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…

The goal of using artificial intelligence to transform drug discovery and development may not be novel. But a new alliance is unique in both the stature of companies belonging to it and its choice of an innovation model. Big Pharma firms AstraZeneca (LON:AZN), Merck KGaA (ETR: MRK), Pfizer (NYSE:PFE) and Teva (NYSE:TEVA) will partner with Amazon…

Merck KGaA (ETR:MRK) subsidiary MilliporeSigma has opened its second facility in Carlsbad, California, near San Diego. The new $110 million, 140,000-ft² facility more than doubles its production capacity supporting viral gene therapy. The company now has two facilities dedicated to serving customers focused on cell and gene therapy. The facilities can support suspension production of…

A preclinical study published in Nature indicates that cannabidiol (CBD)-enriched medical cannabis therapy may potentially bode well for autism spectrum disorder (ASD). Researchers at Tel Aviv University determined that CBD-enriched cannabis therapy improved “repetitive and anxiety behaviors, but not social deficits” in mice with the autism-associated InsG3680 Shank3 mutation. The scientists also found that the treatment led…

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…

Neurotology drug developer Otonomy (NSDQ:OTIC) has announced that its OTO-313 drug appeared to reduce tinnitus severity in some participants in a small study. In the study, summarized in Otology & Neurotology, patients with moderate to severe unilateral tinnitus received intratympanic administration of the drug or placebo. Six OTO-313 recipients out of 14 (43%) showed a meaningful…

Bengaluru, India–based Everest Organics (BOM:524790) saw its share price jump 15% today to ₹347.10 after announcing it has begun manufacturing the active pharmaceutical ingredient (API) for a molnupiravir generic. Molnupiravir is an experimental oral drug that appears to substantially reduce the rate of COVID-19-related hospitalization for patients with mild-to-moderate infections. Reuters has reported that molnupiravir…

To date, FDA has been cautious in its consideration of COVID-19 vaccine boosters. Now, the agency seems to be staying the course. In a recently published document summarizing its current view of Moderna’s booster application, the agency concluded that Moderna had not met all of its criteria for authorization. Rather than taking a position, the…

Dr. Paul Stoffels, who serves as Johnson & Johnson’s chief scientific officer, will end his tenure on December 31. Stoffels, who is also vice-chairman of J&J’s executive committee, was responsible for reinvigorating J&J’s Janssen pharmaceutical pipeline and was instrumental in developing a COVID-19 vaccine. The company’s CEO and executive chairman, Alex Gorsky, is also retiring…

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…

Today, the allogeneic CAR-T company Allogene Therapeutics (NSDQ:ALLO) saw its stock dip to the lowest level since its IPO in 2018. The company announced that FDA had placed a hold on its AlloCAR T clinical trials after the identification of a chromosomal abnormality in a patient enrolled in its ALPHA2 study (NCT04416984). That trial was…

Branford, Connecticut–based Isoplexis (NSDQ:ISO) made its public market debut today with an initial public offering of 8,333,000 shares of common stock initially priced at $15 per share. ISO shares ended up selling for $11.52 apiece at the end of trading, equating to $96 million (less fees and expenses associated with the IPO). That was 23%…

The World Health Organization spokesperson Fadéla Chaib acknowledged undisclosed issues had delayed its emergency use authorization of Russia’s Sputnik V COVID-19 vaccine. Chaib added that the WHO was working through the issues while Russian Health Minister Mikhail Murashko recently said Russian officials were completing the final paperwork needed for the filing. Meanwhile, European Union officials…

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…

AbbVie (NYSE:ABBV) has announced positive top-line results in a Phase 3 trial focusing on patients with active ankylosing spondylitis (AS), an inflammatory disease that can eventually lead to fused vertebrae. The first of two studies, the SELECT-AXIS 2 study examined a daily 15-mg dose of Rinvoq (upadacitinib) in AS patients who had an inadequate response…

Janssen’s Stelara (ustekinumab) was associated with a rate of safety events similar to that of placebo during the control phase of a range of clinical trials. The Johnson & Johnson (NYSE:JNJ) subsidiary shared the data related to adults 60 and older at the virtual United European Gastroenterology Week (UEGW). The study pooled safety data from…

Merck’s (NYSE:MRK) oral drug molnupiravir (MK-4482) could be a COVID-19 game-changer, assuming it wins emergency use authorization. The medicine could also be lucrative for Merck, assuming it finds widespread use. Costing $712 for a treatment course, according to a contract obtained by Knowledge Ecology International, molnupiravir’s retail cost would be almost 40 times more than…

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,…

AstraZeneca (LON:AZN) has filed paperwork with the FDA for an emergency use authorization (EUA) for AZD7442, a long-acting antibody (LAAB) cocktail, as a COVID-19 prophylaxis. The paperwork filed for the EUA request includes data from the PROVENT and STORM CHASER Phase 3 trials. A Phase 3 trial of AZD7442 showed statistically significant protection against COVID-19 infection. Compared…

The gene therapy company Voyager Therapeutics, Inc. (NSDQ: VYGR) has reached an agreement with Pfizer (NYSE:PFE) to license novel capsids from its RNA-driven TRACER screening technology. A capsid refers to the protein shell of a virus protecting its genome. “We believe that our TRACER platform has the ability to produce not only enhanced blood-brain-barrier penetrant…

The World Health Organization (WHO) has backed the first malaria vaccine, which could be especially beneficial in areas such as sub-Saharan Africa with moderate to high malaria transmission rates. In 2019, malaria caused 409,000 deaths, according to WHO.  The vaccine from GlaxoSmithKline (NYSE:GSK) specifically targets plasmodium falciparum, a malaria strain common in sub-Saharan Africa. Plasmodium falciparum…

Sweden and Denmark announced they would recommend younger individuals avoid obtaining Moderna’s (NSDQ:MRNA) vaccine until further notice. The two countries cited the potential risk of myocarditis and pericarditis. Sweden recommended halting the use of the vaccine in individuals born in 1991 or later. Meanwhile, the Danish Health Agency advised that the vaccine should not be…

Messenger RNA (mRNA) therapeutics and vaccines may offer significant promise, but few scientists specialize in the technology. Moderna (NSDQ: MRNA) aims to inspire a new generation of scientists and clinicians to focus on mRNA research with a new fellowship program. The program will support a range of applications within medicine, basic research, epidemiology, pharmacology, nursing…

Antivirals have several advantages over vaccines. They tend to be broadly effective against viral variants and offer faster-acting protection than vaccines. In addition, antivirals are usually simple to transport and don’t require ultra-cold storage. And oral antivirals would have an advantage in terms of the speed of protection they offer. For SARS-CoV-2, antivirals also could…

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.…