The news that Moderna’s (NSDQ:MRNA) COVID-19 had a small risk of facial swelling for patients with dermal fillers has spooked scores of patients. Dermatologists and plastic surgeons have been inundated with queries from concerned patients. But the risk of problems is minuscule, according to Dr. Wilbur Hah, the president of the American Board of Cosmetic Surgery…

Private equity firm SFW Capital Partners recently announced the recapitalization of lab equipment maker Caron Products and Services. The financial terms of the deal were not disclosed. Owned by the Christy family and management, Caron (Marietta, Ohio) manufactures a line of environmental testing chambers, incubators and growth chambers. The equipment goes toward FDA-required QA/QC stability…

OncoSec (NASDAQ: ONCS), a cancer immunotherapy company currently focused on R&D, is planning U.S. promotion of its tavokinogene telseplasmid (TAVO) drug for a type of metastatic melanoma — and eventually other cancers. “We don’t currently have a sales force. If successful, we’re going to need to have a sales and marketing team embedded in the…

COVID-19 has brought a newly heightened awareness of the need to better understand clinical trial statistics and their direct impact on the public. I cannot remember when statistical data was more in the limelight than now. The pandemic’s first wave put many countries into lockdown. All governments and their local representatives delivered press conferences regularly…

COVID-19 is mutating. And while early data suggest vaccines will be effective against more infectious COVID-19 variants that emerged in the U.K., South Africa and Brazil, the mutations could have a measurable impact on vaccine efficacy.   There’s perhaps a 50/50 chance that such new variants could lead to a “numerically meaningful drop” in vaccine efficacy,…

A former director of medical and scientific affairs at Merck (NYSE:MRK) faces criminal charges in federal court in New Jersey for allegedly stealing and transmitting trade secrets. Shafat A. Quadri has been released on $100,000 unsecured bond. He was most recently employed at AstraZeneca (NSDQ:AZN). The single count of trade secret theft carries a maximum potential…

In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). To date, it has analyzed data from 13 of those individuals. The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly…

Is it possible that pharmaceutical innovation has accelerated over the past two decades — with the novelty of small molecule and peptide drugs steadily increasing? That’s the conclusion suggested by a recent study published in ACS Medicinal Chemistry Letters, which found roughly 65% of FDA-approved drugs in 2020 were structurally novel. Last year’s drug approvals…

Last year, FDA approved 53 drugs, leading the industry to describe 2020 as “a strong year for new drug therapy.” There are several drugs that stand out, according to Todd Wills, the co-author of a study that analyzes how innovative drugs are based on their structure. The drugs that follow are examples of notable innovative therapies.…

Catalent (NYSE:CTLT) has entered into a definitive agreement to purchase a dry-powder inhaler (DPI) capsule manufacturing and packaging facility from Acorda Therapeutics (NSDQ:ACOR). The acquisition will enable Catalent to establish a center of excellence for spray-dried dispersion for DPI capsule manufacturing. The transaction will also expand Catalent’s existing U.S.-based commercial-scale capabilities in metered-dose inhalers and nasal…

Reports of severe allergic reactions to COVID-19 vaccines have made consistent headlines in recent weeks. Still, such anaphylactic reactions are rare, occurring in approximately 11 out of every million doses for the vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), according to CDC. While that is roughly 10 times the flu vaccine rate, COVID-19 vaccines so far…

The contract research organization Phastar (London) plans to expand its statistics and data science services with funding from Charterhouse Capital Partners, a European private equity firm. Phastar will also use the funds to expand its international footprint, opening an office in China. “We continue to see strong growth across pharma and biotech services,” said Kevin Kane,…

Patients with dermal fillers have a small potential risk of developing facial swelling after obtaining mRNA vaccines. To date, the FDA has noted the problem in three clinical trial recipients of the COVID-19 vaccine from Moderna (NSDQ:MRNA). The agency hasn’t observed facial swelling in the Phase 3 clinical trial for the COVID-19 vaccine from Pfizer…

The BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) seems to offer protection against the new, more transmissible variant of the novel coronavirus identified in the U.K., according to a study from Pfizer and the University of Texas Medical Branch.  The study has not been currently peer-reviewed.  In additional testing, the Pfizer-BioNTech vaccine appeared to be…

Engineered microchips with living human cells have the potential to accelerate drug development and replace animal testing, said Dr. Donald Ingber, the founding director of the Wyss Institute for Biologically Inspired Engineering at Harvard University. The organ-on-a-chip technology could also enable the industry to rethink its business model, Ingber said in a webinar from the…

Researchers at privately-held Genuity Science and Yale University Medical School have revealed why aortic aneurysms form. The scientists discovered that an expansion in abnormal cells in smooth muscle tissue of the aorta can contribute to aortic aneurysm. The researchers came to that conclusion by using a combination of generative artificial intelligence, single-cell biology and RNA sequencing to…

The European Union has authorized the mRNA-1273 COVID-19 vaccine from Moderna (NSDQ:MRNA) ahead of schedule, responding to criticism that it had been too slow in its mass vaccination plans. The E.U. drug regulator had planned on meeting later in the month to discuss the vaccine.  “This vaccine provides us with another tool to overcome the current emergency,”…

Monoclonal antibodies could play a vital role in the battle against COVID-19. To date, such infusion-delivered antibodies from Eli Lilly (NYSE:LLY) and Regeneron Pharmaceuticals (NSDQ:REGN) have received emergency use authorization from FDA.  Now, a phase 2/3 clinical trial will study the potential of investigational monoclonal antibody therapy for patients with mild-to-moderate COVID-19.  The antibodies, known…

AstraZeneca (LON:AZN) inadvertently discovered halving the first dose of its COVID-19 vaccine could boost its efficacy. Researchers at the National Institutes of Health (NIH) and Moderna (NSDQ:MRNA) are examining vaccine data to determine whether they can halve the 100-microgram dose to vaccinate twice as many people. Some data from Moderna’s clinical trial support that possibility,…

An inexpensive investigational vaccine known as AKS-452 is stable for weeks at room temperature and can potentially be used for both prime and boost vaccination. The vaccine developer, Akston Biosciences (Beverly, Mass.), has hooked up with LakePharma, a San Carlos, Calif.-based contract research, development and manufacturing outsourcing organization, to manufacture the vaccine. Phase 1/2 clinical…

AstraZeneca (NYSE:AZN) announced yesterday that it completed the divestment of the commercial rights to Atacand to Cheplapharm. United Kingdom-based AstraZeneca’s Atacand (candesartan cilexetil) is a selective AT 1 subtype angiotensin II receptor antagonist indicated for managing hypertension in adults and children, along with heart failure in adults. In addition to the commercial rights to Atacand, AstraZeneca…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have decided to offer to inform clinical trial volunteers in its COVID-19 vaccine whether they received a vaccine or placebo. Those who received a placebo will be eligible to receive the first dose of vaccine by March 1 and stay in the study. A second dose will be administered roughly three weeks…

The FDA today released draft guidance designed to make it easier for researchers to seek approvals for drugs designed for individuals with severe genetic diseases. The draft guidance focuses on investigational new drug submissions for antisense oligonucleotide (ASO) products because these are the most common drugs being developed for severely debilitating or life-threatening genetic diseases.…

The National Health Service in the U.K. is increasing the maximum interval between shots for recipients of the Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) vaccine to 12 weeks. In a letter to hospitals, NHS advised that patients scheduled to receive the second dose of the vaccine on Jan. 4 should receive it nine weeks later.  The developers of…

Chinese health authorities have authorized a SARS-CoV-2 vaccine from state-owned Sinopharm (OTCMKTS: SHTDY). The vaccine has an efficacy of 79% based on an interim analysis of a Phase 3 study.  China plans to distribute the BBIBP-CorV vaccine to citizens at no cost and distribute it to other countries that test Chinese vaccine candidates.  The country has…