While there are currently no FDA-approved AI-discovered drugs, interest in generative AI (genAI) could be a game-changer for the pharmaceutical industry in the coming years. Sanofi, which has signaled its intent to go “all in” on AI, has inked a deal with ChatGPT developer OpenAI and Formation Bio to build AI-powered software to speed drug…
Best-selling pharmaceuticals of 2023 reveal a shift in pharma landscape
[Updated May 21, 2024.] 2023 may not go down as the brightest year for the pharma sector, but the entry of Novo Nordisk’s Ozempic (semaglutide) into the ranks of top-selling drugs like Keytruda, Dupixent, and Eliquis signals a new era in the treatment of metabolic disease. Novo Nordisk’s sales jumped by more than one-third in…
Rilzabrutinib on track for regulatory filing after ITP trial win
Sanofi revealed that its investigational BTK inhibitor rilzabrutinib notched a significant win in the LUNA 3 phase 3 study, hitting the primary endpoint of durable platelet response in adults with persistent or chronic immune thrombocytopenia (ITP). The study showed a significantly higher proportion of rilzabrutinib-treated patients achieved the platelet response goal compared to placebo in…
When will drug development have its ChatGPT moment? Inside ambitious AI initiatives at Sanofi and Medable
In episode 4 of Ai Meets Life Sci, Kayleen Brown, managing editor at DeviceTalks and Brian Buntz, pharma and biotech editor, chat with Helen Merianos, Ph.D., head of R+D portfolio strategy at Sanofi and Michelle Longmire, MD, CEO of Medable. The focus? The two-fold application of AI in their respective companies’ technologies, both for scientific advancement…
From Silicon Valley to the lab of tomorrow: Synfini’s leap to large chemistry models
During the COVID-19 pandemic in late 2020, the storied Silicon Valley institution SRI International secured a $4.3 million DARPA contract to develop a tool for generating therapeutic small molecules to combat biological threats. Not just known for innovations like the computer mouse and Siri, SRI International is also responsible for Synfini, a multimodal chemistry model…
Sanofi ALTUVIIIO hemophilia A treatment: FDA accepts sBLA based on pediatric phase 3 data
The FDA has accepted Sanofi’s supplemental Biologics License Application (sBLA) for ALTUVIIIO, a novel, high-sustained factor VIII replacement therapy for adults and children with hemophilia A. The FDA based the decision on positive final data from the pivotal Phase 3 XTEND-Kids trial in children under 12 with hemophilia A. ALTUVIIIO (efanesoctocog alfa) is the first…
Sanofi puts AI ‘Plai’ app at the center of drug discovery and clinical trial operations
The French pharmaceutical giant Sanofi has unveiled a new AI-powered app called Plai, developed in partnership with AI platform Aily Labs. This move is part of Sanofi’s plan to become the pioneer in fully integrating AI into all operations, according to CEO Paul Hudson. Plai, designed to compile and process Sanofi’s internal data from various…
An overview of the RSV vaccine candidate landscape in early 2023
Respiratory syncytial virus (RSV) remains a prominent global health concern. Each year, the virus is to blame for 2.1 million outpatient visits for children under 5 years old, according to CDC. Other vulnerable populations, including older adults and immunocompromised individuals, are also at risk. Nevertheless, RSV has long been a research focus. Scientists first identified RSV in 1956.…
Prominent pharma M&A deals to watch in Q1 2023: Pfizer, Sanofi and others on the hunt
After a relatively quiet 2022, 2023 is anticipated to be a more robust year for pharma M&A activity. In recent months, players such as Pfizer (NYSE:PFE), Sanofi (NYSE:SNY), Chiesi, AstraZeneca (LON:AZN) and Amgen (Nasdaq:AMGN) have unveiled acquisition plans that could reshape the landscape of the sector. This article delves into the details of prominent recent…
Europe approves GSK and Sanofi’s next-gen COVID-19 booster vaccine VidPrevtyn Beta
The European Commission has approved the VidPrevtyn Beta COVID-19 vaccine as a booster for individuals who are at least 18. The vaccine is the first next-gen protein-based adjuvanted COVID-19 booster to win European approval. Sanofi (Nasdaq:SNY) developed the vaccine based on the beta variant using GSK’s (NYSE:GSK) pandemic adjuvant. After announcing the news, Sanofi shares…
Fall 2022 COVID-19 vaccine candidate tracker
Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine. But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus. A variety of companies are developing next-generation COVID-19 vaccines that could potentially…
Sanofi forms pharmacy fellowship program with Howard University
Sanofi today announced a collaboration with Howard University College of Pharmacy for a two-year post-professional Doctorate in Pharmacy fellowship program. The collaboration is a part of the Cambridge, Massachusetts-based company’s ongoing efforts to address disparities in underrepresented communities. The goal is to hire fellows into permanent full-time positions at Sanofi. The program will begin in…
Sanofi-GSK COVID-19 vaccine effective against omicron
GSK plc (LSE/NYSE:GSK) and Sanofi (EPA:SAN) have announced that their adjuvanted bivalent vaccine candidate had 72% efficacy against omicron in adults in stage 2 of a Phase 3 study. For those with SARS-CoV-2 seropositivity, the vaccine was 93.2% effective against omicron. The vaccine is based on the original D614 virus and the beta (B.1.351) strain.…
Sanofi-GSK COVID-19 booster could compete against updated Moderna and Pfizer offerings
Sanofi (Nasdaq:SNY) and GSK (NYSE:GSK) have announced that their next-generation COVID-19 booster vaccine candidate based on the beta variant yielded a substantial immune boost in adults previously primed with mRNA vaccines. The novel vaccine yielded a strong increase in antibody titers above baseline against various variants of concern, including a 40-fold increase against the BA.1 omicron subvariant 15…
Regeneron purchases exclusive rights to Libtayo from Sanofi for $900M
Sanofi (Nasdaq:SNY) has agreed to sell Regeneron (Nasdaq:REGN) exclusive international rights of Libtayo (cemiplimab) for $900 million. Sanofi will also receive an 11% royalty on global sales of the drug. Libtayo is a monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. Sanofi could also receive $100 million if the drug hits regulatory milestones…
Sanofi announces publication of early study of rilzabrutinib for immune thrombocytopenia
Sanofi (Nasdaq:SNY) has announced that the New England Journal of Medicine (NEJM) has published positive data from the Phase 1/2 dose-finding study testing the safety, pharmacokinetics and clinical activity of rilzabrutinib for immune thrombocytopenia. Immune thrombocytopenia is associated with bruising and bleeding. Fewer than 200,000 Americans are diagnosed with the condition each year. Rilzabrutinib is…
Sanofi oncology drug candidate hits roadblock
Amcenestrant, a once-promising investigational optimized oral selective estrogen receptor degrader (SERD) from Sanofi (Nasdaq: SNY), did not meet the primary endpoint in a recent Phase 2 trial focused on advanced or metastatic breast cancer. Sanofi had previously referred to amcenestrant as a “potentially transformative” product. Investigators did not identify any new safety signals for the…
Nirsevimab offers significant protection against RSV in infants in Phase 3 trial
AstraZeneca’s (LON:AZN) and Sanofi‘s (Nasdaq:SNY) nirsevimab had 75% efficacy against lower respiratory tract infections resulting from rr (RSV) in a Phase 3 study. There are currently few treatment options for lower respiratory tract infections stemming from RSV. Two antivirals, palivizumab and ribavirin, are available, while new vaccines are currently authorized. RSV is the most common…
J&J and Roche named to Clarivate’s Top 100 Global Innovators list
Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT). Two companies in pharma and another in medtech, however, made the cut. Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator. Roche was included for the 11th consecutive year…
Sanofi and GSK aim to commercialize COVID-19 vaccine
In the U.S., Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE) continue to dominate the COVID-19 landscape while demand for Johnson & Johnson’s (NYSE:JNJ) vaccine remains limited. Now, Sanofi (NASDAQ:SNY) and GSK (NYSE:GSK) are preparing to get into the game by preparing their regulatory submissions for their COVID-19 vaccine. The companies are currently communicating with the FDA and…
Sanofi’s olipudase alfa fares well in open-label extension ASMD studies
Sanofi (NSDQ:SNY) has announced that olipudase alfa offered a sustained improvement in patients with acid sphingomyelinase deficiency (ASMD) in investigational long-term follow-up studies. ASDM is a rare progressive and potentially life-threatening disease with no authorized treatments. Patients in the trial had improvements in terms of lung function and reduced spleen and liver volumes. The research…
Regeneron and Sanofi withdraw FDA application for Libtayo in advanced cervical cancer
Regeneron Pharmaceuticals (NSDQ:REGN) and Sanofi (NSDQ:SNY) have voluntarily withdrawn the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for advanced cervical cancer. A press release noted that the agency and the sponsors were unable to “align on certain post-marketing studies” that would have been required to greelight the sBLA. FDA first…
7 potential applications of mRNA-based therapies
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…
Novartis to pay up to $1.5 billion to acquire Gyroscope Therapeutics
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…
Moderna releases positive early data for its mRNA flu vaccine; Stock tumbles
Moderna (NSDQ:MRNA) has announced positive interim data from the Phase 1 study of its quadrivalent seasonal flu vaccine candidate, mRNA-1010. Still, the results did not impress investors, as they seemed to be broadly in line with performance of Sanofi’s (NSDQ:SNY) common Fluzone HD flu vaccine. MRNA shares fell roughly 9% to $249.20 in mid-morning trading.…