Drug Discovery

Pfizer’s (NSE:PFE) pneumococcal 13-valent conjugate vaccine Prevnar 13 is one of pharma’s bestsellers, earning nearly $6 billion last year. Now, the company has scored FDA approval for its Prevnar 20 vaccine for adults 18 and older. The vaccine is the first to offer protection against 20 serotypes of pneumococcal disease that cause the majority of pneumonia and…

Valemetostat, a potential first-in-class drug from Daiichi Sankyo, led to durable tumor response in patients with peripheral T-cell lymphoma (PTCL) and adult T-cell leukemia/lymphoma (ATL) in a Phase 1 study.  The company presented highlights from the trial at the European Hematology Association (EHA) 2021 Virtual Congress today.   In the study, the objective response rate was…

After living through the COVID-19 pandemic over the past year, it’s understandable that most people consider viruses to be our enemies causing illness and harm to humans. However, this outlook fails to consider the many surprising advantages these submicroscopic collections of genetic code afford scientists in pushing the boundaries of medicine. Viruses have honed advantageous…

A member of the FDA’s expert panel for nervous system therapies reportedly resigned over the decision to authorize an Alzheimer’s therapy. The FDA controversially authorized Aduhelm (aducanumab) from Biogen on Monday, making it the first novel Alzheimer’s drug treatment in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials. STAT…

COVID-19 vaccines dominated pharma industry news during the first half of this year. It’s little wonder, too, since vaccines are the best hope to return the world to some kind of post-pandemic “normal.” As with any new medical treatments — especially ones authorized amid an emergency — there have been questions about side effects. Drug…

Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years…

Bayer announced today that its BlueRock Therapeutics subsidiary successfully administered the first dose of its Parkinson’s disease therapies. Berlin-based Bayer said in a news release that BlueRock successfully administered the dose of its investigational pluripotent stem cell-derived dopaminergic neruons, called DA01, to a Parkinson’s disease patient in an open-label Phase 1 clinical safety and tolerability…

Dr. Michael Gross, an activist shareholder of immunotherapy specialist IMV (NSDQ:IMV), has launched an offensive intended to cause a leadership shakeup at the company. Gross released a press release on June 1 announcing his plans to oust the company’s board chair Andy Sheldon and the chair of the board’s compensation committee, Julia Gregory. The director…

While drug developers continue to develop promising investigational cancer drugs, conducting clinical research in oncology remains difficult. Here’s how AI-enabled software can help.  The statistics on inadequate trial recruitment and endemic challenges in oncology clinical trials are well known. They have only gotten worse over the past 20 years. While the number of cancer treatments…

Regeneron (NSDQ:REGN) has announced that the FDA has signed off on a 1,200 mg subcutaneous or intravenous dose of its REGEN-COV antibody cocktail. The quantity is half of the initially authorized dose. The agency had previously authorized a 2,400 mg dose of the vaccine, including a combined dose of 1,200 mg of Casirivimab and 1,200…

Tirzepatide from Eli Lilly (NYSE:LLY) continues to show promise for diabetes, outperforming popular diabetes drugs in head-to-head clinical trials, according to GlobalData.  In the recent SURPASS-4 study, tirzepatide supported the reduction of hemoglobin A1C (HbA1c) in people with type 2 diabetes while also supporting weight loss. The study pitted tirzepatide against insulin glargine.  Tirzepatide is a dual glucose-dependent insulinotropic…

A study from Informa Pharma Intelligence and YouGov concluded that vaccine hesitancy remains a significant hurdle in the U.S. A separate study published in JAMA indicates vaccine hesitancy is falling. Specifically, the number of people who were suspicious about COVID-19 vaccines fell from 46% in October 2020 to 35% in March 2021. Conversely, the Informa-YouGov…

Corbus Pharmaceuticals (NSDQ:CRBP) is expanding its pipeline in immuno-oncology and fibrotic disease with licensing deals for two monoclonal antibodies (mAbs), which it has named CRB-601 and CRB-602. Both mAbs target integrins that inhibit activation of transforming growth factor-beta (TGF-β), a cytokine linked to inflammation, fibrosis and cancer. “TGF beta needs to be activated from its…

The Janssen division of Johnson & Johnson (NYSE:JNJ) has announced that its selective IL-23 inhibitor Tremfya (guselkumab) led to joint symptom improvement and skin clearance in the majority of patients with an inadequate response to tumor necrosis factor inhibitors (TNFi’s). After 24 weeks of treatment, 44.4% of patients who received Tremfya had at least a…

  Moderna (Nasdaq:MRNA) announced today that it submitted for full FDA approval of its mRNA COVID-19 vaccine for individuals 18 years of age and older. Cambridge, Mass.-based Moderna initiated the rolling submission process with the FDA for a Biologics License Application (BLA) to license its mRNA COVID-19 vaccine, according to a news release. The move…

Pharmasol (Kaiserslautern, Germany), a provider of pharmacovigilance software and services, has launched psiXchange version 2.4. The software automates the safety document distribution process within clinical trials.  The company created psiXchange software to manage documentation related to drug safety. The latest version of the software includes expanded site views, improved support of clinical operations and site-based teams. PsiXchange version…

CureVac (NSDQ:CVAC) has announced that its first-generation COVID-19 vaccine has passed its first interim analysis but has chosen not to share efficacy data until a statistically significant efficacy analysis is ready. The Tübingen, Germany–headquartered company is developing two mRNA-based vaccines. The mRNA vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) are currently two of the most popular…

An article recently published in JAMA concluded that two inactivated COVID-19 vaccines from Sinopharm (OTCMKTS: SHTDY) were 72.8% and 78.1% effective, respectively, based on interim Phase 3 study results.   The lower figure refers to the protection from a COVID-19 vaccine based on two 5-µg doses based on the SARS-CoV-2 isolate WIV04 complete genome. The second vaccine in the…

While the question of when the vaccinated public will require a COVID-19 booster remains unclear, some long-term care advocates are pushing for guidance to avoid a potential resurgence in infections in the fall and winter.  Nursing home residents were among the first to receive COVID-19 vaccines. Providing boosters to the demographic is vital to prevent…

Researchers at the University of Texas at Austin are touting chemical probes designed to help identify an enzyme produced by bacterias. The team at UT Austin developed the probes to identify the enzyme produced by some types of E. coli and pneumococcal bacteria that are resistant to treatment because of their ability to break down…

Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate. The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according…

Healthcare workers have administered almost 288 million doses of COVID-19 vaccines in the U.S., which now has more than enough vaccine for the present demand.  Against that backdrop, FDA has released updated emergency use authorization (EUA) guidelines for COVID-19 vaccines that state the agency could decline some future EUA requests. “For the remainder of the current pandemic,…

Moderna (NSDQ:MRNA) has joined Pfizer (NYSE:PFE) in announcing that its vaccine was 100% effective in a Phase 2/3 study involving adolescents. It will seek regulatory authorization to expand the use of its vaccine to adolescents as young as 12 in early June. In the TeenCOVE study, no participants who received two doses of the mRNA-1273…

The COVID-19 pandemic has led to fundamental changes in how pharmaceutical companies and physicians interact with patients. And yet — for all of the talk about digital transformation, artificial intelligence (AI) and decentralized clinical trials in medicine in recent years — the adoption of those concepts has lagged. “The reality is that we’ve gone after…

The Mayo Clinic is roughly tripling the size of the new research lab it plans to build in its home city of Rochester, Minn. Before the COVID-19 hit, plans called for a four-story building. But officials at the top-tier health provider say the pandemic taught them that scientific advancements need to accelerate in healthcare. The…