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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 European Medicines Agency (EMA).

In a Phase 3 efficacy trial, two doses of the vaccine in seronegative individuals were 100% effective against severe COVID-19 disease and hospitalization. Protection against moderate or severe COVID-19 was 75%, while protection against symptomatic COVID-19 was 57.9%.

A booster dose of the vaccine increased neutralizing antibodies 18- to 30-fold in recipients of mRNA and adenovirus vaccines.

The companies note that the research was carried out while challenging variants of concern were circulating. “No other global Phase 3 efficacy study…

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 focused on non-central nervous system (non-CNS) manifestations of ASDM.

A sphingomyelin-phosphodiesterase replacement, olipudase alfa, has been the subject of seven clinical trials to date. To date, treatment of ASDM, also known as ASM-deficient Niemann-Pick disease, depends on whether patients have a manifestation known as Niemann-Pick disease type A (NPD-A) or Niemann-Pick disease type B (NPD-B).

Patients with the first type may receive physical and occupational therapy and nutritional consultations.

Some individual…

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Regeneron Pharmaceuticals (NSDQ:REGN) and Sanofi (NSDQ:SNY) have voluntarily withdrawn the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for advanced cervical cancer.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 approved the drug in 2018 for advanced cutaneous squamous cell carcinoma.

Regeneron/Sanofi

The agency approved indications of Libtayo as a first immunotherapy for patients with advanced basal cell carcinoma in 2021 and as a first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%.

Regeneron and Sanofi are continuing discussions with regulators outside of the U.S. regarding Libtayo’s potential as a second-line advanced cervical cancer therapy.

REGN shares increased 2…

7 potential applications of mRNA-based therapeutics

mRNA image courtesy of Wikimedia Commons.

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 mRNA could find use in the coming years.

1. Cardiovascular applications

Image by Raman Oza from Pixabay

Researchers at the University of Pennsylvania recently shared positive data related to the use of mRNA and CAR-T cell therapy to treat cardiac fibrosis in a mouse model.

Last year, AstraZeneca (LON:AZN) announced positive results from a Phase…

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 cause of vision loss in individuals over 55.

GT005 is the subject of three active clinical trials.

Last year, Gyroscope Therapeutics won Fast Track designation from FDA for GT005.

As part of the deal, Novartis will pay $800 million upfront and up to $700 million in further milestone payments.

The acquisition is subject to customary closing conditions.

In November, London-based Gyroscope announced that it had received an investment from Sanofi worth up to $60 million.

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.

“We believe the market was looking for data which supported clearly better efficacy,” wrote Morgan Stanley analyst Matthew Harrison in an investor briefing note.

The vaccine candidate led to elevated hemagglutination inhibition (HAI) assay geometric mean titers against four influenza strains 29 days after vaccination.

Investigators tested a variety of doses in both younger and older adults.

Recipients of the 50-µg dose of vaccine, who had large increases in geometric mean antibody titers against H1N1 and H3N2 strains.

The company is also developing other flu vaccine candidat…

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’s EVP of General Medicines Olivier Charmeil said he thought the French pharma giant’s scale, expertise, and relationships in transplant would enable the realization of the “full potential of Rezurock.” The treatment, he said, addresses the significant unmet medical needs of patients with chronic graft-versus-host disease.

Kadmon’s pipeline includes drug candidates for immune and fibrotic diseases — and immuno-oncology therapies.

Gyroscope Therapeutics to receive investment from Sanofi worth up to $60M

Gyroscope Therapeutics announced today that it received a commitment from Sanofi (NYSE:SNY) to invest up to $60 million.

London-based Gyroscope will receive a $40 million investment from Sanofi initially. That $40 million represents a premium to Gyroscope’s previous Series C financing, with the remaining $20 million to be invested contingent on a future qualifying investment round and other certain closing conditions.

Get the full story at our sister site, Drug Delivery Business News.

Medtech M&A: The industry’s biggest mergers and acquisitions of 2021

[Image from Jp Valery on Unsplash]Across 2021, medtech has seen a wide range of mergers and acquisitions covering several areas of devices, pharmaceuticals and more.

Some have gone off without a hitch, while others fell into serious scrutiny as mouthwatering financial figures were revealed and major technologies were acquired.

Here are the 10 biggest mergers and acquisitions in medtech in 2021:

Next>

Medtech M&A: The industry’s biggest mergers and acquisitions of 2021

[Image from Jp Valery on Unsplash]

Across 2021, medtech has seen a wide range of mergers and acquisitions covering several areas of devices, pharmaceuticals and more.

Some have gone off without a hitch, while others fell into serious scrutiny as mouthwatering financial figures were revealed and major technologies were acquired.

Here are the 10 biggest mergers and acquisitions in medtech in 2021:

Next>>

Sanofi is banking on low-cost 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.

The company is also upbeat about the vaccine’s prospects as a booster.

A Phase 2 trial is currently underway to evaluate its use as a booster. Sanofi has a Phase 3 trial in the works to test its overall safety and efficacy.

The investigational vaccine uses a recombinant protein platform.

Last month, the company scrapped its plans to pursue the development of an mRNA COVID-19 vaccine. Instead, it will continue researching mRNA vaccines that could “address future pandemics and other infectious diseases and therapeutics where there is a strong unmet need,” it announced.

In its Q3 earnings announcement, the company announced that vaccine sales grew 16.5% year ov…

MannKind enrolls first patient in Afrezza study focusing on children

Rapid-acting insulin specialist MannKind Corp. (NSDQ:MNKD) has enrolled the first pediatric patient in its INHALE-1 study evaluating its Afrezza (Technosphere Insulin) with basal insulin versus multiple daily injections of insulin. The study will enroll participants aged four to 17 with type 1 or type 2 diabetes.

Afrezza first won FDA approval in 2014, and MannKind initially partnered with Sanofi (NSDQ:SNY) to market the drug. Sanofi pulled out of the partnership in 2016.

The INHALE-1 is a 26-week open-label, randomized study with a 26-week extension.

The primary endpoint of the study will be the average HbA1c level after 26 weeks. Secondary endpoints include changes in fasting plasma glucose and the rate of hypoglycemic events at the same interval.

Earlier this year, MannKind CEO Michael Castagna said that the company has focused on increasing the number of presentations and publications related to Afrezza to boost its sales.

MNKD shares, …