Zydus barred from selling cancer drug Sigrima as Delhi HC restores injunction in favour of Roche

New Delhi: Upholding the patent rights of Swiss pharmaceutical giant F-Hoffmann-La Roche AG, the Delhi High Court has once again reinstated an interim injunction issued by a single-judge against Zydus Lifesciences, preventing the drug maker from manufacturing, selling, or marketing its biosimilar drug ‘Sigrima’, which is allegedly similar to Roche’s breast cancer drug ‘Perjeta’.

Earlier, a Division Bench of Justice Yashwant Varma and Justice Ravinder Dudeja stated that the single-judge had incorrectly vacated the injunction order of July 9, 2024 despite stating several times that it would not go into the validity of the injunction.

The case centers around a patent infringement suit filed by the Swiss against Zydus, taking objection to the production of ‘Sigrima’ . It alleged that the product was a biosimilar of the original Pertuzumab (Perjeta).

A single-judge on July 9, 2024 had granted interim injunction in the matter to prevent Zydus from manufacturing or marketing the contested product. However, on 9 October 2024, the Single Judge vacated this injunction, reasoning that Roche had failed to establish a prima facie case, the balance of convenience, or the likelihood of irreparable harm.

While passing the order, the single-judge had extended the interim injunction till October 23 to allow the Swiss company to file an appeal.

Also Read: Zydus Life science’s anticancer drug Pertuzumab Gets CDSCO Panel Nod for Additional Indication of Early breast cancer

On appeal, the Division Bench on October 16 reinstated the interim injunction as per which Zydus stands restrained “from marketing/ selling their product “Sigrima”, which is a biological similar of Plaintiffs’ “Perjeta ®”/ “Pertuzumab“.

In its order of October 16, the court had observed;

“Once the learned Single Judge had taken the position that the correctness or otherwise of 09 July 2024 was not being proposed to be gone into, we fail to comprehend or appreciate how the said order could have been ultimately vacated. We consequently have no hesitation in holding that the impugned order is rendered wholly unsustainable.”

Additionally, it directed single-judge to consider the matter afresh.

Also Read: Roche Gets CDSCO Panel Nod To study Anticancer FDC Pertuzumab, Trastuzumab

Subsequently, when the matter came up for hearing before single-judge on November 5, Senior Advocate Rajshekhar Rao, appearing for Zydus, submitted that it has filed an appeal before the Supreme Court against restoration of the injunction.

Recognizing that Zydus has filed a Special Leave Petition (SLP) before the Supreme Court challenging the Division Bench’s reinstatement of the interim injunction, single-judge Justice Amit Bansal decided to defer further hearings on the interim applications. The court emphasized that it would await the Supreme Court’s determination on the matter before proceeding with the case.

In light of this, the judge scheduled the next hearing for December 2, 2024. Until that time, the interim order issued on July 9, 2024, which restrains Zydus from marketing or selling its biosimilar drug Sigrima, will remain in effect, Bansal added.

Justice Bansal said;

“Mr Rajshekhar Rao, senior advocate appearing on behalf of the defendants submits that the defendant has filed an SLP against the aforesaid order of the Division Bench which is likely to be listed shortly. Accordingly, it is submitted that the hearing in the present applications be deferred for some time. In view of the fact that an SLP has been filed on behalf of the defendant, I deem it appropriate to defer the hearing in these applications. List on 2nd December, 2024. In the interregnum, the interim order dated 9th July, 2024 shall continue.”

To view July 9, 2024 order, click on the link below:

To view the latest (November 5, 2024 ) order, click on the link below:

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Medical Bulletin 16/ November/ 2024

Here are the top medical news for the day:

Can AI Detect Cancerous Brain Tumor in 10 seconds?
Researchers have developed an AI powered model that — in 10 seconds — can determine during surgery if any part of a cancerous brain tumor that could be removed remains, a study published in Nature suggests. The technology, called FastGlioma, outperformed conventional methods for identifying what remains of a tumor by a wide margin, according to the research team led by University of Michigan and University of California San Francisco.
When a neurosurgeon removes a life threatening tumor from a patient’s brain, they are rarely able to remove the entire mass. Neurosurgical teams employ different methods to locate that residual tumor during a procedure. They may get MRI imaging, which requires intraoperative machinery that is not available everywhere. The surgeon might also use a fluorescent imaging agent to identify tumor tissue, which is not applicable for all tumor types.
In this international study of the AI driven technology, neurosurgical teams analyzed fresh, unprocessed specimens sampled from 220 patients who had operations for low- or high-grade diffuse glioma. FastGlioma detected and calculated how much tumor remained with an average accuracy of approximately 92%.
In a comparison of surgeries guided by FastGlioma predictions or image- and fluorescent-guided methods, the AI technology missed high-risk, residual tumor just 3.8% of the time — compared to a nearly 25% miss rate for conventional methods. To assess what remains of a brain tumor, FastGlioma combines microscopic optical imaging with a type of artificial intelligence called foundation models.
These are AI models, such as GPT-4 and DALL·E 3, trained on massive, diverse datasets that can be adapted to a wide range of tasks. After large scale training, foundation models can classify images, act as chatbots, reply to emails and generate images from text descriptions. To build FastGlioma, investigators pre-trained the visual foundation model using over 11,000 surgical specimens and 4 million unique microscopic fields of view.
Reference: Hollon, T., Kondepudi, A., Pekmezci, M., Hou, X., Scotford, K., Jiang, C., … & Hervey-Jumper, S. (2024). Visual foundation models for fast, label-free detection of diffuse glioma infiltration.
Neuropathic Pain Medication May Increase Risk of Hip Fracture
Gabapentinoid use was associated with an increased risk of hip fractures, especially in patients who were frail or had chronic kidney disease, according to a study published in JAMA Network. The researchers tracked patients hospitalised for hip fractures in Victoria, Australia from March 2013 through June 2018, who had used gabapentinoids before the injury.
Study co-author and Director of the Centre for Medicine Use and Safety (CMUS) at the Monash Institute of Pharmaceutical Sciences, Professor Simon Bell, said gabapentinoids can be effective for neuropathic pain but can also result in adverse events including dizziness, gait disturbance and balance disorder. The researchers analysed the data for 28,293 patients who experienced hip fractures across a five-year period.
“Our results showed patients had 30 per cent increased odds of suffering a hip fracture within two months of being dispensed a gabapentinoid medication,” Professor Bell said.
“The link between gabapentinoids and hip fractures existed across different age groups but the odds of hip fracture was higher among patients who were frailer or had chronic kidney disease, so these should be important considerations when deciding when to prescribe gabapentinoids.”
Lead author of the study and CMUS PhD candidate Miriam Leung, said the study highlights that caution is needed before prescribing gabapentinoids, especially for people who are prone to falls and fractures.
“Our findings highlight the importance of assessing each patient’s risk before prescribing gabapentinoids,” Ms Leung said.
Reference: Leung MTY, Turner JP, Marquina C, et al. Gabapentinoids and Risk of Hip Fracture. JAMA Netw Open. 2024;7(11):e2444488. doi:10.1001/jamanetworkopen.2024.44488
How Embracing Social Media Mindfully Can Lower Stress
Young people’s mental health may depend on how they use social media, rather than how much time they spend using it, according to a new study by University of B.C. researchers.
The research published in Journal of Experimental Psychology: General, examined the effects of quitting social media versus using it more intentionally.
The results showed that users who thoughtfully managed their online interactions, as well as those who abstained from social media entirely, saw mental health benefits particularly in reducing symptoms of anxiety, depression and loneliness.
With social media use nearly universal among young adults, especially those ages 17-29, concerns over its impact on mental health have grown.
In the six-week study, 393 Canadian young adults with some mental health symptoms and concerns about social media’s impact on their mental health were split into three groups:
• a control group that continued their usual routines
• an abstinence group asked to stop using social media entirely
• a “tutorial” group that was coached in intentional usage
The tutorials guided participants on fostering meaningful online connections, limiting interactions that encouraged self-comparison, and carefully selecting who they followed.
Both the abstinence and tutorial groups reduced their social media use and experienced fewer social comparisons—a common trigger for anxiety and low self-esteem. While the tutorial group didn’t cut back on social media as much as those who tried to abstain completely, they reported notable improvements in loneliness and fear of missing out.
Researchers used an approach with the tutorial group that emphasized quality over quantity in social media interactions. By muting or unfollowing accounts that triggered envy or negative self-comparisons and prioritizing close friendships, tutorial participants built a healthier online environment. Rather than passively scrolling, they were encouraged to actively engage with friends by commenting or sending direct messages—a behaviour that tends to deepen meaningful connections while helping users feel more socially supported.
Reference: Mikami, A. Y., Khalis, A., & Karasavva, V. (2024). Logging out or leaning in? Social media strategies for enhancing well-being.Journal of Experimental Psychology: General. Advance online publication. https://doi.org/10.1037/xge0001668
Plastic Waste to Double by 2050 But Study Finds Bluprint to Tackle Plastic Crisis
Without intervention, global plastic waste could double by 2050, a new machine learning study predicts. However, according to simulations by the study’s authors, a mix of policy interventions could cut plastic waste by more than 90% and it could cut plastics-related emissions by a third. With UN treaty negotiations underway, these findings provide a crucial blueprint for tackling the plastic crisis. Plastic production has increased relentlessly for decades, leading to surging plastic waste generation and environmental mismanagement. As plastic degrades, it fragments into micro- and nano-plastics, which harm ecosystems globally – from the Arctic to deep ocean habitats – and pose significant health risks, including heightened cancer risks, cardiovascular disease, and reproductive issues. The plastic lifecycle also intensifies climate change through emissions from oil and gas extraction, production, and waste processing. The disproportionate plastic waste burden on the Global South and the frequency of situating plastic facilities near marginalized communities have sparked pressing environmental justice concerns. Recently, there has been global momentum to address these issues, culminating in a 2022 United Nations resolution to negotiate a legally binding treaty to curb plastic pollution.
To help in this effort, Samuel Pottinger and colleagues developed a novel machine learning model to forecast trends in global plastic production, trade, and waste management to 2050. They also simulated the effects of eight plausible policy interventions to mitigate waste and emissions. Pottinger et al. found that, without interventions, annual mismanaged plastic waste is anticipated to almost double by 2050, reaching 121 million metric tons. Concurrently, annual greenhouse gas emissions from the global plastic system are projected to rise by 37% over the same period. However, the authors also show that a combined policy intervention approach involving a production cap, recycling mandate, packaging tax, and infrastructure investment could reduce mismanaged plastic waste by up to 91% and decrease 2050 plastics-related emissions by about a third. “Collectively, these observations provide timely insight into how to maximize the impact of the UN plastic pollution treaty both as it is being drafted and over the longer time horizon of its implementation,” write Pottinger et al. “It is clear from these results that, with sufficient political will, there is enough technical potential to dramatically reduce mismanaged plastic waste and meaningfully address some of the more insidious associated issues.”
Reference: A. Samuel Pottinger et al., Pathways to reduce global plastic waste mismanagement and greenhouse gas emissions by 2050.Science0,eadr3837DOI:10.1126/science.adr3837

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10 MBBS students of Mahabubnagar Medical College suspended for ragging juniors

Hyderabad: Acting on complaints of ragging instances at Mahabubnagar Medical College, the authorities recently suspended 10 second-year MBBS students for allegedly ragging juniors during a freshers’ party in the college hostel. 

According to the administration, these seniors belonging to the 2023 batch were captured ragging the freshers in the CCTV footage of the college. After investigating the matter, the administration found evidence of their involvement and suspended them till December 1.

Also read- 8 MBBS students of Barmer Medical College expelled for ragging juniors, 6 issued warning

Although the incident came to light recently, it happened on November 10 when a group of seniors allegedly harassed and mistreated freshmen. Feeling humiliated, the juniors raised their voice against the alleged mistreatment and inappropriate behaviour of the seniors and approached the college management. 

As per a TOI news report, the freshers wrote anonymous complaints to the college authorities informing them about the ragging incidents.  

Speaking on this matter, a senior professor from the college said “There were a lot of complaints from the junior students against the 10 students. Hence, they were suspended for 20 days starting Nov 11. Their parents were summoned to the college in connection with the incident.”

Intervening in the matter, the college management held a counselling session for both the seniors and the juniors involved in the incident on November 13. After the session was over, the college authorities reviewed the complaints and CCTV footage on the day of the incident and accordingly suspended the seniors. 

According to a Telangana Today news report, the Director of the college, Dr Ramesh asked the junior students to approach the management, if they were being ragged or if someone misbehaved with them. He stated that no such incidents would be tolerated on the campus.

Further, the college management has constituted a committee to take note of any further ragging incidents on the campus. It had also decided to intensify surveillance on the campus, especially during the night. 

Also read- Juniors forced to shave heads- 5 MBBS students of Raipur’s Medical College suspended for ragging

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Multi-quantifying maxillofacial traits via a demographic parity-based AI model

A study published in BME Frontiers has unveiled a novel artificial intelligence (AI) model capable of multi-quantifying maxillofacial traits with remarkable precision and demographic parity. The research was conducted by a team of experts including Zhuofan Chen, Xinchun Zhang, Zetao Chen, and their colleagues at the Hospital of Stomatology, Guanghua School of Stomatology.

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New imaging technique reveals detailed map of brain’s blood flow in 3D

A newly developed technique uses a Bessel beam to extend the focus of optical coherence microscopy, allowing for a detailed imaging of large sections of the brain. Unlike traditional methods that either look at tiny volumes or lose detail over larger areas, this approach provides a comprehensive view of the vascular network.

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Scientists discover a rare missense variant in STAT6 that protects against asthma

Scientists at deCODE genetics and collaborators have published a study in the Journal of Allergy and Clinical Immunology reporting a rare missense variant in STAT6 that protects against asthma.

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Experts forecast an ongoing depression and cost of care burden through 2032 in Hong Kong

The first depression health economic modeling study, led by Professor Shirley Li Xue, from the LKS Faculty of Medicine, the University of Hong Kong (HKUMed), revealed that Hong Kong will face a significant and ongoing burden of depression from 2023 to 2032. While fewer than 20% of the cases are expected to develop treatment-resistant depression (TRD) or related comorbidities, this group is expected to account for close to half of depression-related medical costs in the city.

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Students who use dating apps take more risks with their sexual health, research finds

In May, the WHO raised the alarm over the rise in the incidence of sexually transmitted illnesses (STIs) in many regions of the world, currently running at more than a million new cases per day. Among high-income countries, the US has one of the highest prevalence of STIs, and this problem is getting worse. For example, the incidence of chlamydia has more than doubled since 2000, while gonorrhea increased by 40% and syphilis by 400%. The highest prevalence is among young adults between 20 and 34 years of age.

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NABH adopts FOGSI’s Manyata maternal health standards in certification programs

Mumbai: In an effort to enhance maternal healthcare services and support the goal of achieving Universal Health Coverage, the National Accreditation Board for Hospitals & Healthcare Providers (NABH) has integrated The Federation of Obstetric and Gynaecological Societies of India (FOGSI)’s Manyata maternal health quality standards across NABH Certification programs.

According to the PTI report, this move forms part of a strategic collaboration inked in 2022 between NABH and FOGSI, to improve the quality of maternity services and advance the Indian government’s vision of ‘One Nation One Standard’. By promoting standardization in maternal healthcare through the adoption of uniform standards nationwide, the collaboration will drive systemic improvements and contribute to efforts to achieve Universal Health Coverage.

Manyata is FOGSI’s flagship quality improvement and certification initiative that acts as a stamp of quality ensuring consistent, safe, and respectful care for mothers during and after childbirth. It promotes the adoption of evidence-based clinical standards based on the World Health Organization’s (WHO) standards of quality care in maternal health for antenatal, intrapartum, and postpartum care.

Also Read:Apollo Clinic secures NABH certification for its clinics in Karnataka

To launch the collaboration, a pilot program was conducted where 200 private maternity facilities trained on Manyata standards were assessed by NABH assessors, who were specifically onboarded and trained for this purpose by FOGSI. The pilot results showed consistent certification success rates whether facilities were assessed by FOGSI or NABH assessors.

Moving forward, facilities pursuing NABH Entry-Level certification will be able to achieve dual certifications for NABH and Manyata, validating their compliance with both national healthcare standards and specialized maternity care protocols, with the NABH HOPE portal providing a digital platform for application processing and assessments. Additionally, leveraging its network, FOGSI will identify assessors who will be trained by NABH to create a dedicated pool of NABH assessors specializing in obstetrics and gynaecology.

Reflecting on the announcement, Mr Rizwan Koita, Chairman of NABH said, “Uniform standards are crucial for ensuring that every mother receives consistent care, regardless of where she delivers. By incorporating Manyata guidelines into NABH certification programs, we are not only strengthening our accreditation framework, but also setting a new benchmark for maternal health.

This standardization will play a vital role in transforming maternal care across India. In addition, NABH will incorporate maternal health guidelines into NABH Digital Health Standards for Hospitals and HIS/EMR Systems engaged in mother and childcare.”

Dr Madhuri Patel, Secretary General, FOGSI said, “With 1.3 million Indian women having lost their lives to maternal causes over the past two decades, and despite a 70% overall decline in maternal mortality rates, there is a need to accelerate the progress. To achieve the UN’s 2030 Sustainable Development Goals and realize universal health coverage, we must deepen our resolve to bolstering healthcare systems. By harnessing the power of collaborations we can standardize care protocols, improve service delivery, and create sustainable solutions that enhance maternal healthcare accessibility.”

Dr Hrishikesh D. Pai, Trustee, FIGO Asia Oceania, Immediate Past President, FOGSI, and Chief Administrator, FOGSI-Manyata initiative, remarked, “The collaboration between FOGSI and NABH represents a pivotal step towards fostering a culture of excellence, accountability, and patient-centric care in the private healthcare sector. We are dedicated to building on this success and broadening the impact of the initiative. It will not only encourage wider adoption of best practices but also forge a path towards a future where every childbirth experience is safe, supported and dignified”, news agency PTI reported.

Dr Rishma Pai, Former President, FOGSI said, “By embedding Manyata’s comprehensive protocols into NABH’s certification guidelines, we aim to create a robust, unified system that elevates the quality of maternal care across the board. Expanding access to quality healthcare and standardizing the care delivered is not merely a goal but a moral imperative-one that will ensure the safety of every mother and child who visit these facilities.”

Preventable maternal deaths continue to be a significant concern in India. The announcement promises a welcome step towards addressing the issue. Establishing standardized care protocols in the healthcare sector is critical to enhance the delivery of maternal care in India, helping achieve better health outcomes.

Additional quotes from key stakeholders, who are not present in the room but have shared their perspectives, are included below:

Dr. Atul Mohan Kochhar, CEO of NABH said, “The integration of Manyata’s standards into our accreditation process marks a transformative step toward enhancing safe maternal healthcare. This collaboration allows us to align our efforts with FOGSI’s expertise, ensuring that accredited hospitals meet comprehensive maternal health protocols. Our aim is to create a sustainable model for quality accreditation that benefits mothers and newborns nationwide.”

Dr. Hema Divakar, National Convener, FOGSI-Manyata initiative said, “This announcement reflects FOGSI and NABH’s shared vision of ensuring that every mother, regardless of her circumstances, receives the compassionate and exceptional care she deserves.

Through a joint Technical Working Group, with members from FOGSI and NABH, we are working to streamline the quality standards to ensure they represent an ideal blend of infrastructure and labor room compliance, serving the best interests of mothers and newborns. This strategic alignment not only reinforces our commitment to patient safety and clinical excellence but also highlights the benefits of a unified approach to delivering high-quality, standardized care.”

Also Read:First in Vadodara: Parul Sevashram Hospital achieves NABH Platinum Level Digital Accreditation

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NTRUHS Invites Applications for PG AYUSH Courses 2024, Registration Open Till November 18

Andhra Pradesh- Dr NTR University of Health Sciences (Dr NTRUHS) is inviting applications from candidates who fulfil the eligibility criteria for admission to PG AYUSH i.e. MD (Homeo) and MD/MS (Ayurveda) courses under the competent authority quota of Dr. NTRUHS for the academic year 2024-25. On this, Dr NTRUHS has released a notification detailing the fees, qualifying percentile, etc regarding the admission to said courses.

The eligible candidates can apply for the PG AYUSH i.e. MD (Homeo) and MD/MS (Ayurveda) courses admission under the competent authority quota of Dr NTRUHS 2024 from today i.e. 15th November 2024, 09.00 AM to 18th November 2024, 06.00 P.M.

REGISTRATION FEES

S.NO

CATEGORY

REGISTRATION FEE INCLUDING 18% GST

TOTAL AMOUNT

BHMS & BAMS Completed Within AP

1

OC/BC

Rs.5,900/- (5,000/- + 900/- GST 18%)

Rs.5,900/-

2

SC/ST

Rs.4, 956/- (4,200/- + 756/- GST 18%)

Rs.4,956/-

S.NO

CATEGORY

REGISTRATION FEE INCLUDING 18% GST

IN ADDITION TO REGISTRATION & VERIFICATION FEE INCLUDING 18& FE

TOTAL AMOUNT

BHMS & BAMS Completed Outside AP

1

OC/BC

Rs.5,900/- (5,000/- + 900/- GST 18%)

Rs.3,540/- (3,000/- + 540/- GST 18%)

Rs.9,440/-

2

SC/ST

Rs.4, 956/- (4,200/- + 756/- GST 18%)

Rs.3,540/- (3,000/- + 540/- GST 18%)

Rs.8,496/-

However, it is to be noted that once the fee is paid will not be refunded under any circumstances.

ELIGIBILITY

National Commission for Homoeopathy (NCH) & National Commission for Indian System of Medicine (NCISM), Ministry of AYUSH, Govt. of India New Delhi notified that the minimum qualifying percentile criteria of AIAPGET-2024 are reduced by Fifteen percentile across all categories for admission into PG ASU i.e., MD (Homoeo) & MD/MS (Ayurveda) courses for the Academic year 2024-25. Therefore, candidates having the following qualifying cut-off scores and above are eligible to apply for PG AYUSH i.e., MD (Homoeo) & MD/MS (Ayurveda) Courses-

S.NO

CATEGORY

REVISED MINIMUM QUALIFYING CRITERIA

1

General Category (UR/EWS).

35th percentile

2

OBC/SC/ST.

25th percentile

3

General (UR) Category (EWS/PwBD) Persons with Benchmark Disability.

30th percentile

4

OBC/SC/ST/ (PwBD) Persons with Benchmark Disability.

25th percentile

To view the notification, click the link below

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