STAT

OCTOBER 31, 2023

This article was adapted from STAT’s latest report , “Subgroup analysis: how to evaluate post hoc tests for significance in failed clinical trials.” ” C linical trials of newly developed drugs often don’t work out. Read the rest…

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STAT

NOVEMBER 1, 2023

An important Phase 3 trial has shown that a new drug that targets gonorrhea works as well as the last existing antibiotic to treat the sexually transmitted infection, results that could lead to licensure of the first new treatment for gonorrhea in decades. released topline results of the clinical trial on Wednesday.

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STAT

MAY 2, 2024

Amgen said Thursday that it will no longer develop an early-stage obesity pill, and will instead focus on a more advanced injectable candidate that’s seen as a potential competitor to Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. Topline data are expected late this year. Amgen shares were up 13% in post-market trading.

Diabetes 268

Diabetes 268

STAT

MAY 8, 2024

The clinical trial is meant to measure safety and efficacy of DB-OTO, a gene therapy drug Regeneron is developing to treat children who have hearing loss due to changes in the otoferlin gene. Several teams are targeting this rare form of congenital deafness that affects 1% to 8% of deaf people globally.

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STAT

DECEMBER 13, 2023

In 2016, a trial for a hormonal male birth control pill was halted after men reported side effects including acne and mood swings — though such side effects are also experienced by women on various hormonal contraceptives. The pill entered its Phase 1 clinical trial today in the U.K.,

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STAT

DECEMBER 21, 2023

WASHINGTON — Sometime next year drug and medical device companies will have to tell the Food and Drug Administration how they plan to include people of color in clinical trials. Congress in late 2022 passed a law requiring companies to give FDA their plans for diversifying clinical trials.

Drug Development 285

Drug Development 285

STAT

OCTOBER 6, 2023

Califf proposed something radical: that private health care insurance companies (payers) should participate in clinical research on FDA-approved drugs. This challenges the prevailing convention that only drug developers conduct such studies — and it’s an idea worth considering.

Drug Development 234

Drug Development 234

STAT

MARCH 29, 2023

A growing shortage of monkeys used for early-stage pharmaceutical research is causing concern that many companies will soon face costly delays starting clinical trials — leading to a slowdown in drug development. In recent weeks, the U.S

Drug Development 315

Drug Development 315

STAT

MAY 7, 2024

Drug development is essentially a long, expensive bet: 90% of drugs fail during clinical trials, goes one of the life science industry’s most oft-quoted statistics. But they cautioned that the pace of future successes will depend on whether the industry can streamline and rethink drug development.

Drug Development 234

Drug Development Vaccines 234

STAT

NOVEMBER 6, 2023

SAN DIEGO — Ventyx Biosciences reported on Monday that it was ending development of an experimental drug for treating plaque psoriasis though it proved safe and moderately effective in a mid-stage trial. Within hours, the company’s stock tanked by more than 80%. Shares in Ventyx plummeted from $14.09

Drug Development 236

Drug Development 236

STAT

DECEMBER 1, 2023

Pfizer on Friday said it was stopping development of a twice-daily oral obesity medication after an underwhelming clinical trial, a blow to the company’s efforts to compete in the booming field of weight-loss medications.

Drug Development 284

Drug Development 284

PharmExec

MARCH 28, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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STAT

OCTOBER 16, 2023

People with obesity often go underrepresented in drug development trials, a critical gap that researchers say leaves drugmakers and doctors unsure of efficacy or risks in that patient population. “People with obesity are underrepresented in clinical trials for drug approval.” ” Read the rest…

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Drug Development 288

STAT

JANUARY 30, 2024

A pain relief drug developed by Vertex Pharmaceuticals succeeded in late-stage clinical trials, the company announced Tuesday, bringing the biopharma giant a step closer to launching what observers believe could be a potential blockbuster and upending decades of pharma failure in a complicated field.

Drug Development 288

Drug Development 288

STAT

MARCH 6, 2023

Issues of fairness and justice echo across the health ecosystem, including drug development. Much of the conversation on improving equity in the development of novel therapeutics centers on increasing diversity in clinical trials. Continue to STAT+ to read the full story…

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Drug Development 216

STAT

NOVEMBER 7, 2023

WASHINGTON — Current and former government officials proffered a clear-eyed, and often depressing, take Tuesday on the state of clinical trials, the pharmaceutical industry, and biotech investors coming out of the Covid-19 pandemic. Continue to STAT+ to read the full story…

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Vaccines 246

STAT

MAY 1, 2024

The work is only in mice so far, but it reflects a surge of interest, including a new clinical trial, in using mitochondria to help regrow blood vessel linings. Any advances could help people with diabetes, who commonly develop vascular problems such as diabetic ulcers, or end up facing limb loss.

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Diabetes Hospitals 304

STAT

APRIL 2, 2024

The news represents a setback for an ambitious project to not only bring forward one of the first gene-editing treatments in humans, but to also do so not for a rare condition but for the leading killer in the developed world.

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Compounding 249

STAT

JANUARY 4, 2024

Allogene Therapeutics is making unexpected changes to development plans for its off-the-shelf cell therapy for a type of blood cancer — a concession that competition from personalized CAR-T treatments, already entrenched in the market, has become more challenging.

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LifeProNow

MARCH 12, 2023

The mission of the partnership is to improve the lives of dermatology patients with access to innovative clinical trials and the launch of new medicines. The mission of the partnership is to improve the lives of dermatology patients with access to innovative clinical trials and the launch of new medicines.

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MAY 14, 2024

clinical trial for the AstraZeneca Covid-19 vaccine is suing the company, claiming it left her “permanently disabled,” The Telegraph writes. made vaccine was tested in clinical trials but never approved for use. An American woman who took part in the U.S. where the U.K-made

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Vaccines 183

STAT

SEPTEMBER 27, 2023

The deal highlights the possibility of developing a new approach to Covid shots. Gritstone CEO Andrew Allen said that the project will allow the company to develop a proof of concept for its vaccine platform that it might not be able to afford otherwise.

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Vaccines 318

STAT

JANUARY 31, 2024

Biogen will also terminate an ongoing clinical trial meant to prove the treatment’s benefits for patients in the early stages of Alzheimer’s. Neurimmune, the Swiss company that invented Aduhelm, will regain full rights to the intravenous medicine, Biogen said Wednesday.

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STAT

SEPTEMBER 26, 2022

Here’s a scenario anyone who has done clinical research will recognize: A 32-year-old woman participating in a Phase 1 healthy-volunteer crossover clinical trial tested negative for pregnancy when she enrolled and agreed to use contraception during the course of the trial, as specified in the protocol.

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SEPTEMBER 29, 2022

A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. Read the rest…

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Vaccines 352

STAT

APRIL 4, 2024

Bankruptcies, restructurings, clinical trial setbacks, and falling stock prices: It’s been a disconcerting week in Biotech Land. Today, the company is developing a treatment for obesity that was discovered through research into marijuana, and that might be additive to the GLP-1 blockbusters. I want to hear from you!

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MARCH 20, 2024

is working on a new type of T-cell engager developed by Johns Hopkins researchers Bert Vogelstein and Drew Pardoll. Critically, that funding will be enough to bring the company into clinical trials and gather early proof-of-concept clinical data.    Clasp, which has dual headquarters in Cambridge, Mass.,

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Pharmaceutical Technology

FEBRUARY 13, 2024

Two FDA representatives FDA spoke at the ongoing 2024 SCOPE Summit about how the agency is focusing on AI.

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Drug Development 52

STAT

SEPTEMBER 29, 2023

In 2020, as biotech stocks surged amid the pandemic, a startup called Taysha Gene Therapies raised over $300 million off an audacious promise: It was going to license and develop gene therapies for at least 18 different rare and serious neurological diseases. Last week, the grand plan took perhaps a final blow.

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STAT

SEPTEMBER 27, 2023

Biogen, the iconic but embattled biotech firm, is shuttering Biogen Digital Health, its roughly 150-person group focused on using new types of data like those from mobile phones and smart watches, and ending a clinical trial being conducted with Apple early, STAT has learned. ” Continue to STAT+ to read the full story…

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STAT

NOVEMBER 15, 2022

As the Covid-19 pandemic spread across the world two years ago, one of India’s leading biotech companies was racing to develop a vaccine with crucial backing from the Indian government. Read the rest…

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Documentation Vaccines 363

Outsourcing Pharma

JUNE 15, 2023

The digital biomarkers company has partnered with Beacon Biosignlas, a computational neurodiagnostics company to launch a clinical trial investigate the integration of Beaconâs at-home electroencephalogram (EEG) into Koneksaâs neuroscience solution toolkit.

Drug Development 52

Drug Development 52

pharmaphorum

MAY 9, 2024

A new metric developed by Phesi can predict the burden that clinical trials will impose on patients, allowing amendments that can improve the design, efficiency and cost

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STAT

JUNE 27, 2023

But developing treatments for patients with rare diseases — conditions that afflict fewer than 200,000 people in the United States — is particularly challenging. When there are only a few thousand or even a few hundred people living with a particular condition, finding enough patients for clinical trials can take years.

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Drug Development 228

STAT

DECEMBER 8, 2022

Over the past few years, the biopharmaceutical industry has revved up efforts to diversify clinical trials. But clinical trials for rare diseases are still too often homogeneous.

Pharmaceutical Companies 244

Pharmaceutical Companies Pharmaceutical Companies 244

pharmaphorum

FEBRUARY 21, 2024

Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.

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Drug Development 119

STAT

NOVEMBER 28, 2023

RIGT submitted a development plan to the FDA for a phase III clinical trial focused on estradiol — the most common form of estrogen for hormone treatments — and received the agency’s written feedback on Nov. 17 in lieu of a live pre-investigational new drug meeting.

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Labelling 338