Drug Discovery

​​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…

Merck (NYSE:MRK) announced today that it received FDA approval for Keytruda for treating high-risk, early-stage, triple-negative breast cancer (TNBC). Kenilworth, N.J.-based Merck’s Keytruda anti-PD-1 therapy received approval for use in combination with chemotherapy as neoadjuvant treatment, then continued as a single agent as adjuvant treatment after surgery, according to a news release. Approval was based…

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…

PerkinElmer (NYSE:PKI) today posted Street-beating second-quarter revenues and announced the $5.3 billion acquisition of BioLegend. The Waltham, Mass.-based company posted profits of $245.9 million, or $2.19 per share, on sales of $1.2 billion for the three months ended July 4, 2021, for a 79.3% bottom-line gain on sales growth of 51.3%. Get the full story at…

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…

Many researchers are exploring the potential of the psychedelic compound psilocybin to treat conditions such as depression and post-traumatic stress disorder. But psilocybin offers broader therapeutic promise as it appears to spur neuroplasticity, according to Greg McKee, CEO of Tryp Therapeutics (San Diego). The company is exploring the use of psilocybin-based drugs for treating eating disorders…

Reyvow (lasmiditan) is an FDA-approved treatment from Lilly for the acute treatment of migraine with or without aura in adults. FDA has not approved it as a preventive treatment of migraine. In October, Lilly announced that the drug showed superior pain freedom after two hours of ingestion in two-thirds of migraine attacks in a Phase…

In November, 2020, Zokinvy (lonafarnib) from Eiger BioPharmaceuticals became the first drug to win FDA approval to lower the risk of death resulting from Hutchinson-Gilford progeria syndrome, a progressive genetic disorder that leads to rapid aging in children. The FDA indication also covered the treatment of some processing-deficient progeroid laminopathies in patients one year of age…

An accelerated rebound in medical device sales helped drive Johnson & Johnson (NYSE:JNJ) second-quarter results that topped the consensus forecast. The New Brunswick, N.J.-based company posted profits of $6.3 billion, or $2.35 per share, on sales of $23.3 billion for the three months ended June 30, 2021, for a 73.1% bottom-line gain on sales growth of 27.1%…

The FDA’s independent Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted against approving Roxadustat from FibroGen, which would be a novel treatment of anemia resulting from chronic kidney disease (CKD). Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. FibroGen’s CEO said in a statement that the company believes scientific evidence warrants approval of…

A retrospective study published in JAMA concluded that the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) offered statistically significant protection against SARS-CoV-2 infection. The pivotal trial Pfizer used to win emergency use authorization for the vaccine excluded pregnant women. COVID-19, however, increases the risk of pregnancy-related complications — particularly in the third trimester. To determine how…

The drama surrounding the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) continues with the Cleveland Clinic and Mount Sinai refusing to use it until more data are available.  The company’s stock dropped 6.79% to $328.16.  After FDA decided to conditionally approve the drug for Alzheimer’s disease, three members of an FDA advisory committee have resigned, and politicians and…

Privately-held PurMinds BioPharma (Burlington, Ontario, Canada) recently announced an investment in the psychedelic drug company IMIO Life Ltd., a subsidiary of Tel Aviv–based Nextage Therapeutics Ltd. (TASE:NXTG). Nextage Therapeutics is itself a division of the pharmaceutical company Nextar Chempharma Solutions (Ness Ziona, Israel). We reached out to PurMinds’ chief strategy and financial officer, Aron Buchman,…

Cellares Corp. (South San Francisco, Calif.), which is focused on accelerating cell therapy manufacturing, is teaming up with Poseida Therapeutics, Inc. as part of its Early Access Partnership Program (EAPP). Poseida is the third company to join the program after PACT Pharma and Fred Hutchinson Cancer Research Center. “We’ve had relationships with several key stakeholders within Poseida for years,” said…

Eli Lilly (NYSE:LLY) announced today that it acquired peptide- and protein-engineering platform developer Protomer Technologies. The potential value of the transaction is over $1 billion, depending on the achievement of future development and commercial milestones. Pasadena, Calif.–based Protomer Technologies develops next-generation protein therapeutics designed to identify and synthesize molecules that can sense glucose or other endogenous…