Pharma News

Roche announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its COVID-19 At-Home Test. The test uses a simple anterior nasal swab sample that can be conveniently self-collected and self-tested by individuals aged 14 years and older, and by an adult for children aged 2-13 years old. The test is able to produce accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron.

A new study from Columbia researchers, in collaboration with scientists at the University of Hong Kong, adds more evidence that the omicron variant can evade the immune protection conferred by vaccines and natural infection and suggests the need for new vaccines and treatments that anticipate how the virus may soon evolve.

The virus that causes COVID-19 has adopted some stealth moves to stay alive and kicking, and one secret to its success is hiding from the immune system by spreading through cell-to-cell transmission, a new study has found. 

Viruses enter cells to make copies of themselves and cause infection. One secret to SARS-CoV-2’s success is hiding from the immune system by spreading between cells. This transmission electron micrograph shows COVID-causing virus particles that were isolated from a patient.

Merck announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for molnupiravir, an investigational oral antiviral (MK-4482, EIDD-2801).

U.S. Food and Drug Administration (FDA) has authorized the emergency use of PAXLOVID (nirmatrelvir tablets and ritonavir tablets) of pfizer for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Strides Pharma gets No Objection Certificate (NOC) from Central Drugs Standard Control Organization (CDSCO) to export 50 million doses of Russia based, Sputnik vaccine which is developed by RDIF. The Russian COVID-19 vaccine Sputnik V (Gam-COVID-Vac) is an adenoviral-based, two-part vaccine against the SARS-CoV-2 coronavirus. Initially produced in Russia, Sputnik V uses a weakened virus to deliver small parts of a pathogen and stimulate an immune response.

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc and Shionogi Limited (Shionogi) as shareholders, today announced that the US Food and Drug Administration (FDA) approved Apretude, the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually acquired HIV-1. The long-acting injectable was approved for use in adults and adolescents weighing at least 35 kg who are at risk of sexually acquiring HIV and who have a negative HIV-1 test prior to initiation.

Merck, a leading science and technology company announced a strategically focused expansion of its neurology pipeline with the acquisition of the rights to develop cladribine for the treatment of generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Merck entered into an agreement to secure the global rights by acquiring Chord Therapeutics, a Swiss-based biotech company focused on rare neuroinflammatory diseases.

Remote monitoring of health-related behaviour with wearable sensor technology is feasible for people with complex health conditions, shows a recent University of Waterloo study.