Bio Pharma Dive

NOVEMBER 14, 2022

Eight years after gantenerumab failed a Phase 3 study, the drug came up short in late-stage testing again, proving unable to meaningfully slow cognitive decline in two closely watched trials.

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Bio Pharma Dive

MAY 3, 2023

approval based on the trial results, which showed a consistent benefit to treatment with the drug, called donanemab. The company plans to quickly submit an application for U.S.

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Pharmaceutical Technology

APRIL 19, 2023

Neuronascent plans to start a potential Phase II trial of its neurorestorative agent NNI-362 in Parkinson’s disease in H1 2024, said CEO Judith Kelleher-Andersson in an interview with P harmaceutical Technology. The potential Phase II trial in Parkinson’s disease will recruit between 75 and 100 patients, said Kelleher-Andersson.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2023

The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.Merck Sharp and (..)

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Pharmaceutical Technology

JULY 29, 2022

For the last five years (2017 to 2021), there has been a steady increase in the total number of schizophrenia clinical trials by trial start year, apart from 2020, a decrease that may be due to the focus on Covid-19 relief. Last year saw the most with 167 trials. The other top sponsors can be seen in Figure 1.

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ProRelix Research

JUNE 6, 2023

Being the second most populous country in the world with skilled labor and good infrastructure, India is a favorable destination for clinical trials for a wide variety of diseases.

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Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2023

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.

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Bio Pharma Dive

MARCH 20, 2023

The results add to a growing body of evidence that Karuna’s drug, known as KarXT, could be a valuable new option for patients living with the brain disorder.

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Bio Pharma Dive

APRIL 27, 2023

Trial participants lost up to 15% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

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Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has granted rare paediatric drug designations for IPS HEART’s stem cell therapeutics, GIVI-MPC and ISX9-CPC, to treat Duchenne muscular dystrophy (DMD) patients. The drug candidate received an orphan drug designation (ODD) from the FDA in February 2023.

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Bio Pharma Dive

DECEMBER 6, 2022

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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Bio Pharma Dive

JUNE 5, 2023

Results from a “basket” trial of the antibody-drug conjugate show it shrank tumors across a half dozen cancers, suggesting a broader role to targeting the protein HER2.

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Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The orally administered, non-systemically absorbed drug candidate SYNB1934 has been designed for reducing blood phenylalanine (Phe) levels in PKU patients.

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Bio Pharma Dive

DECEMBER 8, 2022

The company claimed an “unplausible” placebo response caused both studies to fail and is making substantive changes to its other remaining late-stage trial as a result.

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Bio Pharma Dive

OCTOBER 26, 2022

On the heels of a major approval for Enhertu, the pharma reported positive results for two experimental drugs in settings where rival medicines from Roche and Sanofi recently failed.

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Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

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Pharmaceutical Technology

MARCH 6, 2023

Whether one refers to such research as “longevity”, “anti-aging” or “extending healthspan”, it is clear this area has evolved massively over the last few years with more scientists now eager to get drugs in this area from bench to bedside. Within these hallmarks, different laboratories have found distinct ways to track and quantify aging.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2023

The National Pharmaceutical Pricing Authority (NPPA) may fix the retail price of formulations which are under phase IV clinical trials based on the company’s application submitted to the central drug regulator for conducting the phase of clinical trials and other documents along with the relevant form.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 16, 2023

A popular obesity drug has been found to restore the function of immune cells that target cancer, regardless of whether people lost weight with the treatment.

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Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

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World of DTC Marketing

OCTOBER 6, 2020

WHAT’S THIS ABOUT THEN : Researchers are rushing to launch clinical trials of experimental vaccines against the coronavirus, and treatments for COVID-19. Eli Lilly recently announced that it would halt enrolment in ongoing studies and delay the launch of new trials.

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Pharmaceutical Technology

MARCH 29, 2023

The trial, which is investigating healthy adults with a minimum body mass index of 30 kg/m2, will see VK2735 administered as an oral tablet once daily for 28 days. The Phase I study is an extension of a previously completed Phase I trial that evaluated the subcutaneous administration of VK2735.

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World of DTC Marketing

AUGUST 27, 2021

SUMMARY: Over half of all clinical trial sites are outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient. 78 % of all subjects were enrolled outside the U.S.

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Clinical Trials Clinical Trials Trials Drugs 187

Bio Pharma Dive

MARCH 9, 2023

Prior trial failures hadn’t halted testing of solanezumab, once Lilly’s top Alzheimer’s drug candidate. But its final study defeat may help scientists better understand how to target the brain disease.

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Bio Pharma Dive

SEPTEMBER 28, 2022

The companies said the drug, called lecanemab, met all of its goals in the Phase 3 study. The data are a significant finding and provide stronger support for a much-debated hypothesis for treating Alzheimer’s.

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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 2, 2023

The Subject Expert Committee (SEC) that advises the drug regulator of the country has recommended waiver of local phase III and IV clinical trials in India for Sanofi Healthcare India’s orphan drug to treat the Pompe disease. The […]

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Bio Pharma Dive

JANUARY 6, 2023

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.

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Bio Pharma Dive

SEPTEMBER 17, 2021

Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug. With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline.

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Pharmaceutical Technology

APRIL 4, 2023

On April 3, Janssen Pharmaceutical Companies of Johnson & Johnson announced the availability of an additional 240mg strength tablet for its prostate cancer drug ERLEADA (apalutamide) in the United States. Previously, the drug was only available as a 60mg tablet – four of the which would need to be daily.

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Bio Pharma Dive

NOVEMBER 29, 2022

At a medical conference, the companies detailed clinical trial results that could help support approval of their drug, lecanemab. However, some doctors aren’t yet convinced the medicine’s risks are worth its potential benefits.

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Worldwide Clinical Trials

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Psychedelic trials need to be done with scientific rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials.

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Pharmaceutical Technology

JANUARY 22, 2023

However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. Major pharmaceutical acquisitions have taken place in recent months in the rare disease space, as the number of orphan drug approvals continues to grow. This was not always the case. “Up

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Pharmaceutical Technology

APRIL 3, 2023

Ablaze Pharmaceuticals is set to develop a new GPC3-targeted peptide drug candidate for the treatment of liver cancer in China. The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio. The agreement allows Ablaze to clinically develop and commercialise the drug in Greater China.

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Bio Pharma Dive

MARCH 3, 2023

The setback is the second for the pairing of Cabometyx and Roche’s immunotherapy Tecentriq, dimming Exelixis’ hopes of further expanding its drug’s use before a key patent expires.

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Bio Pharma Dive

JANUARY 10, 2023

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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Bio Pharma Dive

NOVEMBER 28, 2022

Shares of the New York-based biotech rose by a third Monday morning, as fresh clinical trial results showed its drug AXS-05 both delayed and prevented the recurrence of Alzheimer’s agitation.

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