clinical trials

Not long ago, diversity in clinical research seemed like an obscure topic. Ben Enejo, a partner at Arthur D. Little, recalls mentioning the theme in the past and getting blank stares. But the pandemic and the murder of George Floyd helped highlight the importance of diversity on multiple fronts, including in clinical research. As a result, there are…

Decades after compounds like LSD and psilocybin were made illegal , psychedelic medicine appears poised to go mainstream in the coming years, potentially treating conditions ranging from anxiety to PTSD. In the interim, however, hurdles remain. The American Psychiatry Association (APA) recently released a conservative position statement on psychedelics and empathogens such as MDMA. In…

In 2016, the FAIR Guiding Principles for scientific data management and stewardship were published, laying out guideposts for scholarly data producers to make their data discoverable and usable in the future. The FAIR principles seek to ensure that data is Findable, Accessible, Interoperable, and Reusable. At the time of their publication, they articulated and centralized many points…

New York City-based Kallyope is one of the few biotechs focused solely on the gut-brain axis.  The privately-held company has built a cross-disciplinary team that weaves together advanced technologies in sequencing, bioinformatics, neural imaging, human genetics, and cellular and molecular biology to interrogate the hormonal and neural signaling pathways that comprise the gut-brain axis.  The…

Axcella Therapeutics (Nasdaq:AXLA) has announced positive topline results from a Phase 2a randomized, double-blind, placebo-controlled study of the metabolism-modulator AXA1125 in patients with fatigue from long COVID. The biotech’s Phase 2a study was among the first drug studies to focus on long COVID. In February, FDA granted a Fast Track Designation to AXA1125 to treat…

It’s easy to feel like clinical trials are complex. They are experiments involving human beings — so things change. But, despite feeling like complexity is everywhere, there is little clarity on what constitutes a complex trial and what sponsors need to do to prepare these trials for success. Both the FDA and EMA, for example,…

As a growing number of emerging biopharma companies seek to develop novel treatments for chronic diseases, the clinical trials market could be worth $78.3 billion by 2030.  Clinical trials, however, continue to be difficult and expensive to manage. Yet successful clinical trials, however, remain critical for investors. Small biopharmas are thus looking for guidance in navigating…

Clinical-stage biopharma Olema Oncology’s (Nasdaq:OLMA) lead product candidate is OP-1250, an orally-available small molecule that recently won FDA Fast Track Designation for the treatment of ER+/HER2– metastatic breast cancer. OP-1250 is a complete estrogen receptor antagonist with combined activity as a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). The drug…

As federal officials wax poetic about the prospect of intranasal COVID-19 vaccines and other novel vaccine platforms, Pfizer Inc. (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) have announced that a randomized Phase 2 study will study an incrementally improved COVID-19 vaccine known as BNT162b5. The updated vaccine candidate includes a modified spike protein designed to bolster immunogenicity…

Antidepressants remain some of the most widely prescribed drugs, but most popular antidepressants are now available as generics. While selective serotonin reuptake inhibitors (SSRIs) and SNRIs (serotonin and norepinephrine reuptake inhibitors) remain the most commonly prescribed antidepressants, various new types of drugs may be available in the future. For example, drug companies are working on…

EEG data can bolster rare disease drug research and trials. An epilepsy drug trial, for instance, could ask patients to log the number of seizures they experience in a day. “If you look at a seizure diary, there might be 10 seizures a day. But if you look at EEG, there could be 150,” said Dr.…

The pandemic, climate change, rapid inflation and a surge in violence are contributing to a mental health crisis. Against that backdrop, demand for antidepressants, anti-anxiety and anti-insomnia drugs is booming. In 2021, there were more than 337 million antidepressant prescriptions in the U.S., according to data from IQVIA. In the first four months of 2022,…

Merck (NYSE:MRK) has announced that it will stop the Phase 3 LYNK-003 trial focused on Lynparza (olaparib) with or without bevacizumab for patients with unresectable or metastatic colorectal cancer. Two experimental arms in the trial, one focused on Lynparza as monotherapy or in combination with the immunotherapy drug bevacizumab, will be suspended. The primary endpoint…

Takeda (NYSE:TAK) recently announced that in the open-label Phase 3 SPRING study, children aged 2 to 12 had 94.8% fewer hereditary angioedema (HAE) attacks when receiving Takhzyro (lanadelumab-flyo) over 52 weeks compared to baseline The primary objectives of the SPRING study was to evaluate the safety and pharmacokinetics of Takhzyro in HAE patients aged 2…

Amazon (Nasdaq:AMZN) and the Fred Hutchinson Cancer Research Center are working together on a Phase 1 FDA-approved clinical study that will investigate a personalized neo-antigen peptide vaccine for melanoma and certain types of breast cancer. According to a listing on clinicaltrials.gov, the study aims to recruit 20 participants. Amazon will offer scientific and machine learning capabilities…

Facing potential competition from Novo Nordisk’s (NYSE:NVO) investigational blood coagulation factor stimulants Mim8, Roche (SIX:RO, ROG; OTCQX:RHHBY) released positive new data from the Phase 3 HAVEN 6 study focused on the use of Hemlibra (emicizumab) in patients with mild or moderate hemophilia A. Hemlibra won FDA approval in 2018 for hemophilia A without factor VIII…

Clairvoyant Therapeutics, a Canadian drug developer, has initiated the first of 15 planned sites for the Phase 2 CLARITY clinical study investigating the use of magic mushroom molecule psilocybin to treat alcohol use disorder (AUD). The randomized, placebo-controlled study will evaluate the safety and efficacy of 25 mg of synthetic psilocybin with Motivational Enhancement Therapy…

Cancer treatment has been a critical point for clinical diagnostics. Over the years, various treatment approaches- from naked nucleic acid-based therapy, targeting microRNAs, oncolytic virotherapy, and suicide-gene-based therapy to CRISPR/Cas-9-based therapy. More recently, drug-based therapy has also emerged as a promising area for cancer therapeutics. Regarding drug administration, a major buzz has been created around…

Roche (SIX:RO, ROG; OTCQX:RHHBY) has announced that it has accepted the company’s Biologics License Application (BLA) and granted priority review for Lunsumio (mosunetuzumab), a CD20xCD3 T-cell engaging bispecific antibody developed by the company’s Genentech subsidiary. In February, Biogen (Nasdaq:BIIB) said it would pay $30 million to exercise an option to participate in the development and…

The synthetics biology company CB Therapeutics recently named Tiffany Hurd as its new business development lead. At Carlsbad, California-based CB Therapeutics, Hurd will focus on creating business partnerships with companies in the psychedelic, cannabinoid and food tech industries.  In May, CB Therapeutics won a patent covering the use of microorganisms to produce psychedelic tryptamines and…

Takeda (NYSE:TAK) has announced that in the open-label Phase 3 SPRING study, children aged 2 to 12 had 94.8% fewer hereditary angioedema (HAE) attacks during treatment with Takhzyro (lanadelumab-flyo) over 52 weeks compared to baseline. The Osaka, Japan–based company plans on presenting the data at the European Academy of Allergy and Clinical The SPRING study…

Pfizer Inc. (NYSE:PFE) has filed a new drug application (NDA) with the FDA for approval of Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for individuals facing a high-risk for progression to severe illness from COVID-19. Paxlovid consists of the SARS-CoV-2 main protease inhibitor nirmatrelvir (PF-07321332) and  the HIV-1 protease inhibitor and CYP3A inhibitor ritonavir. Because…

Gilead Sciences (Nasdaq: GILD) has asked FDA for the second time in a year to approve the capsid protein inhibitor lenacapavir. The drug won Breakthrough Therapy Designation from FDA in 2019 for HIV-1-infected individuals who are heavily treatment-experienced and have resistance to multiple drugs. The designation covered the potential use in tandem with other antiretroviral…

Where would clinical trial diversity be without the COVID-19 pandemic and the death of George Floyd on May 25, 2020? It likely wouldn’t be the priority it is today across the industry, according to Ariel Katz, CEO and co-founder of H1, a New York–based healthcare and data analytics platform firm. After the death of George…

The clinical-stage pharma company Acer Therapeutics Inc. (Nasdaq:ACER) has begun screening patients for its Phase 3 DiSCOVER (Decentralized Study of Celiprolol on vEDS-related Event Reduction) clinical study of EDSIVO (celiprolol) to treat COL3A1-positive vascular Ehlers-Danlos syndrome (vEDS). There are presently no FDA-approved drugs available for vEDS, which is associated with a risk of internal bleeding,…