covid-19

Gilead Sciences’ (NSDQ:GILD) Veklury (remdesivir) became the first FDA-approved COVID-19 drug when it was approved in October 2020. Now, the company has announced that the FDA has granted expedited approval of a supplemental new drug application (sNDA) for the drug to treat non-hospitalized adult and adolescent patients with a high risk of progression to severe…

IntelGenx Corp. (TSX:IGX/OTCQB:IGXT) has dosed the first patient in a resumed Phase 2a clinical trial involving an oral film of montelukast for Alzheimer’s disease (AD).  The COVID-19 pandemic previously interrupted the study for more than one year.  In 2019, IntelGenx initially announced that the study would enroll roughly 70 individuals with mild-to-moderate AD and test a…

Sorrento Therapeutics (NSDQ:SRNE) has received the go-ahead from the Brazilian Health Regulatory Agency (ANVISA) for a Phase 2a study involving its COVI-MSC allogeneic adipose-derived mesenchymal stromal cells. The company hopes the experimental treatment will benefit patients with so-called “long COVID,” a syndrome linked with a variety of symptoms ranging from fatigue to pulmonary compromise. The…

The use of decentralized clinical trials (DCTs) exploded during the pandemic, but quantifying their financial benefits has been elusive.  Medable (Palo Alto, California), the maker of a cloud-based DCT platform, has announced that DCTs can accelerate clinical trial timelines and lead to significant cost savings.  Medable and its research partner, the Tufts Center for the Study…

​​Vir Biotechnology (NSDQ:VIR) with its partner GSK (LSE/NYSE:GSK) recently announced growing traction for the investigational COVID-19 monoclonal antibody sotrovimab. Now, San Francisco–based Vir has expanded its partnership with the Bill & Melinda Gates Foundation to focus on developing broadly neutralizing antibodies intended to provide a “vaccinal effect” for treating HIV and preventing malaria. Vir Biotechnology…

GlaxoSmithKline (LSE/NYSE GSK) and Vir Biotechnology (NSDQ:VIR) are seeking to expand the use of the investigational monoclonal antibody sotrovimab. Intravenous sotrovimab is currently authorized to treat mild-to-moderate COVID-19 in patients at least 12 years of age, weighing at least 40 kg (88 pounds). The authorization is constrained to patients who face a high risk of…

The pharmaceutical industry appears to have addressed a decade-long decline in R&D productivity, according to a recent analysis from Deloitte. In 2021, the projected R&D return on investment (ROI) rose 7%. For comparison, the ROI level in 2010 was 2.7%. Forecast peak sales per asset hit $521 million, up more than 23% over the $422 million…

U.S. researchers have found that cannabinoid acids extracted from cannabis sativa prevented infection of human epithelial cells. They conclude cannabinoids may also have the potential to treat COVID-19. Using a pseudovirus expressing the SARS-CoV-2 spike protein, the scientists found that cannabigerolic acid (CBGA) and cannabidiolic acid (CBDA) effectively blocked infection from the alpha (B.1.1.7) and beta…

Bharat Biotech (Hyderabad, India) and its partner Ocugen (NSDQ:OCGN) have announced that their Covaxin (BBV152) COVID-19 vaccine candidate generated a strong neutralizing antibody response to the omicron (B.1.529) and delta (B.1.617.2) variants. The data comes from a study at Emory University involving sera from participants who received three doses of the vaccine with a 28-day…

BioNTech (NSDQ:BNTX) and the enterprise AI company InstaDeep have announced that they have created an early warning system to improve the monitoring of potentially dangerous SARS-CoV-2 variants. The companies claim that the system spotted more than 90% of WHO-designated variants an average of two months before the organization officially classified them. For example, the system…

When confronting an onslaught of new SARS-CoV-2 variants, COVID-19 vaccine makers such as Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have tested tweaked versions of their vaccines but ultimately decided that they were unnecessary. Signs are growing that vaccines developed based on the original strain of the novel coronavirus will struggle to offer durable protection against the omicron…

As COVID-19 case counts surge worldwide, executives at Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have voiced support for additional doses of their COVID-19 vaccines. Moderna CEO Stéphane Bancel predicted that a fourth dose would be necessary by the fall as the protection of vaccine-induced antibodies fades. In late December, Pfizer’s chief scientific officer Dr. Mikael Dolsten…

A large retrospective study found that a recombinant adjuvanted zoster vaccine was associated with a 32% reduced risk of COVID-19-associated hospitalization. The study, published in The Journal of Infectious Diseases, also found that individuals who received at least one dose of the Shingrix vaccine were 16% less likely to be diagnosed with COVID-19 during the trial…

With the U.S. facing the biggest surge of COVID-19 infections to date, the FDA has decided to amend the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover adolescents aged 12 to 15 and for some immunocompromised children between the ages of 5 and 11. The agency has also reduced the window between…

Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics have won emergency use authorization from FDA for the investigational oral antiviral molnupiravir (MK-4482, EIDD-2801).  In late November, an FDA advisory panel narrowly voted in favor of authorizing molnupiravir.  FDA recently also granted emergency use authorization to Pfizer’s (NYSE:PFE) oral SARS-CoV-2 antiviral Paxlovid (nirmatrelvir and ritonavir).  FDA’s authorization of…

Pfizer’s (NYSE:PFE) Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) became the first oral SARS-CoV-2 antiviral to win emergency use authorization (EUA). The EUA covers the use of the drug to treat mild-to-moderate COVID-19 in patients who are at least 12 and weighing at least 40 kg (88 pounds). The agency has yet to officially…

The Walter Reed Army Institute of Research (WRAIR) is planning to announce positive early clinical results related to a novel nanoparticle-based COVID-19 vaccine, according to media reports. A Phase 1 study involving the vaccine found that it was effective against omicron, other SARS-CoV-2 variants and other coronaviruses, including SARS-CoV-1. That study began in April. A…

Novavax (NSDQ:NVAX) has announced that the European Commission has granted it conditional marketing authorization (CMA) for its Nuvaxovid COVID-19 vaccine. Novavax had received funding early in the pandemic but encountered manufacturing-related delays. In August, the U.S. announced that it was withholding funding from the company over these concerns. The company had initially received $1.7 billion in…

Moderna (NSDQ:MRNA) is touting preliminary data suggesting that its COVID-19 vaccine booster led to robust antibody increases against the Omicron variant, both at the 50 µg and 100 µg dose levels. The 50 µg booster dose, which is currently authorized under emergency use authorization, led to a 37-fold increase compared to pre-boost levels 29 days…

GlaxoSmithKline (LSE/NYSE:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have received marketing authorization from the European Commission for the dual-action monoclonal antibody Xevudy (sotrovimab). The marketing authorization covers individuals 12 and older who weigh at least 40 kg who do not need supplemental oxygen. It also requires that such individuals have a heightened risk of developing…

Regeneron Pharmaceuticals (NSDQ REGN) plans to develop antibodies that hold up to the Omicron SARS-CoV-2 variant. Lab results from German researchers indicate that the company’s REGEN-COV/Ronapreve (casirivimab and imdevimab) antibody cocktail lost potency against the variant.  REGN shares fell almost 4% to $631.74 today.  “Our antibody cocktail works against Delta. Delta is still surging,” said Dr. Len…

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided advice about using Pfizer’s COVID-19 antiviral Paxlovid. CHMP has concluded that Paxlovid (nirmatrelvir/ritonavir) could be used for adults with COVID-19 who don’t need supplemental oxygen and face an elevated risk of developing severe disease. CHMP also stressed the…

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) have received emergency use authorization for BNT162b2 mRNA COVID-19 vaccine for individuals at least 16 years old. To coincide with the announcement, CDC Director Dr. Rochelle Walensky recommended that everyone 16 and older receive a booster. “Although we don’t have all the answers on the Omicron…

FDA issued an emergency use authorization (EUA) for AstraZeneca’s (NSDQ:AZN) Evusheld antibody cocktail as pre-exposure prophylaxis for COVID-19. The indications for use limit its use to adults and children at least 12 years old who weigh at least 40 kg. The EUA covers individuals who are not sick with COVID-19 who have not been exposed…

Pfizer (NYSE:PFE) and BioNTech SE (NSDQ:BNTX) have announced that their vaccine remains effective against the Omicron variant (B.1.1.529 lineage) of SARS-CoV-2 in early lab studies. Two doses of the vaccine significantly reduced neutralization titers, while three neutralized the variant. The lab studies showed that three doses of the BNT162b2 vaccine were similar in efficacy against Omicron as two…