Brian Buntz

As the rise of SARS-CoV-2 variants threatens to prolong the pandemic, a growing number of researchers are calling for the development of vaccines that can work on not just all SARS-CoV-2 variants but other coronaviruses as well. The idea of a pan-coronavirus vaccine is not new. A handful of scientists have supported the concept of pan-coronavirus…

Reality is beginning to sink in. Despite the availability of a growing number of COVID-19 vaccines and other therapies, the SARS-CoV-2 virus is likely to become endemic in the medium term, if not longer. A handful of coronaviruses — among them strains of NL63, OC43, 229E and HKU1 — are already endemic. For drug developers,…

Portugal health authorities recently recommended that AstraZeneca’s (LON:AZN) COVID-19 vaccine not be used for those who are over 65. South Africa recently paused its deployment of the vaccine over worries that it is ineffective against a variant circulating there.   In addition to Portugal, several European countries have expressed reservations about the vaccine’s efficacy in…

South Africa has scrapped its plans to vaccinate a portion of its population with the COVID-19 vaccine from Oxford University and AstraZeneca (LON:AZN) after a small study showed it was ineffective against a variant widely circulating there. In the interim, South Africa will rely on vaccines from Johnson & Johnson (NYSE:JNJ) and Pfizer (NYSE:PFE). Researchers at Oxford University…

Remote patient monitoring (RPM) is among the trends that will have the greatest impact on the pharma sector in 2021, according to the recent report, “The State of the Biopharmaceutical Industry, 2021 Edition,” from GlobalData. After a period of gradual uptake, RPM “witnessed a massive uptake in the life-sciences sector in 2020,” according to the…

Late last year, GlaxoSmithKline (NYSE:GSK) and Sanofi (NYSE:SNY) announced that their joint COVID-19 vaccine was delayed. Now, GlaxoSmithKline is hooking up with Germany-headquartered CureVac (NSDQ:CVAC) to develop a COVID-19 vaccine that can target multiple variants of the virus simultaneously. GSK plans on spending €150 million on the project, paying the first half to CureVac initially and the latter half…

Hopes for COVID-19 vaccines to beat back the pandemic assumed mass-vaccination would slow viral transmission, and not just prevent moderate-to-severe disease. Now, early data suggest that AstraZeneca’s (LON:AZN) COVID-19 vaccine, which it jointly developed with Oxford University, can curb viral transmission by up to 67%. The researchers didn’t study transmissibility per se; the inferred it…

One of the most troubling mutations among SARS-CoV-2 variants is E484K. Found in the highly transmissible variants in Brazil and South Africa, the mutation may diminish vaccine efficacy and pose a higher risk of reinfection than other virus lineages. Now, the mutation has appeared spontaneously in a portion of viral samples from Kent, Bristol and…

The Sputnik V COVID-19 vaccine could be more efficacious than those from AstraZeneca (LON:AZN) or Johnson & Johnson (NYSE:JNJ) based on interim trial results. The two-dose Sputnik vaccine was 91.6% effective at preventing symptomatic COVID-19 and 100% effective at preventing severe and moderate disease in a study involving 19,866 participants. The data were published in The Lancet. No…

In 2014, FDA approved two medications for idiopathic pulmonary fibrosis (IPF) — nintedanib from Boehringer Ingelheim and pirfenidone from Roche (OTCMKTS:RHHBY). “That was a huge success for our community but certainly, it’s the beginning of what we need to be doing for our patients,” said Dr. Joyce Lee, a senior medical advisor for the Pulmonary…

Idiopathic pulmonary fibrosis (IPF) is frequently a debilitating disease associated with significant morbidity and mortality. Although a rare disease, its incidence has increased in recent decades, and it leads to more deaths than some cancers.  The treatment landscape for the condition changed in 2014 when FDA approved the first drugs indicated for IPF, nintedanib from Boehringer…

Highly-transmissible COVID-19 variants have likely been circulating undetected for months in places like the U.K., South Africa and Brazil. They then seemed to burst onto the scene, fueling large outbreaks that dwarfed preceding ones. While the variants aren’t well understood, they suggest that SARS-CoV-2 is mutating in ways that confer an evolutionary advantage. They thus…

A Pfizer-BioNTech preprint published today suggests that their BNT162b2 vaccine will be effective against SARS-CoV2 variants from the U.K. and South Africa, leading to “small differences in viral neutralization” compared with earlier variants.  The U.K variant has been identified in 26 states in the U.S., while the South Africa variant has been found circulating in South…

Johnson & Johnson (NYSE:JNJ) is poised to announce new data related to its Ad26 COVID-19 vaccine early next week.  In an earnings call yesterday, management hinted that they expect results from the vaccine to be positive but stopped short at revealing details. “We think it’s very important to follow the data — to follow the science,”…

While the so-called ‘U.K. variant’ of COVID-19 has triggered alarm, it may be a harbinger of things to come, as the novel coronavirus mutates across the world, complicating mass-vaccination efforts.  Moderna (NSDQ:MRNA) detailed its plans to combat the matter in a briefing with investors. While it expects two 100-µg doses of its mRNA-1273 vaccine to be…

In July 2020, the clinical-stage biotech Tevogen Bio (Metuchen, N.J.) announced its plans to use its proprietary T-cell therapy to treat COVID-19. Now, the company has announced that it has received funding from HMP Partners, a team of physician-investors, to advance what it terms an “investigational curative” therapy. Tevogen will use the funding to support…

Last week, Norwegian officials raised eyebrows when they announced that they were investigating the deaths of 23 elderly patients who had recently received COVID-19 vaccine doses.  Now, California authorities are investigating the death of a Placer County-based patient who received a COVID-19 vaccine dose on Jan. 21. The patient died hours afterward.  Placer County officials…

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…

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 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…