Zydus Gets CDSCO Panel Nod To Manufacture Market Letermovir 240 mg, 480 mg Tablet

New Delhi: The drug major Zydus has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Letermovir 240 mg and 480 mg tablets with Phase-III clinical trial waiver.

However, this nod is subject to the condition that Zydus should submit the Phase-IV clinical trial (CT) protocol to CDSCO within three months of the grant of permission.

Furthermore, the expert panel suggested that the drug product be sold on the prescription of specialists in organ transplant, infectious disease, hematologist, etc.

This came after Zydus presented the proposal for a grant of permission to manufacture and market Letermovir tablets 240mg and 480 mg with a Phase-III clinical trial waiver request, along with a bioequivalence (BE) study report.

Letermovir is an antiviral medication used for prophylaxis in adult transplant recipients at risk of cytomegalovirus (CMV) infection and disease.

Letermovir is indicated for prophylaxis against cytomegalovirus (CMV) infection and disease in adult recipients of an allogeneic hematopoietic stem cell transplant (HSCT) who are CMV-seropositive. It is also indicated for prophylaxis against CMV disease in adult kidney transplant recipients who are at risk (i.e. donor CMV-seropositive/recipient CMV-seronegative).

Letermovir is a viral terminase inhibitor. It specifically inhibits the CMV viral terminase complex which is encoded by the CMV genes UL56, UL51, and UL89. This inhibition has the effect of preventing cleavage of CMV DNA concatamers, resulting in long-uncleaved DNA and noninfectious viral particles.

At the recent SEC meeting for Antimicrobial and Antiviral held on 10th April 2024, the expert panel reviewed the proposal presented by the drug major Zydus for the approval to manufacture and market the drug Letermovir.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market Letermovir tablets 240mg and 480 mg in the country with the following conditions:

i) The firm shall submit Phase-IV CT protocol to CDSCO within three months of grant of permission.

ii) The drug product to be sold on prescription of specialists in organ transplant, infectious disease, hematologist, etc.

Also Read: Novartis Gets CDSCO Panel Nod to Study anti-cancer drug Ribociclib

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Invoke steps under health act: Kerala minister directs officials on bird flu outbreak

The recent outbreak of bird flu in two wards of Alappuzha has prompted Health Minister Veena George to take swift action under the Kerala Public Health Act, 2023. She has instructed the director of the health department to initiate necessary measures to contain the spread of the virus.

Panchayat-level committees are being urgently convened in all panchayats of Alappuzha to address the situation effectively. Additionally, neighboring areas are under close surveillance, with district-level monitoring in place. Progress reports are mandated to be submitted at the state level to ensure coordinated efforts.

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Ludhiana doctor gets extortion call, asked to pay Rs 2 crore

Ludhiana: In yet another case of extortion, a city-based doctor filed a complaint after receiving a call from unidentified persons who demanded Rs 2 crore and threatened to kill him and his family members if he failed to pay.  

The doctor said that he was followed by the accused on several occasions for a few months and received an extortion call of Rs 2 crore and death threats if the money was not paid which prompted him to approach the police.   

The police have registered an FIR under sections 384, 386 (Extortion by putting a person in fear of death or grievous hurt) and 120 B (Punishment of criminal conspiracy) of the Indian Penal Code (IPC) based on his complaint. 

Also read- Orthopaedic Surgeon Gets Extortion Call, Accused Arrested

In his complaint, the doctor identified as Dr Damandeep Singh Makkar claimed that he noticed a a Toyota Fortuner following him on several occasions in December last year. Thinking it was a mere coincidence, the doctor ignored it. 

However, on January 27 and February 2, he received WhatsApp calls and messages from foreign numbers where the accused demanded Rs 2 crore extortion. The accused allegedly threatened the doctor that if he failed to pay the amount, he and his family members would be killed. 

The accused is reported to have shared photographs of his family when they were out of the house to show that they were keeping tabs on the movement of his family members. 

Following this, he filed a complaint at the police station. While investigating the case, the police found that the two accused identified as Amritpal Singh of Mullanpur Dakha and Tajinderpal Singh Gill of Sidhwan Bet who were arrested for threatening an Aggar Nagar resident for ₹3 crore extortion money are suspected to be behind the doctor’s extortion call.

The police suspect these two accused are targeting the doctor based on the mobile number and the registration number of the Toyota Fortuner car which is believed to be a match. 

Investigating officer ASI Pardeep Kumar told The Tribune, “A case against unknown persons had been registered. However, the circumstantial evidence suggests that Amritpal and Tajinderpal could be behind this case as well.”  

Also read- Dhanbad Doctor Couple Gets Extortion Text Of Rs 1 Cr: IMA Seeks CM Help To Arrest Extortionists, Threatens Strike If Govt Fails To Act

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Women’s heart disease is underdiagnosed, but new machine learning models can help solve this problem

When it comes to matters of the heart, cardiovascular disease in women is underdiagnosed compared to men. A popular scoring system used to estimate how likely a person is to develop a cardiovascular disease within the next 10 years is the Framingham Risk Score. It is based on factors including age, sex, cholesterol levels, and blood pressure.

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Active military service may heighten women’s risk of having low birthweight babies

Active military service may heighten a woman’s risk of having a low birthweight baby, suggests a review of the available scientific evidence published online in the journal BMJ Military Health.

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Significant global variation in COVID-19 guidelines: Most countries recommend at least one treatment that doesn’t work

National clinical guidelines for the treatment of COVID-19 vary significantly around the world, with under-resourced countries the most likely to diverge from gold standard (World Health Organization; WHO) treatment recommendations, finds a comparative analysis published in the open access journal BMJ Global Health.

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Cost increasingly important motive for quitting smoking for 1 in 4 adults in England

Health concerns are still the primary motive for more than half of those who say they want to stop smoking in England, but cost is now a key factor for more than 1 in 4, finds an analysis of national survey responses, published in the open access journal BMJ Public Health.

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Study connects enjoyment of nature to lower inflammation levels

Plenty of studies link exposure to the natural world and improved mental and physical health, but a new Cornell study connects enjoyment of nature to a specific biological process—inflammation.

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Sandoz confirms European Commission nod of Pyzchiva

Basel: Sandoz has announced that the European Commission (EC) has granted marketing authorization for Pyzchiva (biosimilar ustekinumab) developed and registered by Samsung Bioepis. Pyzchiva is a key biosimilar value driver for the company over the mid-term and this approval is a major step in advancing Sandoz growth strategy.

Pyzchiva is approved as a biologic therapy within gastroenterology, dermatology, and rheumatology.

Rebecca Guntern, President Sandoz Europe, said, “Chronic inflammatory diseases affect millions of people around the world and can have a profoundly negative impact on their quality of life. This approval is a crucial step towards offering European patients an additional safe and effective treatment option and further demonstrates our commitment to pioneer access to potentially life-changing medicines.”

The comprehensive regulatory submission package included extensive analytical, preclinical, and clinical data, including a Phase I PK/PD study and a Phase III confirmatory study.

Sandoz entered into a development and commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to commercialize Pyzchiva in the US, Canada, the European Economic Area (EEA), Switzerland, and the UK. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing and supply.

Pyzchiva is a trademark of Samsung Bioepis Co. Ltd.

Pyzchiva (ustekinumab) has been developed to match the reference medicine, a monoclonal antibody medication to interleukin (IL)-12/23 for the treatment of autoimmune disorders including within gastroenterology, dermatology, and rheumatology.

Sandoz’s leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the first biosimilar in 2006. In 2023, Sandoz recorded sales of USD 9.6 billion.

Read also: Sandoz concludes acquisition of Cimerli business from Coherus BioSciences

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1st-year MBBS student of Chirayu Medical College hangs self in hostel room

Bhopal: In a tragic incident, a first-year MBBS student of Chirayu Medical College and Hospital was found hanging in her hostel room on Monday morning. The police have initiated an investigation into the matter.

Speaking to PTI, the police informed, “A 22-year-old MBBS student of a private medical college in Bhopal committed suicide by hanging from the ceiling fan in the girls’ hostel on Monday. The body of the student, identified as ***, was found hanging from the ceiling fan of her hostel room this morning with rope… Originally from Khargone, she was a first-year student of Chirayu Medical College and Hospital situated under the Khajuri police station limits.”

According to police officials, no suicide note was found during the search of the room. The Forensic Science Laboratory (FSL) team has also examined the room. Her laptop and mobile phone have been confiscated. The police are obtaining call details from the mobile to determine the last person she spoke to, reports FPJ.

As per FPJ report, she had gone to bed Sunday night, however she didn’t come out of the room till late Monday morning. The warden went to check on her and despite the repeated knocks on her door, there was no response from inside. Sensing something fishy, the warden informed the staff. A carpenter was called to break open the door of the room. The entire staff and students were shocked to see her hanging.

The student’s body was found hanging from the ceiling fan by a scarf tied as a noose. Following this, the police were informed of the incident. The police took custody of the body and placed it in the mortuary of Hamidia Hospital. 

“No suicide note has been found from the spot,” a police official told PTI, adding that a case has been registered and further investigation is underway.

The police are waiting for the arrival of her family members, he said, adding that the exact reason behind the medico taking the extreme step is not known yet.

Also Read:Depressed over low marks in prep test, NEET aspirant commits suicide in UP’s Etah

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