Bio Pharma Dive
JUNE 21, 2023
While treated patients appear to be doing better than history suggests they would, mixed findings involving a key surrogate marker perplexed Wall Street analysts and sent shares falling 38%.
Pharmaceutical Technology
JUNE 21, 2023
AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease. LODOCO is indicated for reducing the risk of stroke, myocardial infarction and cardiovascular death in adults with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for the disease.
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Bio Pharma Dive
JUNE 21, 2023
Empress Therapeutics claims its technology allows it to identify chemical drug candidates faster and more reliably. It has $50 million from Flagship to prove it can.
Pharmaceutical Technology
JUNE 21, 2023
The US Food and Drug Administration (FDA) has granted Teikoku Pharma’s dexmedetomidine transdermal system a fast track designation. The delivery candidate, called TPU-006, delivers dexmedetomidine for up to four days. Dexmedetomidine is a common non-opioid analgesic that activates alpha-2 receptors, which inhibits the release of noradrenaline and subsequent propagation of pain signals.
Bio Pharma Dive
JUNE 21, 2023
The regulator will issue a decision on lovo-cel by Dec. 20, roughly two weeks after a verdict is expected on a rival gene editing treatment from Vertex and CRISPR Therapeutics.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 21, 2023
A large study covering 37 years from start to finish has revealed something about those who tend to stay up late: These night owls are more likely to die at a younger age, but due to smoking and drinking-related causes rather than how late they go to bed.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 21, 2023
The Central Drugs Standard Control Organisation (CDSCO) has started carrying daily updates of the number of batches of cough syrup samples submitted with each of the laboratories prior to exports in its website, in order to enable time bound testing and release of reports.
Rethinking Clinical Trials
JUNE 21, 2023
In this Friday’s PCT Grand Rounds, Miguel Vazquez of the University of Texas Southwestern Medical Center and George “Holt” Oliver of the Parkland Center for Clinical Innovation will present “Improving Delivery of Care for Chronic Kidney Disease, Diabetes, and Hypertension,” including results from the ICD-Pieces Demonstration Project.
Pharmaceutical Technology
JUNE 21, 2023
PharmaTher and Vitruvias Therapeutics have entered a collaboration deal to commercialise PharmaTher’s Ketarx (racemic ketamine) in the US. Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list.
Bio Pharma Dive
JUNE 21, 2023
Clearance of a subcutaneous form of Argenx’s medicine, known as Vyvgart, could help pad a launch that’s already exceeded Wall Street expectations.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
JUNE 21, 2023
The Drug Controller General of India (DCGI) has granted emergency use authorisation (EUA) for Gennova Biopharmaceuticals’ Omicron-specific mRNA-based Covid-19 booster vaccine, GEMCOVAC-OM. GEMCOVAC-OM was developed using indigenous platform technology. The project was supported under the Mission Covid Suraksha, which has been implemented by India’s Biotechnology Industry Research Assistance Council (BIRAC).
Pharma Times
JUNE 21, 2023
Candidate is a cancer therapy that has been chemically modified with Avacta’s pre|CISION platform - News - PharmaTimes
Pharmaceutical Technology
JUNE 21, 2023
The US Food and Drug Administration (FDA) has granted approval to Pfizer’s Talzenna (talazoparib) along with Xtandi (enzalutamide) for prostate cancer. The combination therapy is indicated to treat homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) in adult patients. Talzenna is an oral inhibitor of poly ADP-ribose polymerase (PARP) that plays a role in repairing DNA damage.
XTalks
JUNE 21, 2023
Patient-generated health data (PGHD) is a major trend in healthcare for 2023. In fact, multinational contract research organization (CRO) Syneos Health included a discussion of PGHD in their 2023 Health Trends report. PGHD refers to data that is generated by patients through their interactions with medical providers, devices and other digital health trackers.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Fierce Pharma
JUNE 21, 2023
After Merck and Bristol Myers Squibb took shots at the Inflation Reduction Act (IRA) in separate lawsuits, influential trade group Pharmaceutical Research and Manufacturers of America (PhRMA)—plus | Trade group PhRMA is the latest to go after the IRA in a lawsuit claiming violations of the Fifth and Eighth amendments. The suit follows similar legal efforts by Merck and Bristol Myers Squibb.
Pharma Times
JUNE 21, 2023
During research there were not any clinically-relevant adverse events or psychotomimetic effects - News - PharmaTimes
Fierce Pharma
JUNE 21, 2023
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will vote this afternoon on recommendations for the use of new respiratory syncytial virus (RSV) | The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will vote this afternoon on recommendations for the use of new RSV shots from GSK and Pfizer.
pharmaphorum
JUNE 21, 2023
Pharmaphorum Editor-in-Chief Jonah Comstock spoke with Jennifer Elliott, global solid tumour lead at Takeda, about the company’s Fruquintinib product in late-stage metastatic colorectal cancer, in-licensed from HUTCHMED, and how it could provide new hope for patients with few options.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Fierce Pharma
JUNE 21, 2023
The PARP inhibitor class is welcoming its second FDA approval in prostate cancer in the span of several weeks. The new approval, for Pfizer, is broader than the first but still limited. | The PARP inhibitor class is welcoming its second FDA approval in prostate cancer in the span of several weeks. The new approval, for Pfizer, is broader than the first but still limited.
BioSpace
JUNE 21, 2023
The biotech is leveraging the potential of antibody-drug conjugates for non-internalizing targets in solid tumors through its proprietary Click-to-Release platform.
Fierce Pharma
JUNE 21, 2023
Merck is back home again in Rahway, New Jersey, at the site that it established 90 years ago as Merck Research Laboratories. | Merck is back home again in Rahway, New Jersey, at the site that it established 90 years ago as Merck Research Laboratories. After being headquartered for eight years, seven miles to the north in Kenilworth, and before that, for 23 years in Whitehouse Station, 35 miles to the west, Merck has returned to its “reimagined” Rahway facility.
BioSpace
JUNE 21, 2023
Elevidys, authorized Thursday to treat ambulatory patients 4 to 5 years of age, is the first in vivo gene therapy to win the FDA’s accelerated approval. It is also the first such therapy for DMD.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Cloudbyz
JUNE 21, 2023
In the world of clinical research, Electronic Data Capture (EDC) systems play a pivotal role in efficiently collecting, managing, and analyzing clinical trial data. Once the data is captured and thoroughly reviewed, it needs to be exported in a standardized format for further analysis and regulatory submissions. The Study Data Tabulation Model (SDTM) is a widely accepted format that ensures consistency and interoperability of clinical trial data.
pharmaphorum
JUNE 21, 2023
How are clinical trials becoming more environmentally friendly? Mike.
BioSpace
JUNE 21, 2023
The majority of ALS patients are excluded from clinical trials. Experts say using biomarkers and stratifying trial populations can expand eligibility and provide additional scientific insights.
pharmaphorum
JUNE 21, 2023
NHS data in spotlight again as Palantir wins new contract Phil.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Pharmaceutical Commerce
JUNE 21, 2023
Initiative to support developing manufacturers launch new products.
Drug Channels
JUNE 21, 2023
This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: PBMs and the Battle Over Patient Support Funds: Accumulators, Maximizers, and Alternative Funding. Click here to see the original post from April 2023. Time for Drug Channels Institute’s annual update on the gross-to-net bubble —the ever-growing dollar gap between sales at brand-name drugs' list prices and their sales at net prices after rebates and other reductions.
pharmaphorum
JUNE 21, 2023
Pfizer joins three-way PARP battle in prostate cancer Phil.
BioSpace
JUNE 21, 2023
Under the merger announced Thursday, Tourmaline shareholders will own nearly 80% of the new company, which will retain its name and continue to focus on developing its anti-IL 6 antibody.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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