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.…
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,…
Sanofi is banking on a $10 COVID-19 vaccine
Sanofi (NSE:SANOFI) and its partner GSK (NYSE:GSK) are hoping the low price of their experimental COVID-19 vaccine will stoke interest. In a call with analysts, Thomas Triomphe, head of the Sanofi Pasteur vaccines division, said that its vaccine would cost less than $10 per dose. For the sake of comparison, Pfizer-BioNTech and Moderna COVID-19 vaccines generally cost…
Sanofi completes Translate Bio acquisition
Sanofi (NSDQ:SNY) announced today that it has completed the purchase of its mRNA partner Translate Bio. The previously announced deal, according to Sanofi, accelerates the French pharma giant’s efforts to develop transformative vaccines and therapies using mRNA technology. The deal comes during a year in which mRNA-based Moderna (NSDQ:MRNA) and Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccines are…
Pfizer’s abrocitinib goes head-to-head with Sanofi’s Dupixent
Pfizer (NYSE: PFE) recently announced that its once-daily oral Janus kinase 1 (JAK1) inhibitor abrocitinib bested Sanofi’s Dupixent (dupilumab) in a Phase 3 study focused on moderate to severe atopic dermatitis (AD). Meanwhile, Sanofi (EPA:SAN) announced that a Dupixent pivotal trial met its primary and secondary endpoints, making it the first biologic to demonstrate significant…
FDA approves Sanofi’s Nexviazyme for late-onset Pompe disease
With its recent approval of Nexviazyme (avalglucosidase alfa-ngpt), Sanofi (NSDQ:SNY) has asserted its control over the Pompe disease landscape. In 2006, FDA approved Genzyme’s Myozyme (alglucosidase alfa) for Pompe disease. Sanofi acquired the company a decade ago. Additionally, FDA approved Lumizyme in 2010, which uses the same biologic, but is indicated for patients eight years of…
Sanofi reshapes mRNA landscape with $3.2B Translate Bio buy
Sanofi (NSDQ:SNY) may be one of the biggest vaccine manufacturers in the world, but the quick rise of the mRNA vaccine platform during the pandemic caught the company by surprise. The company could be on the way to rectify that with its $3.2 billion acquisition of its mRNA partner Translate Bio. Sanofi began working with…
Several companies could vie for next-gen COVID-19 vaccine market share
A couple of years ago, mRNA vaccines remained at the research stage. Now, they are among the best-selling pharmaceutical products with Pfizer (NYSE:PFE), BioNTech (NSDQ:BNTX) and Moderna (NSDQ:MRNA) dominating the market. However, that could change in the long run as a growing number of companies develop next-generation mRNA COVID-19 vaccines, which promise to be more effective…