Aurobindo Pharma arm gets marketing authorization in UK for Dyrupeg

Hyderabad: Aurobindo Pharma Ltd wholly owned step-down subsidiary CuraTeQ Biologics has obtained
marketing authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for
Dyrupeg, its pegylated filgrastim biosimilar version.

Earlier in April 2025, Dyrupeg received marketing
authorization in the European Union from the European Commission (EC).

This is CuraTeQ’s third
biosimilar to be approved by MHRA after the approval of Bevqolva in December 2024 and Zefylti in May
2025.

Aurobindo Pharma Limited, is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 30+ manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s product portfolio is spread over seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and AntiAllergic, supported by a strong R&D set-up.

Read also: Aurobindo Pharma arm Curateq Biologics incorporates new wholly owned subsidiary in Netherlands

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Common pregnancy complications may be signals of future stroke risk

Women who experience complications during pregnancy face a higher risk of stroke in the following decades, according to research published in the European Heart Journal.

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Phase III trial shows gene therapy skin grafts help heal chronic wounds in blistering skin disease

Skin grafts genetically engineered from a patient’s own cells can heal persistent wounds in people with an extremely painful dermatologic disease, a Stanford Medicine-led clinical trial has shown. The grafts treat severe dystrophic epidermolysis bullosa, or EB, a genetic condition in which the skin is so fragile the slightest touch can cause blistering and wounds, eventually leading to large, open lesions that never heal and are immensely painful.

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‘Pill-on-a-thread’ could replace endoscopies for half of all patients being monitored for esophageal cancer risk

Endoscopies could be replaced by far less invasive capsule sponge tests for half of all patients with Barrett’s esophagus, a known precursor to esophageal cancer, according to a new study by researchers at the University of Cambridge, Addenbrooke’s Hospital and Queen Mary University of London. The research was published in The Lancet.

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Zoning out could be beneficial—and may actually help us learn faster

Aimlessly wandering around a city or exploring the new mall may seem unproductive, but new research from HHMI’s Janelia Research Campus suggests it could play an important role in how our brains learn.

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Heart valve for young children shines in early-stage preclinical testing

Researchers at the University of California, Irvine have successfully performed preclinical laboratory testing of a replacement heart valve intended for toddlers and young children with congenital cardiac defects, a key step toward obtaining approval for human use. The results of their study were published recently in the Journal of the American Heart Association.

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Gland Pharma Visakhapatnam facility gets USFDA EIR

Hyderabad: Gland Pharma, a generic injectable & ophthalmic focused pharmaceutical company, has announced that the Company has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (US FDA) indicating closure of the inspection at its facility at JNPC, Visakhapatnam.

The USFDA had conducted a Pre-Approval Inspection (PAI) for Sterile Active Pharmaceutical Ingredients (APIs) at the site from February 19 to February 25, 2025. 

Read also: Gland Pharma ropes in Wriddhee Maitra as Vice-President (Human Resources)

Medical Dialogues team reported in February that the company had received three Form 483 observations from the USFDA following the inspection. 

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Read also: Gland Pharma gets 3 USFDA observations for Visakhapatnam facility

Separately, on June 4, Gland Pharma received approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Angiotensin II Acetate Injection, 2.5 mg/mL. This injection is indicated for increasing the blood pressure in adults with septic or other distributive shock. 

The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), GIAPREZA of La Jolla Pharma LLC.

Read also: USFDA greenlights Gland Pharma BP injection in adults with septic shock

Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It operates primarily under a business-to-business (B2B) model and develops, manufactures, and markets sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.

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Delay in 504-Bed approval hits patient care at Sassoon Hospital

Pune: Despite being fully operational and serving hundreds of patients daily, the 11-storey building at BJ Medical College and Sassoon General Hospital (BJMC & SGH) in Pune is still awaiting official approval for 504 beds from the state’s Medical Education and Drugs Department (MEDD). According to hospital officials, the delay has severely affected recruitment, procurement of medicines, and the delivery of essential patient services. 

Hospital officials further stated that, following approval by the Medical Education and Drugs Department (MEDD), the file would be forwarded to the state finance department for final clearance.

The building—which houses the paediatric, pulmonary, orthopaedic, and radiology departments—was originally proposed in 2009 following the swine flu epidemic. However, it took over a decade to construct and was hurriedly made operational in 2020 during the COVID-19 pandemic to accommodate the surge in serious cases.

Dr Eknath Pawar, dean at BJMC & SGH, said, “As of now, we are working at 66% of staff strength at the hospital and medical college. For the hospital’s old buildings, we have an approval for 1,296 beds and for that we have an approved staff strength of 3,091,” reports TOI.

As per hospital records, of the 2,359 sanctioned posts for Class 1 to 4 employees in the older hospital buildings, only 1,565 have been filled. The remaining 794 vacancies significantly hinder service delivery. Similarly, BJ Medical College has filled only 424 of its 732 sanctioned posts.

Also Read: Less than 50 per cent Faculty, Infrastructure Gaps: NMC Issues show-cause notices to Pune GMCs

According to TOI, Dr Pawar said, “We had in 2022 sent a proposal seeking approval for 504 beds at the 11-storey building and also the staff required for those beds. We are yet to get a response on it. About the vacancies in the approved posts, we have already issued a tender to fill the class four posts, and in the next two months, 350 workers will be recruited. For class 1 and 2 posts, the recruitment process is underway via the Maharashtra Public Service Commission.”

The impact of the staff shortage is evident in the daily struggles faced by patients and their families. Maya Jagtap, whose relative is admitted to the orthopedic ward of the 11-storey building, mentioned that nurses or class IV workers are often unavailable to assist patients in reaching the radiology department for scans. As a result, she said, family members must remain near the building constantly to support their loved ones.

Hasan Mushrif, Minister of Medical Education, stated that he would look into the matter and, if the approval was pending at his level, ensure it was completed within a week. He added that he would immediately follow up on the proposal with the Secretary of the Medical Education and Drugs Department (MEDD).

Dr Sanjay Dabhade, a BJMC alumnus and city-based health activist, criticized the state’s handling of the issue. He pointed out that it took 11 years to complete the construction of the 11-storey building, which was only inaugurated during the COVID-19 pandemic, and now the government is further delaying the approval of beds.

Also Read: BJ Medical College Pune ragging case: HOD Orthopaedics removed, transferred

Speaking to TOI, he said, “The hospital is always struggling to manage the existing patient load, but with additional patients coming in, it will soon reach a breaking point. Why should it take five years to approve the beds that are already in use? This hospital is not only the hope for serious patients who come from different districts of Maharashtra but also for many homeless and poor people. Without enough staff, patient services are hampered gravely and there would be constant conflict between patients and healthcare workers. State govt must immediately approve these beds and the staff required.”

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Odisha doctor promoted posthumously, sparks outrage

Rourkela: The Odisha government has drawn criticism after promoting and transferring a doctor from the Birkera Community Health Centre (CHC) in Sundargarh district, even though he passed away over two months ago. The incident has raised questions about administrative oversight, especially during a time when several regions are reportedly dealing with a cholera outbreak. 

Medical Dialogues had previously reported that Odisha Chief Minister Mohan Charan Majhi directed the health department to take urgent measures to prevent the spread of diarrhoea and cholera to neighbouring districts. As part of the containment measures, the authorities have begun disinfecting drinking water sources, temporarily banned street food sales, and intensified food safety inspections in affected areas. According to a statement from the Chief Minister’s Office (CMO), all health facilities in the affected districts have been placed on high alert. “Neighbouring districts have also been advised to remain vigilant. Disinfection of drinking water sources has begun in Jajpur, alongside a temporary ban on street food sales and intensified food safety inspections,” the statement added.

Also Read: Odisha CM directs measures to curb rising diarrhoea, cholera cases

Dr Smruti Ranjan Samal, a 46-year-old block public health officer from Sundargarh district, was listed in a recent government order as having been promoted to additional public health officer (TB), despite his death on April 6.

Speaking to TOI, Chief District Medical Officer Guru Mahanta said Samal’s demise was communicated to the health department, but the letter may have been overlooked.

The apparent oversight occurred in an order issued on Thursday by the commissioner-cum-secretary of the health department, which included the promotion and transfer of several doctors, including Dr. Samal.

Also Read: Odisha HC directs immediate action as Cholera Outbreak spreads

According to TOI, the order also said the authorities concerned are requested to relieve the medical officers under their administrative control without waiting for a substitute, in order to enable them to join their new places of posting to ensure seamless functioning of the health system amid the ‘cholera outbreak’.

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Anti-aging drug Rapamycin extends lifespan as effectively as eating less: Study

The anti-aging drug Rapamycin has the same life-extending effect as eating less, according to new research from the University of East Anglia and University of Glasgow.

Dietary restriction has long been considered one of the most reliable methods for increasing lifespan across species.But if fasting for hours sounds unpleasant, science may suggest another route to achieving a longer and healthier life.A new study published today reveals compelling evidence that Rapamycin, a compound originally developed as an immunosuppressant, offers comparable life-extending benefits in eight species of vertebrates, not including humans.Co-lead researcher Dr Zahida Sultanova, from UEA’s School of Biological Sciences, said: “Dietary restriction – for example through intermittent fasting or reduced calorie intake – has been the gold standard for living longer. But it’s difficult for most of us to maintain long-term.“We wanted to know if popular anti-aging drugs like Rapamycin or Metformin could offer similar effects without the need to cut calories.”The research team looked at data from 167 studies of lifespan across eight vertebrate species including fish, mice, rats and primates – in this, the largest study of its kind.

They investigated the effect of dietary restriction on longevity – as well as that of Rapamycin and Metformin, both of which have been touted as life-extending drugs.

The team found that Rapamycin extends lifespan almost as consistently as eating less, while the Type 2 diabetes medicine, Metformin, does not.

Key findings:

  • Dietary restriction – from intermittent fasting to cutting calories – consistently extended lifespan across all vertebrate species analysed in this study.
  • Rapamycin increased lifespan to the same extent as dietary restriction.
  • Metformin showed no clear longevity benefit although it is widely used for type 2 diabetes.
  • Lifespan gains were the same for males and females, and did not depend on the type of diet restriction.

As scientists continue the search for interventions that can improve our health and help us live longer, Rapamycin may stand out as one of the most promising tools – potentially sidestepping the challenges of long-term caloric restriction while offering similar benefits.

Co-lead researcher Dr Edward Ivimey-Cook, from the University of Glasgow, said: “These findings don’t suggest we should all start taking Rapamycin. But they do strengthen the case for its further study in aging research and raise important questions about how we approach longevity therapeutics.”Dr Sultanova added: “Our findings show that drug repurposing is a promising approach to improving people’s health and lifespan”.Both Rapamycin and Metformin are currently being used in human trials, with results still pending.

The authors note that Rapamycin may have negative effects on the immune system, and further research into safety in humans is necessary, although recent work indicates that low-dose Rapamycin has no serious adverse effects in healthy people.

This research was funded by the Natural Environment Research Council (NERC) and the Leverhulme Trust.‘Rapamycin, not metformin, mirrors dietary restriction-driven lifespan extension in vertebrates: a meta-analysis’ is published in the journal Aging Cell.

Reference:

Zahida Sultanova, Aging Cell, Rapamycin, not metformin, mirrors dietary restriction-driven lifespan extension in vertebrates: a meta-analysis.

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