Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) Single-Dose Vial, a generic therapeutic equivalent version of (RLD), LEVOPHED injection of Hospira Inc.

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients with acute hypotensive states. According to IQVIA (IMS Health), Norepinephrine Bitartrate Injection USP had US sales of approximately $40 million for the 12-month period ending June 2023.

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Venus Remedies has secured marketing authorisation from Serbia for gemcitabine and docetaxel, widely used chemotherapy drugs. With this, the company has secured 511 marketing approvals for its oncology products across 66 countrles.

Oncology drugs constitute the largest proportion of the Serbian pharma market (projected to reach $397.40 million in 2023), where Venus Remedies has secured five marketing approvals, all ln the oncology space. The high prevalence of breast cancer, ovarian cancer, pancreatic cancer and cancers of the lung and intestine is a key driver of the global oncology market, which was valued at $286.04 billion in 2021 and is projected to reach $536.01 billion by 2029 at a compounded annual growth rate (CAGR) of 8.2 per cent from 2021 to 2030.

Aditi K Chaudhary, President, International Business, Venus Remedies, said, “We have more than 40 marketing authorisations in South Eastern Europe and Balkan region, including nine for oncology drugs, and we are now banking on the product registrations for gemcitabine and docetaxel from Serbia to pave the way for faster approvals for cancer medicines in other countries in this part of Europe.”

Venus Remedies secured a marketing authorisation for gemcitabine from Bosnla a few months ago, which was followed by marketing approvals for docetaxel from Georgia and two other key cancer drugs from Moldova.

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Biocon has approved the appointment of Peter Bains as the Group CEO, with effect from September 18, 2023. He will be reporting directly to Biocon Group Chairperson, Kiran Mazumdar-Shaw.

Bains has accordingly stepped down from his role on the Biocon Board as an Independent Director with immediate effect, to assume this strategic executive responsibility.

Welcoming this appointment, Mazumdar-Shaw said, “Biocon is entering a dynamic phase of growth for its three core businesses, Biocon Biologics, Biocon Generics and Syngene, and for the Group as a whole. I am delighted to welcome Peter back to the Biocon Group in the role of Group CEO.  Siddharth Mittal, CEO & MD, Biocon, Shreehas Tambe, CEO & MD Biocon Biologics and Jonathan Hunt, CEO & MD, Syngene International will continue to have independent charge of their businesses and will work with Peter to strengthen synergistic strategic leadership at a Group level to maximise the combined value of all three businesses. Peter has a unique fit and profile for the role having both extensive global leadership experience and success across the biopharmaceutical field and a comprehensive understanding of the Biocon Group, having led Syngene for five years, taking it through its very successful IPO in 2015. I am confident that this appointment will serve the integrated business objectives of the Biocon Group of companies and deliver added value to all stakeholders.”

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Dassault Systèmes introduced “Emma Twin,” an avatar designed to raise awareness of the key role that virtual twins have in advancing healthcare and the innovations that are shaping the future of medicine.

Through a social media programme, Emma Twin will share stories explaining how the virtual twin of her body was created from anonymous health data to be used for an infinite number of tests that give doctors and researchers a profound understanding of diseases and the effects of new and improved treatments.

Her social media posts will document her participation in ongoing research and medical innovations including:  clinical trials using Medidata solutions; the reaction of her heart to different procedures in the Living Heart project; testing CorNeat Vision’s corneal transplants; epilepsy and Alzheimer’s disease studies in the Living Brain project; wearing the IASO drug administration and monitoring device; and optimizing the home for older adults.  They will also highlight: DAMAE Medical’s portable microscope for detecting skin cancer; Dynocardia’s blood pressure monitoring solution; FEops’ cardiac monitoring; LUCID Implants’ customised facial implants; and the VORTHEx radiotherapy simulation experience.

“Through Emma Twin, we will share stories about the impact of virtual twins on healthcare, in an engaging, meaningful way. Our virtual twins have been used to swiftly develop COVID-19 vaccines, optimise surgical procedures, and provide patients with a greater understanding of treatment options.  By leveraging our pioneering technology, we can draw attention to major healthcare challenges and demonstrate how the virtual world improves outcomes in real life,” said Victoire de Margerie, Vice President, Corporate Equity, Marketing & Communications, Dassault Systèmes.

Virtual twins accelerate the development of solutions to urgent needs for more precise, preventive healthcare by enabling research and health-related disciplines to model, test and treat a human body as precisely, safely and effectively as other industries can with cars, buildings or airplanes.

Emma Twin is the next act in Dassault Systèmes’ “The Only Progress is Human” initiative, dedicated to healthcare and patient experience.  In 2020, the company launched The Only Progress is Human to increase awareness of societal and environmental challenges and inspire the use of virtual worlds to drive sustainable innovations in areas such as urbanisation and water conservation.

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The World Spice Congress hosted at Mumbai by the Spices Board of India saw the launch of a cardamom-based nutraceutical called Recovereez. Zum Heilen Diagnostic & Therapeutics, a startup company based in Thrissur in Kerala has developed the product and formulation and has been awarded the Indian patent. The product was launched by Amar Singh Bhatia IAS -Chairman Spices Board, D Sathyan, IFS – Secretary Spices Board, and Dr Remahsree, Director, Spices Board.

Reportedly, a comprehensive clinical study conducted by Dr Varkey and his team has revealed that cardamom has profound anti-inflammatory activities, solidifying its potential as a valuable addition in treatment of various conditions ranging from respiratory health to cancer.

The ongoing studies being done by Dr Varkey along with Dr Remashree and her team at the Indian Cardamom Research Institute (ICRI) under the Spices Board of India also substantiated cardamom’s anti-inflammatory properties applicable in the treatment of triple receptor negative breast cancer, a variant of breast cancer that often has poor response to current treatments.

Dr Varkey said,  “Our research sheds light on cardamom’s untapped potential as a natural anti-inflammatory agent and its application across many diseases with a simultaneous monitoring of the inflammatory genes that give confidence to the treating doctors. We have developed novel molecular diagnostic tests done from saliva that measure gene markers that are capable of giving the doctor and the patient information on the response to   the cardamom-based nutraceuticals. The implications for such an integrated approach are unique and immense, offering a promising avenue for both preventive measures and therapeutic interventions.

Indian Cardamom Research Institute is collaborating with Zum Heilen on completion of clinical trials in breast cancer to then offer this product to the global market as an adjunct treatment along with standard care

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Torque Pharmaceuticals has launched a campaign in honour of World Pharmacist’s Day on September 25, 2023. This film portrays the compassion and dedication demonstrated by pharmacists, showcasing their willingness to go the extra mile in caring for their customers. This initiative seeks to pay tribute to and celebrate pharmacists.

Abhay Iqbal Singh Bedi, Director Torque Pharmacueticals said, “On World Pharmacist Day, we pay tribute to the compassionate unsung champions of healing. This film beautifully encapsulates the profound connection of empathy and gratitude shared between a pharmacist and a customer. Through this cinematic endeavor, we aspire to raise awareness and champion the pivotal role of pharmacists in enhancing global healthcare, aligning with this year’s theme: ‘Pharmacists fortifying the foundations of health systems.’

Created and conceptualised by Torque Pharma, this campaign kickstarted with a digital film. Post the digital film, the campaign aims to share examples of empathy and going the extra mile for customers. Through this film, Torque Pharmaceuticals aims celebrates every pharmacist who play an active role in bettering people’s lives in times of sickness and placing customers’ interest above theirs.

Watch the digital film here: https://youtu.be/wPPv4QCTCTE

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Blue Star Industrial Solutions, a division of Blue Star Engineering & Electronics, has forged a partnership with the Gebhardt Intralogistics Group, a German corporation. Blue Star Industrial Solutions specialises in quality testing and automation offerings and the collaboration with Gebhardt further strengthens its capabilities. Gebhardt offers automated picking, packaging, conveying and storage solutions, including mechatronics, controls and software systems.

Through this partnership, Blue Star will enhance its warehouse automation solutions capabilities in India. Simultaneously, Gebhardt will leverage this collaboration to expand its global presence, with a focus on emerging markets like India.

The demand for warehouse space in India is growing rapidly due to GST, the growth of the e-Commerce sector, and investments by PEs.  Grade A warehouses ideal for automation are becoming more common and the increasing scale of warehouse operations is driving demand for automated solutions that provide better inventory management and operational excellence. Warehouse Automation Solutions help manage growing SKU-mixes, deliver higher throughput, and better utilise vertical space to counter high rentals. They also adhere to export standards and reduce touch points (especially in the F&B and pharma sectors), improve productivity and optimise manpower requirement.

Blue Star Industrial Solutions offerings include automatic storage and retrieval systems, automated truck loading systems, conveying and palletising solutions, and packaging optimisation, complemented by tailored software designed for warehouse operations.

The alliance between Blue Star Industrial Solutions and Gebhardt Intralogistics Group will empower both organisations to seize the rising demand for advanced warehouse automation solutions and serve a broader customer base.

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Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day (USRLD: Ortho Evra Transdermal System, 150 mcg/35 mcg per day).

Norelgestromin and Ethinyl Estradiol Transdermal System contains combination hormone medication and is used to prevent pregnancy. This is the third hormonal transdermal patch to be approved from Zydus’ generics portfolio. The transdermal patch will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad.

Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day had annual sales of $330 million in the US (IQVIA MAT July 2023).

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LIC has sold two per cent of its holding in Sun Pharma for Rs 4,699 crore via open market sale.

“Corporation’s shareholding in Sun Pharma has diluted from 12,05,24,944 to 7,22,68,890 equity shares decreasing its shareholding from 5.023 per cent to 3.012 per cent of the paid-up capital of the said company,” said LIC  in a regulatory filing.

It also informed that the shares were sold at an average price of Rs 973.80 per share.

(Edits by EP News Bureau)

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Strides Pharma Science announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tivicay Tablets of ViiV Healthcare Company. The approval adds to a list of products that Strides has approved under the PEPFAR pathway taking the total to 13 products.

The Dolutegravir 50mg tablet has a market opportunity in the US of $1,345 million per IQVIA. The products will be manufactured at the company’s facility in Bengaluru. The conversion of this tentative approval to a full approval is expected upon expiry of the constraining patents.

The PEPFAR tentative approval for Strides qualifies the Company to participate in global donor funded programs that procure this lifesaving medicine and it is supplied in 126 countries. As of full year 2022, donor procurement for Dolutegravir 50mg tablet is estimated at a value of $35 million. This product further strengthens the available offerings in HIV treatment from Strides.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch 60 new products over three years in the US.

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