Cell and gene therapies are the fastest growing area for drug development. The groundwork for this category was laid with the mapping of the human genome in 2003, and the field has developed rapidly in the intervening decades. These powerful therapies have significant potential for the treatment of cancer and other previously “undruggable” diseases. But…
The 50 best-selling pharmaceuticals of 2022: COVID-19 vaccines poised to take a step back
The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19…
Lonza and ABL Bio partner on bispecific antibody development for immuno-oncology and neurodegenerative diseases
Lonza (LON:0QNO) and South Korea-based ABL Bio (KOSDAQ:298380) have joined forces to accelerate bispecific antibody development for immuno-oncology and neurodegenerative diseases. Over email, Basel, Switzerland–headquartered Lonza noted that its experience with novel molecular formats enables the company to handle ABL Bio’s unique challenges. In the partnership, Lonza will provide submission-ready chemistry, manufacturing and controls (CMC) data…
FDA grants GSK’s Benlysta orphan drug designation for systemic sclerosis
GSK (NYSE:GSK) announced that FDA has granted Orphan Drug Designation (ODD) to Benlysta (belimumab) for systemic sclerosis (SSc), a rare autoimmune disease that can affect multiple organs. Interstitial lung disease (ILD) is the leading cause of death in SSc patients. The monoclonal antibody Benlysta is a B-lymphocyte stimulator (BLyS) specific inhibitor that binds to soluble…
A closer look at the potential of Takeda’s Takhzyro in pediatric hereditary angioedema study
Takeda (NYSE:TAK) recently announced that in the open-label Phase 3 SPRING study, children aged 2 to 12 had 94.8% fewer hereditary angioedema (HAE) attacks when receiving Takhzyro (lanadelumab-flyo) over 52 weeks compared to baseline The primary objectives of the SPRING study was to evaluate the safety and pharmacokinetics of Takhzyro in HAE patients aged 2…
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Takeda (NYSE:TAK) has announced that in the open-label Phase 3 SPRING study, children aged 2 to 12 had 94.8% fewer hereditary angioedema (HAE) attacks during treatment with Takhzyro (lanadelumab-flyo) over 52 weeks compared to baseline. The Osaka, Japan–based company plans on presenting the data at the European Academy of Allergy and Clinical The SPRING study…
AstraZeneca paying up to $157M for broad-spectrum monoclonal antibodies against COVID
RQ Biotechnology (London) emerged from stealth mode today, saying that AstraZeneca will pay it up to $157 million plus royalties for its existing mAbs against SARS-CoV-2. “Our vision is to build on our successful debut with neutralizing antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral…
Pfizer ticks up on Street-beating Q1, lessens full-year guidance
Pfizer (NYSE:PFE) shares rose today on first-quarter financial results that came in ahead of the consensus forecast. The New York-based pharmaceutical company posted profits of $7.9 billion, or $1.37 per share, on sales of $25.7 billion for the three months ended April 3, 2022, for a 61.2% bottom-line gain on sales growth of 76.8%. Adjusted…
NIH to study allergic reactions to COVID-19 mRNA vaccine
Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines. The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants…
MIT researchers come up with new strategy to create a potential antibiotic
Researchers at MIT are touting a novel method to synthesize a natural compound that has shown potential as an antibiotic. The chemists produced himastatin using the synthesis method and also managed to generate variants of the molecule, some of which showed antimicrobial activity, according to a news story from the university’s website. The compound appears…
Moderna skyrockets on Street-beating Q4 driven by COVID-19 vaccine sales
Moderna (NSDQ:MRNA) shares are on the rise on fourth-quarter results that came in ahead of the consensus forecast. MRNA shares were up 11.7% at $161.51 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 1.1%. The Cambridge, Massachusetts-based company posted…
PharmaJet partner touts interim safety results for needle-free COVID-19 vaccine
PharmaJet announced today that its partner, Technovalia, reported positive interim safety results from a needle-free COVID-19 vaccine trial. Golden, Colorado-based PharmaJet’s needle-free injection systems are being studied with Covigen, a DNA-based vaccine developed by French-Thai pharmaceutical company BioNet-Asia in collaboration with Melbourne, Australia-based Technovalia. Enrollment for the trial began in June 2021. Get the full story at…
Pfizer dips on Q4 revenue miss, provides 2022 guidance
Pfizer (NYSE:PFE) shares slid today on fourth-quarter results that came up shy of the consensus sales forecast. The pharmaceutical giant posted profits of $3.4 billion, or 59¢ per share, on sales of $23.8 billion for the three months ended Dec. 31, 2021, more than quadrupling its bottom-line on revenues that were more than doubled year-over-year.…
Could nasal vaccines be the next big weapon against COVID-19?
Because of the way they provide protection, nasal vaccines could be the best long-term way to prevent COVID-19 infection, according to experts cited in The New York Times. The Times reported that India-based Bharat Biotech, which has the Covaxin COVID-19 vaccine authorized in India and elsewhere, has an experimental COVID-19 nasal vaccine that may offer…
Rani Therapeutics names president of CVS Kidney Care to its board
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…
FDA could soon authorize Pfizer-BioNTech boosters for all adults
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 completes $1.9B purchase of Kadmon Holdings
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 shares new positive Stelara data for Crohn’s disease and ulcerative colitis
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.…
Functional single-cell proteomics firm Isoplexis misses IPO target
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%…
BioAegis publishes data on protein’s role in regulating immune cell inflammatory response
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…
TFF Pharmaceuticals sees promise in Phase 1 trial of inhaled tacrolimus powder for lung transplant
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…
Tremfya bests Cosentyx in psoriasis study
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 acquires Abexxa Biologics and its targeted cancer therapies
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 points to positive prostate cancer study results for masitinib plus docetaxel
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…
Could COVID-19 vaccines guard against dementia?
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…