Vutrisiran, to be marketed under the brand name Amvuttra, has won an FDA approval to treat hereditary transthyretin amyloidosis (hATTR) polyneuropathy in adults. In the phase III HELIOS-A study, Amvuttra helped ATTR polyneuropathy patients achieve an average 2.2-point improvement on a modified neuropathy impairment score after nine months; half of the patients experienced some level of improvement. In the same study, Onpattro takers got 1.4 points better. By comparison, patients who took placebo in a historical Onpattro clinical trial called APOLLO experienced disease worsening of an average 17 points.
VoqueznaTriple Pak(vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak(vonoprazan, amoxicillin) is approved for the treatment of Helicobacter pylori (H. pylori) infection in adults.
The approval was based on data from a randomized, controlled, double-blind triple therapy/open-label dual therapy, phase III study HP-301, which compared the efficacy and safety of Voquezna Triple and Dual Pak with lansoprazole in combination with amoxicillin and clarithromycin in 1046 adults with H. pylori infection.
Mounjaro is an injectable prescription medicine that is used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus. Mounjaro is not for use in people with type 1 diabetes. It is not known if Mounjaro is safe and effective for use in children under 18 years of age. Mounjaro is a dual GLP-1 and GIP agonist and has demonstrated superior efficacy compared to other diabetes medications.The approval of Mounjaro was based on results from the phase III SURPASS program, which compared it to competitors such as injectable semaglutide, insulin glargine, and insulin degludec.
Vtama(tapinarof) Cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.
The approval was based on data obtained from 2 identical phase III trials that assessed the safety and efficacy of Vtama in 1025 adults (18 to 75 years of age) diagnosed with plaque psoriasis.
The primary endpoint for both studies was the hope that patients would earn a Physician Global Assessment (PGA) score of clear (0) or almost clear (1). Results from both trials showed that 36% and 40% of patients met the primary endpoint, respectively. Following 12 weeks of treatment, 73 Vtama patients achieved complete disease clearance (PGA 0).
Sanofi and GSK Collaborate to Develop Vaccine for COVID-19
Sanofi and GlaxoSmithKline
have signed a letter of intent to develop an adjuvanted vaccine for COVID-19,
using innovative technology. Sanofi would contribute its S-protein COVID-19
antigen, which is based on recombinant DNA technology whereas the GSK would contribute
its pandemic adjuvant technology. The use of an adjuvant technology would help
in reducing the amount of vaccine protein required per dose, allowing more
vaccine doses to be produced and therefore help in protecting the more people.
China Approves Two Experimental Coronavirus Vaccines to enter Clinical Trials
China has approved early-stage human tests for two experimental vaccines to combat the new coronavirus. One vaccine is being developed by a Beijing-based unit of Nasdaq-listed Sinovac Biotech, and another vaccine is being developed by the Wuhan Institute of Biological Products.
AstraZeneca to Test the Impact of Cancer Drug Calquence on Coronavirus Patients
is planning to start a clinical trial of its cancer drug i.e. Calquence to
assess its potential to control the exaggerated immune system response
associated with COVID-19 infection in severely ill patients.
(acalabrutinib) belongs to a class of drugs called Bruton’s tyrosine kinase
(BTK) inhibitors which can suppress autoimmune diseases. Calquence is currently
used to treat certain types of blood cancers, has already been approved for the
treatment of adult patients with chronic lymphocytic leukaemia in the United States
and several other countries.
Celltrion Identifies Antibody Candidates against COVID-19
Celltrion has successfully selected the most potent antibody candidates to neutralise SARS-CoV-2, the virus causing COVID-19. Celltrion will begin cell-line development mass production of the selected therapeutic monoclonal antibody. The Company would conduct the efficacy and toxicity testing with Korea Centers for Disease Control and Prevention (KCDC) of the selected therapeutic monoclonal antibody in mice and non-human primates.
Immunomic collaborates with PharmaJet and EpiVax for COVID-19 Vaccine
Immunomic Therapeutics has entered into a collaboration with PharmaJet and EpiVax to develop a nucleic acid vaccine candidate against COVID-19. This collaboration would help in developing a vaccine that is scalable, heat-stable and easy to administer using PharmaJet’s Tropis needle-free injection system.
Vir selects Samsung Biologics to Produce COVID-19 Antibodies
Vir Biotechnology has selected South Korea-based Samsung Biologics for large-scale production of antibodies to potentially treat Covid-19. Under the terms of the collaboration, Samsung Biologics would provide the manufacturing services for Vir’s monoclonal antibody (mAb) programme targeting the novel coronavirus, SARS-CoV-2. Vir’s lead mAb candidates, VIR-7831 and VIR-7832, had showed high affinity for the spike protein of SARS-CoV-2 and ability
Eli Lilly to Begin Testing RA Drug Olumiant and
an Anti-Ang2 Drug in COVID-19 Patients
Eli Lilly plans to explore the use of its rheumatoid arthritis drug i.e., Olumiant (oral JAK1/JAK2 inhibitor) as a treatment for hospitalized patients with COVID-19. Olumiant (Baricitinib) is approved in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. The clinical trial of Olumiant for COVID-19 would begin this month and results are expected within the next two months.
the company is planning to advance LY3127804, an investigational selective
monoclonal antibody against Angiopoietin 2 (Ang2), to Phase II testing in
pneumonia patients hospitalized with COVID-19 who are at a higher risk of
progressing to Acute Respiratory Distress Syndrome (ARDS). Ang2 is known to be
elevated in ARDS patients and Lilly will test whether inhibiting the effects of
Ang2 with a monoclonal antibody can reduce the progression to ARDS or the need
for mechanical ventilation in COVID-19 patients
Promising Clinical Trial Results of Gilead Sciences’ Antiviral Drug Remdesivir for COVID-19
Gilead Sciences Inc.’s experimental drug i.e. remdesivir has shown the promise results in early analysis. All the patients received remdesivir for up to 10 days on a compassionate use basis. The clinical trial demonstrated the clinical improvement was observed in 36 of 53 patients (68%) over the 18 days with 17 of the 30 patients on mechanical ventilation being able to get off the breathing device. Almost half of the patients studied were ultimately discharged, while 13% died. Mortality was highest among those who were on a ventilator, with 18% of them dying. Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy
FDA Approves Rutgers’ Saliva Test for COVID-19
The diagnostic saliva test developed by RUCDR Infinite Biologics with Spectrum Solutions and Accurate Diagnostic Labs (ADL) has received the Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test involves the use of the saliva for the diagnosis of the COVID-19.
This test has eliminated the need for collecting the sample through nasopharyngeal or oropharyngeal as the current COVID 19 diagnostic test requires a swab from deep in the nasal passages or the back of the throat. It puts the healthcare workers at risk of catching an infection. The diagnostic saliva test uses easy-to-collect saliva samples instead of the more difficult deep nose swabs in comparison to the existing diagnostic tests and would reduce the risk of healthcare workers from getting the infection.
FDA Approves First Rapid Point-Of-Care COVID-19 Diagnostic Test
Sunnyvale-based molecular diagnostic company Cepheid received FDA approval for the first rapid coronavirus test with a 45-minute detection time. This test will be used primarily in hospitals and emergency rooms.
Abbott receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus
Abbott has received FDA emergency
use authorization for a molecular test for novel coronavirus (COVID-19). The
Abbott m2000 RealTime System is
a molecular solution featuring a broad menu of tests, including ones for
infectious diseases. The platform uses polymerase chain reaction (PCR)
technology, which amplifies a single piece (or few copies of a piece) of DNA to
quickly and accurately diagnose a patient. The m2000 is currently used in
labs around the world.
Roche begins shipments of first 400,000 COVID-19 tests to laboratories across the US to begin patient testing under FDA Emergency Use Authorization
Roche plans to ship an additional 400,000 tests per week to
the laboratory testing sites across the nation that are set up to run the test
immediately under the guidelines of the FDA Emergency Use Authorization (EUA).
The Cobas SARS-CoV-2 Test provides
reliable and high-quality results for clinical decision-making for the improved
management of COVID-19 patients and to reduce the risk of SARS-CoV-2
(coronavirus) infection. These
highly automated tests provide results in 3-½ hours.
Eli Lilly teams with Indiana Health Agency to provide speedy Coronavirus Testing to Indiana Residents
Eli Lilly teams with the Indiana State Department of Health
(ISDH) to rapidly expand and accelerate testing for the SARS-CoV-2 coronavirus
Thermo Fisher plans to produce up to 5 million of a new test to detect the Novel Coronavirus
Thermo Fisher, the largest maker of scientific tools, plans
to produce up to 5 million of a new test to detect the novel coronavirus that
causes Covid-19. The Food and Drug Administration granted the new test an
emergency use authorization status.
*Emergency Use Authorization (EUA): Under section 564 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may
allow unapproved medical products or unapproved uses of approved medical
products to be used in an emergency to diagnose, treat, or prevent serious or
life-threatening diseases or conditions caused by CBRN threat agents when there
are no adequate, approved, and available alternatives.