Lupin to buy established products portfolio in Europe, Canada from Sanofi for Rs 91 crore

New Delhi: Home-grown pharma major Lupin Ltd has said it acquired a portfolio of established products in Europe and Canada from Sanofi for a purchase consideration of EUR 10 million (Rs 91 crore).

Lupin Atlantis Holdings SA, Switzerland, a wholly-owned subsidiary of the company, has signed an asset purchase agreement with Sanofi, a French multinational pharmaceutical and healthcare company, for the purpose, Lupin said in a regulatory filing.

The purchase consideration is EUR 10 million (Rs 91 crore) plus sales milestones up to EUR 8 million (Rs 72.8 crore), contingent upon future sales, it added.
Under the agreement, Lupin will acquire brands AARANE in Germany and NALCROM in Canada and the Netherlands. The turnover of the said brands in these markets for the year ended March 31, 2023 was about USD 6.494 million (Rs 53.7 crore), the company said.
“The proposed transaction is of strategic interest by bringing accretive assets in the respiratory field to help structure the company’s new respiratory franchise in Germany following the launch of LUFORBEC in Germany, the launch of Gx SPIRIVA and the acquisition of XOPENEX and BROVANA in the US,” it added.
The transaction will require approval of the Foreign Direct Investment Bureau of Canada and is planned to be completed by the first quarter of 2024, Lupin said.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.

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WHO adds SII-Oxford University Malaria vaccine to its list of prequalified vaccines

Geneva: WHO has added the R21/Matrix-M malaria vaccine to its list of prequalified vaccines. In October 2023, WHO recommended its use for the prevention of malaria in children following the advice of the WHO Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Group.

Read also: Serum Institute-Oxford University malaria vaccine bags WHO recommendation

The prequalification means larger access to vaccines as a key tool to prevent malaria in children with it being a prerequisite for vaccine procurement by UNICEF and funding support for deployment by Gavi, the Vaccine Alliance.

The R21 vaccine is the second malaria vaccine prequalified by WHO, following the RTS,S/AS01 vaccine which obtained prequalification status in July 2022. Both vaccines are shown to be safe and effective in clinical trials, for preventing malaria in children. When implemented broadly, along with other recommended malaria control interventions, they are expected to have a high public health impact.

Malaria, a mosquito-borne disease, places a particularly high burden on children in the African Region, where nearly half a million children die from the disease each year. Globally, in 2022, there were an estimated 249 million malaria cases and 608 000 malaria deaths across 85 countries.

The prequalification of the world’s second malaria vaccine, developed by Oxford University and manufactured by Serum Institute of India, is poised to expand access to malaria prevention through vaccination. Demand for malaria vaccines is high but the supply has thus far been limited. The availability of two WHO recommended and prequalified malaria vaccines is expected to increase supply to meet the high demand from African countries and result in sufficient vaccine doses to benefit all children living in areas where malaria is a significant public health risk.

Dr Rogério Gaspar, Director of the Department of Regulation and Prequalification at WHO said, “Achieving WHO vaccine prequalification ensures that vaccines used in global immunization programmes are safe and effective within their conditions of use in the targeted health systems. WHO evaluates multiple products for prequalification each year and core to this work is ensuring greater access to safe, effective and quality health products”.

Dr Kate O’Brien, Director of WHO’s Department of Immunization, Vaccines and Biologicals, said, “Today marks a huge stride in global health as we welcome the prequalification of R21/Matrix-M, the second malaria vaccine recommended for children in malaria endemic areas. This achievement underscores our relentless commitment to wiping out malaria which remains a formidable foe causing child suffering and death. This is another step toward ensuring a healthier, more resilient future for those who have lived for too long in fear of what malaria could do to their children. Together with our partners we are united in the pursuit of a malaria-free future, where every life is shielded from the threat of this disease.”

As part of the prequalification process, WHO applies international standards to comprehensively evaluate and determine whether vaccines are safe, effective and manufactured to international standards. WHO also ensures the continued safety and efficacy of prequalified vaccines through, for example, regular re-evaluation, site inspection and targeted testing. Prequalification supports the specific needs of national immunization programmes with regards to vaccine characteristics such as potency, thermostability, presentation, labelling and shipping conditions

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Medical Bulletin 23/December/2023

Here are the top medical news of the day:

Brain lesions in former football players linked to vascular, brain changes

Signs of injury to the brain’s white matter called white matter hyperintensities, as seen on brain scans, may be tied more strongly to vascular risk factors, brain shrinkage, and other markers of dementia in former tackle football players than in those who did not play football, according to a study published in the December 20, 2023, online issue of Neurology, the medical journal of the American Academy of Neurology.

“Studies have shown that athletes exposed to repetitive head impacts can have increased white matter hyperintensity burden in their brains,” said study author Michael L. Alosco, PhD, of Boston University Chobanian & Avedisian School of Medicine. “White matter hyperintensities are easily seen on MRI as markers of injury of various causes. We know these markers are more common as people age and with medical conditions such as high blood pressure, but these results provide initial insight that they may be related to multiple aspects of brain damage from repetitive head impacts.”

Reference: Brain lesions in former football players linked to vascular, brain changes; Neurology

Study: Spinal cord injury causes acute and systemic muscle wasting

Acute spinal cord injury (SCI) patients lose body weight and muscle mass, despite being on a high-calorie diet while in the intensive care unit. Their muscle wasting is substantial and extends beyond what can explained by inactivity or denervation (loss of nerve supply) alone.

Research led by The Ohio State University Wexner Medical Center and College of Medicine published in the journal Science Translational Medicine sheds new light and decodes early muscle loss after SCI to provide an unprecedent first understanding that muscle wasting.

Reference: Study: Spinal cord injury causes acute and systemic muscle wasting; Science Translational Medicine, DOI: 10.1126/scitranslmed.adh2156

Women’s risk of infertility increases by 3% for every Kg of weight gained

Obesity has significant implications for fertility and reproductive health. However, evidences linking abdominal obesity to female infertility were limited and inconclusive. Our objective was to figure out the potential relationship between waist circumference (WC) and infertility among women of childbearing age in the United States using data from the National Health and Nutrition Examination Survey (NHANES).

Researchers conducted cross-sectional study included 3239 female participants aged 18–45 years. To explore the independent relationship between WC and female infertility, the weighted multivariable logistic regression and smoothed curve fitting were performed. Interaction and subgroup analyzes were then conducted for secondary analysis.

Reference: Ke J, Feng Y, Chen Z (2023) Association between waist circumference and female infertility in the United States. PLoS ONE 18(12): e0295360. https://doi.org/10.1371/journal.pone.0295360

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Just In: MCC releases Final Results For NEET SS Round 2 Counselling

Delhi: The Medical Counselling Committee (MCC) has released the Final Result for Round-2 of NEET SS Counselling 2023 (for D.M/ M.Ch/ DNB SS Courses).

The provisional seat allotment result includes Rank, Qualifying Exam, Allotted Institute, Course and Remarks. To view the list, click on the link below –

https://medicaldialogues.in/pdf_upload/2023122398-228584.pdf

The candidates can now approach the allotted college/institute only after the declaration of the Final Result and only after downloading the allotment letter from the MCC website.

Recently, the provisional allotment results were announced. If any discrepancy in the result was found, the candidates were asked to inform to MCC of DGHS up to 12:00 Noon of 23.12.2023 through email on the Email id: mccresultquery@gmail.com.

The Medical Counselling Committee (MCC) is an organisation under the Directorate General of Health Services (DGHS) affiliated to the Ministry of Health and Family Welfare, Government of India and responsible for allotting seats for undergraduate, postgraduate and super-speciality medical and dental courses in government-run/aided colleges and deemed-to-be-university colleges. It allots seats online on the basis of the candidate’s score in the National Eligibility cum Entrance Test (NEET). Factors considered during allotment are merit, reservation eligibility and the preference list submitted by the candidate.

Also Read:Provisional Results Of NEET SS Round 2 Counselling released

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MP: Stray dog roams inside patient ward of Chhatarpur district hospital, probe ordered

Chhatarpur: In a shocking incident, a stray dog was allegedly found roaming inside the patient ward of the Chhatarpur district hospital on Thursday. The concerned authorities are probing the mattter.

A serious negligence of the Chhatarpur district hospital management has come to light as a stray dog was found roaming inside the patient wards of the hospital on Thursday. 

After the incident, the Chief Medical and Health Officer (CMHO) said that it was a serious matter and strict action would be taken against the concerned person.

“It is a very serious matter that stray dogs are roaming inside the patient ward. I will instruct the civil surgeon to take strict action against the concerned employees. There should not be such mismanagement.

Also Read:Resident Doctor Safdarjung Hospital gets brutally attacked by pet dog, FIR registered against owner

It also causes infection, it may bite anyone and anything can happen. So, it is a very serious issue, I will tell the civil surgeon to make proper arrangements and ensure that this kind of carelessness should not happen again,” CMHO Lakhan Tiwari told ANI.  

According to the hospital management, there has been an influx of women patients for sterilisation operations here these days and around 80 women patients were operated on Thursday.

Meanwhile, amid the sterilisation operations in the hospital, construction works are also going on the hospital due to which there is dust near the operation theatre but no prevention arrangements were made by the hospital management.

Reacting to it, CMHO Tiwari said, “There are arrangements where the operation is being conducted in the district hospital. There are no major issues of dust but the civil surgeon can make arrangements to stop it by putting curtains. The civil surgeon is being directed to fix the disorders at earliest and there should be no such carelessness again.”

Besides, an Anganwadi ASHA worker, Sangeeta Yadav also said that there was no proper cleanliness in the hospital and there was a lot of fear of the infection.

“We encourage women from our villages and bring them here for sterilisation. After the operation, we take them home and take care of them for eight days. I want to say that attention should be paid here for cleanliness and also we Asha workers and our beneficiaries are not treated properly,” She told ANI.

“There is a lot of fear of infection among the women because of dust and the construction work going on here. We all have been informed about the problems in our respective blocks but we didn’t hear back from them yet,” the ASHA worker added.

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USFDA issues 6 observations for Zydus Lifesciences Ahmedabad facility

Ahmedabad: Zydus Lifesciences has announced that the U.S. Food and Drug Administration (USFDA) has closed the inspection with 6 observations at the Company’s API site situated at Changodar,
Ahmedabad.

This PAI-cum-GMP USFDA inspection was conducted from December 14 to December
22, 2023.
“There were no Data Integrity related
observations. There are no repeat observations from the previous inspection.
There are 4 DMFs of this site under approval with the USFDA. The Company will closely work with
the USFDA to address the observations” the Company informed in a recent BSE filing.
Medical Dialogues team had earlier announced that the Company had received the Establishment Investigation Report (EIR) report from the USFDA for the injectables manufacturing facility at Zydus Biotech Park located at Changodar, Ahmedabad.

Read also: Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad

Formerly known as Cadila Healthcare Limited, Zydus Lifesciences Limited is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the production of generic drugs. Cadila was founded in 1952 by Ramanbhai Patel.

Read also: Zydus Lifesciences arm Zydus Noveltech dissolves

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Dr M Jayachandra Reddy honoured with prestigious Young Surgeon of India Award

Tirupati: Dr M Jayachandra Reddy, Oncology specialist and OSD at Srinivasa Balaji Institute of Oncology (SVIMS) has bagged the prestigious award of Young Surgeon of India given by the Association of Surgeons of India. The award was presented to Dr Jayachandra Reddy at its annual convention held at Visakhapatnam.

A press release has been issued in this regard by TTD Public Relations Officer, Tirupati. Dr. Jayachandra Reddy is the first person to receive this prestigious award in the state of Andhra Pradesh. He is working as an Honorary Consultant for Andhra Pradesh Government Cancer Detection – Prevention and Chemotherapy Day Care Centers. TTD EO Sri AV Dharma Reddy and JEO for Health and Education Smt Sada Bhargavi lauded the SVIMS doctor for his great achievement. 

Also Read: UCMS Professor Dr Satendra Singh conferred National Annual Award for Medical Humanities 2023

The prestigious award underscores Dr Reddy’s exceptional skills, dedication, and significant impact within the realm of surgery, particularly in the field of oncology. As an accomplished oncologist, Dr Jayachandra Reddy has played a pivotal role in advancing the understanding and treatment of cancer, contributing to both patient care and the broader medical community. The Young Surgeon of India award is a testament to his commitment to excellence, innovative practices, and noteworthy service in the domain of surgical oncology. 

The Association of Surgeons of India (ASI) was established in 1938 to facilitate surgeons across the country to share their experiences. It started with 112 doctors and now has grown up to have over 30,000 doctors in the association. The association calls for applications for the Young Surgeon of India Award for which those under the age of 40 years are eligible. However, the doctor must be a Full Member of ASI for a minimum of 5 years. Marks will be calculated based on paper presentation, publication, participation in CME, conferences, and workshops. 

Also Read: Renowned Diabetologist Dr V Mohan Receives Prestigious Lakshmipat Singhania Award from President Droupadi Murmu

In 2022, Dr. Shivanshu Misra from Kanpur received the award and in 2021, Dr. K Senthil Kumar from Chennai was honoured with the award. SVIMS Director Dr B Vengamma, Dean Dr Alladi Mohan, Registrar Dr KV Sreedhar Babu, Medical Superintendent Dr Ram, RMO Dr Koti Reddy and other faculty congratulated Dr Reddy for becoming the first doctor to get the award from AP.

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MUHS Releases Tentative Timetable For 2nd, 3rd, 4th BDS New Practical Exams Winter 2023

Maharashtra: Maharashtra University of Health Sciences (MUHS) has released the tentative timetable for the 2nd, 3rd, and 4th BDS (New) practical exams (winter 2023).

The exams will be conducted in the month of January 2024. The timetable is divided into 3 parts: 2nd, 3rd, and 4th BDS (New) practical exam. The detailed schedules are enclosed in the notice below.

The following are the courses included –

2nd BDS (New) –

1. Gen Patho & Micro

2. Gen Dental Pharma & Therapy

3. Dental Material

4. Pre-Clinical Conser

5. Pre-Clinical Prostho

3rd BDS (New) –

1. General Medicine

2. General Surgery

3. Oral Patho & Oral Micro

4th BDS (New) –

1. Public Health Dentistry

2. Periodontology

3. Orthodontics & Dentofacial Orthopaedic

4. Oral Medicine & Radiology

5. Oral & Maxillofacial Surgery

6. Conservative & Endodontics

7. Prosthodontics and Crown & Bridge

8. Paediatric & Preventive Dentistry

No right or equality can be claimed for a change in the date and schedule of practical examinations (winter 2023). This is a tentative timetable and is likely to change based on the strength of students appearing for respective subjects. Club centers of Practical Examination (if any) are likely to change based on the actual strength of students appearing for respective subjects.

The college and batch-wise timetable will be forwarded separately.

Maharashtra University of Health Sciences (MUHS) is a higher education institution in Nashik, Maharashtra. The university was established on June 3, 1998, by the Government of Maharashtra through an ordinance. The State Legislature passed the ordinance, and the Maharashtra University of Health Sciences was declared open by the governor of Maharashtra on June 10, 1998. All colleges and institutions imparting education in health science in the state of Maharashtra have been affiliated with this new university under Section 6(3) of the Act.

To view the notice, click on the link below –

https://medicaldialogues.in/pdf_upload/examinationpractical-time-table-winter2023181223-1-228148.pdf

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NIMHANS and Ashraya Hastha Trust sign MoU to implement mental health programme in two taluks

Bengaluru: The National Institute of Mental Health and Neuro Sciences (NIMHANS), Bengaluru and the Ashraya Hastha Trust (AHT) have signed a Memorandum of Understanding (MoU) with multiple stakeholders to implement a comprehensive rural mental health programme named ”NAMAN” in two different taluks in India to test the feasibility of rolling out such a programme across the country, a press release by the Health and Family Welfare Department said on Monday.

The national launch of the programme will be held today at the Convention Centre, NIMHANS.

According to the statement, the proposed Naman programme will be completed within three years. NIMHANS will develop the road map for the overall implementation of the programme, and All India Institute of Medical Sciences (AIIMS), Rishikesh, will collaborate with NIMHANS as a sub-hub for successful implementation of the programme in Uttarakhand.

Also Read:New mental health hospital to come up in Kolhapur with hi-tech facilities

Both NIMHANS, Bengaluru, and AIIMS, Rishikesh, will collaborate with the health departments of the governments of Karnataka and Uttarakhand. The Ashraya Hasta Trust has provided financial assistance for the smooth operation of the programme, the release further stated.

“The vision of NAMAN is to implement a comprehensive taluka-level mental health programme that incorporates mental health promotion, preventive strategies, treatment of mental disorders, and rehabilitation.

The two taluks selected to implement the programme are Munsiyari taluk of Pithoragarh district of Uttarakhand State and Belur taluk of Hassan district of Karnataka, to cater to the mental health needs of the whole population of the two taluks. The programme plans to follow a lifespan approach, which would cover the entire population from womb to tomb,” the statement further stated.

Dinesh Gundu Rao, Minister, Department of Health and Family Welfare Services, Karnataka, will grace the occasion.

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Increased Skin Cancer Risk in Lower Extremity Lymphedema Patients

A recent retrospective cohort study conducted at the Mayo Clinic in Rochester, MN, sought to evaluate whether individuals with lower extremity (LE) lymphedema had a higher propensity for skin cancer compared to matched controls without lymphedema. Led by Dr. Nimay C. Anand and colleagues from Meharry Medical College in Nashville, Tennessee, the study spanned from January 2000 to December 2020 and encompassed 4,437 patients with LE lymphedema, alongside age-, race-, and sex-matched controls.

The comprehensive analysis revealed a striking association between LE lymphedema and an increased risk of skin cancer. Patients with lymphedema in their lower extremities exhibited a significantly elevated risk compared to the control group. Specifically, within the subset of patients with unilateral lymphedema, the lymphedematous extremity showed 2.65 times the likelihood of developing skin cancer, particularly basal cell carcinoma, compared to the nonlymphedematous lower extremity.

The findings underscore the importance of vigilance and specialized monitoring for individuals grappling with LE lymphedema. Clinicians caring for these patients should remain vigilant and conduct regular screenings, especially considering the increased risk of skin cancer, including basal cell carcinoma and squamous cell carcinoma, as well as angiosarcoma as anticipated.

The study prompts further investigations into the underlying mechanisms and pathogenesis of skin cancer development in individuals with LE lymphedema. Dr. Anand and the research team emphasized the necessity for future studies to delve deeper into the distinctive aspects of skin cancers arising in lymphedematous lower extremities. This includes exploring whether these cancers exhibit unique histological characteristics or differ in prognostic outcomes compared to those occurring in nonlymphedematous extremities.

The study, published online in Mayo Clinic Proceedings, disclosed associations between some authors and the pharmaceutical industry, emphasizing the need for transparency regarding potential conflicts of interest in medical research.

  • Participants: 4,437 patients with LE lymphedema

  • Risk Association: Lymphedema group showed significantly increased risk of skin cancer compared to matched controls

  • Risk Magnitude: Lymphedematous extremity in unilateral lymphedema showed 2.65 times increased likelihood of skin cancer, notably basal cell carcinoma

This study highlights a critical consideration for clinicians, accentuating the need for tailored monitoring and vigilant care for patients coping with LE lymphedema. Further research is anticipated to illuminate the nuanced aspects of skin cancer development in this demographic, paving the way for more personalized and effective management strategies.

Reference:

Anand, N. C., Campbell, E. H., Baum, C. L., Gibson, L. E., Todd, A., Bradt, J. L., & Alavi, A. Association of lower extremity lymphedema and nonmelanoma skin cancers. Mayo Clinic Proceedings. Mayo Clinic,2023;98(11):1653–1659. https://doi.org/10.1016/j.mayocp.2023.02.030

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