Drug Discovery

Following allegations of sexual harassment, former head of Operation Warp Speed Moncef Slaoui has left roles at two more companies. Yesterday, Slaoui was terminated as the Galvani board of directors’ chair, GlaxoSmithKline’s board of directors announced. The same day, Vaxcyte confirmed in an SEC filing that it had axed Slaoui as its chairman of the…

  GlaxoSmithKline’s board of directors announced today that it terminated Moncef Slaoui as the chair of the Galvani board of directors. Slaoui, who served as the head of Operation Warp Speed — the Trump administration’s program to accelerate COVID-19 vaccine development — was terminated effective immediately, according to a news release from GSK, the majority…

An experimental oral antiviral from Pfizer will be the focus of a Phase 1 study involving healthy adults. Known as PF-07321332, the drug has shown promise during in vitro studies against SARS-CoV-2. PF-07321332 belongs to a class of drugs known as protease inhibitors, which are commonly used to treat HIV/AIDS and hepatitis C. Protease inhibitors bind to…

Endevica Bio (formerly TCI Peptide Therapeutics) started in 2009, focusing on peptides that affect the melanocortin system, which mammals use to regulate food intake and energy homeostasis. The company’s core focus is on a drug candidate known as TCMCB07, a potential treatment for cachexia in cancer patients. Cachexia, a wasting disorder that can result in…

Regeneron Pharmaceuticals (NSDQ:REGN) announced today that its COVID-19 antibody drug reduced hospitalization and death risk by 70% in clinical trials. The definitive Phase 3 outcomes trial in high-risk, non-hospitalized COVID-19 patients met its primary endpoint in displaying that the REGEN-COV (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death by 70% (1,200 mg…

Signs are growing that the diabetes drug Ozempic (semaglutide) from Novo Nordisk can support weight loss in overweight and obese individuals. A recent JAMA study involving overweight and obese individuals gave recipients a 2.4-mg subcutaneous dose of semaglutide once weekly for 20 weeks. After that period, investigators continued administering the drug to half of the participants while…

The National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial. NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned that information the company released from its AZD1222 vaccine clinical trial may be outdated.In turn, that may…

AstraZeneca announced today that its COVID-19 vaccine demonstrated statistically significant efficacy in preventing COVID-19 in a U.S. trial. AZD1222, developed in a collaboration between London-based AstraZeneca and Oxford University, was 79% effective in preventing symptomatic COVID-19 and 100% effective in preventing severe disease and hospitalization, according to a news release. Efficacy was consistent across ethnicity…

Premas Biotech (Gurugram, India) and Oramed Pharmaceuticals (Jerusalem) have announced that they are developing an oral COVID-19 vaccine that has shown efficacy after a single dose in animals. To accelerate the development of the vaccine, the two companies have created a joint venture known as Oravax Medical. The availability of effective single-dose oral COVID-19 vaccines…

COVID-19 vaccines launched BioNTech and Moderna into the limelight, making these once little-known companies prominent companies. But neither wants to be pigeonholed as a COVID-19 vaccine company. BioNTech cofounder Özlem Türeci stressed in a recent interview with AP that the mRNA vaccine technology that is its focus could be a powerful weapon against cancer. “We have several different…

Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical announced today that it received FDA approval for its Ponvory treatment. Ponvory (ponesimod) is a once-daily, oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator for treating adults with relapsing forms of multiple sclerosis (MS). It’s areas of treatment include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease,…

Oramed Pharmaceuticals (NSDQ:ORMP) announced today that it is forming a joint venture to develop novel oral COVID-19 vaccines. New York-based Oramed entered into definitive agreements to form Oravax Medical, which is based on Oramed’s proprietary POD (protein oral delivery) technology and Premas Biotech’s novel vaccine technology, according to a news release. Get the full story…

Emulate has debuted what it terms a “colon intestine chip” targeted at pharma and biotech companies, academics and other researchers. The company believes the system will accelerate the identification of drug candidates to treat inflammatory damage in the colon. The technology could be a boon for understanding inflammatory bowel disease, which approximately 1.6 million people in…

HRS Heat Exchangers announced that it received orders for pharmaceutical heat exchangers for use with the manufacturing of COVID-19 vaccines. Orders were placed by subcontractors working with Pfizer and Moderna, which both have vaccines authorized in the U.S., and Oxford/AstraZeneca, which has been approved across Europe but not yet in the U.S. The orders are…

The ChAdOx1 COVID-19 vaccine jointly developed by AstraZeneca and the University of Oxford is not effective against the B.1.351 variant first identified in South Africa, according to a recent study published in NEJM. In a five-month study involving HIV-negative adults, 23 of 717 placebo recipients developed mild-to-moderate COVID-19 while 19 of 750 vaccine recipients did. Based…

Frequency Therapeutics (Woburn, Mass.) recently announced data related to its experimental FX-322 drug. The small Phase 1/2 study, published in Otology & Neurotology, found hearing improvements in adults with age-related sensorineural hearing loss. At present, there are no FDA-approved drugs for preventing or restoring such hearing loss. However, administering steroids can facilitate recovery of hearing…

The precision oncology company 4D Path has committed to partnering with the U.K.-based University of Leeds at least until 2027. The two entities are already collaborators, having worked together on three completed breast cancer clinical trials. In particular, researchers at the University of Leeds have used 4D Path’s Q-plasia OncoReader Breast software to analyze data from more…

Moderna (Nasdaq: MRNA) announced today that it has started dosing the first participants in its Phase 2/3 KidCOVE study evaluating its COVID-19 vaccine among children between the ages of 6 months and 12 years. The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and HHS’s Biomedical Advanced Research and Development Authority (BARDA) are collaborating…

MIT researchers are touting a new machine-learning technique called DeepBAR that can quickly calculate the binding affinities between drug candidates and their targets. DeepBAR produces precise calculations in a fraction of the time compared to conventional techniques, according to the researchers. They think the software could potentially accelerate drug discovery and protein engineering. “Our method…

The concept of precision drug-dosing has gained ground in recent years, given its ability to boost efficacy and curb side effects. Yet imprecise dosing regimens continue to be common for many drugs, leading to significant rates of adverse drug reactions (ADRs).  “ADRs are one of the top ten causes of death in the developed world,”…

Recent real-world data from the Israel Ministry of Health found that unvaccinated individuals were 29 times more likely to die due to COVID-19 complications than those who received two doses of the BNT162b2 Pfizer-BioNTech vaccine.  Also, those who were unvaccinated were 44 times more likely to contract symptomatic COVID-19.  The data also suggest that the…

Novavax (Gaithersburg, Md.) may not be the best-known vaccine developer, but its COVID-19 vaccine offers performance in line with those from Moderna and Pfizer. Its vaccine was 96.4% effective at preventing COVID-19 caused by the original strain of the virus in a Phase 3 study. The Moderna and Pfizer vaccines offered efficacy in the mid-90%…

The Danish Medicines Agency announced that it is investigating the AstraZeneca COVID-19 vaccine after reports of blood clots. In collaboration with the European Medicines Agency, the Danish Medicines Agency launched the investigation as it considers there to be a reason to look into the circumstances further after cases in which citizens developed blood clots shortly…

Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications. “I’m nervous about the prospect of there never being a COVID vaccine that meets the…

A recent Phase 3 trial found that bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) administered jointly led to an 87% reduction in hospitalization and deaths in high-risk patients recently diagnosed with COVID-19. The randomized, double-blind, placebo-controlled trial administered 700 mg of bamlanivimab (LY-CoV555) and 1400 mg of etesevimab (LY-CoV016) to 511 patients in the treatment arm. FDA…