Company 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.

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).

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.

Cipla Limited announced that it has received final approval for its Lanreotide Injection, from the United States Food and Drug Administration (US FDA). The FDA approval was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. Lanreotide Injection is supplied in 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL singledose pre-filled syringes. It is indicated for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs).

Lupin Limited (Lupin) has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (US FDA) for its Goa manufacturing facility, after the inspection of the facility in September 2021. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

Icure Pharmaceutical Inc a biopharmaceutical company in Korea, announced that its donepezil patch, a treatment of Alzheimer’s-type dementia, received a drug product approval from the Ministry of Food and Drug Safety of Korea.

The drug product approval process took 7 months after it filed an application in April 2021. With the approval, Icure marks the first commercialization of the donepezil patch in the world.

Glenmark Pharmaceuticals, a research-led, global integrated pharmaceutical company, today announced the successful completion of its Post Marketing Surveillance (PMS) study on Favipiravir (FabiFlu®) in India. The PMS study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 patients. A total of 1083 patients were enrolled in the prospective, open label, multicentre, single arm study.