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 95

Safety Leads FDA Biopharma 95

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 104

FDA Safety Marketing Biopharma 104

PharmaTech

JANUARY 4, 2024

Recognizing the urgency associated with short shelf-life products, Eurofins BioPharma Product Testing has developed a comprehensive set of services to address the need for swift and reliable testing. Eurofins acknowledges the significance of Cell and Gene Therapies, particularly Autologous Cell Therapies , in the healthcare industry.

Biopharma 40

Biopharma Safety Healthcare Healthcare 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 93

Safety FDA Biopharma Pharma 93

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 81

Food and Drug Administration Manufacturing Safety Transportation 81

PharmaTech

DECEMBER 5, 2022

Eurofins BioPharma Product Testing supports the development of cell & gene therapies by providing comprehensive GMP-compliant CMC testing support to ensure the identity, potency, purity, and safety.

Biopharma 40

Biopharma Safety 40

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 95

Biopharma Medicine Healthcare Healthcare 95

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

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 74

Management Safety Patients Pharmaceutical 74

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 80

Side effects Safety Biopharma Recruitment 80

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 123

Electronics Media Safety Biopharma 123

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 113

Manufacturing Pharma Biopharma Management 113

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 86

Manufacturing Medicine Biopharma Engineering 86

Pharmaceutical Technology

SEPTEMBER 13, 2022

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.

Biopharma 52

Biopharma Manufacturing Pharmaceutical manufacturing Consulting 52

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 119

Safety Pharma Pharmaceutical Biopharma 119

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 85

Safety Medicine Biopharma Patients 85

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 90

Manufacturing Biopharma Engineering Safety 90

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 104

Safety Biopharma Patients 104

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. Both biopharma companies have lead assets focusing on obesity and diabetes.

Biopharma 94

Biopharma Safety Medical Patients 94

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

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 Patients 126

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.

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FDA Patients Safety Biopharma 95

European Pharmaceutical Review

SEPTEMBER 11, 2023

Clinical evidence for SB17 Phase I results presented by Samsung Bioepis at the American Academy of Dermatology (AAD) Annual Meeting, in March 2023 demonstrated that SB17 matches the pharmacokinetic (PK) bioequivalence, safety, tolerability, and immunogenicity of ustekinumab.

Biopharma 76

Biopharma Manufacturing Medicine Safety 76

European Pharmaceutical Review

SEPTEMBER 14, 2023

The pharma company’s sites in Macclesfield, Cambridge, Luton and Speke will be supplied by energy from the biomethane facility. A total of 100 gigawatt hours (GWh) per year, equivalent to the heat demands of over 8,000 homes will be supplied. This increases renewable energy capacity to the national gas grid.

Manufacturing 104

Manufacturing Pharmaceutical manufacturing Medicine Biopharma 104

European Pharmaceutical Review

DECEMBER 14, 2023

This opinion was based on the results from the BRIGHT SKY programme, which included three Phase III clinical trials to monitor efficacy and safety in women with moderate to severe VMS. 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 76

Food and Drug Administration Biopharma Medicine Food 76

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

Pharmaceutical Technology

FEBRUARY 16, 2023

Accord BioPharma (Accord US), the business partner of Shanghai Henlius Biotech, has submitted the BLA. The studies include a Phase I PK similarity study, comparative analytical studies, a multicentric, international Phase III safety, efficacy, and immunogenicity study, and nonclinical studies.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Biopharma 52

Pharma Pathway

SEPTEMBER 20, 2022

Ltd- Biopharma started its operations in 1987 at Raichur, Karnataka-India. As part of Covid-19 safety measures, candidates are requested to sanitize their hands at the entrance, Maintain social distance and ware face mask before entering the venue. Job Description. Shilpa Biologicals Pvt. Contact : 9809818187, 8099056599.

Electronics 85

Electronics Biopharma Safety Manufacturing 85

Pharmaceutical Technology

MAY 23, 2023

The safety and effectiveness of the drug prophylaxis for acute HAE attacks are yet to be proved. In January 2022, BioCryst announced a partnership with Swixx BioPharma to commercialise Orladeyo in central and eastern Europe.

Marketing 52

Marketing Biopharma Safety Pharma 52

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 141

Safety Biopharma 141

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.

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FDA Food and Drug Administration Biopharma Food 127

Clarivate

JUNE 29, 2023

billion (read our recent report on biopharma dealmaking to learn more about activity in this space). Predicting safety and efficacy by using large language models to identify relevant documents and ways to optimize existing solutions.

Patients 98

Patients Safety Healthcare Healthcare 98

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 101

Competition Safety Pharma Biopharma 101

Pharmaceutical Technology

APRIL 13, 2023

The agreement between PharmaLex and Cpharm also creates an opportunity to provide end-to-end solutions for biopharma clients in Australia and New Zealand. The merger plan will enable the delivery of complementary services and widen the service portfolio of both firms.

Biopharma 52

Biopharma Medical Safety Management 52

Pharmaceutical Technology

OCTOBER 19, 2022

Syncromune and Biocytogen Pharmaceuticals’ wholly owned subsidiary Eucure Biopharma have entered an exclusive global licence agreement for OX40 antibody YH002 and two other active ingredients. . A co-stimulating molecule for the OX40 target, YH002 has shown favourable safety and anti-tumour activity against solid tumours.

Biopharma 52

Biopharma Safety Pharmaceutical Marketing 52

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 117

Management Safety Biopharma 117

pharmaphorum

DECEMBER 9, 2022

Nasdaq: AUTL), a clinical-stage biopharma and a portfolio company of Syncona Ltd., Autolus Therapeutic Plc. Obe-cel showed comparable expansion and initial persistence (median follow-up 6.4 months) to the data observed in the prior ALLCAR19 study.

Food and Drug Administration 82

Food and Drug Administration Safety Biopharma Patients 82