Drug Target Review

FEBRUARY 10, 2025

In the rapidly advancing field of cell therapies, Dr Jason Bock has emerged as a leader, known for his innovative approach to optimising the development process. With over 25 years of experience in therapeutics, Bock has played a pivotal role in shaping the future of cell therapies, particularly through his work at CTMC.

Therapies 65

Therapies Treatment Engineering Clinical Trials 65

Drugs.com

MAY 29, 2024

WEDNESDAY, May 29, 2024 -- People battling advanced colon cancers might have a new treatment option that could extend their survival, a new trial finds.A combination of two experimental immunotherapy drugs plus standard chemotherapy led to a median.

Therapies 297

Therapies Trials Treatment Drugs 297

BioPharma Drive: Drug Pricing

JUNE 4, 2024

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

FDA 329

FDA FDA Approval Clinical Trials Therapies 329

Science Daily: Pharmacology News

MARCH 7, 2024

Four children have remained free of detectable HIV for more than one year after their antiretroviral therapy (ART) was paused to see if they could achieve HIV remission, according to new research.

Treatment 323

Treatment Clinical Trials Therapies Trials 323

Drugs.com

JUNE 27, 2024

THURSDAY, June 27, 2024 -- Acupuncture can help breast cancer patients deal with the hot flashes that often accompany hormone therapy, a new clinical trial says.Nearly 2 in 3 women who got acupuncture during hormone therapy reported fewer and less.

Clinical Trials 263

Clinical Trials Treatment Therapies Trials 263

Drugs.com

JUNE 7, 2023

TUESDAY, June 6, 2023 -- Radiation therapy might not be necessary in treating some forms of rectal cancer and lymphoma, sparing patients from the toxic treatment, a pair of new clinical trials shows. One trial found that rectal cancer patients.

Therapies 246

Therapies Clinical Trials Trials Treatment 246

BioPharma Drive: Drug Pricing

MAY 23, 2024

The findings, from two trials involving tens of thousands of women, could influence guidelines around the use of hormonal treatment for menopausal symptoms.

Therapies 293

Therapies Trials Treatment 293

BioPharma Drive: Drug Pricing

SEPTEMBER 27, 2023

Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment was effective for treating ALS.

Therapies 284

Therapies Clinical Trials FDA Trials 284

BioPharma Drive: Drug Pricing

SEPTEMBER 27, 2023

Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment was effective for treating ALS.

Therapies 274

Therapies Clinical Trials FDA Trials 274

Science Daily: Pharmacology News

FEBRUARY 22, 2024

A large-scale clinical trial of treatment strategies for Crohn's disease has shown that offering early advanced therapy to all patients straight after diagnosis can drastically improve outcomes, including by reducing the number of people requiring urgent abdominal surgery for treatment of their disease by ten-fold.

Therapies 226

Therapies Clinical Trials Treatment Disease 226

Drugs.com

AUGUST 13, 2024

12, 2024 -- An experimental drug based on ancient Chinese herbal medicine can help ease the toxic side effects of chemotherapy and radiation therapy in cancer patients, the results of a small new trial results suggest.A TUESDAY, Aug. small group of.

Treatment 235

Treatment Therapies Trials Drugs 235

Science Daily: Pharmacology News

AUGUST 18, 2023

Novel stem cell therapy called a CALEC transplant was performed safely in four patients with serious chemical burns tracked in a phase I clinical trial for 12 months. CALEC procedure takes small amount of stem cells from healthy eye, grows and expands stem cells on a graft, before it is transplanted into the patient's damaged eye.

Therapies 186

Therapies Trials Clinical Trials Treatment 186

Science Daily: Pharmacology News

AUGUST 28, 2024

Preliminary trials show the therapy relieves pain after a single treatment. Engineers have developed a device that noninvasively stimulates deep brain regions, potentially disrupting the faulty signals that lead to chronic pain.

Engineering 302

Engineering Therapies Trials Treatment 302

Drugs.com

DECEMBER 21, 2023

21, 2023 -- A new treatment appears to reduce food allergies in children and teens, according to interim clinical trial results.A THURSDAY, Dec. lab-made monoclonal antibody called omalizumab (Xolair) significantly increased the amounts of common.

Clinical Trials 260

Clinical Trials Therapies Trials Treatment 260

BioPharma Drive: Drug Pricing

JUNE 13, 2024

The failure of another trial adds to uncertainty around the benefits of the gene-based treatments, though industry analysts still expect Sarepta’s Elevidys’ to be unaffected.

Therapies 244

Therapies Trials Treatment 244

BioPharma Drive: Drug Pricing

AUGUST 28, 2023

The treatment, developed by a biotech Bayer acquired in 2019, appeared safe in a small trial and showed signs of an effect on disease progression.

Therapies 246

Therapies Trials Treatment Disease 246

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Clinical Development Production Clinical Trials Treatment 69

Drug Target Review

DECEMBER 20, 2024

However, recent breakthroughs in AI, such as predictive modelling, clinical trial optimisation, and personalised medicine, have demonstrated its potential. We spoke with Aaron Smith, a mathematician-turned-machine learning scientist and the founder of Unlearn , a company leading the charge in applying AI to optimise clinical trial efficiency.

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Clinical Trials Trials Pharmaceuticals Drug Development 128

Drugs.com

SEPTEMBER 26, 2024

25, 2024 -- A new gene therapy approved earlier this year can serve as a sustainable single-dose treatment for people with hemophilia B, newly published clinical trial data shows. THURSDAY, Sept. People with hemophilia B saw their bleeding episodes.

Therapies 130

Therapies Trials Clinical Trials Treatment 130

Drugs.com

FEBRUARY 26, 2024

26, 2024 -- In a finding that suggests sooner is better than later, a new trial shows that giving advanced treatment early to Crohn’s patients can dramatically improve their gut health.About 80% of those who got therapy with an. MONDAY, Feb.

Therapies 290

Therapies Trials Treatment 290

Conversations in Drug Development Trends

NOVEMBER 12, 2024

By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. Operationalizing these trials requires proactive and flawless management at every stage.

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Therapies Clinical Supply Clinical Trials Trials 72

Drugs.com

JULY 11, 2024

THURSDAY, July 11, 2024 -- Radioactive substances injected into the body could provide a better way of treating glioblastoma, the most malignant form of brain cancer, a new review says.The cancer treatment, called targeted alpha therapy (TAT).

Treatment 130

Treatment Trials Therapies 130

BioPharma Drive: Drug Pricing

MAY 7, 2024

Weeks after a safety setback derailed its lead candidate, the company has treated the first participant in a trial of its heart disease treatment Verve-102.

Therapies 176

Therapies Trials Treatment Disease 176

BioPharma Drive: Drug Pricing

OCTOBER 7, 2024

The study, of Intellia’s treatment for hereditary angioedema, is the second Phase 3 trial the biotech has begun testing its “in vivo” gene editing medicines.

Therapies 190

Therapies Disease Trials Treatment 190

Drug Target Review

APRIL 7, 2025

As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. A surrogate endpoint is a marker used in clinical trials as a substitute for a direct clinical outcome. There are several types of biomarkers to consider.

Clinical Development 59

Clinical Development Clinical Trials Clinical Pharmacology Trials 59

Antidote

JULY 13, 2022

Before a potential new therapy can be administered to patients, it must go through several clinical trial phases designed to test the drug or device for safety and effectiveness. For many new treatments, it will take approximately ten years for the therapy to progress from initial discovery to being approved.

Clinical Trials 134

Clinical Trials Trials Therapies Treatment 134

BioPharma Drive: Drug Pricing

SEPTEMBER 11, 2023

The decision follows a review by a trial monitoring committee, which concluded data for the geographic atrophy treatment didn't support further development.

Therapies 184

Therapies Trials Treatment 184

PPD

NOVEMBER 11, 2024

As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients. However, getting essential treatments to patients quickly and safely requires more than just technological innovation. billion in 2023 to 1.2

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Drug Development Clinical Trials Drugs Small Molecule 97

Drug Target Review

MARCH 4, 2025

Obesity treatment is undergoing a major shift, much like the advances seen in cancer care. Phenomix Sciences , led by CEO Mark Bagnall, is using precision medicine to make treatments more targeted and effective. Phenomix Sciences, built on over a decade of clinical research at the Mayo Clinic, is disrupting this outdated approach.

Therapies 52

Therapies Treatment Clinical Trials Science 52

BioPharma Drive: Drug Pricing

OCTOBER 9, 2024

The Series B round will fund a Phase 1/2 trial of the company’s experimental treatment for IgA nephropathy.

Therapies 157

Therapies Disease Trials Treatment 157

BioPharma Drive: Drug Pricing

NOVEMBER 12, 2023

Early clinical trial results are the first for a base editing treatment and show Verve’s therapy can substantially lower cholesterol levels by editing the genes of liver cells.

Clinical Trials 209

Clinical Trials Therapies Trials Treatment 209

Antidote

NOVEMBER 9, 2023

Before any new treatment or therapy is able to be used by the patient population, it must go through the process of a clinical trial — this is the case for any new prescription drug, but also true for over-the-counter medications, medical devices, and more.

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Clinical Trials Trials Therapies Treatment 126

Drug Target Review

DECEMBER 23, 2024

While these therapies hold great promise for improving cancer treatment outcomes, their development presents significant challenges, especially in achieving the optimal balance between efficacy and safety. Properly managing these toxicities is crucial to enhancing the safety and therapeutic effectiveness of ADC treatments.

Research 52

Research Treatment Therapies Drug Development 52

BioPharma Drive: Drug Pricing

JUNE 4, 2024

Longer follow-up results from a mid-stage trial indicate the company’s treatment for a genetic cause of dwarfism may be competitive to an approved therapy from BioMarin Pharmaceutical.

Therapies 176

Therapies Pharmaceuticals Trials Treatment 176

New Drug Approvals

APRIL 11, 2025

2] The label also has a warning about liver toxicity and the need to monitor liver blood tests at baseline and then monthly for at least six months after initiating treatment with fitusiran or after a dose increase of fitusiran. [2] Fitusiran 1711.0g/mol, 1] It is an antithrombin-directed small interfering ribonucleic acid. [1] 28 March 2025.

Clinical Trials 106

Clinical Trials FDA FDA Approval Trials 106

SugarCone Biotech

MARCH 2, 2025

Interim data Phase 1/1b clinical trial data showed that combining ficerafusp alfa with pembrolizumab resulted in anti-tumor activity in patients with recurrent/metastatic HPV-negative HNSCC: Based on these results, Bicara initiated a pivotal Phase 2/3 clinical trial named FORTIFI-HN01 that has just begun enrollment.

Therapies 70

Therapies Clinical Trials Trials Clinical Development 70

PPD

OCTOBER 17, 2024

Cell and gene therapy (CGT) studies are rapidly gaining momentum in the Asia-Pacific region, fueled by growing patient demand and a thriving ecosystem of innovation. In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches.

Therapies 97

Therapies Clinical Trials Clinical Research Trials 97