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  • Roivant, Pfizer form new Vant company focused on developing TL1A drug candidate for inflammatory and fibrotic diseases


    Roivant Sciences and Pfizer Inc. announced formation of a new Vant to develop and commercialize PF-06480605 (now RVT-3101). RVT-3101 is a fully human monoclonal antibody targeting TL1A, which is currently in phase 2b development in ulcerative colitis (UC). The Vant has the exclusive option to collaborate with Pfizer on a next-generation TL1A directed antibody which recently entered phase 1.

    RVT-3101 is a potential first-in-class agent that targets both inflammatory and fibrotic pathways by inhibiting TL1A, which has been shown to modulate the location and severity of inflammation and fibrosis by stimulating TH1 and TH17 pathways, in addition to activating fibroblasts. As such, RVT-3101 has the potential to provide greater efficacy by hitting multiple inflammatory pathways as well as fibrotic pathways.

    RVT-3101 has been evaluated in an earlier phase 2 study (TUSCANY) in 50 patients, and is being evaluated in a large global phase 2b study (TUSCANY-2) in 245 adult participants with moderate to severe ulcerative colitis. The induction portion of TUSCANY-2 is complete, and the maintenance portion remains ongoing.

    “Our internally discovered antibody against TL1A, could potentially be the first agent to bring biomarker-selected precision medicine to people living with inflammatory bowel disease,” said Mikael Dolsten, Pfizer’s chief scientific officer, President, Worldwide Research, Development and Medical. “We are very excited about the preliminary data from the TUSCANY-2 study and for this new Vant to drive the advancement of this asset. At the same time, it enables Pfizer to bring additional innovative breakthrough medicines and vaccines to patients in need more quickly, allowing us to serve more people.”

    “We believe in RVT-3101’s potential to transform the inflammatory bowel disease landscape, which has long been in need of new, innovative therapies with greater efficacy,” said Mayukh Sukhatme, president and chief investment officer of Roivant. “We are excited about this collaboration with Pfizer on a potential first-in-class program, which we intend to pursue in both ulcerative colitis and in additional inflammatory and fibrotic diseases. TUSCANY-2 builds on the earlier TUSCANY data with many firsts for the class – TUSCANY-2 is the first study with subcutaneous efficacy data and the first dose-ranging study – and is among the largest phase 2b studies ever conducted in the indication. We are encouraged by the preliminary data and look forward to presenting our data and to seeing other results from the class.”

    Inflammatory bowel diseases are chronic inflammatory diseases of the gastrointestinal tract. It is estimated that up to 2 million US adults suffer from inflammatory bowel diseases, which include ulcerative colitis and Crohn’s disease. There is significant unmet treatment need for patients with inflammatory bowel disease. High rates of treatment failure mean that approximately 50% of patients are cycling off a given therapy within 6 to 12 months and are unlikely to achieve sustained remission. The commercial markets for these diseases for advanced therapies is nearly $15 billion per year in the US alone and growing. Available treatments have very low remission rates, and thus there is a large need for an efficacious and safe therapy.

    A new Vant or Roivant subsidiary has been created to develop and fund these programs. The Vant will be fully responsible for funding global development of RVT-3101 in UC and in additional inflammatory and fibrotic diseases and holds commercial rights in the US and Japan. Pfizer owns a 25% equity position in the Vant and maintains commercial rights outside of the US and Japan as well as representation on the company’s board of directors.

    In addition, the Vant has the exclusive option to collaborate with Pfizer on a next-generation TL1A directed antibody which recently entered phase 1. The Vant will have the right to enter into an agreement for global development with a 50/50 cost share as well as co-commercialization rights with Pfizer prior to phase 2 (expected in 2025).

    Roivant’s mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity.

  • Metropolis Foundation commences the on-ground execution of adopting TB patients under the Pradhan Mantri TB Mukt Bharat Abhiyaan


    Metropolis Foundation, the CSR arm of Metropolis Healthcare, announced that it has commenced the on-ground execution of adopting TB patients under the Pradhan Mantri TB Mukt Bharat Abhiyaan. Under the Ni-Kshay Mitra 2.0 initiative, Metropolis is extending the nutritional support to 650 consented TB patients in Mumbai district residing at ‘L’ ward (Kurla).

    According to Brihanmumbai Municipal Corporation (BMC), Mumbai has a high load of TB patients with few of the 24 wards with high TB burden. And it has been observed that one such ward with higher number of TB cases is ‘L’ ward (Kurla) in Mumbai.

    Metropolis Foundation (being a Ni-Kshay Mitra) will be working closely with DTO, L ward and will be supporting the TB patients with monthly grocery kits from Apna Bazaar Co-op for the next 6 months. Under this initiative, the patient will be provided with a printed voucher at the health post where he/she is receiving medicines. The patient will then have to reach out to one of the Apna Bazar stores identified to collect their pre-packed high protein Nutrition Kit. The store will honour the voucher and the kit will be handed over to the patient free of cost. The reimbursement will be done later to the respective store by Metropolis Foundation.

    Dr. Duru Shah, chairperson of Metropolis Foundation said, “The global target to end TB as per the Sustainable Development Goals is to reduce TB incidence by 80%, TB deaths by 90% & cut catastrophic costs due to TB by 2030. The ‘Pradhan Mantri TB Mukt Bharat Abhiyaan’ envisioned by our Hon’ble Prime Minister of India intends to eliminate TB in India by 2025 which is 5 years ahead of global target of 2030. In line with the ongoing campaign, we are delighted to collaborate with the Brihanmumbai Municipal Corporation (BMC) and Apna Bazar Co-op. to support the government’s efforts in the National TB Elimination Programme.”

    Dr. Kirti Chadha, chief scientific officer and group head – CSR, Metropolis Healthcare commented, “The ultimate aim of this initiative is to ensure continued adherence to treatment, improvement in weight and overall immunity of the patient, decreasing the out-of-pocket expenses and sick leaves. We believe that the quicker recovery of TB patients can help in lesser transmission of TB in society.”

    At Metropolis, we all understand that underdiagnosis and multi-drug resistance are the two areas in TB, which needs timely, accurate and accessible diagnostic support. Metropolis’ Infectious Disease Division ‘Microxpert’ will handhold the patients and clinicians throughout their journey from diagnosis to treatment by enabling access to accurate lab results and WHO/NTEP approved advisory services through a novel model developed by the Metropolis Healthcare’s Innovation Cell. We strongly believe that this will further support in strengthening the government’s efforts in achieving the TB elimination goals by 2025.

  • iPhone 14 Emergency SOS via satellite rescues US man

    Best features in iPhone 14 Pro you must know about







    Apple iPhone 14 feature “Emergency SOS via satellite” has saved a US man’s life after he became stranded in a rural area.

    With iOS 16.1, Apple introduced Emergency SOS via Satellite feature, which allows iPhone 14 owners to contact emergency services even without a cellular or WiFi connection.

    According to MacRumors, Alaska State Troopers received an alert on December 1 that a man travelling by snow machine from Noorvik to Kotzebue had become stranded.

    In a cold, remote location with no connectivity, the man activated Emergency SOS via satellite on his iPhone 14 to alert authorities to his predicament.

    Emergency SOS via satellite now available on iPhone 14 lineup in US, Canada

    Emergency SOS via satellite now available on iPhone 14 lineup in US, CanadaIANS

    Apple’s Emergency Response Center with local search and rescue teams send out volunteer searchers directly to the GPS coordinates that were relayed to Apple using the emergency function.

    The man was rescued successfully and there were no injuries, according to the report.

    He was located in a remote area with limited satellite coverage.

    Apple says, as Noorvik and Kotzebue are close to 69Ao latitude, satellite connectivity might not be available in places above 62Ao latitude, such as northern parts of Canada and Alaska, the report added.

    Apple Logo

    Apple LogoCourtesy

    Last month, Apple revealed that it invested $450 million in developing the critical infrastructure that supports Emergency SOS via satellite for iPhone 14 models.

    Currently, satellite connectivity is available in North America, and the company will soon expand to France, Germany, Ireland and the UK.

    (With inputs from IANS)

  • Egg Medical’s EggNest radiation protection system receives CE marking


    Egg Medical, Inc., a medical device company commercializing technologies to reduce scatter radiation exposure during interventional angiographic procedures, announced that it has achieved CE Mark for the EggNest XR radiation protection system. The EggNest protects the entire interventional team in hospital x-ray labs (cardiac catheterization, electrophysiology, interventional radiology, and operating rooms) from the harm of long-term exposure to scatter radiation.

    “Occupational exposure of hospital staff to x-rays during medical procedures is an important workplace risk. Almost everyone in the interventional cardiology and radiology profession knows someone with a radiation related illness. There have been minimal improvements in x-ray shielding over the past 30 years, leaving the medical teams working in these environments exposed to scatter radiation every day,” said Robert F. Wilson MD, Egg Medical CEO. “The EggNest platform addresses the problem of hospital personnel radiation exposure for everyone working in these environments by reducing scatter radiation by an average of 91 per cent.”

    With the CE Mark certification, Egg Medical will continue expansion into all markets recognizing the CE Mark.

    “At Egg Medical, our belief is that everyone deserves protection, meaning the entire interventional team,” said Wilson. “With CE mark approval of the EggNest platform, we are bringing this protection to more interventional teams worldwide.”

    Scatter radiation is a form of secondary radiation created when the primary x-ray beam used to image the patient’s anatomy during interventional fluoroscopy procedures is reflected off the patient’s body in the procedure room. Physicians and staff who work in these environments are exposed to scatter radiation during medical procedures (such as angioplasty, stenting, and transcatheter valve treatment), putting them at increased risk for long-term health effects. Mounting published data show a link between this occupational radiation exposure and cancer, cataracts, hypertension, and neuro-degenerative issues, despite the use of standard x-ray shielding.

    The EggNest XR is a comprehensive, scatter radiation protection system fully integrated into the workflow of the modern Cath Lab. The system is built on a novel carbon fiber platform with integrated radiation shielding that replaces the patient mattress on the x-ray table. It protects the entire medical team regardless of location, dramatically reducing scatter radiation exposure. Testing performed by the company and confirmed by independent hospital studies have shown that the EggNest system reduces room scatter radiation by 91 per cent vs. standard shielding.

  • Apple’s AR headset to use xrOS operating system; what to expect

    Apple Far Out event quick highlights







    Apple’s upcoming AR (augmented reality) headsets will reportedly feature the tech giant’s own operating system ‘xrOS’ (extended reality).

    According to Bloomberg, the tech giant decided to name the software powering its AR headsets ‘xrOS’ instead of the previously rumoured RealityOS or rOS, reports Gizmochina.

    It will also come with a dedicated app store, similar to the Apple TV and Apple Watch.

    Apple AR headset

    Apple AR headsetIANS

    The company is also developing a Software Development kit, which will allow third-party developers to make applications for the new platform.

    It is still unclear when the new device will be launched but some reports indicated that the product might be launched in the first half of 2023, the report said.

    In October this year, it was reported that the tech giant’s AR headsets are likely to use iris scan instead of Face ID or Touch ID to identify people.

    Apple, Special Event, September 2018, live update

    AppleApple Event Page (screen-grab)

    The design of the upcoming AR devices are expected to feature mesh fabrics, aluminium, and glass.
    It was rumoured that the company is working on three different AR headsets.

    One of the headgear is likely to launch in 2023. It might cost up to $3,000 and include a pair of 4K OLED panels as well as 15 side-facing camera modules.

    (With inputs from IANS)

  • Flipkart joins Polygon to launch metaverse use cases in e-commerce space

    Flipkart Group walks the talk; empowering 20mn Indians in next decade through Flipkart Foundation







    Flipkart on Friday partnered Ethereum-based Blockchain platform Polygon to set up a centre of excellence (CoE) that will work on research and development of Web3 and metaverse commerce use-cases in India.

    Still in its early days, decentralised technologies are yet to become more mainstream.

    However, the partnership will be an opportunity to create a large impact and deliver on the promise of Web3 for all, the companies said in a statement.

    flipkart

     [Representational Image]Reuters

    “With the COE, we look forward to working with Polygon and leveraging their expertise and technical know-how to successfully onboard users not just to the value proposition of Web3 or Metaverse commerce but also Web3 in general,” said Jeyandran Venugopal, Chief Product and Technology Officer, Flipkart.

    Earlier this year, the e-commerce platform announced Flipkart Labs to incubate various solutions to bring innovation to the e-commerce space in the country.

    With Labs, Flipkart ventured into Web3 and metaverse commerce to explore non-fungible tokens (NFTs), virtual immersive stores, and other Blockchain-related use cases.

    Global metaverse market expected to reach $996 bn in 2030

    Global metaverse market expected to reach $996 bn in 2030IANS

    Flipkart has launched FireDrops, an easy-to-use NFT platform for brands to explore community building and pivot the value of NFTs around utilities.

    During the festive sale, Flipkart also partnered with eDAO to launch a virtual shopping experience in the metaverse called Flipverse.

    Sandeep Nailwal, Co-Founder of Polygon, said the aim is to bring the next billion users to Web3 and “this partnership will pioneer research and development at the intersection of Web3 and experiential retail”.

    “We see the Blockchain-eCommerce Centre of Excellence as an engine for the evolution of e-commerce in the years to come,” he added.

  • NIH awards $3 million grants to Case Western Reserve University researchers to study second generation fungerp to fight drug-resistant fungi


    Scynexis, Inc., a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, announced that researchers from Case Western Reserve University in Cleveland have been awarded a competitive research grant of more than $3 million by the National Institutes of Health (NIH), to investigate a second generation fungerp (SCY-247) developed by Scynexis as a potential treatment for Candida auris (C.auris), a multidrug-resistant yeast that causes serious and often deadly infections.

    The five-year grant from the National Institute of Allergy and Infectious Diseases of NIH will allow the team led by researchers at the Case Western Reserve School of Medicine and University Hospitals Cleveland Medical Center to evaluate this novel antifungal drug developed by Scynexis. The research team will be led by Mahmoud Ghannoum, Ph.D., professor of dermatology and pathology at the School of Medicine and director of the Center for Medical Mycology at University Hospitals Medical Center, Case Western Reserve University, as principal investigator, and Thomas McCormick, Ph.D., an associate professor at the School of Medicine.

    “It is thrilling to see the NIH fund this important research to investigate oral and IV SCY-247, one of our patented triterpenoid antifungals, to target drug resistant C. auris, where there is great need due to limited treatment options and the potential to save lives,” said Marco Taglietti, M.D., president and chief executive officer of Scynexis. “We congratulate Dr. Ghannoum on receiving this grant and want to express our gratitude for his ongoing commitment to patients suffering from terrible and deadly fungal infections.”

    C. auris has emerged in recent years as a global threat causing serious invasive infections with mortality as high as 60 percent worldwide. The majority of C. auris infections are reportedly resistant to fluconazole (FLU) with variable resistance to other members of the three major classes of clinically available antifungals (azoles, polyenes, echinocandins). Some strains are resistant to all three antifungal classes, thereby limiting treatment options. C. auris has been classified as an “urgent threat” by the Centers for Disease Control (CDC). The World Health Organization (WHO) recently released its first ever fungal priority pathogens list (FPPL), which includes C. auris in the “critical priority group.”

    “There is an enormous need to identify and develop new modalities to treat infections caused by the fungal pathogen Candida auris,” Dr. Ghannoum said. “Because C. auris colonizes the skin and acts as a nidus of infection, developing a drug that can concurrently target skin and exhibit systemic efficacy will be highly innovative and desirable. We will investigate whether SCY-247 is a viable option for eradication of C. auris, and whether this compound is effective against known resistant Candida species. The ability of the compound to treat C. auris brain infection also will be assessed.”

    SCY-247 is a second generation fungerp, a triterpenoid class of antifungals, which represents the first new class of antifungal compounds since 2001, and is under development as a potential systemic therapeutic option. The first generation fungerp, ibrexafungerp, formerly known as SCY-078, [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of the novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. These agents combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. While ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients, SCY-247 is in early pre-IND development. SCY-247 has demonstrated broad-spectrum antifungal activity, in vitro and in vivo. SCYNEXIS anticipates that the US Food and Drug Administration (FDA) may grant SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of SCY-247.

    Scynexis, Inc. is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant.

  • Stock market tanks for the first time after 8th consecutive rise

    Sensex crashes by 1,800 pts as Russia announces military operations against Ukraine







    The domestic benchmark BSE Sensex and NSE nifty-fifty slumped on Friday, owing to the global uncertainty after a sustained rise of 8 days.

    The Sensex is trading at 62,843.39 or down by 440.80 points (0.70%) at 02:00 p.m. and the Nifty is also operating in red at 18,682.60 or down by 129.90 points (0.69%).

    The market is anxiously awaiting the monthly non-farm US payroll data, which is scheduled to be released later in the day as it indicates the Fed’s stance on future rate hikes. The monthly non-farm payroll data provides an important vantage point to look at the overall macroeconomic condition and future course of monetary policy.

    In theory, a rapid increase may lead to higher inflation expectations and the higher-than-usual inflation expectation may lead to higher rate hikes to cool down the economy. The market will respond negatively if the Fed decides to hike above investors’ expectations.

    Sensex

    V K Vijayakumar, Chief Investment Strategist, Geojit Financial Services, said the declining manufacturing activity in the US for November will positively affect the market by confirming the effects of the Fed’s rate hikes in taming inflation.

    The 10-year US bond is around 3.43% which is positive news for the equity market because there is an inverse relationship between bond yields and equity returns. The lower return in the debt market compared to the equity market may discourage investors from investing in bonds and divert the capital inflow towards more attractive investment opportunities like stocks.

    nse nifty, nifty at new high, nifty at historic high, nifty at lifetime high, nifty to cross 10000, nifty to hit 10000, sensex gainers, 3 years of modi govt

    Reuters file

    Despite having some cushioning from lower inflation expectations, some experts believe that market is likely to drift lower and consolidate. As Prashanth Tapse, Senior Vice President for Research at Mehta Equities said, the market is in an overbought technical condition and has been ignoring the recession warning from the US bond market.

    Usually, when the bond market assesses that the US economic outlook is bright, it is reflected in the trading activity through higher yields on long-dated bonds compared to the yields on short-dated bonds. The classic recession indicator is when the yield on short-dated bonds outpaces the yield on long-dated bonds.

    As recovery is unlikely today, it remains to be seen how the veterans react tomorrow with either massive entry into buying or wait for the next week’s performance.

  • US FDA grants 510(k) premarket clearance to NanoVibronix’s dual-actuator ultrasound pain therapy device, PainShield Plus


    NanoVibronix, Inc .,, a medical device company utilizing the company’s proprietary and patented low intensity surface acoustic wave (SAW) technology, announced US Food and Drug Administration (FDA) 510(k) clearance of its PainShield MD Plus, its dual-actuator ultrasound pain therapy device.

    Brian Murphy, CEO of NanoVibronix, stated, “Securing 510(k) clearance for PainShield Plus is a key milestone towards achieving permanent clearance from the FDA and full-scale commercial marketability. Increasingly, healthcare providers and patients are seeking effective, non-pharmaceutical therapies for the treatment of chronic pain. PainShield Plus expands on the effectiveness of its predecessor, our original PainShield M.D., by covering twice the treatment area and broadening the opportunities for application. As a result, we have started the process of making the recommended modifications to the device in order to comply with the FDA standard. In addition, this approval opens the door for us to submit a 510(k) application for our over-the-counter product, PainShield Relief, in the near term.”

    PainShield Plus, like the original PainShield, utilizes ultrasound therapy for the treatment of pain and various soft tissue injuries either directly over joints or orthopaedic hardware and without the need for messy ultrasound gels. The device is an effective solution for avoiding opioid treatments and equips patients to receive therapy independently in the comfort and safety of their own homes.

    The device consists of a reusable driver unit and disposables, which includes a proprietary therapeutic transducer and cover adhesive to deliver a localized ultrasound effect to treat pain and induce soft tissue healing in a targeted area, while keeping the level of ultrasound energy at a safe and consistent level. Its range of applications includes acute and chronic pain resolution through its many mechanisms of action and can be used by patients at home, work or in a clinical setting and can be used even while the patient is sleeping. Patient benefits include ease of application and use, faster recovery time, high compliance, and increased safety and efficacy over existing devices that rely on higher-frequency ultrasound.

    NanoVibronix, Inc. is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including for disruption of biofilms and bacterial colonization, as well as for pain relief.

  • Indian Immunologicals ventures into fish vaccines


    Indian Immunologicals Limited (IIL), a leading vaccine manufacturer, has announced partnership with Central Institute of Fisheries Education (CIFE), Mumbai, an Indian Council of Agricultural Research (ICAR) Institute for the commercial development of vaccine against common bacterial diseases in freshwater fishes. IIL has forayed into Aqua business in October 2022 by launching products for aquaculture health market dealing with pond management and fish or shrimp gut management.
     
    Aquaculture sectors play a vital role in meeting the rising global protein demand as world population is expected to reach 9.8 billion by 2050. India is the 3rd largest fish producer in the global sphere and more than 65 per cent of India’s fish is through Inland Fisheries and Aquaculture. In terms of employment, the sector supports the livelihood of over 28 million people in India, especially the marginalized and vulnerable communities. Export earnings from the fisheries sector was USD 7.76 billion during 2021-2022.
     
    Speaking on the occasion, Dr K Anand Kumar, managing director, Indian Immunologicals Limited said, “IIL has introduced several innovative veterinary vaccines first to the world, like porcine cysticercosis vaccine, FMD+HS+BQ combination vaccine and Theileria vaccine. IIL is again the first in India to get fish vaccines. We are committed to introducing more and more products for the aquaculture market and help shrimp and fish growers to increase their productivity and protect fish schools from various diseases.”
     
    IIL strives to explore solutions for the prevailing challenges faced by Indian fish farmers in their farm production system. CIFE will provide technology for two inactivated bacterial vaccines, one for Columnaris disease, a serious condition affecting numerous freshwater fish species, and other for Edwardsiellosis that cause high degree of mortality, leading to severe economic losses. Both the diseases are extremely common in freshwater fishes and are generally considered to be ubiquitous.
     
    Dr Priyabrata Pattnaik, deputy managing director, Indian Immunologicals Limited added “IIL is planning to introduce vaccines and immunostimulants with tech transfer from various fisheries institutes under ICAR. Several fish vaccine candidates are currently being evaluated by IIL for commercialization. Launch of such vaccines may have a positive impact on reducing indiscriminate use of chemical or antibiotic based treatment methods, helping reduce antimicrobial resistance by fish farmers practicing environmentally sustainable ways of pond and fish health management.”
     
    Dr. CN Ravishankar, director and Vice Chancellor of ICAR-CIFE said “In support of India’s Blue Revolution, I am glad that CIFE and IIL have come together to partner in developing India’s first bacterial fish vaccine”.
     
    Aquaculture in India suffers economic losses due to infections caused by several bacterial, viral, fungal, and other aetiological agents. Currently these infections are being managed by anti-infectives and other conventional measures with varying degrees of success. With the rising concern pertaining to antimicrobial resistance (AMR) and chemical free food products both at global and domestic platforms, there is a growing need for better control measures against these infections. Currently there are no fish vaccines available in India on a commercial scale to prevent aquaculture infections.