Brian Buntz

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…

Demand for Biogen’s (NSDQ:BIIB) monoclonal antibody Aduhelm (aducanumab) has been weak, leading the company to cut the wholesale cost of the drug in half to $28,200 for patients of average weight. Now, Medicare officials reached a preliminary conclusion that federal coverage of the drug should be limited to clinical trial participants. The agency went further, stating that…

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…

Psoriatic arthritis (PsA) is a complex heterogeneous disease involving the peripheral joints, affecting between 7% and 26% of psoriasis patients. Among the popular treatment options for psoriasis are tumor necrosis factor (TNF) inhibitors. A significant portion of psoriatic arthritis patients, however, fail to respond to TNF inhibitors.  Janssen announced last month that Tremfya (guselkumab) fared…

Pfizer (NYSE:PFE) aims to have an omicron-specific version of its vaccine available by March. However, it still isn’t sure if the tweaked version will be necessary, said CEO Dr. Albert Bourla in an interview with CNBC’s Squawk Box. The “new version” of its COVID-19 vaccine, which it developed jointly with BioNTech (NSDQ:BNTX), should hopefully offer better…

Idorsia Ltd (SIX:IDIA) has received FDA approval for 25- and 50-mg doses of Quviviq (daridorexant), a dual orexin receptor antagonist. Quiviviq is the first compound in its pipeline to win FDA approval. The drug works differently from traditional benzodiazepines, which modulate neuronal activity. By contrast, daridorexant inhibits the binding of orexins to reduce excessive wakefulness.…

AbbVie (NYSE:ABBV) has submitted applications asking for approval of upadacitinib (Rinvoq) from the FDA and the European Medicines Agency (EMA) to treat adults with active non-radiographic axial spondyloarthritis (nr-axSpA). If approved, Rinvoq would be indicated for nr-axSpA patients with objective signs of inflammation with an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). The Janus kinase…

Robotic drug-delivery pill company Rani Therapeutics Holdings (NSDQ:RANI) has added Lisa Rometty to its board of directors. Rometty is the president of CVS Kidney Care. Previously, she worked as an executive at Syneos Health and IBM Watson Health. “I’m delighted to welcome Lisa to our Board,” said Talat Imran, CEO of Rani Therapeutics, in a statement. “Lisa’s…

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory. Researchers are now exploring dozens of new possibilities for the mRNA platform. Here, we summarize several areas where…

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…

Eli Lilly (NYSE:LLY) has acquired exclusive rights to Entos Pharmaceuticals’ Fusogenix proteolipid vehicle (PLV) drug-delivery technology for central and peripheral nervous system applications. Indianapolis-based Lilly plans on using the platform to discover and develop nucleic acid products. Entos said Fusogenix brings together the best features of viral and lipid-based delivery approaches while avoiding their respective downsides.…

Moderna (NSDQ:MRNA) has dosed the first volunteer in the Phase 1 Eclipse study of mRNA-1189, an Epstein-Barr virus vaccine candidate. The study will take place at roughly 15 sites in the U.S. and involve approximately 272 healthy adults between the ages of 18 and 30. The study will be randomized, observer-blind, placebo-controlled and involve a range of doses.…

Zymeworks (NYSE:ZYME) will install Ken Galbraith as chairman and CEO, replacing the company’s outgoing leader Ali Tehrani on or before February 1.  Galbraith has more than 30 years of experience working in life sciences, venture capital and global commercialization.  “Ken Galbraith is an outstanding global leader who brings more than 30 years of life science…

Pfizer Inc. (NYSE:PFE) and mRNA vaccine specialist BioNTech SE (NSDQ:BNTX) will collaborate to develop an mRNA-based vaccine to prevent the herpes zoster virus (shingles). Roughly one million people in the U.S. get shingles each year, according to the CDC. Currently, the two-dose Shingrix shingles vaccine from GSK (NYSE:GSK) is the only such product available in the U.S. market.…

Genome editing company Intellia Therapeutics (NSDQ:NTLA) and cell therapy firm Kyverna Therapeutics have entered into a licensing and collaboration agreement to develop an allogeneic CD19 chimeric antigen receptor (CAR) T-cell therapy for various B cell-mediated autoimmune diseases. Under the terms of the agreement, Intellia (Cambridge, Massachusetts) will get an equity stake in Kyverna (Emeryville, California)…

NaNotics LLC (Mill Valley, California) has announced that it will work with the Mayo Clinic to develop a cancer treatment known as NaNots that works by depleting targeted pathogenic molecules from the blood. The NaNot would target a soluble form of programmed death-ligand 1 (PD-L1), a tumor-generated immune inhibitor, while ignoring membrane forms of PD-L1.…

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…

Immix Biopharma (NSDQ:IMMX) has announced that the FDA has granted a rare pediatric disease designation related to the potential use of IMX-110 for rhabdomyosarcoma, a rare cancer affecting skeletal muscle. Roughly 400 to 500 cases of rhabdomyosarcoma occur each year in the U.S., according to cancer.org.  IMMX shares jumped 62.36% to $5.78 after the announcement. Immix…

Soon after the omicron emerged, notable companies such as Moderna (NSDQ:MRNA), Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced efforts to develop a booster specific to the variant.   But several pharmaceutical companies are developing custom versions of COVID-19 vaccines for the variant or testing the efficacy of existing vaccines against omicron.  In October, the Moscow-based…

The pandemic continued to remake the pharma and biotech industry this past year. A handful of companies fared exceptionally well at commercializing COVID-19 therapies. This fact promises to lead to sizable shifts in the rankings of pharma leaders. These trends were not yet evident in our spring roundup of the 50 largest pharma companies, which…

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…

Radius Health (NASDAQ:RDUS) has announced that the FDA has approved removing a boxed warning from the label of Tymlos, an osteoporosis drug. The warning had described a risk of osteosarcoma, a type of bone cancer. The agency reviewed long-term post-marketing data related to the drug and the broader class of related parathyroid hormone (PTH) drugs.…

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…

Japan could follow the lead of the European Medicines Agency, which recommended refusing the marketing authorization of the controversial drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (Tokyo).  Japan’s First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council recommended further discussion of the application for the drug. The NDC also requested additional information as…

Novartis (NYSE:NVS) has entered into an agreement to acquire U.K.-based Gyroscope Therapeutics, which specializes in ocular gene therapy company. The acquisition would add GT005, an investigational gene therapy for geographic atrophy, to its pipeline. Geographic atrophy is an eye-sight-threatening condition occurring in some patients with dry age-related macular degeneration. Dry AMD is the most common…