Kyowa Kirin North America (KKNA) is working to address the racial disparities affecting the care and outcomes of African American patients with Cutaneous T-cell Lymphoma (CTCL). CTCL is a rare form of blood cancer that first appears on the skin and is often mistaken for more common dermatologic conditions. CTCL can affect the skin as…

UBS recently issued a report upgrading Eli Lilly (NYSE:LLY) to a “Buy” rating as its diabetes and Alzheimer’s drugs present lucrative opportunities. According to the report, the pharmaceutical giant’s Mounjaro (tirzepatide) “could be the biggest drug ever.” The type 2 diabetes treatment received FDA approval in May. GlobalData said at the time that tirzepatide could…

The complement C5 inhibitor Ultomiris (ravulizumab) from AstraZeneca (LON:AZN) has won approval in Europe as adjunctive therapy for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.  The regulatory nod represents the first approval for a long-acting C5 complement inhibitor for treating gMG in Europe.  While myasthenia gravis is a chronic…

Ensysce Biosciences CEO Lynn Kirkpatrick oversees the development of novel medicines to reduce or eliminate prescription drug abuse. The La Jolla, California-based company’s oxycodone prodrug candidate PF614 is now in a Phase 2 clinical trial. It is designed to offer similar pain relief as prescription opioids with a limited risk of drug abuse and addiction.…

FDA has published draft guidance to clarify its perspective on including children in clinical trials. The agency notes that it wrote the draft guidance to help industry, sponsors and institutional review boards (IRBs) protect children in clinical studies testing drugs, biological products and medical devices. The draft guidance is titled “Ethical Considerations for Clinical Investigations of Medical…

Startup BioNanoTech has developed a patented platform technology for purifying proteins/antibodies across size ranges. In particular, the company has developed a new class of Immobilization Metal Affinity Chromatography (IMAC) nanoresins. “We are building something new at a new scale, and something that can do chemistry and physics on a scale that is more closely to…

On the heels of launching a Phase 2b study of LSD in generalized anxiety disorder, MindMed (Nasdaq: MNMD) has dosed the first subject in a Phase 1 study evaluating MDMA-like substances in healthy volunteers.  MindMed is developing a synthetic enantiomer of MDMA as a potential treatment for core symptoms of autism spectrum disorder (ASD). Early…

Dr. Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, says her entry into the pharmaceutical industry was serendipitous. “I always wanted to be a doctor, and during medical school, I was fascinated by the science behind how cancer happens and what we can do to better treat it,” she said. After following this…

The computational disease model developer CytoReason has announced that it has entered into a multi-year partnership with Pfizer (NYSE:PFE) that is potentially worth $110 million over the next five years.  In the recent partnership, Pfizer will make a $20 million equity investment in CytoReason. The company will also obtain options to license platform and disease models from…

With top-notch universities, federal research institutes, leading companies from nine major industry sectors, and 14 top-ranked hospital systems, Ohio is a “quiet giant” of innovation in industrial sectors and life science. Ohio has the fifth-highest number of Fortune 500 and Fortune 1000 companies — and is home to more than 120 NYSE/Nasdaq companies with a…

Cell and gene therapies are ushering in a new era of promise across a multitude of therapeutic applications, offering hope for overcoming previously insurmountable medical challenges. As a result, the sector has grown immensely, with more than 3,500 cell and gene therapies currently in development, from preclinical to pre-registration stages. Based on the current pipeline and clinical…

Johnson & Johnson (NYSE:JNJ) has opened an almost 200,000 ft2 science and technology campus in the San Francisco Bay Area. The new facility more than doubles the company’s presence in the Bay Area, which has been a hub for life sciences innovation for decades. Up to 400 employees will work at the facility. “This campus is…

First synthesized in 1962, the dissociative anesthetic ketamine is rapidly growing in popularity for its off-label use in treating depression and mood disorders. In recent years, hundreds of clinics across the U.S. have begun offering ketamine for depression, anxiety and other mood disorders.   The surge in interest has also attracted startups such as Mindbloom…

Ferring Pharmaceuticals Chief Scientific Officer Dr. Elizabeth Garner guides clinical development, medical affairs, pharmacovigilance, project planning and regulatory affairs. Garner has almost 30 years of experience in medicine and industry. Before joining Ferring in 2022, Garner held chief medical officer roles for biotech firm ObsEva and women’s healthcare company Agile Therapeutics. Earlier, she held leadership…

One of the largest industry conferences, DPharm, was recently held on September 13 to 14 in Boston. Focusing on innovations to modernize clinical research, this year’s event featured speakers ranging from the popular author Malcolm Gladwell to former FDA Commissioner Dr. Scott Gottlieb and BIO CEO Dr. Michelle McMurry-Heath. Here, we provide reflections from several…

Aiming to extend its vaccine empire, Pfizer (NYSE:PFE) has announced that its meningococcal vaccine (MenABCWY) candidate met primary and secondary endpoints in a Phase 3 study. The NCT04440163 study tested the vaccine in healthy individuals between the ages of 10 and 25. The vaccine candidate demonstrated non-inferiority to the licensed vaccines Trumenba and Menveo for…

The early-stage biotech Neuron23 and Qiagen (NYSE:QGEN) will work together to develop the first next-generation sequencing (NGS) companion diagnostic for Neuron23’s leucine-rich repeat kinase 2 (LRRK2) inhibitor for Parkinson’s disease NEU-723.  In the collaboration, Qiagen will focus on developing and validating a clinical trial assay to detect biomarkers that predict the responsiveness of Parkinson’s disease…

Big Pharma behemoth Pfizer (NYSE: PFE) has dosed the first participants in a pivotal Phase 3 clinical trial to test its quadrivalent modified RNA (modRNA) influenza vaccine candidate.  The mRNA flu vaccine study will enroll roughly 25,000 healthy U.S. adults. Pfizer is not the only company to develop an mRNA flu vaccine. In December, Moderna (Nasdaq:MRNA)…

The FDA and NIH have debuted the Critical Path for Rare Neurodegenerative Diseases (CP-RND), a public-private partnership focused on developing new therapies for amyotrophic lateral sclerosis (ALS) and rare neurodegenerative diseases. One of the goals of the CP-RND is to foster innovation in drug discovery and development as well as clinical testing. In addition, CP-RND…

In January 2020, rare disease biopharma Insmed (Nasdaq: INSM) hired Sara Bonstein as its chief financial officer. At that point, Bonstein had more than 15 years of operational and financial experience in the life sciences industry. In the following interview highlighting her role as a female pharma leader, Bonstein shares what initially attracted her to…

Focused on developing therapies for neuropsychiatric and neurological disorders, Mindset Pharma (CSE:MSET/FSE:9DF) has identified three families of next-generation psychedelics. Families 6, 7 and 8 are chemically distinct, small molecule non-tryptamine scaffolds. Tryptamine hallucinogens include LSD, DMT and psilocybin. Mindset Pharma has filed provisional patent applications for the three families. The Toronto-based company had already announced it…

The idea of inhalable COVID-19 vaccines may not be new, but, until recently, no country had approved a COVID-19 vaccine with an alternative delivery route. That changed on March 31, 2022, when Russia greenlit the Galaleya Institute’s Sputnik V inhaled vaccine. The country authorized a similar nasal-drop-based vaccine known as Salnavac on July 4, 2022.…

Brentford, UK–headquartered GSK (LSE/NYSE:GSK) reported long-term data from the phase 3 PRIMA study indicating that the PARP inhibitor Zejula (niraparib) promoted a sustained and clinically meaningful progression-free survival (PFS) benefit in ovarian cancer patients. The survival benefit was evident across biomarker subgroups, including BRCAm, HRd and HRp. Patients in the HRd subgroup had a 48%…

Eli Lilly and Company’s (NYSE:LLY) Phase 3 monotherapy ADvocate trials in atopic dermatitis (AD) found that the investigational interleukin 13 inhibitor lebrikizumab supported durable skin clearance and reduced itching in a subset of patients with atopic dermatitis. The Indianapolis–based company defined responders as those with at least 75% improvement in the Eczema Area and Severity…

Medipost has announced that its allogeneic human umbilical cord blood-derived mesenchymal stem cell product for knee osteoarthritis was featured in the peer-reviewed Orthopaedic Journal of Sports Medicine. The Seoul, Korea–headquartered company specializes in allogeneic umbilical cord blood-derived mesenchymal stem cells for various therapeutic applications. Medipost’s Phase 3 study found that 97% of recipients of its…