clinical trials

Animal models, long the basis of academic research and preclinical drug discovery, continue to play an important role in advancing our understanding of basic pharmacology and bringing critical therapies to those in need. However, animal models have some natural drawbacks (e.g., not being humans) that hamper their ability to fully predict the interaction of new…

Bayer (ETR:BAYN) had planned to retool a facility in Wuppertal, Germany, to produce CureVac’s (NSDQ:CVAC) COVID-19 vaccine. But Leverkusen, Germany–headquartered Bayer has put those plans on ice, according to the German paper Leverkusener Anzeiger. Bayer had planned on producing 160 million doses of the vaccine annually. In June, CureVac reported that its COVID-19 vaccine was 48% efficacious…

Demand for ketamine has surged in recent years with growing interest in its off-label use for treating depression, anxiety and PTSD. Ketamine has “shown to be very effective,” said Linnea Butler, founder and CEO of Bay Area Mental Health (Campbell, California), which recently began offering ketamine-assisted psychotherapy. Also this week, Pasithea Therapeutics Corp. (NSDQ:KTTA), announced…

Eli Lilly (NYSE:LLY) has announced that it has approved Verzenio (abemaciclib) for certain patients with HR+ HER2– high-risk early breast cancer. The drug will become the first inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6) to hit the U.S. market. “Over time, the collective results of the Verzenio clinical development program have demonstrated a differentiated…

Our industry’s response to COVID-19 defied the conventional wisdom that it takes years to deliver new drugs. Makers of monoclonal antibodies led the pack, most notably Regeneron (NSDQ:REGN), which manufactured the 8-g, two-antibody cocktail administered to then-President Donald Trump last fall. Eli Lilly (NYSE:LLY) and Vir Biotechnology (NSDQ:VIR) pulled off similar feats. Prior speed records…

Roche (OTCQX: RHHBY) has announced that its investigational anti-amyloid beta antibody gantenerumab for Alzheimer’s disease received breakthrough therapy designation from FDA.  The agency has granted the status to a range of investigational Alzheimer’s, including lecanemab from Eisai and Biogen and donanemab from Eli Lilly. Biogen’s aducanumab had also received the designation before FDA approved it in…

Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) announced today that they submitted a request to the FDA to expand the authorization of their COVID-19 vaccine to younger children. Expanded FDA emergency use authorization would allow for the use of the COVID-19 vaccine candidate, which has full FDA approval for people 16 years of age and older,…

Drugs that work well in adults don’t always translate well for treating pediatric patients. The problem has inspired clinicians such as the pediatric cardiologist Dr. Brian McCrindle at the Hospital for Sick Children in Toronto to work with the pharma industry on trials focused on pediatric patient populations and introduce newer agents to clinical practice.…

Johnson & Johnson’s Janssen division (NYSE:JNJ) has requested that FDA expand the emergency use authorization (EUA) for its Ad26.COV2.S COVID-19 vaccine to include boosters for people 18 and older. The previous EUA covered a single dose of the vaccine. On October 14 and 15, FDA will convene meetings of its Vaccines and Related Biological Products…

The antiviral molnupiravir appears to be destined to become the first oral treatment for COVID-19. Merck and its partner Ridgeback Biotherapeutics intend to file for emergency use authorization after announcing that the drug appears to reduce the risk of hospitalization or death by about 50%. One potential hurdle for the drug is whether unvaccinated individuals…

The oral antiviral molnupiravir from Merck (NYSE:MRK) and Ridgeback Biotherapeutics fared well in a planned interim analysis of the Phase 3 MOVe-OUT trial. If authorized by FDA, the pill would be the first oral antiviral for SARS-CoV-2 in the U.S. To date, all authorized or approved COVID-19 drugs require subcutaneous, intramuscular or intravenous administration. Merck…

Regeneron Pharmaceuticals (NSDQ:REGN) and Roche (OTCQX: RHHBY) are touting positive results from a Phase 2/3 study investigating the potential of REGEN-COV (casirivimab and imdevimab) antibody cocktail in hospitalized COVID-19 patients. The study met its primary endpoint of reducing viral load within one week in seronegative patients needing low-flow or no supplemental oxygen. REGEN-COV, known as…

Merck (NYSE:MRK) has agreed to acquire the biopharma Acceleron Pharma (NSDQ:XLRN) for $180 per share in cash, bringing the purchase price to roughly $11.5 billion. The companies expect the deal to close in the fourth quarter of 2021. Cambridge, Massachusetts–based Acceleron specializes in developing drugs that aim to balance transforming growth factor (TGF)-beta, which plays…

Moderna (Nasdaq: MRNA) announced today that it will create a 462,000-square-foot Moderna Science Center just a half-mile drive from its present headquarters location in Cambridge, Massachusetts. The creator of messenger RNA (mRNA) therapeutics and vaccines saw its fortunes skyrocket during the COVID-19 pandemic. It successfully created a vaccine against the novel coronavirus that millions have…

The FDA could authorize the use of Moderna (NSDQ:MRNA) COVID-19 vaccine boosters at a half-dose level, according to a report from Bloomberg. Each primary series dose of the Moderna vaccine contains 100 µg of mRNA. By contrast, the Pfizer-BioNTech vaccine uses a 30-µg dose level for the primary series and boosters. Earlier this month, Moderna CEO…

Pfizer (NYSE:PFE) has announced the launch of the Phase 2/3 EPIC-PEP study to test its oral antiviral candidate PF-07321332 as a post-exposure prophylaxis against COVID-19. The EPIC-PEP study, whose name is an acronym of “Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis,” will test the efficacy of PF-07321332 with low-dose ritonavir to prevent COVID-19…

Oncology-focused Ayala Pharmaceuticals (NASDAQ: AYLA) has published two positive case studies of adults with desmoid tumors treated with gamma secretase inhibitor AL101 in Current Oncology. Desmoid tumors are noncancerous and most often appear in the abdomen, arms or legs. They can also occur in the head and neck, chest and other areas of the body.…

Merck & Co. (NSDQ:MRNA) scientists have explored fighting cancer by way of the STING (stimulator of interferon genes)-controlled innate immune pathway. Now, the company has published research in Advanced Therapeutics detailing a preclinical study with its partner Vesselon Inc. that reported impressive pharmacokinetics results related to MSA-1, a STING agonist. The researchers found that low…

Janssen’s Tremfya (guselkumab) generally had higher efficacy in treating moderate-to-severe psoriasis than Cosentyx (secukinumab) from Novartis, according to recent data published in the Journal of Dermatological Treatment.  In the 48-week Phase 3 ECLIPSE study, a greater number of guselkumab recipients achieved at least a 90% and 100% improvement from baseline in Psoriasis Area and Severity…

Ivy Brain Tumor Center and its partner Sonalasense have announced positive initial results in a first-in-human Phase 0/1 clinical trial involving recurrent glioblastoma patients. Sonalasense has developed a sonodynamic therapy (SDT) that pairs low-intensity ultrasound with chemotherapeutic agents known as sonosensitizers. The therapy is noninvasive. Data from the trial indicate that SDT swiftly causes targeted…

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older, and individuals at high risk of developing severe COVID-19. The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to…

FDA has expanded the emergency use authorization for Lilly’s (NYSE:LLY) bamlanivimab and etesevimab combo to include post-exposure prophylaxis. Earlier in the year, federal authorities had counseled against the use of the  monoclonal antibody cocktail in several states given the rise of SARS-CoV-2 variants in the U.S., including Gamma (P.1) and Beta (B.1.351). Meanwhile, demand for…

Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion. The committee recommended using long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia. The recommendation…

Minorities tend to participate in clinical trials at far lower rates than their real-world demographics and prevalence of the disease, according to the American Society of Clinical Oncology. In addition, minorities often have worse outcomes for certain cancers than the broader public. Just one example: the mortality rate for Black women with breast cancer is 40% higher than…

Privately-held biotech QurAlis plans to begin clinical development for the first-in-class molecule QRL-201 for amyotrophic lateral sclerosis (ALS) in the second half of 2022. QRL-201 is now the subject of IND-enabling studies. The drug candidate targets the restoration of STATHMIN-2 (STMN2) expression in ALS. STMN2 is a protein encoded by the STMN2 gene that is involved in…