Brian Buntz

​​Rani Therapeutics Holdings ​​(NSDQ:RANI), developer of a robotic drug-delivery pill system, generated $73.3 million in its underwritten initial public offering (IPO) of Class A common stock. The San Jose, Calif.–based company’s IPO of 6.7 million shares priced at $11 a share, generating gross proceeds of $73.3 million. The company initially targeted an IPO worth approximately…

Cyclo Therapeutics (NSDQ:CYTH) has announced new safety and efficacy data from the its ongoing Phase 1 open-label extension study of Trappsol Cyclo to treat Niemann-Pick disease type C (NPC). NPC is a rare, progressive genetic disorder that involves abnormal cellular cholesterol accumulation. Initial results from the study demonstrated disease stabilization with considerable clinical improvements in…

Describing itself as an “industrial biotechnology company,” Bota Bio has secured a total of $145 million in funding, thanks to a recent Series B funding round worth more than $100 million. Bota Bio engineers microorganisms and biological components to make traditional manufacturing processes more sustainable. “One part of Bota Bio’s pharmaceutical business is focused on…

With vaccines generating a significant portion of Pfizer’s (NYSE:PFE) revenue in the first six months of 2021, the company shed light on its vaccine plans in its most recent quarterly earnings call. While the company recently won FDA approval for its potential blockbuster pneumococcal 20-valent vaccine, its mRNA vaccine strategy understandably took center stage during…

Satsuma Pharmaceuticals (NSDQ:STSA) has announced that it has enrolled the first patient in its SUMMIT Phase 3 efficacy trial of STS101, a drug-device product that is a potential acute treatment of migraine. STS101 is a nasal powder containing dihydroergotamine (DHE), an analgesic already available to treat migraines and cluster headaches. In fact, migraine patients have…

Takeda (NYSE:TAK) has won breakthrough therapy designation from FDA for TAK-994, an experimental oral orexin agonist. Now in a Phase 2 trial, TAK-994 is formulated to selectively target orexin 2 receptors. Orexin is a neuropeptide that supports normal wakefulness. Orexin deficiency is associated with narcolepsy. Takeda is testing the potential of TAK-994 to treat excessive…

An ongoing study involving the BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) could potentially underscore the need for boosters. But more data are needed to understand vaccine performance over time, according to a preprint published on MedRxiv. Pfizer CEO Dr. Albert Bourla has previously predicted that booster doses of the vaccine would be needed. Still,…

Given the demand for a potential disease-modifying therapy for the disease, early demand for Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) is considerable from patients. Many neurologists, however, continue to view the drug with skepticism. Fewer than half of neurologists expect they will prescribe the drug in the first six months of availability, according…

FDA has granted orphan drug designation for Novartis’s (SWX:NOVN) NIS793, an anti-TGF-β IgG2 monoclonal antibody. Specifically, the designation covers the use of NIS793 in conjunction with standard-of-care chemotherapy to treat pancreatic cancer. NIS793 has been the subject of eight clinical trials for indications ranging from solid tumors to myelofibrosis. NIS793 would be a first-in-class antibody specific…

The FDA has announced that it is looking for feedback on seven drugs, including kratom (mitragynine, 7-hydroxymitragynine), a popular recreational drug that remains legal at the federal level. FDA has warned consumers not to use kratom, which targets opioid receptors in the brain. There are no FDA-approved uses for the psychotropic herbal extract. WHO had reached…

As a result, Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have agreed to expand clinical trials of their vaccines in children aged five to 11 before seeking emergency use authorization. In April, Israel first reported suspected cases of heart inflammation in recipients of the COVID-19 vaccine from Pfizer and its partner BioNTech. Since then, FDA has substantiated the risk of myocarditis,…

GlaxoSmithKline (NYSE:GSK) received permission from FDA to expand the use of its Shingrinx shingles vaccine to include immunocompromised and immunosuppressed adults 18 years old or older. Having won initial FDA approval in 2017 for individuals 50 and older, the shingles (herpes zoster) vaccine is a non-live, recombinant subunit adjuvanted vaccine. Shingrix is the first shingles…

A recent Canadian pre-print study found that AstraZeneca’s Vaxzevria vaccine was 82% effective in preventing hospitalization or death from the Beta and Gamma SARS-CoV-2 virus variants. Using the same benchmark, its efficacy against the Alpha and Delta variants was 87% and 90%, respectively, 21 days after administering the first dose. The BNT162b2 vaccine from Pfizer and BioNTech…

The possibility of mRNA causing facial palsy continues to make headlines. A month after a JAMA study found no link between the Pfizer-BioNTech vaccine and facial paralysis, an article in BMJ Case Reports describes the case of a 61-year-old U.K. man who experienced facial palsy episodes after receiving both doses of the Pfizer-BioNTech vaccine. The journal reports that…

The backlash surrounding aducanumab post-approval has put Biogen (NSDQ:BIIB) on the defensive, prompting the company’s head of research and development, Dr. Alfred Sandrock, to post an open letter to the Alzheimer’s disease community on Biogen’s website. In the letter, Sandrock lamented that there was “extensive misinformation and misunderstanding” regarding the drug. In recent weeks, the company also requested…

Several countries have embraced the idea of using distinct COVID-19 vaccines for the first and second doses. But a death in Korea is fueling concerns about the strategy, and some public authorities have warned against the practice. Canada, Korea, Thailand and Germany have authorized the use of a heterologous prime-boost COVID-19 vaccination strategy to manage…

Entresto (sacubitril-valsartan) from Novartis is FDA indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure. Entresto remains the only FDA-approved option for patients with a variety of heart failure symptoms. A recent pilot study shows that the drug may also benefit patients with heart failure…

Adakveo (crizanlizumab-tmca) from Novartis is FDA indicated for reducing the number of vaso-occlusive crises in people aged 16 years and older with sickle cell disease. Novartis describes it as “the first and only once-monthly medication to reduce the number of pain crises in sickle cell disease.” The drug works by inhibiting selectin, a group of carbohydrate-binding transmembrane molecules…

Adhansia XR from Adlon Therapeutics is a long-acting central nervous system stimulant indicated for attention deficit hyperactivity disorder (ADHD) in children aged 6 and older. Adlon recently announced that in a clinical trial, ADHD patients had a significant improvement in symptoms starting after one hour after taking the drug and up to 16 hours. Adlon recently…

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…

Tpoxx (tecovirimat) from SIGA Technologies is a unique small-molecule drug. In 2018, it became the first drug to win an FDA indication for smallpox. While smallpox was eradicated around 1980s, governments across the world have worried that the variola virus that causes the disease could provide the basis for bioweapons. The U.S. maintains a stockpile…

Asparlas from Servier Pharmaceuticals is an asparagine-specific enzyme that is FDA-indicated as a treatment for acute lymphoblastic leukemia in patients aged one month to 21 years. In 2018, FDA approved the drug for use as part of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL).

Gamifant from Sobi, Inc. is an interferon gamma (IFNγ) blocking antibody that is FDA-indication to treat adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH). The indication covers refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. First approved in the U.S. in 2018, Gamifant has run into regulatory roadblocks in Europe. The European…

Tukysa from Seagen won FDA approval for HER2-positive breast cancer in conjunction with chemotherapy (trastuzumab and capecitabine) to treat advanced unresectable or metastatic HER2-positive breast cancer. The indication covers patients with brain metastases who previously received anti-HER2-based therapies for metastatic cancer.

In 2018, FDA indicated Annovera from TherapeuticsMD to prevent pregnancy. A drug-device combination, Annovera combines a ring-shaped vaginal delivery system with hormones. The manufacturer designed the device to remain in place for three weeks followed by removal for one week. The product is effective for up to one year (or 13 menstrual cycles). The manufacturer…