Prospecting, Safety and Side effects

FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. For this approach, a “3+3” model is used where a study enrolls three patients into a given dose cohort.

FDA

FDA Side effects Pharmacology Patients

GSK shelves arthritis blockbuster hope otilimab after lacklustre data

pharmaphorum

OCTOBER 27, 2022

There has been somewhat better news for GSK for another of its top pipeline prospects – renal anaemia drug daprodustat – although that also came with disappointment. GSK licensed otilimab from German biotech MorphoSys in 2013 in a deal valued at up to €423 million, including around €23 million upfront. Daprodustat backed.

Side effects

Side effects FDA Patients Sales

Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

JUNE 12, 2024

The main objective was to evaluate the efficacy and safety of MBK-01 compared to fidaxomicin, providing significant insights into the potential of MBK-01 as a treatment for primary or recurrent CDI and contributing to the advancement of microbiome-based therapies. The study included 92 adult patients with confirmed CDI.

Safety

Safety Patients Side effects Management

FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

Pharma Leaders

MAY 18, 2023

We are excited about the prospect of working collaboratively with the FDA to finalise this review over the next few months. “We Diarrhea was the most common side effect with XPHOZAH. The biopharmaceutical company expects XPHOZAH to be commercially available in Q4 2023 after an approval from the regulatory body.

Food and Drug Administration

Food and Drug Administration FDA Side effects Prospecting

FDA slaps partial hold on Biogen, InnoCare MS drug

pharmaphorum

DECEMBER 28, 2022

While the partial hold may simply be a hiccup for InnoCare and Biogen’s programme, it does undermine prospects for orelabrutinib, which is one of several oral BTK inhibitors being developed for MS and other autoimmune diseases. Antibodies like Ocrevus also struggle to penetrate the CNS and hit MS at the site of the problem.

FDA

FDA Side effects Biopharma Prospecting

Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

JANUARY 22, 2023

Dr. Jerry Mendell, MD, professor of paediatrics and neurology at the Ohio State University College of Medicine, is optimistic for its approval and says the drug has a good safety profile. However, before the drug can receive an approval, Santhera will have to overcome doubts about vamorolone’s safety. compared to 38.5% on placebo.

FDA

FDA Safety Pharmaceutical Patients

Francis Medical Announces First Patient Treated in VAPOR 2 Pivotal Study for Water Vapor Ablation of Prostate Cancer

Legacy MEDSearch

JULY 19, 2023

VAPOR 2 is a prospective, multicenter, single-arm study that will treat 235 patients with intermediate-risk, localized prostate cancer at up to 30 U.S. The therapy is designed to ablate cancer cells while protecting surrounding structures, lessening the likelihood of life-altering side effects common with other prostate cancer treatments.

Medical

Medical Side effects Patients Recruitment

SNIPR targets antibiotic resistance with CRISPR-based gene therapy trial

Pharmaceutical Technology

MAY 31, 2023

The Danish CRISPR biotech SNIPR BIOME has released the first glimpse at the safety profile for SNIPR001, a gene therapy intended to target antibiotic resistance. Interim clinical results from a Phase I trial have demonstrated SNIPR001’s safety in healthy volunteers.

Food and Drug Administration

Food and Drug Administration Safety Side effects FDA

Overcoming Sales Objections Part 1: Pharma Sales Challenges

Pharmaceutical Representative Training

OCTOBER 9, 2024

Introduction Every sales professional has experienced deals collapsing at the last minute due to objections from prospects. In the competitive world of pharmaceutical sales, effectively handling customer objections is crucial for success. There are times when your prospect will have multiple objections at once.

Sales

Sales Pharma Pharmaceutical Sales Prospecting

The evolution of AAVs in cell and gene therapy

European Pharmaceutical Review

JULY 20, 2023

Dr Baghirzade continued, highlighting that since a particular defining moment for the industry in the late 90s, which resulted in an unfortunate patient fatality, “there is a lot more focus on safety” in gene therapy clinical trials today. For cell and gene therapy, a “big issue” she stated, was the complexity of manufacturing.

Consulting

Consulting Manufacturing Side effects Safety

Mastering Pharmacology: A Game-Changer for Pharma Sales Reps Communicating with HCPs

Pharmaceutical Representative Training

JANUARY 8, 2025

Without this information, providers cant ensure the safety or efficacy of the medications they prescribe. 1] How can mastering pharmacology give sales reps a competitive advantage when meeting with prospective HCPs? link] How can mastering pharmacology give sales reps a competitive advantage when meeting with prospective HCPs?

Pharmacology

Pharmacology Pharma sales reps Sales Pharma

ASCO 2023: Summit Therapeutics plans to rise with bispecific NSCLC data

Pharmaceutical Technology

JUNE 5, 2023

With a higher expression of PD-1 and VEGF in tumour tissue and the tumour microenvironment, Summit claims that ivonescimab can more effectively target tumour tissue to provide safer treatment with fewer side effects. The treatment had an acceptable safety profile in combination with chemotherapy.

Side effects

Side effects Patients Leads Prospecting

Digitalisation of the clinical trial landscape

European Pharmaceutical Review

JUNE 16, 2023

By incorporating a more comprehensive range of individuals in clinical trials, researchers can obtain valuable insights into the efficacy and safety of drugs across various populations. For organisations looking to standardise the measurement of safety data, what approach is the most impactful?

Safety

Safety Electronics Recruitment Patients

Oncolytic viruses: past and present

European Pharmaceutical Review

AUGUST 25, 2022

the promise of leveraging oncolytic viruses stands out because of their excellent safety profile, minimal predicted side effects and potent ability to kill cancer cells while leaving healthy cells unscathed2. Stem cells’ safety profile is well-established in human therapies.

Side effects

Side effects Safety Patients Engineering

Top 5 Emerging Trends in Pharma Industry

Medico Reach

FEBRUARY 8, 2023

With the use of trailblazing digital platforms, cost-effective technologies, big data analytics, blockchain, and artificial intelligence (AI), the landscape is undergoing a massive transition. The Grand View Research published a report highlighting the stark growth prospects of the pharma industry. billion during 2020-2024.

Pharma

Pharma Medicine Marketing Prospecting

New Study Demonstrates Consistent Positive Long-Term Adherence and Efficacy of Nerivio® for Treatment of Migraine

Legacy MEDSearch

OCTOBER 25, 2023

Theranica , a neuromodulation therapeutics company, announced the publication of a comprehensive clinical study in Advances in Therapy examining the long-term utilization, clinical efficacy, and safety of Nerivio ® , a Remote Electrical Neuromodulation (REN) device for the treatment of migraine.

Side effects

Side effects Recruitment Networking Management

FDA proposes new model for easy-to-understand prescription guides

Pharmaceutical Technology

MAY 31, 2023

The document would include the drug/biological product name, side effects, directions for use, safety information, and a concise summary of indications and uses. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.

Prescription

Prescription FDA Food and Drug Administration Medical

Telehealth in the 2022 Medicare Physician Fee Schedule: Audio-Only Telehealth for Mental Health Made Permanent, and CMS Punts on Remote Direct Supervision

Nixon Gwilt Law

NOVEMBER 5, 2021

Citing MedPAC’s concerns about patient safety, CMS declined to address this in the final rule, stating that the agency will consider addressing the issues raised by these comments in future rules or guidance, as appropriate.

Physicians

Physicians Professional Services Medical Side effects

Pharma Rep Focus

FDA drug dosage optimisation guidelines signal clinical trial reform

GSK shelves arthritis blockbuster hope otilimab after lacklustre data

Trending Sources

Developing the EU’s first intestinal microbiota-based biologic

FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

FDA slaps partial hold on Biogen, InnoCare MS drug

Can the FDA keep the momentum going for rare disease drug approvals?

Francis Medical Announces First Patient Treated in VAPOR 2 Pivotal Study for Water Vapor Ablation of Prostate Cancer

SNIPR targets antibiotic resistance with CRISPR-based gene therapy trial

Overcoming Sales Objections Part 1: Pharma Sales Challenges

The evolution of AAVs in cell and gene therapy

Mastering Pharmacology: A Game-Changer for Pharma Sales Reps Communicating with HCPs

ASCO 2023: Summit Therapeutics plans to rise with bispecific NSCLC data

Digitalisation of the clinical trial landscape

Oncolytic viruses: past and present

Top 5 Emerging Trends in Pharma Industry

New Study Demonstrates Consistent Positive Long-Term Adherence and Efficacy of Nerivio® for Treatment of Migraine

FDA proposes new model for easy-to-understand prescription guides

Telehealth in the 2022 Medicare Physician Fee Schedule: Audio-Only Telehealth for Mental Health Made Permanent, and CMS Punts on Remote Direct Supervision

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