Healthcare 98

MedCity News

NOVEMBER 7, 2022

No details about the FDA’s questions or concerns were disclosed; so far, no serious safety problems have been reported in the U.K. The FDA placed a clinical hold on Verve Therapeutics’ application to begin human testing of its gene-editing therapy for an inherited form of high cholesterol.

FDA 122

FDA Safety Biopharma Pharma 122

MedCity News

APRIL 4, 2023

The Scorpion drugs could have safety advantages over approved Johnson & Johnson and Takeda therapies that address the same rare genetic signature.

Safety 119

Safety Biopharma Pharma 119