Immunology

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…

The FDA reportedly is planning to authorize the ​​Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccine booster for all adults in the coming days. FDA could make an announcement on the subject as soon as tomorrow, according to The New York Times. CDC’s Advisory Committee on Immunization Practices (ACIP) plans on discussing the Pfizer-BioNTech booster data on November 19.…

Sanofi announced today that it has completed its acquisition of Kadmon Holdings, maker of the FDA-approved Rezurock to treat chronic graft-versus-host disease in transplant patients. Kadmon shareholders approved the deal on November 5 and will receive $9.50 per share in cash. The company becomes a wholly-owned subsidiary of Sanofi. When announcing the deal in September,…

Janssen (NYSE:JNJ) has released new positive data for Stelara (ustekinumab) as first-line therapy in ulcerative colitis (UC) and treatment persistence in Crohn’s disease (CD). The data indicated that the monoclonal antibody Stelara was “the best choice” as a “first-line therapy in bio-naive patients with moderately to severely active ulcerative colitis and Crohn’s disease,” said Dr.…

Branford, Connecticut–based Isoplexis (NSDQ:ISO) made its public market debut today with an initial public offering of 8,333,000 shares of common stock initially priced at $15 per share. ISO shares ended up selling for $11.52 apiece at the end of trading, equating to $96 million (less fees and expenses associated with the IPO). That was 23%…

Privately-held BioAegis Therapeutics has announced that researchers have identified a previously unknown role of the protein gelsolin in regulating immune responses. BioAegis’s therapeutic focus is to restore waning gelsolin levels associated with disease. In a paper published in The Journal of Immunology, researchers reported that the gelsolin is involved in a signaling system in macrophages, which…

The biopharma TFF Pharmaceuticals (NSDQ:TFFP) has announced that its inhalation powder of the immunosuppressive drug tacrolimus was well tolerated in a Phase 1 trial in lung transplant patients. Tacrolimus is a traditional option for preventing rejection of a transplanted organ, albeit in tablet or capsule form. It is common for lung transplant recipients to have…

Janssen’s Tremfya (guselkumab) generally had higher efficacy in treating moderate-to-severe psoriasis than Cosentyx (secukinumab) from Novartis, according to recent data published in the Journal of Dermatological Treatment.  In the 48-week Phase 3 ECLIPSE study, a greater number of guselkumab recipients achieved at least a 90% and 100% improvement from baseline in Psoriasis Area and Severity…

Boehringer Ingelheim announced today that it acquired Abexxa Biologics, a developer of precision medicines for treating cancer. Acquiring Abexxa, which utilizes a new approach in immuno-oncology and oncology research, offers Boehringer Ingelheim access to the company’s expertise in targeting cancer-specific proteins located inside the cell instead of those expressed on the cell membrane, according to…

AB Science today touted results from a study of masitinib in combination with docetaxel in treating prostate cancer. Paris-based AB Science presented the data at the 2021 American Urological Association (AUA) annual meeting, according to a news release. Masitinib in combination with docetaxel as a first-line treatment of metastatic castrate refractory prostate cancer (mCRPC) eligible…

COVID-19 vaccines could potentially guard against dementia and Alzheimer’s disease, according to an op-ed in WSJ.  COVID-19 infection itself can lead to long-term cognitive decline in some individuals and can accelerate Alzheimer’s symptoms, concluded an Alzheimer’s Association study. An Alzheimer’s Research & Therapy echoed those findings.  Pointing to data suggesting that vaccinations against tetanus and flu lead to reduced…

As a result, Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have agreed to expand clinical trials of their vaccines in children aged five to 11 before seeking emergency use authorization. In April, Israel first reported suspected cases of heart inflammation in recipients of the COVID-19 vaccine from Pfizer and its partner BioNTech. Since then, FDA has substantiated the risk of myocarditis,…

Gamifant from Sobi, Inc. is an interferon gamma (IFNγ) blocking antibody that is FDA-indication to treat adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH). The indication covers refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. First approved in the U.S. in 2018, Gamifant has run into regulatory roadblocks in Europe. The European…

Tukysa from Seagen won FDA approval for HER2-positive breast cancer in conjunction with chemotherapy (trastuzumab and capecitabine) to treat advanced unresectable or metastatic HER2-positive breast cancer. The indication covers patients with brain metastases who previously received anti-HER2-based therapies for metastatic cancer.

Boston Children’s Hospital announced today that it partnered with ElevateBio for a five-year cell and gene therapy advancement program. The collaborative agreement will seek to advance cell and gene therapy programs originating out of Boston Children’s Hospital with an introduction to Boston Children’s translational research capabilities. Get the full story at our sister site, Drug Delivery Business…

Sanofi (NYSE:SNY) announced today that it plans to invest approximately $476.3 million (€400 million) per year on mRNA vaccine development. Paris-based Sanofi’s intends for its annual investment to go toward a first-of-its-kind vaccine “mRNA Center of Excellence” to accelerate the development and delivery of next-generation vaccines. Approximately 400 employees will integrate end-to-end mRNA vaccine capabilities…

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…

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…

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…

Pfizer’s (NSE:PFE) pneumococcal 13-valent conjugate vaccine Prevnar 13 brought in $5.85 billion last year, but Merck (NYSE:MRK) is hoping to increase its presence in the market with its investigational 15-valent pneumococcal conjugate vaccine. Although Merck has a pneumococcal vaccine on the market known as Pneumovax 23, its sales were $1.1 billion last year. While technically a…

Rybrevant, a novel fully-human bispecific antibody from the Janssen division of Johnson & Johnson, became the first treatment for people with non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. In particular, the indication covers such cancer that has progressed on or after platinum-based chemotherapy. The agency also approved the…

The pandemic has heightened interest in COVID-19 therapies, sometimes stealing attention from other pharmaceutical breakthroughs. But the pandemic has also served as a reminder that investment in new drugs can pay dividends while leading to a greater societal appreciation for the industry. A 2019 study published in International Health concluded that pharmaceuticals that have launched…

The past year has been an unprecedented time for the pharmaceutical industry. On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society.  While the…

A partnership with J&J’s Janssen Pharmaceuticals is helping PhysIQ advance with its device-agnostic clinical data collection and analysis platform.  Over the course of the last year and some change, the impact of digital health and the need for it has increased by an immeasurable amount. Virtual care became the norm after the COVID-19 pandemic hit, and, although…

Johnson & Johnson’s (NYSE:JNJ) pharmaceutical subsidiary Janssen has announced that its Tremfya (guselkumab) selective interleukin (IL)-23 inhibitor therapy led to durable, complete skin clearance in the majority of adults with moderate-to-severe plaque psoriasis (PsO) for up to five years. The drug also showed substantial efficacy in treating active psoriatic arthritis (PsA) for up to one…