March 2024

Mar 27,2024 London: Gene therapy maker bluebird bio said on Tuesday it plans to revise its financial statements for 2022 and the first three quarters of last year due to accounting errors related to some contract manufacturing agreements. The company said it has identified “material weakness in its internal control over financial reporting”, and will take time till April 16 to file its 2023 annual report that was expected this month. The restatement will have no impact on its revenue or current cash position, said a spokesperson for the company, which has contract manufacturing agreements with Thermo Fisher Scientific and Lonza, among others, according to bluebird’s annual report released last year. Shares of bluebird were down 17 per cent at $1.12 in morning trading. The company said it incorrectly separated the lease and non-lease components of some of the contracts in its reporting, resulting in an estimated understatement of lease assets and liabilities between $100 million and $200 million in 2022. For the first three quarters of 2022 and 2023, the understatement was between $30 million and $125 million each. The restatements come at a time when bluebird is focused on commercialising its three gene therapies, including its recently approved sickle cell disease treatment, Lyfgenia, which is expected to generate revenue from the third quarter. Source: Healthworld

Mar 28,2024 Merck, known as MSD outside of the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved sotatercept-csrk (US Brand Name: Winrevair, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. Winrevair was previously granted Breakthrough Therapy Designation by the FDA. Winrevair is the first FDA-approved activin signaling inhibitor therapy for PAH, representing a new class of therapy that works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH. “Pulmonary arterial hypertension is a rare, progressive and ultimately life-threatening disease in which blood vessels in the lungs thicken and narrow, causing significant strain on the heart,” said Dr. Marc Humbert, Professor of Medicine and Director of the Pulmonary Hypertension Reference Center at the Université Paris-Saclay and investigator on the phase 3 STELLAR study. “Based on the phase 3 STELLAR trial, adding Winrevair to background PAH therapy demonstrated significant clinical benefits compared to background PAH therapy alone. This approval is an important milestone, as it offers healthcare providers a novel therapeutic option that targets a new PAH treatment pathway.” The approval is based on the phase 3 STELLAR trial, which compared Winrevair (n=163) to placebo (n=160), both in combination with background standard of care therapies in adult patients with PAH (WHO Group 1 FC II or III). Results showed adding Winrevair to background therapy increased six-minute walk distance from baseline by 41 meters (95% CI: 28, 54; p<0.001; placebo-adjusted) at Week 24 and significantly improved multiple important secondary outcome measures, including reducing the risk of death from any cause or PAH clinical worsening events by 84% versus background therapy alone (number of events: 9 vs 42, hazard ratio=0.16; 95% CI: 0.08, 0.35; p<0.001). Healthcare providers should monitor hemoglobin and platelets before each dose of Winrevair for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine if dose adjustments are required. Winrevair may increase haemoglobin and may lead to erythrocytosis, which if severe may increase the risk of thromboembolic events or hyperviscosity syndrome. Winrevair also may decrease platelet count and lead to severe thrombocytopenia, which may increase the risk of bleeding; thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Treatment should not be initiated if platelet count is <50,000/mm3. “The Pulmonary Hypertension Association welcomes the development of new therapies for those with PAH,” said Matt Granato, president and chief executive officer, Pulmonary Hypertension Association. “A diagnosis of PAH is a life-changing experience for patients and families due to its chronic, progressive nature. Patients with PAH experience limiting symptoms such as shortness of breath and fatigue. We are excited to see industry research leading to a better understanding of PAH and the development of a medicine in a novel treatment pathway that expands options for the patient community.” “New treatment options continue to be needed for patients with pulmonary arterial hypertension that support important clinical goals, including increasing exercise capacity and improving functional class,” said Dr. Aaron Waxman, executive director of the Center for Pulmonary Heart Diseases at Brigham and Women’s Hospital and investigator on the phase 3 STELLAR study. “Sotatercept added to background therapy has the potential to become a new standard of care option for patients with pulmonary arterial hypertension.” Winrevair is given once every three weeks by subcutaneous injection and may be administered by appropriate patients or caregivers with guidance, training and follow-up from a healthcare provider. Healthcare providers and patients/caregivers should refer to the Instructions for Use for information on the proper preparation and administration of Winrevair. Merck estimates that Winrevair will be available for dispensing by select specialty pharmacies in the US by the end of April. Source: Pharmabiz

Mar 20,2024 Gurgaon: Medanta Hospital on Tuesday filed a complaint alleging that a “deepfake” video that features its chairperson and managing director Dr Naresh Trehan endorsing a weight loss drug is circulating on social media. DCP (cybercrime) Siddhant Jain said an FIR was registered at the Cyber East police station against unidentified accused under sections 419 (impersonation for cheating) and 420 (cheating) of the IPC. The Facebook link of the video, which features Dr Trehan’s face and voice, was deactivated after the complaint was filed. Deepfake refers to content – audio, video and image – that is digitally altered using a type of artificial intelligence called deep learning. It is often used to create fake or hoax online content, mostly to spread misinformation. According to the complaint by Medanta Health Care’s assistant vice-president for marketing, the matter was of “grave concern”. “A fabricated video has surfaced on social media that contains misleading information about a medical treatment. The deep fake video features our CMD Dr Naresh Trehan who can be seen endorsing this particular medication,” the complaint said, adding that the clip “damages the reputation” of the hospital and Dr Trehan. The 35-second clip, the complaint said, has the potential to create panic and confusion by making false claims about a medical breakthrough for obesity. “I request you to take immediate action to remove the video from social media platforms and bring the perpetrators of this deceitful act to justice,” the complainant added. DCP Jain said preliminary investigation suggests the video had manipulated voice recordings of the doctor and a news anchor. “The doctor did not prescribe any such medication as mentioned in the deepfake video. We will be able to say what kind of technology was used to create the fake video after investigation. We have registered a case and started the investigation. A special team was formed to arrest the accused and we have already got credible leads regarding the same,” Jain said. In January this year, Union minister of state for information technology Rajeev Chandrasekhar said the central govt will notify rules that will mandate social media to tackle deepfakes. The rules were being considered as govt’s advisories to the companies weren’t enough, he had said. Source: Healthworld

Mar 25,2024 New Delhi: About 77% of the 56,000 IT sector corporate employees in the age group of 25-40 years suffers from deranged values in several health parameters and 61% have high cholesterol, a clinical study conducted by HCL Healthcare has revealed. The study was conducted on people working in the sector who underwent health checks and doctors’ consultations at its onsite clinics. The objective of this study was to underline the growing need for preventive care in the corporate spectrum of India. The clinical parameters studied included 8 key health conditions – obesity, prediabetes, diabetes, prehypertension, hypertension, anaemia, hypothyroidism and high cholesterol. The study has revealed that high cholesterol (61%) tops the chart with nearly two-thirds of corporate individuals showing deranged values. It is followed by obesity (around 22%), prediabetes (17%), hypothyroidism and anaemia (11% each), diabetes (7%), and then other health problems. The same individual can have more than one abnormal health condition. It was also observed that nearly 44% of the younger population below 25 years of age also suffered from deranged cholesterol followed by anaemia (14%), obesity (13%), hypothyroidism (8%), and prediabetes (7%). These chronic health conditions appear to be growing at a rapid pace and with a higher prevalence among those with advancing age. “We see a considerable rise in the prevalence of these health conditions in the above-40 age group, with high cholesterol, obesity, pre-diabetes, and diabetes topping the list,” quality data analysts said. Only 23% of these employees had their health parameters within range. About 37% of the individuals who were studied had a single chronic health condition while 26% suffered from two conditions followed by 11% having three (comorbidities). Doctors said that the above parameters make up a constellation of common lifestyle problems and noncommunicable diseases which mean that these conditions may have a common underlying cause and can co-exist in an individual. This is clinically called metabolic syndrome and requires timely intervention. Shikhar Malhotra, vice-chairman and CEO of HCL Healthcare, said: “The data clearly shows the incidence of diseases and health abnormalities starting at a much younger age. The health issues that used to begin in the 40s have now shifted base to early 30s. Some fluctuations in health and vitality are normal, attributed to hormonal and metabolic shifts but what is concerning is the amplified stress and lifestyle-induced ailments that are becoming synonymous with such health issues now seen in the 30s.” He added that employers need to give access to basic health check-ups because early intervention in these conditions can help people control symptoms and find timely treatments. “Today, we suffer not just from health problems, but we suffer from a lack of awareness,” he said. Source: Healthworld

Mar 19,2024 New Delhi: Noting that there was no mention of ‘health drink’ in the Food Safety and Standards Act 2006 , the National Commission for Protection of Child Rights has written to the department of consumer affairs of all states and Union Territories recommending that “no drink, beverages including Bournvita and other similar products should be sold under the category of health drink in stores/shops.” NCPCR chief Priyank Kanoongo has also written to the ministry of commerce and industry and recommended that directions may be issued to all e-commerce companies to remove drinks and beverages from the category of health drinks from their sites. The commission has sought an action taken report by March 23. NCPCR said it had taken cognisance of reports regarding “some health — powder drinks claiming to be energy drinks containing high percentage of sugar and other harmful content for health of children ie — Bournvita an energy drink for children”. NCPCR had issued notices to Mondelez India food Pvt Ltd that manufactures Bournvita, ministry of consumer affairs and Food Safety and Standard Authority of India (FSSAI). FSSAI in its response said the word ‘health drink’ is not defined under the Food Safety and Standard Act 2006. Source: Healthworld

Mar 13,2024 The Drugs Controller General (India) (DCGI) has directed the state drug regulators in the country to cancel the product permission granted by them for manufacturing and marketing of certain antibiotic drug combination meropenem and disodium EDTA for injection since it is a new drug and needs approval from the Centre also. DCGI Dr Rajeev Singh Raghuvanshi said that it has come to the notice of the Central Drugs Standard Control Organisation (CDSCO) that some manufacturers are involved in manufacturing and marketing of unapproved drugs which is not yet approved by his office for manufacturing or marketing in the country and falls under the category of new drug. “No new drug shall be manufactured for sale unless it is approved by the licensing authority as defined in Rule 3 of New Drugs and Clinical Trial Rules, 2019,” said Raghuvanshi in a communication to all State and Union Territory drug controllers. As per Rule 80 of the New Drugs and Clinical Trial Rules (NDCTR), 2019, a person who intends to manufacture new drug in the form of active pharmaceutical ingredients or pharmaceutical formulation, as the case may be for sale or distribution, shall make an application for grant of permission to the Central Licensing Authority in Form CT-21 along with a fee as specified in Sixth Schedule. “…you are hereby directed to convey the matter to all the manufacturers under your jurisdiction and cancel the product permission granted by you of the subject drug,” said the DCGI. The necessary information about the status and action taken in the matter may be intimated to the CDSCO at the earliest, he added. According to the online trading portals, the drug combination is sold by a manufacturer as an ultra broad spectrum antibiotic and claimed as effective and well-tolerated for the treatment of infections including bacterial meningitis, lower respiratory tract infections and used in treatment of certain types of cancer.  It may be noted that this is not the first time the national drug regulator takes up the issue of drug combinations and new drugs getting manufactured and marketed in the country without its approval, using the license issued by the state or UT drug regulators. Regulatory experts points towards the issues in proper communication between the regional and central drug regulatory mechanism, among others, as a reason for such mistakes. The Drugs Technical Advisory Board (DTAB) has recently suggested the Drugs Consultative Committee (DCC) to collect opinion from the States in the upcoming meetings on having a single licensing or approval authority in the country. The discussions for a centralised drug regulatory mechanism has been discussed in the past, especially after the incidents where the Indian made medicines such as cough syrups reportedly had an adverse impact and resulted in the death of many children overseas. The drug regulatory experts also suggested that there should be a single national portal where the state drug regulators could update the status of a drug license and quality test results, so that the information would be available to the national drug regulator for any reference. It may be noted that a national effort to take action against irrational fixed dose combinations in the country earlier has brought out the information that several FDCs were approved by the state or UT regulatory authorities without the approval of the Central drug regulator. Source: Pharmabiz

Mar 26,2024 New Delhi: It’s an almost entirely preventable disease but cervical cancer kills one woman in India every seven minutes. That represents 21 per cent of global cervical cancer deaths, and makes it the second most common cancer in Indian women with 1,25,000 women being diagnosed and over 75,000 dying from the disease in India each year. Vaccinating people against the human papillomavirus or HPV which causes the vast majority of cervical cancer cases is a highly effective way of preventing the disease. HPV vaccines were first introduced in 2006 in the United States, and Australia became the first country to roll out a national vaccination programme the following year. But until recently, the cost of the vaccines – as much as Rs 4,000 for a single dose with usually at least two doses required – has put preventing cervical cancer this way out of reach of most low- and middle-income countries across the world, including India. Launched in September 2022, India’s first indigenously developed quadrivalent HPV vaccine, Cervavac, has the potential to improve access to vaccines and revolutionise cervical cancer prevention in these countries. Developed by the Serum Institute of India, one of the largest vaccine producers in the world, it’s currently priced at half of the cost of its competitors Merck & Co’s Gardasil and GlaxoSmithKline ‘s Cervarix at Rs 2,000 per dose with plans announced to produce 200 million doses. But as production is scaled up, the Institute hopes to be able to make a dose of Cervavac available to the public at a price of between Rs 200-400 in the near future. The vaccine alliance Gavi signed a new three-year partnership with the Indian government in February 2023, with the aim to extend life-saving vaccines to millions of children nationwide, including helping the country introduce the HPV vaccine into India’s national immunisation regimen. And in February 2024, the government announced the vaccine would be part of the Universal Immunisation Programme, following endorsement from the National Technical Advisory Group on Immunisation. During her recent interim budget speech for 2024-25, Indian Finance Minister Nirmala Sitharaman emphasised the government’s commitment to actively “encourage” vaccination as a proactive measure against cervical cancer – a significant announcement for women’s health in India. It hasn’t only been affordability that has hindered the widespread adoption of HPV vaccines in India. Source: Healthworld

Mar 22,2024 London: The European Union’s medicines regulator did not mention Eisai and Biogen’s Alzheimer’s drug in its notes and recommendations on Friday. The European Medicines Agency had said it would hold a oral hearing to discuss the drug, lecanemab, this week. The 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. The infusion given twice a month removes sticky clumps of a protein called amyloid beta, believed to be a hallmark of Alzheimer’s, from the brain. Source: Pharma

Mar 19,2024 New Delhi: ENTOD Pharmaceuticals on Tuesday announced the developement of human insulin eye drops designed to treat corneal eye conditions like neurotrophic corneal ulcers and dry eyes. Although Insulin has traditionally been administered through injections to manage blood sugar levels in diabetic patients globally, recent research from various global studies and literature searches has demonstrated its potential effectiveness when applied as eye drops. These findings suggest that insulin eye drops can aid in repairing corneal tissue and addressing ocular surface conditions. The company’s next step involves initiating the drug regulatory approval process in India. This will begin with an application to the CDSCO for approval to conduct clinical trials of these eye drops. Subsequently, the company will seek approval from the DCGI for commercialization. ENTOD Pharmaceuticals’ CEO, Nikkhil K Masurkar , said, “There is compelling and growing global evidence suggesting that insulin eye drops could revolutionize ophthalmic therapeutics. Our eye drop formulation, EyeSulin, would be the first of its kind in the world to treat eye conditions once approved. Upon regulatory clearance, we aim to produce these eye drops as part of the ‘Make in India’ initiative, making them accessible across India and globally at an affordable price. As far as our knowledge extends, no commercially viable insulin eye drops exist worldwide or are in development. Therefore, we are thrilled to lead the charge ahead of the US and other Western nations in pioneering this potentially groundbreaking eye medicine, poised to benefit millions.” Source: Pharma

Mar 27,2024 Mumbai, March 26, 2024. An exclusive distribution and marketing agreement was today announced between Sanofi India and Cipla for Sanofi’s Central Nervous System (CNS) product line in India. As part of this collaboration, Cipla will handle the distribution of Sanofi India’s six CNS brands, which include the industry-leading Frisium® brand of anti-epileptic drugs. Cipla will make use of its skills and strong India-wide network of distributors, institutions, and market outreach programmes to expand access to these treatments for patients who need them, while Sanofi India will continue to own, import, and manufacture its entire range of CNS products across plants in India and abroad. Rodolfo Hrosz, Managing Director, Sanofi India Limited, said “Sanofi India’s CNS products are leaders in their respective categories. These well-established brands already improve lives of many patients across urban centres in the country. Cipla’s wide presence will enable us to expand the reach of this portfolio to healthcare professionals and patients across all India.” Mr. Achin Gupta, Chief Executive Officer – One India Business, Cipla Limited, said “Enhancing access to high quality treatments is central to our purpose of ‘Caring for Life’. We are pleased to collaborate with Sanofi India to enhance accessibility to highly efficacious and quality therapeutic solutions in CNS and bring value to patients across the country. Central Nervous System is one of the most challenging areas in medicine, and we believe this partnership is a significant step forward to address unmet needs of patients.” Sanofi India continues to focus on accelerating its strong innovation pipeline into India, across multiple therapeutic areas including Diabetes, Transplants, Rare Diseases, Consumer Healthcare and Vaccines. Source: Pharma