Phase I-II

Neurocrine’s schizophrenia drug succeeds at phase 2, but dosing questions remain

29-Aug-2024 By Helen Albert

Neurocrine Biosciences has achieved late-stage success with muscarinic M4 selective agonist in schizophrenia.

Ayvakit's explosive 185% revenue growth: A game-changer in rare disease treatment

20-Aug-2024 By Liza Laws

Ayvakit, a groundbreaking therapy developed by Blueprint Medicines, has witnessed a remarkable 185% year-over-year revenue growth in the second quarter of this year (2024).

Lonza boosts clinical services with new bottling capabilities

15-Aug-2024 By Liza Laws

Lonza, a global leader in the pharmaceutical, biotech, and nutraceutical markets, has announced a significant expansion of its clinical manufacturing services at its small molecules site in Bend, Oregon.

FDA to decide on Lykos' MDMA therapy for PTSD, offering hope for millions

06-Aug-2024 By Liza Laws

The FDA is expected to make a pivotal decision on Sunday (August 11) regarding the approval of Lykos Therapeutics’ MDMA-assisted therapy for PTSD.

NIH awards Cellibre $2M to advance sustainable cannabinoid ingredient production

18-Jun-2024 By Liza Laws

Cellibre, a pioneer in sustainable biochemical manufacturing, has received a $2 million grant from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH).

IGC Pharma - unlocking new horizons in Alzheimer’s care with personalized medicine

11-Jun-2024 By Liza Laws

Yesterday (June 10) IGC Pharma, Inc. announced the publication of groundbreaking research in the European Society of Medicine Journal.

Exclusive interview: Diane Lacroix talks innovations in clinical data management

04-Jun-2024 By Liza Laws

In celebration of Clinical Trials Day last month, OSP sat down with Diane Lacroix, vice president of clinical data management at eClinical Solutions, to delve into the latest advancements and future directions in clinical trials.

Interview: Has Cybin hit the biggest breakthrough in 40 years to treat psychiatric disorders?

30-May-2024 By Liza Laws

In an intriguing interview with Cybin’s CEO, Doug Drysdale, OSP senior editor, Liza Laws found out how second-generation psychedelics could be the biggest breakthrough in psychiatry in 40 years.

UK health offers course for professionals to learn from the forefront of psychedelic research hub

02-May-2024 By Liza Laws

Clerkenwell Health is proud to announce the launch of its foundation course for Psychedelic-Assisted Therapy, a comprehensive 30-hour program that brings together leading experts in the field.

Has Response Pharmacauticals won the fight against antipsychotic weight gain?

29-Apr-2024 By Liza Laws

Response Pharmaceuticals, Inc., has unveiled significant findings from its Phase 1b clinical trial of RDX-002, signaling a potential breakthrough in combatting antipsychotic-induced weight gain (AIWG).

Edinburgh's Kynos Therapeutics reveals significant findings from trial of leading drug candidate

22-Apr-2024 By Liza Laws

Kynos Therapeutics Ltd, based in Edinburgh, UK, focuses on developing small molecule kynurenine 3-monooxygenase (KMO) inhibitors for inflammatory disorders.

Pacylex Pharma's phase one trial: Zelenirstat safety in heavily pre-treated patients

22-Apr-2024 By Liza Laws

Pacylex Pharmaceuticals Inc. has announced the presentation of phase 1 safety and efficacy findings for small molecule drug zelenirstat for cancer treatment.

How are GSK improving outcomes for people with the most prevalent gynaecological cancer in the UK?

08-Apr-2024 By Liza Laws

GSK's Jemperli (dostarlimab) has been approved for use within NHS Scotland, marking a significant step in the treatment of eligible endometrial cancer patients in the region.

Enrollment completed for trial of drug to treat children with rare primary immunodeficiency

08-Apr-2024 By Liza Laws

Pharming Group N.V. has declared the successful enrollment completion in its phase 3 clinical trial of leniolisib, an investigational drug designed for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS).

Molecure reports accelerated progress in clinical and preclinical programs for 2023

03-Apr-2024 By Liza Laws

Molecure S.A., a leading biotechnology company focused on drug discovery and development, has unveiled its annual report for 2023 at the start of the new financial year.

Can psychedelics with shorter yet more intense experiences cure people with alcohol dependence?

27-Mar-2024 By Liza Laws

In an exciting collaboration, modern mental health company, Clerkenwell Health, and Beckley Psytech, a clinical-stage biotechnology company, have launched a phase 2a study aimed at investigating a potential breakthrough treatment for alcohol use disorder...

Johnson & Johnson announces approval of OPSYNVI for pulmonary arterial hypertension patients

25-Mar-2024 By Liza Laws

In a significant milestone for pulmonary arterial hypertension (PAH) patients, Johnson & Johnson has announced the approval of OPSYNVI.

GI-targeted ROCK inhibitor for fibrostenotic Crohn’s disease in phase 1 study

29-Feb-2024 By Liza Laws

Yesterday, (February 28), a clinical-stage biotechnology company, Redx, announced that the first participant has been dosed in a phase 1 clinical trial for RXC008.

Patients with treatment-resistant depression sought for trial of psychedelic drug

20-Feb-2024 By Liza Laws

Some forms of depression cannot be cured by current treatments including antidepressants or going to psychological counselling or psychotherapy.

European Commission grants approval for first therapy to treat Friedreich’s ataxia

13-Feb-2024 By Liza Laws

Biogen Inc. has taken a step closer to bringing its ‘groundbreaking treatment’ to patients with a rare, genetic, life-shortening, debilitating, and neurodegenerative disorder.

With half of alcoholics refusing to abstain, Kinnov's new drug to fight addiction couldn't come soon enough

05-Feb-2024 By Liza Laws

No new treatments to combat the major public health issue of alcohol use disorder (AUD), have been brought to market for ten years - and with half of heavy drinkers refusing the abstinence route, new drug could be the answer.

Hope for multiple myeloma patients who have exhausted standard-of-care therapies

11-Dec-2023 By Liza Laws

Last-line multiple myeloma patients, who have exhausted other treatment options have been responding to oral drug inobrodib in combination with pomalidomide and dexamethasone (pom and dex).

Important step forward for Phathom Pharmaceuticals as FDA accepts NDA for new daily heartburn drug

11-Dec-2023 By Liza Laws

Millions of US adults suffering from heartburn associated with non-erosive-gastroesophageal-reflux-disease (GERD) could benefit from an impending treatment by Phathom Pharmaceuticals.

Astellas Pharma's treatment for hot flashes and night sweats approved

11-Dec-2023 By Liza Laws

A treatment option to reduce the number and intensity of hot flashes and night sweats associated with menopause has been approved by the European Commission (EC).

Alto Neuroscience bolstered by positive study results for its precision medicine for the brain

05-Dec-2023 By Liza Laws

A significantly greater improvement in people with depression was achieved after they were given ALT-300, an adjunctive treatment, during a phase 2a study.

Calliditas' hope to provide treatment for Alport syndrome boosted by studies

05-Dec-2023 By Liza Laws

A phase 2 study looking into the treatment setanaxib for inherited kidney disease, Alport syndrome, has begun it was announced last week.

Takeda's enzyme replacement therapy receives FDA approval for life-threatening blood disorder

16-Nov-2023 By Liza Laws

The first and only enzyme replacement therapy for the treatment of a very rare and complex blood disorder has been approved by the US Food and Drug Administration.

uMotif and Cogstate collaboration will include work on psychedelic trial

10-Nov-2023 By Liza Laws

A partnership between clinical research technology company uMotif and cognitive science company, Cogstate Limited, will see the companies continue existing work that includes a major phase 2 clinical trial of a psychedelic therapeutic.

Medidata recommits to Catalyst Clinical Research expanding multi-year partnership

06-Nov-2023 By Liza Laws

Medidata has recommitted to Catalyst Clinical Research to support its worldwide oncology brand, Catalyst Oncology.

Center focused on finding cure for glioblastoma reveals AstraZeneca drug may be a success

21-Oct-2023 By Liza Laws

A small molecule kinase inhibitor has been trialed in humans for the first time as part of a glioblastoma treatment study.

Amylyx Pharmaceuticals hopes to launch largest PSP trial to date by the end of 2023

20-Oct-2023 By Liza Laws

The treatment of rare brain disease, progressive supranuclear palsy (PSP), that has no disease modifying therapies, has been given a glimmer of hope by Amylyx Pharmaceuticals.

'Extremely important outcome for Alzheimer's patients' following Synaptogenix trial

16-Oct-2023 By Liza Laws

Patients with severe Alzheimer's Disease (AD) showed no cognitive decline throughout a ten-month trial while being treated with Bryostatin-1.

Interview: EDETEK's Munther Baara on the paradigm shift in clinical trials

12-Oct-2023 By Liza Laws

Munther Baara has worked in the life sciences arena for more than 30 years. He has always been completely committed.

‘Remarkable’ effect of evenamide, Newron's treatment-resistant schizophrenia (TRS) drug

10-Oct-2023 By Liza Laws

The unique glutamatergic mechanism of action in Newron Pharmaceuticals’ investigational new drug can potentially produce a long-lasting antipsychotic response in patients with TRS, and the benefits will accrue over time.

Positive opinion on Calliditas' Alport Syndrome drug from EMA

09-Oct-2023 By Liza Laws

Calliditas Therapeutics AB announced on Friday (October 5) that the European Medicines Agency (EMA) has issued a positive opinion on the company’s drug, setanaxib in Alport Syndrome (AS).

Curavit VCRO chosen to manage study of MedRhythm's neurorehabilitation system for stroke patients

21-Sep-2023 By Liza Laws

A study of MedRhythm’s MR-001 neurorehabilitation system, designed to improve walking and ambulation in adults with chronic stroke impairment, will use Curavit Clinical Research as its virtual contract research organization (VCRO).

Amit Etkin: the former Stanford professor pioneering a new treatment for depression

31-Aug-2023 By Isabel Cameron

More people are talking about mental illness than ever before. However, despite increased awareness, it remains one of the most neglected areas of public health globally, with research and quality of care lagging behind physical health conditions.

FDA 'recognises potential' of Redx drug to treat idiopathic pulmonary fibrosis

21-Aug-2023 By Liza Laws

The US Food and Drug Administration (FDA) has given orphan drug designation (ODD) to Redx’s Zelasudil for the potential treatment of idiopathic pulmonary fibrosis (IPF).

Sosei and Cancer Research UK announce first patient dosed with oral immunotherapy drug

15-Aug-2023 By Liza Laws

The first patient has been dosed with an orally available small molecule cancer immunotherapy drug, Sosei Group Corporation and Cancer Research UK have announced.

First patient enrolled in Japan for Pharming's trial of leniolisib for the treatment of APDS

09-Aug-2023 By Liza Laws

The first patient has been enrolled in a phase 3 clinical trial of leniolsib a treatment for a rare inherited condition affecting how the immune system works.

Cannabis-based, non-cancer, chronic pain trial approved by NHS ethics committee

01-Aug-2023 By Liza Laws

The National Health Service (NHS) research ethics committee has approved a non-cancer chronic pain clinical trial being rolled out by private health clinic LVL Health.

Scottish company starts clinical trial for toenail fungus after recruiting world-renowned expert

06-Jul-2023 By Liza Laws

Toenail fungus is an embarrassing problem to have but Scottish health tech firm, Emblation is hopeful its treatment could prove effective.

Complex road ahead, despite phase 3 progress, for Annovis’ buntanetap in Parkinson’s Disease

04-Jul-2023 By Liza Laws

Drugs like Annovis Bio’s buntanetap and prasinezumab have the potential to “revolutionize the treatment of Parkinson’s Disease” says analytics company, GlobalData, an analytics company, but it is a complex road ahead.

'World-first' anti-fibrotic inhibitor to treat IPF continues to gain traction

27-Jun-2023 By Liza Laws

The world’s first anti-fibrotic small molecule inhibitor, discovered and designed by generative artificial intelligence (AI) has completed the first patient dose in a phase 2 clinical trial.

Breakthrough for liver disease patients with ascites that could eliminate needle paracentesis

22-Jun-2023 By Liza Laws

Sequana Medical has just announced additional data on safety, quality of life and survival from its North American alfapump study, called Poseidon which could signal an end to manual draining of ascites.

Remarkable trial results from Avacta's tumor targeting drug

22-Jun-2023 By Liza Laws

The escalation of a drug targeting tumors, by releasing active chemotherapy into the disease tissue, has had ‘remarkable’ results and also shown a reduction in side-effects.

AstraZeneca's Tagrisso 'backbone treatment' for EGFR-mutated lung cancer

12-Jun-2023 By Liza Laws

AstraZeneca’s small molecule drug, Tagrisso (Osimertinib) achieved unprecedented survival in early-stage epidermal growth factor receptor mutated (EFGRm) lung cancer.

Cannabinoid receptor given approval for trial after benefits revealed for chemo and IBS patients

08-Jun-2023 By Liza Laws

A cannabinoid receptor, that has shown potential as an effective treatment for chemotherapy induced peripheral neuropathy (CIPN) has been given approval for a phase 1 clinical trial by the Medicines and Healthcare Products Regulatory Agency (MRHA) and...

Amgen’s Lumakras data and research shows positive results across CodeBreaK clinical trial program

06-Jun-2023 By Liza Laws

Research has reinforced the efficacy of Lumakras (sotorasib), a small molecule inhibitor in advanced non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC).

Patient recruitment - what the problems are and how Greenphire is tackling them

06-Jun-2023 By Liza Laws

Jim Murphy is Greenphire's CEO and leads the company's strategy and he says he is committed to fostering a culture of growth, innovation, excellence and employee satisfaction. Under his leadership, the company has expanded exponentially - in...