Pharma & Health News Top Stories Today – HealthUS lawmaker seeks answers on FDA inspection of Musk's Neuralink 26/03/2024Blumenauer also cited reports by Reuters since late 2022 that described employees' complaints of "hack jobs" of animal experiments due to a rushed schedule, causing needless suffering and deaths. Employees also worried that data quality would be compromised, the media organization reported at the time. He asked the FDA to explain how it reconciled reports […]Regeneron's blood cancer therapy faces setback as FDA raises trial concerns 26/03/2024The FDA said in its response letter that it needs more data from enrollments in dose-finding and confirmatory portions of trials, delaying its decision on the drug, while confirming no issues with clinical efficacy or safety, trial design, labeling or manufacturing.Wipro GE Healthcare to invest Rs 8,000 cr in 5 yrs on medical devices manufacturing, local R&D 26/03/2024Wipro GE Healthcare on Tuesday said it will invest over Rs 8,000 crore in India over the next five years to increase local manufacturing and research and development (R&D) initiatives. The company, a leading global medical technology, pharmaceutical diagnostics, and digital solutions provider, said as a part of the investment, its 'Made in India' PET […]Obesity, a prominent health concern, demands heightened awareness 26/03/2024According to GlobalData's Pharmaceutical Intelligence Centre, the incident cases of obesity in India are expected to increase from 27,295 in 2021 to 34,273 in 2031, ranking it as the highest among the five major markets (Australia, China, India, Japan, and South Korea) in the Asia-Pacific (APAC) region.City’s air quality improved in 5 years, but still above WHO limit, says study 26/03/2024Shared by the Telangana State Pollution Control Board (TSPCB), the study was conducted by IQAir, a Swiss-based air quality technology company. It took records between 2019 and 2023. While an improvement in certain parameters is undeniable, a thorough analysis shows that the PM 2.5 levels in the city continue to be nearly eight times above […]AbbVie to bolster immunity illness drug pipeline with Landos deal 26/03/2024Landos is currently conducting a mid-stage study of its lead experimental drug NX-13 in a type of an inflammatory bowel disease called ulcerative colitis.Higher burden of breast cancer in Tamil Nadu, Telangana, Karnataka, Delhi: ICMR study 24/03/2024According to the projections, the burden of female breast cancer in India in 2025 is expected to be 5.6 million DALYs. Premature deaths due to breast cancer (YLLs) would contribute 5.3 million DALYs to the total burden, with the remaining due to disability (YLDs).Spanish TB vaccine MTBVAC commences clinical trials in India 24/03/2024The trials are carried out by Bharat Biotech in close collaboration with Biofabri. Trials to evaluate the safety and immunogenicity of MTBVAC have started with a pivotal safety, immunogenicity and efficacy trial planned to start in 2025.NEET crash course for govt school students to begin from March 25 24/03/2024Of 12,997 students from govt schools who appeared for NEET 2023 exam, 3,982 of them have cleared the exam. Tamil Nadu has 5000 MBBS seats in 37 govt medical colleges. The state is providing 7.5% special reservation for students from govt schools in MBBS admissions.Centre issues advisory to states, UTs on measures to prevent hospital fires during summer months 24/03/2024The administration has been directed to conduct comprehensive fire safety audits and on-site inspections of all hospitals to assess fire safety compliance. The states have also been asked to ensure that fire-fighting systems, including fire alarms, fire smoke detectors, fire extinguishers, fire hydrants, and fire lifts, are present and fully functional, according to the release. Pharma & Health NewsRegeneron's blood cancer therapy faces setback as FDA raises trial concerns 26/03/2024The FDA said in its response letter that it needs more data from enrollments in dose-finding and confirmatory portions of trials, delaying its decision on the drug, while confirming no issues with clinical efficacy or safety, trial design, labeling or manufacturing.IIT Guwahati completes technology transfer of first recombinant vaccine for swine fever virus 26/03/2024This first recombinant virus-based vaccine for pigs harnesses a reverse genetic platform pioneered and refined at IIT Guwahati. Swine fever, a highly contagious disease among pigs, poses a severe threat with a very high mortality rate, although it does not affect humans.Axsome's sleep disorder drug succeeds in late-stage trial, shares rise 26/03/2024The New York-based company is looking to expand its reach in the market for treatments against the chronic neurological disorder that causes excessive daytime sleepiness and inadvertent naps.Novo ready to seek German insurance coverage of Wegovy for heart use 26/03/2024German health agency G-BA said in guidance documents last week that regulation banning Germany's health system from paying for weight-loss drugs such as Wegovy would not apply in the case of other approved uses of the weekly injection, a boost for Novo Nordisk's efforts to convince governments of its wider medical benefits.AbbVie to bolster immunity illness drug pipeline with Landos deal 26/03/2024Landos is currently conducting a mid-stage study of its lead experimental drug NX-13 in a type of an inflammatory bowel disease called ulcerative colitis.Dr Reddy's inks licencing pact with Pharmazz of US for innovative hypovolemic shock drug Centhaquine 23/03/2024Hypovolemic shock can be caused by severe loss of blood or fluids due to traumatic haemorrhage, postpartum hemorrhage, gastrointestinal bleeding, post-surgical bleeding, diarrhoea or vomiting and can lead to multi-organ failure and death.US FDA grants full approval to AbbVie's ovarian cancer therapy 23/03/2024Elahere was approved for adult patients with a type of cancer which affects the ovaries, fallopian tube, or walls of the abdomen, and have received one to three prior lines of treatment, according to the FDA.Germany's health insurance could cover Wegovy for strokes, heart conditions, agency says 22/03/2024The European Union's drug regulator has been reviewing wider use of the highly popular weight-loss drug Wegovy to include reducing the risk of strokes and heart attacks, adding to the previously-approved use to tackle obesity.EU drug regulator does not refer to Eisai-Biogen Alzheimer's drug in meeting notes 22/03/2024The drug, sold as Leqembi in the United States has been under review in Europe since January 2023. It gained traditional approval in the United States last year and is also approved in other countries, including China and Japan.Dr Reddy’s inks license agreement with Pharmazz to commercialise Centhaquine (Lyfaquin) in India 22/03/2024As per the agreement, Dr Reddy's has received exclusive rights to market and distribute Centhaquine in India. Pharmazz will be entitled to upfront payments and royalties. Dr Reddy’s will market the product under the brand name Lyfaquin, which it shall own. In addition to India, Dr Reddy’s also receives marketing rights for Lyfaquin from Pharmazz […]Entod launches probiotic for management of nasal allergies 22/03/2024The company claims that its R&D has developed an innovative blend of specific clinically evaluated probiotic strains that together could suppress nasal allergies and be useful in managing conditions such as allergic rhinitis. This probiotic called Lactoshield RH is now commercially available following the advice & recommendation of an ENT specialist or rhinologist.Committee to overhaul drug price control mechanism should be chaired by independent expert: Pradeep S Mehta 22/03/2024Mehta was apprehensive of the fact that the said committee will comprise of officials from the Department of Pharmaceuticals, the National Pharmaceutical Pricing Authority (NPPA) and industry representatives.US FDA approves Italfarmaco's drug for Duchenne muscle-wasting disorder 22/03/2024The U.S. FDA has approved privately held Italfarmaco Group's drug to treat Duchenne muscular dystrophy (DMD), an inherited muscle-wasting disorder, the health regulator said on Thursday. The oral drug, to be sold under the brand name Duvyzat, is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD, according to the […]Pharma companies under TSPCB scanner for pollution donated to BRS 22/03/2024In a similar case, Hazelo Lab Private Limited in Yadadri was under scrutiny for groundwater and water pollution. TSPCB, after inspection and monitoring, issued notices on February 5, 2022, to Hazelo Lab Pvt. Ltd. to clear the contaminated water and send it to CETP for further treatment to avoid groundwater contamination. PCB instructed Hazelo Lab […]US FDA classifies recall of Vyaire Medical's respiratory devices as most serious 22/03/2024The medical equipment maker recalled certain models of its AirLife Manual Resuscitators, a single patient-use device intended for respiratory support, due to a manufacturing defect.Wegovy to be covered by US Medicare for heart disease patients 22/03/2024Medicare prescription drug plans administered by private insurers, known as Part D, currently cannot cover obesity drugs. Under the new guidance, however, such drugs would be paid for if they receive U.S. approval for a secondary use that Medicare does cover, the U.S. Centers for Medicare and Medicaid Services(CMS) said.German health ministry says Ozempic exports are not a concern 21/03/2024The head of German drugs regulator BfArM, which is subordinate to the ministry, in November suggested banning exports of Novo Nordisk's Ozempic if other steps fail, as Europe's health systems grapple with shortage of the diabetes drug.'Lupin Digital Health planning India's largest study on impact of digital therapeutics on cardiac rehab' 20/03/2024We’re witnessing an increase in the adoption of the subscription-based model every month, with a growth rate of 40 per cent compared to the previous month. This suggests that doctors are gaining more confidence in the programme, and patients are adopting it even though they have to pay for it out of pocket.Cadila Pharmaceuticals launches iron injection to address anaemia 20/03/2024Redshot injection is an intravenous iron preparation that not only delivers effective amounts of iron but also boasts an exemplary safety profile. With superior tolerability and minimal to zero risk of anaphylaxis, the injection accelerates the improvement of haemoglobin levels and efficiently replenishes depleted iron stores.Dr Reddy's launches cancer treatment drug Versavo in UK 20/03/2024Versavo is a biosimilar of Avastin, a registered trademark of Roche, and is indicated for the treatment of several types of cancers, including metastatic colorectal cancer, lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and metastatic breast cancer, Dr Reddy's Laboratories said in a regulatory filing. WHO newsWHO calls for access to health and humanitarian assistance on fourth day of conflict in Israel and the occupied Palestinian territory 10/10/2023The World Health Organization (WHO) repeats its call for an end to the hostilities that are causing untold suffering in Israel and the Gaza Strip. Over 1000 people have died and many more injured following horrific acts of violence by Hamas and others on Saturday in Israel. Nine hundred people have died and many more […]New funding to ensure 370 million children receive polio vaccinations and to boost health innovation in low-income countries 10/10/2023Today, the European Commission, the European Investment Bank and the Bill & Melinda Gates Foundation announced a new financing partnership to address critical global health opportunities: eradicating polio and ensuring that innovations in health are more accessible to the people who need them most.WHO issues global plan to tackle leading cause of death in childbirth 10/10/2023WHO today released its first roadmap to tackle postpartum haemorrhage (PPH) – defined as excessive bleeding after childbirth - which affects millions of women annually and is the world’s leading cause of maternal deaths.WHO-OHCHR launch new guidance to improve laws addressing human rights abuses in mental health care 09/10/2023Ahead of World Mental Health Day, the World Health Organization (WHO) and the Office of the High Commissioner on Human Rights (OHCHR) are jointly launching a new guidance, entitled “Mental health, human rights and legislation: guidance and practice”, to support countries to reform legislation in order to end human rights abuses and increase access to […]WHO commends Egypt for its progress on the path to eliminate hepatitis C 09/10/2023The Arab Republic of Egypt has become the first country to achieve the "gold tier” status on the path to elimination of hepatitis C as per WHO criteria. This means that Egypt has fulfilled WHO's programmatic coverage targets that will set the country up to achieve the reduced incidence and mortality targets of full elimination […]Governments make progress towards agreeing amendments to the International Health Regulations (2005) 07/10/2023Progress was made this week on many of the over-300 proposed amendments to the International Health Regulations 2005 (IHR). In this fifth round of intensive discussions, taking place under the aegis of the Working Group on Amendments to the IHR (WGIHR) – which includes the 196 States Parties to the IHR, the European Union and the […]WHO recommends R21/Matrix-M vaccine for malaria prevention in updated advice on immunization 02/10/2023 The World Health Organization (WHO) has recommended a new vaccine, R21/Matrix-M, for the prevention of malaria in children. The recommendation follows advice from the WHO: Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Group (MPAG) and was endorsed by the WHO Director-General following its regular biannual meeting held on 25-29 […]WHO, WADA sign memorandum of understanding to collaborate on clean, drug-free sport 02/10/2023The World Anti-Doping Agency (WADA) and WHO have signed a four-year memorandum of understanding (MOU) to allow experts from both international organizations to collaborate and share information on issues where anti-doping and public health intersect.Recommended composition of influenza virus vaccines for use in the 2024 southern hemisphere influenza season 29/09/2023 The World Health Organization (WHO) today announced the recommendations for the viral composition of influenza vaccines for the 2024 influenza season in the southern hemisphere. The announcement was made at an information session at the end of a 4-day meeting on the Composition of Influenza Virus Vaccines, a meeting that is held twice annually. WHO organizes these consultations […]Top donor Germany signs major contribution to WHO for health emergencies; signs host agreement for WHO pandemic hub 28/09/2023Germany deepened its longstanding engagement with WHO on Thursday with two new agreements: one to contribute a further €40 million to WHO’s work in health emergencies, and a second to host the Berlin-based WHO Hub for Pandemic and Epidemic Intelligence.With the new contribution, Germany has provided €53.5 million so far this year to support WHO’s […]