Never miss a story

Get subscribed to our newsletter


×
US FDA grants orphan drug status to Lupin drug. Wikimediacommons

Pharma major Lupin on Monday said the US health regulator Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its drug mexiletine hydrochloride for the treatment of myotonic disorders. The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 2 lakh people in the US.

“The decision by the US FDA to grant orphan drug designation to mexiletine brings us closer to providing a licensed treatment option for patients in the US,” Vinita Gupta, CEO, Lupin Limited, said in a statement.


Myotonic disorders are a group of neuromuscular disorders characterized by a shared symptom called myotonia which is an inability to relax a contraction of skeletal muscle which originates from a voluntary muscular contraction such as shaking someone’s hand and blinking, or everyday activities such as walking across a street and climbing stairs.


FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 2 lakh people in the US. Pixabay

Mumbai-based Lupin’s drug NaMuscula (mexiletine hydrochloride) is the only licensed product to treat myotonia in adults with non-dystrophic myotonic (NDM) disorders. “We are pleased to have this opportunity to further our commitment to these patients,” Gupta added. In April, the company had received an Establishment Inspection Report (EIR) from US FDA for its manufacturing plant in Nagpur.

Follow Newsgram on Facebook for more updates

Lupin is the third-largest pharmaceutical company in the US by prescriptions and in India by global revenues. The company invests 9.6 per cent of its revenues on research and development.

Also Read: This New ‘Ensilication’ Method Allows Childhood Vaccines To be Kept Safe In All Temperatures

It has 15 manufacturing sites and seven research centres, with more than 20,000 professionals working globally. (IANS)


Popular

Photo by Campaign Creators on Unsplash

Services and products, like at-home workouts, popped up all over social media from new and exciting businesses.

By- Laura

The pandemic brought about a global boom of entrepreneurship in 2020. Thousands of small businesses launched in the UK last year, and many were very successful. Some businesses started as passion projects, while others aimed to fill a hole in the pandemic market. Services and products, like at-home workouts, popped up all over social media from new and exciting businesses. The pandemic left many Brits financially unstable and scared for the future of their career. Launching their own business gave them something to focus on again and a small amount of income.

Keep Reading Show less
Wikimedia Commons

The brand focuses on creating quality products that are high efficacy made with all-natural and no chemicals in the formulae.

One of Indias fast growing Direct To Consumer (DTC) beauty and personal care brands, MyGlamm, launches its national TVC around the message 'All Natural #NoNasties today with actress Shraddha Kapoor, who is also an investor in the brand.

Kapoor who has a great millennial and Gen Z connect introduces 'My SUPERFOODS Kajal' which has No Parabens, No Mineral Oils, No Nasties while still being long-lasting and smudge-free and made with the goodness of nature. This is followed by many girls trying applying the kajal with confidence and while highlighting the ingredients Avocado Oil, Goji Berries, Vitamin E and Sunflower Seed Oil.

Keep Reading Show less
Pixabay

Phishing attacks targeting organisations rose up considerably during the pandemic.

Phishing attacks targeting organisations rose up considerably during the pandemic, as millions of employees working from home became a prime target for cybercriminals. A large majority (83 per cent) of IT teams in India said the number of phishing emails targeting their employees increased during 2020, according to a report by UK-based cybersecurity firm Sophos on Monday.

"It can be tempting for organisations to see phishing attacks as a relatively low-level threat, but that underestimates their power. Phishing is often the first step in a complex, multi-stage attack. According to Sophos Rapid Response, attackers frequently use phishing emails to trick users into installing malware or sharing credentials that provide access to the corporate network," Sophos' Principal Research Scientist, Chester Wisniewski said in a statement. The findings also reveal that there is a lack of common understanding about the definition of phishing. For instance, 67 per cent of IT teams in India associate phishing with emails that falsely claim to be from a legitimate organisation, and which are usually combined with a threat or request for information.

Scam Phishing Fraud The findings also reveal that there is a lack of common understanding about the definition of phishing. | Pixabay

Keep reading... Show less