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Alnylam details anticipated results from heart disease drug trial

Bio Pharma Dive

Fuller data from Alnylam’s APOLLO-B trial confirm the success reported by the company last month, but won’t end a debate on the degree of benefit offered by its drug

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Amgen to test new way to lower heart risk with large drug trial

Bio Pharma Dive

Buoyed by strong mid-stage study results, the biotech will soon start a cardiovascular outcomes trial of a drug designed to target a genetic risk factor called lipoprotein(a

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MEI, Kyowa stop lymphoma drug trials after FDA meeting

Bio Pharma Dive

The decision not to run a Phase 3 trial of their medicine is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs known as PI3 kinase inhibitors

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Alexion discontinues ALS drug trial due to 'lack of efficacy'

Bio Pharma Dive

The decision, which follows the recommendation of a data monitoring committee, is yet another setback in the search for more treatments for the neurological disease

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Springworks shares fall despite drug trial's success

Bio Pharma Dive

The biotech plans to seek FDA approval for its soft-tissue tumor treatment after positive study results. But investors still sent the stock down by nearly 10

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Alnylam reveals longer wait for anticipated drug trial results

Bio Pharma Dive

Important data from the APOLLO study of the biotech's drug Onpattro are due before the end of August, Alnylam said Thursday

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Beckley adds digital element to its psychedelic drug trials

Pharma Phorum

Phase 2 trials of Beckley Psytech’s psychedelic drug candidates will make use of digital technologies for patient monitoring, thanks to a new partnership with Empatica. The post Beckley adds digital element to its psychedelic drug trials appeared first on.

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Kibow Biotech celebrates 25th anniversary as drug trials commence

BioPharma Reporter

Kibow Biotech is celebrating its 25th anniversary as the company pivots toward developing a drug based on its proprietary probiotic strains that benefit kidney disease suffers.

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BioSig abandons COVID-19 drug trial on safety concerns

Pharma Phorum

US biotech BioSig Technologies has abandoned a phase 2 trial of its antiviral drug merimepodib with Gilead’s Veklury in severe COVID-19 patients, after concluding the safety of the combination was in doubt.

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PureTech launches phase II ‘long COVID’ drug trial

Pharma Times

LYT-100 will be evaluated in patients with persistent symptoms caused by COVID-19

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Small Pharma stock market launch funds DMT-based depression drug trial

Pharma Phorum

DMT is a powerful hallucinogenic drug found in several plants including the South American plant chacruna and when used recreationally is mixed with the ayahuasca plant to make the shamanic brew of the same name. News R&D depression DMT psychedelic drugs

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Review reports improved transparency in antidepressant drug trials

Scienmag

New research suggests manufacturers of newly developed antidepressant drugs have become more forthcoming about clinical trials that don’t pan out. Latest News antidepressant Drug Improved reports review Transparency trials

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Digital silver lining seen in failed COVID-19 drug trial

Scienmag

Medicine & Health COVID19 digital Drug failed lining silver trial

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Scepticism in press over Kintor’s COVID-19 US drug trial

Pharma Phorum

China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. Kintor is in talks with the Brazilian health regulator Anvisa about a further trials.

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Impel Pharmaceuticals reports progress with ASD-related drug trial

Outsourcing Pharma

The company reports dosing of the first subject in a Phase IIa proof-of-concept study investigating a drug for an autism spectrum disorder related condition. Drug Delivery

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Florida woman jailed for lying to FDA about children's drugs trial

Outsourcing Pharma

A Florida doctor has been sent to prison after submitting a false affidavit claiming she had screened children in a clinical study looking at the effectiveness of drugs given to children with asthma when she had not.

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Vertex Moves Full Steam Ahead on Type 1 Diabetes Drug Trial With FDA’s OK

BioSpace

Food and Drug Administration (FDA) has cleared an Investigational New Drug application that will allow Boston-based Vertex Pharmaceuticals to proceed with a clinical trial of its investigational stem cell-derived, fully differentiated pancreatic islet cell treatment for type 1 diabetes

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Lundbeck gets cold feet, axes schizophrenia drug trial

Pharma Phorum

Lundbeck has axed a phase 2 trial of a schizophrenia drug, saying that the study was unlikely to meet its efficacy target. The company said it made the decision after a futility analysis indicated that the trial was not likely to succeed, when measured against a standard scale.

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JPM23: Vaccine developers as dealmakers, Gilead’s trial tea leaves and building platform companies

Bio Pharma Dive

Moderna’s Stéphane Bancel and Pfizer’s Albert Bourla hinted Monday at greater dealmaking to come for their companies, while Gilead gave investors an update on an important cancer drug trial

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What the FDA’s guidance on diversity means for rare disease sponsors

Bio Pharma Dive

Bringing more diversity to clinical trials is a slow process and it takes time to get right. Learn how Worldwide Clinical Trials can diversify the reach of your orphan drug trial

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Washington Man Faces 28 Years in Prison for Fraudulent Drug Trial Scandal

BioSpace

was convicted on 47 counts of fraud and drug related charges on Oct. A 41-year-old man from Richland, Wash. 1, according to the U.S. Justice Department’s Eastern District of Washington

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FDA Places Partial Clinical Hold on Cortexyme’s Alzheimer’s Drug Trial

BioSpace

According to a statement made by Cortexyme, the partial hold was placed on the development program for atuzaginstat after an FDA review of the trial data identified hepatic adverse events

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Lilly's Longest Diabetes Drug Trial Lowers A1C and Increases Weight Loss

BioSpace

?SURPASS-4 is part of the Phase III trial evaluating tirzepatide as a possible treatment for type 2 diabetes

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Roche Puts the Kibosh on Huntington's Drug Trial

BioSpace

Ionis Pharmaceuticals announced that its collaboration partner, Roche, was discontinuing dosing in the Phase III GENERATION HD1 trial of tominersen in manifest Huntington’s disease (HD

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New system that defines Huntington’s Disease will ‘revolutionise’ drug trials

Scienmag

A novel staging framework that assesses the progression of Huntington’s disease (HD), similar to the way cancer is staged 0 to 4, has been developed by UCL scientists as part of an international consortium; this ‘significant’ step paves the way for clinical trials of drugs in the earliest phase of disease. Latest News defines Disease Drug Huntingtons revolutionise system trials

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Merck Drops Late-Stage Cancer Drug Trial Due to Disappointing Efficacy | 2021-01-20

The Pharma Data

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

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Bellicum’s Phase 1/2 Cancer Drug Trial Stopped Following Patient Death | 2020-12-08

The Pharma Data

The FDA has issued a clinical hold on Bellicum Pharmaceuticals for its ongoing phase 1/2 trial evaluating CAR-T therapy BPX-601 in patients who received prior treatment for metastatic pancreatic or prostate cancer, following the death of a trial participant.

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aTyr Pharma Finishes Enrollment of Respiratory Drug Trial for COVID-19 Patients | 2020-10-27

The Pharma Data

based aTyr Pharma has finalized enrollment for a phase 2 trial to evaluate an investigational anti-inflammatory drug in COVID-19 patients with severe respiratory complications. The double-blind, placebo-controlled trial, which has 32 participants across the U.S.,

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Mathematical models and computer simulations are the new frontiers in COVID-19 drug trials

Scienmag

The models allow for virtual trials of drugs and vaccines, opening the possibility of pre-assessment for drug and vaccine efficacy against the virus. Biology Biomedical/Environmental/Chemical Engineering Cell Biology Clinical Trials Diagnostics Disease in the Developing World Epidemiology Infectious/Emerging Diseases Public Health Technology/Engineering/Computer Science Vaccines

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FDA Approvals for a Liquid Epilepsy Drug and Vitiligo Medication – Xtalks Life Science Podcast Ep. 71

XTalks

The drug is the first FDA approved oral suspension form of zonisamide. Hear about how the drug could help increase accessibility and flexibility for epilepsy patients and improve treatment adherence.

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Reporting of adverse effects in drug trials has only improved slightly in 17 years, new study shows

Scienmag

Researchers, including academics from the University of York, analysed systematic reviews of 1,200 Randomised Controlled Trials (RCTs) to assess whether reporting had improved over time. Medicine & Health Clinical Trials Health Professionals Medicine/Health Public HealthHowever, the information the researchers needed to assess what adverse effects were reported (and how they were reported) was only included in less than half of the RCTs they analysed. […].

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#news #biotech Troubled Cytokinetics’ stock soars as gets much needed phase 2 heart drug trial win, plans late-stage effort by year’s end

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Troubled Cytokinetics’ stock soars as gets much needed phase 2 heart drug trial win, plans late-stage effort by year’s end.Troubled Cytokinetics’ stock soars as gets much needed … Continue reading → #news

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Global Mantle Cell Lymphoma Clinical Landscape Market Report 2021: Marketed and Pipeline Drugs, Trials, Key Events, Success Probability, 10-Year Disease Prevalence Forecast, Deals, Revenue Forecasts – ResearchAndMarkets.com

BioTech 365

Global Mantle Cell Lymphoma Clinical Landscape Market Report 2021: Marketed and Pipeline Drugs, Trials, Key Events, Success Probability, 10-Year Disease Prevalence Forecast, Deals, Revenue Forecasts – ResearchAndMarkets.com Global Mantle Cell Lymphoma Clinical Landscape Market Report 2021: Marketed and Pipeline Drugs, … Continue reading → Business Wire

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Study coordinator pleads guilty to trial data falsification

Outsourcing Pharma

A former employee of Tellus Clinical Research in Miami has admitted to charges related to a conspiracy to falsify data on a list of clinical drug trials.

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FDA Halts Poseida’s CAR-T Trial for Prostate Cancer Following Patient Death

BioSpace

Food and Drug Administration halted a cancer drug trial due to safety concerns Shares of Poseida Therapeutics plunged more than 20% in premarket trading this morning after the company announced the U.S.

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AstraZeneca Cancer Trial Hit with Clinical Hold Following Cardiac Issues

BioSpace

An experimental AstraZeneca cancer drug trial has been placed on hold due to safety concerns. This news comes two years after Amgen was also forced to pause a study of a drug within the same class

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HCPs sound off on pharma marketing

World of DTC Marketing

Attitudes are indeed changing, but one need remains clear: access to data obtained during clinical and ongoing trials. This was especially true with new drugs that have a significant competitive market.

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FDA Panel Rejects Lilly’s Cancer Drug Tested Only in China

NY Times

The panel debated whether overseas trials could be applied to a more diverse U.S. The decision may affect other Chinese drug trials, and spotlights the high cost of immunotherapy. population.

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Do Therapies for Alzheimer’s & Parkinson’s that Clear Abnormal Brain Proteins Make the Diseases W.

BioSpace

To date, these drug trials have not been particularly successful at i One of the common research approaches to treating brain diseases such as Parkinson’s disease (PD) and Alzheimer’s disease (AD) is using antibodies designed to clear the accumulated misfolded proteins implicated in the diseases.

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HCP’s use of social media: the good and the not so good

World of DTC Marketing

The best approach is to use social media to connect HCPs to clincial information and drug trials. A leading pharma company recently sponsored a series of Q&A around the use of their new cancer drug.

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What DTC marketers can learn from people who refuse a COVID vaccination

World of DTC Marketing

CDC and new drugs have fostered an era of mistrust with some people. DTC marketers need to be more forthcoming when it comes to drug trials and side effects. This means that trust will be a huge issue for new drugs that promise breakthrough results.

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LSD biotech MindMed buys digital trial firm HealthMode

Pharma Phorum

million, which uses artificial intelligence (AI) technology to speed up drug development. With the acquisition MindMed gains access to HealthMode’s intellectual property, platforms for clinical drug trials, and its entire 24-strong digital medicine team.

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Leading clinical packaging companies in contract marketing

Pharmaceutical Technology

Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. The increasing investment in pharmaceutical research and development, and the growing adoption of contract manufacturing and marketing practices are driving the demand for clinical trial contract packaging solutions. Finding the best clinical trial packaging services providers.

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