Drug Discovery

FDA’s Vaccines and Related Biological Products Advisory Committee has endorsed the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccine for children 5 to 11. A total of 17 out of 18 members voted that the vaccine’s benefits outweighed the risk in the age group. VRBPAC member Dr. Michael Kurilla, the director of NIH’s Division of Clinical Innovation, abstained from…

DNA Script announced today that it raised $165 million in a Series C financing round, bringing its total capital raised to $280 million. South San Francisco-based DNA Script earmarked the funds raised to accelerate expansion and commercialization for the company’s Syntax benchtop nucleic acid printer and to broaden its portfolio of products powered by enzymatic…

The developer of a cloud-based application for oncology care and research, SimBioSys, has raised $15 million in Series A funding. Genoa Ventures and Northpond Ventures led the funding round, which also involved AV8 Ventures, Heritage Medical Group, and Mayo Clinic. SimBioSys also announced that existing investors and its founders participated in the financing, raising a total of $21 million. The company…

The pharmaceutical industry is like many others today in that there is a high turnover rate. The surge in new clinical trials starting and post-pandemic changes in hiring amplify these concerns for clinical investigators. For example, a 2017 study using the FDA’s Bioresearch Monitoring Information system classified 54.2% of principal investigators as “one-and-done,” meaning they had only…

Moderna (NSDQ:MRNA) said two 50-μg doses of its mRNA-1273 vaccine fared well in a planned interim analysis of the Phase 2/3 KidCOVD study involving children between the ages of 6 and 11. Last week, rival vaccine maker Pfizer (NYSE:PFE) announced that two 30-μg doses of the BNT162b2 vaccine were 90.7% against COVID-19 in a study…

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have announced that their COVID-19 vaccine was 90.7% effective at protecting against symptomatic COVID-19 in children ages 5 to 11.  The study concluded that a 10-µg dose of the BNT162b2 vaccine, which is one-third the amount authorized for people 12 and older, had the best benefit-risk profile. Recipients…

Shares of Athira Pharma (NSDQ:ATHA) jumped 9.35% in mid-day trading after the company announced the resignation of embattled CEO Leen Kawas. Kawas will also give up her seat on the Bothell, Washington–based company’s board. Facing allegations that she doctored a series of images in research papers, Leen Kawas was placed on leave in June. Several…

Biogen (NSDQ:BIIB) shares ticked up today on third-quarter results that were mixed compared to the consensus forecast. The Cambridge, Massachusetts-based company posted profits of $329.2 million, or $2.22 per share, on sales of $2.2 billion for the three months ended Sept. 30, 2021, for a -53.1% bottom-line slide on a sales decline of -18%. Adjusted…

Amgen (NSDQ:AMGN) has acquired privately-held immunotherapy specialist Teneobio (Newark, California). The transaction includes an upfront $900 million upfront payment and future contingent milestone payments worth up to an additional $1.6 billion. Tenebio’s stated mission was to tap human heavy-chain antibodies to “redirect the immune system to safely fight disease.” Earlier this year, it had three drug…

Last year, Humira (adalimumab) was the top-selling drug in the U.S., racking up nearly $20 billion in international sales. Now, Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) has become the first interchangeable Humira biosimilar. First winning FDA approval in August 2017, Cyltezo is a tumor necrosis factor blocker indicated for everything from arthritis to Crohn’s, ulcerative colitis and…

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…

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…

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…

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…

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%…

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,…

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…

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.…