Latest news with #INSPIRE
Yahoo
24-05-2025
- Business
- Yahoo
FDA Approves Liquidia Corporation (LQDA)'s YUTREPIA Amid Patent Dispute
Liquidia Corporation (NASDAQ:LQDA) announced today that the U.S. Food and Drug Administration (FDA) has approved YUTREPIA (treprostinil) inhalation powder for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). A healthcare professional working on a computer terminal with a patient in the background. YUTREPIA, enabled by Liquidia Corporation (NASDAQ:LQDA)'s proprietary PRINT technology, is the first and only prostacyclin dry-powder formulation designed for deep-lung delivery using a low-effort, portable inhalation device. The approval is based on results from the Phase 3 INSPIRE trial, which showed YUTREPIA to be safe and well-tolerated, offering a new treatment option for over 105,000 U.S. patients suffering from PAH and PH-ILD. Liquidia Corporation (NASDAQ:LQDA)'s commercial team is preparing to launch YUTREPIA, aiming to improve exercise ability and quality of life for patients. However, United Therapeutics Corporation has filed a patent infringement lawsuit and is seeking a court order to block YUTREPIA's commercial launch, with a decision on the injunction still pending. While we acknowledge the potential of LQDA to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than LQDA and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
The Hindu
23-05-2025
- Science
- The Hindu
Research scholars upset over DST's delay in release of stipends
For several weeks, research scholars spanning a range of Central and State universities and scientific disciplines across India, have been pleading with the Department of Science and Technology (DST) for their research stipends. The forum for their complaints are primarily X and LinkedIn, and their prime gripe is the delay – ranging anywhere from eight months to 13 months – for their scholarship funds. Citing the mental agony of being penniless plus a lack of responsiveness from the DST, which is under the Ministry of Science and Technology, some are openly expressing 'regret' at choosing to pursue scientific research in India. 'Timely disbursal is a dream. For some, delays have lasted for over a year without any stipend. Worse, when we reach out for help, our emails go unanswered. The helpline responses are often rude, as though we are begging — not requesting what we're rightfully owed. Is this how we treat our country's researchers? Is this the encouragement we give to our brightest minds?' posted Sanket Jagale, an INSPIRE-Fellowship scholar working at the Plasma and Nano-materials laboratory lab at the Savitrabai Phule University, Pune, on LinkedIn. 'No money for rent' Another scholar, affiliated to the same university but who declined to be identified, told The Hindu that she hadn't received her scholarship money since March 2024. 'I have money for rent only for another month or so. It is humiliating to pursue research this way, especially when I have cleared the very challenging requirements to be a DST-INSPIRE scholar in the first place, do research and then see my contemporaries who have pursued engineering jobs earn dependable salaries,' she told The Hindu. Scholarship for researchers from minority background face four-month delay Several scholarships are conferred on doctoral students by the Council for Scientific and Industrial Research (CSIR) and the University Grants Commission (UGC). Scientists and research scholars say that a three- or four-month delay in the disbursal of money is common and factored into the average research scholar's yearly planning. Until 2022, the INSPIRE fellowships offered by the DST too largely followed this regime. However, two significant changes have reportedly made the disbursal crisis worse in the DST – incidentally the largest source of research funds for civilian research in India. The first was in September 2022 when as part of a directive by the Finance Ministry to streamline funds spent by the Central government, recipients of DST funds (grants to scientists for research and scholarships) at the institutional level (universities, research institutes etc.) had to open 'zero-balance accounts' with the Bank of Maharashtra. Thus, all the unspent funds with universities had to first be redirected to these new bank accounts. The Hindu has learnt that the technological architecture guiding the fund flow didn't work well. Following this, in December 2024, all the institutions were required to open new 'zero-balance accounts' with the Union Bank of India under a new initiative called 'Hybrid-TSA,' whereby schemes valued over ₹1,000 crore required a new set of accounting procedures. The net result was that all the work done in creating new accounts and verifying account balances had to be duplicated, thus delaying disbursement and causing the backlog. The new process also brought the stipends payable to research scholars under the same category as funds for buying equipment and conducting research. The latter usually involves a detailed and time-consuming appraisal process. 'Keeping the scholarships/ fellowships in the same category seems illogical. Imagine the same scientists or officials in the treasury are asked to do work for nine-plus months, then all their salaries come at once. They will be up in arms,' a PhD scholar with a top-ranked Indian Institute of Technology told The Hindu, requesting anonymity. 'Problems addressed' The Hindu reached out to the DST with a detailed questionnaire but didn't get a response till press time. When contacted, DST Secretary Abhay Karandikar didn't explain the rationale behind the changes in processes and the reasons for the delay. He said he was 'aware' of the disbursement crisis but said that from June 2025, all scholars would get their money on time. 'All problems have been addressed. I don't foresee any issue in future.' The INSPIRE fellowships, which commenced in 2008, were envisioned to ensure that students with an aptitude and talent for basic sciences were financially motivated to be researchers in basic sciences, rather than more immediately lucrative careers in information technology, engineering, and finance. Every year, around 1,000 aspirant doctoral candidates are awarded the scholarships. The basic eligibility criteria for an INSPIRE fellowship are that the aspirant should either be a first rank holder in engineering, sciences or applied sciences streams at the post-graduate level or be an 'INSPIRE scholar' with a 70% aggregate score through graduation and post-graduation. An 'INSPIRE scholar' is someone who was in the top 1% of students in Class XII Boards and top 10,000 performers in the IIT-JEE and other national exams. A screening committee will then select doctoral candidates based on their research proposals.
Yahoo
23-05-2025
- Business
- Yahoo
U.S. FDA Approves Liquidia's YUTREPIA™ (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
FDA's approval of YUTREPIA paves the way for prescribers to add a new treatment option for patients with PAH and PH-ILD YUTREPIA is designed to enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort Demonstrated tolerability and titratability in the pivotal INSPIRE study Liquidia will host a webcast Tuesday, May 27, 2025 at 8:30 a.m. ET to provide an update on commercial launch preparations MORRISVILLE, N.C., May 23, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, announced today that the U.S. Food and Drug Administration (FDA) has approved YUTREPIA™ (treprostinil) inhalation powder, a prostacyclin analog for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability. YUTREPIA is the first and only prostacyclin dry-powder formulation enabled by Liquidia's proprietary PRINT™ technology, which yields uniform, free-flowing particles designed to enhance deep-lung delivery via an easy-to-use, low-effort device requiring less inspiratory effort. Dr. Roger Jeffs, Chief Executive Officer of Liquidia, said: 'Today, we celebrate for the patients and physicians who will now have access to a potential best-in-class dry-powder form of treprostinil with exceptional portability, tolerability, titratability and durability. Thank you to the clinical investigation team, our steering committee, and the members of the pulmonary hypertension patient communities who helped make this day a reality. With today's milestone, our commercial team is prepared to launch YUTREPIA and bring meaningful change to the lives of patients in need, and we look forward to speaking with physicians and patients about the unique benefits of YUTREPIA in the days and weeks ahead.' The approval of YUTREPIA is based on findings from the Phase 3 INSPIRE trial which evaluated patients who were naïve to treprostinil, as well as those transitioning to YUTREPIA from nebulized treprostinil. YUTREPIA was shown to be safe and well-tolerated regardless of a patient's previous exposure to treprostinil. Results from the INSPIRE study were published in the Pulmonary Circulation Journal in 2022 and the Vascular Pharmacology Journal in 2021. Please see the 'Selected Safety Information' in the section entitled 'About YUTREPIA™ (treprostinil) Inhalation Powder.' Dr. Nicholas Hill, Chief Pulmonary, Critical Care & Sleep Division, Professor of Medicine at Tufts University School of Medicine and Principal Investigator on the Phase 3 INSPIRE study, said: 'I am so pleased that patients with PAH and PH-ILD now have this newly introduced option for inhaled treprostinil. Having treated patients for more than six years in Liquidia's INSPIRE and extension studies, I am confident in the safety, tolerability and dosing that YUTREPIA offers. The low-effort inhalation device used to deliver YUTREPIA may make it easier to start and maintain patients on treatment, especially those with limited inspiratory flows or lung capacity.' Matt Granato, President and Chief Executive Officer of the Pulmonary Hypertension Association, said: 'PAH and PH-ILD impact more than 105,000 patients in the U.S. alone. These patient communities and the physicians who serve them need therapies that can lead to the improvement of quality of life. We are always glad to see industry research leading to development of drugs that expand options for the patient community.' As previously disclosed, United Therapeutics Corporation (UTHR) filed a complaint on May 9, 2025, in the U.S. District Court for the Middle District of North Carolina (Case No. 1:25-cv-00368) against Liquidia alleging infringement of U.S. Patent No. 11,357,782 (the '782 patent) and seeks to enjoin Liquidia from commercializing YUTREPIA to treat PAH and PH-ILD. UTHR has filed a motion for temporary restraining order and preliminary injunction to block Liquidia from commercially launching YUTREPIA. Oral argument on the motion was held on May 20, 2025. The motion remains pending with the Court. Webcast InformationLiquidia will provide an update on YUTREPIA commercial launch preparations via a live webcast on Tuesday, May 27, 2025, at 8:30 a.m. ET. Access to the webcast will be available on the 'Investors' page of Liquidia's website at A replay and transcript of the webcast will be archived on the company's website for at least 30 days. About Pulmonary Arterial Hypertension (PAH) Pulmonary arterial hypertension (PAH) is a rare, chronic, progressive disease caused by narrowing, thickening or stiffening of the pulmonary arteries that can lead to right heart failure and eventually death. Currently, an estimated 45,000 patients are diagnosed and treated in the United States. There is currently no cure for PAH, so the goals of existing treatments are to alleviate symptoms, maintain or improve functional class, delay disease progression, and improve quality of life. About Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) Pulmonary hypertension (PH) associated with interstitial lung disease (ILD) includes a diverse collection of up to 200 different pulmonary diseases, including interstitial pulmonary fibrosis, chronic hypersensitivity pneumonitis, connective tissue disease-related ILD, and chronic pulmonary fibrosis with emphysema (CPFE) among others. Any level of PH in ILD patients is associated with poor 3-year survival. A current estimate of PH-ILD prevalence in the United States is greater than 60,000 patients, though population size in many of these underlying ILD diseases is not yet known due to factors including underdiagnosis and lack of approved treatments until March 2021, when inhaled treprostinil was first approved for this indication. About YUTREPIA™ (treprostinil) Inhalation PowderYUTREPIA is an inhaled dry-powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device. YUTREPIA was designed using Liquidia's PRINT® technology, which enables the development of drug particles that are precise and uniform in size, shape and composition, and that are engineered for enhanced deposition in the lung following oral inhalation. Liquidia has completed the INSPIRE trial (NCT03399604), or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, an open-label, multi-center phase 3 clinical study of YUTREPIA in patients diagnosed with PAH who are naïve to inhaled treprostinil or who are transitioning from Tyvaso® (nebulized treprostinil). YUTREPIA is currently being studied in the ASCENT trial (NCT06129240), or An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH, with the objective of informing YUTREPIA's dosing and tolerability profile in patients with PH-ILD. YUTREPIA was previously referred to as LIQ861 in investigational YUTREPIA (treprostinil) inhalation powder is a prostacyclin analog indicated for the treatment of: Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). SELECTED SAFETY INFORMATION: WARNINGS AND PRECAUTIONS Treprostinil is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with Treprostinil may produce symptomatic hypotension. Treprostinil inhibits platelet aggregation and increases the risk of bleeding. Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness. Like other inhaled prostaglandins, YUTREPIA may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment. Most common adverse reactions with YUTREPIA (≥10%) are cough, headache, throat irritation and dizziness. Prescribing Information and Instructions for Use for YUTREPIA (treprostinil) inhalation powder are available at About Liquidia Corporation Liquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease. The company's current focus spans the development and commercialization of products in pulmonary hypertension and other applications of its proprietary PRINT® Technology. PRINT enabled the creation of YUTREPIA™ (treprostinil) inhalation powder, a drug that has been approved for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD). The company is also developing L606, an investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer and currently markets generic Treprostinil Injection for the treatment of PAH. To learn more about Liquidia, please visit Tyvaso® is a registered trademark of United Therapeutics Corporation. Cautionary Statements Regarding Forward-Looking StatementsThis press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy and plans and our objectives for future operations, are forward-looking statements. Such forward-looking statements, including statements regarding clinical trials, clinical studies and other clinical work (including the funding therefor; anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs); regulatory applications and related submission contents and timelines; our ability to successfully commercialize our products, including YUTREPIA, for which we obtain FDA or other regulatory authority approval; the acceptance by the market of our products, including YUTREPIA, and their potential pricing and/or reimbursement by third-party payors, if approved (in the case of our product candidates) and whether such acceptance is sufficient to support continued commercialization or development of our products; the successful development or commercialization of our products, including YUTREPIA; our revenue from product sales and whether or not we may become profitable in the near term, or at all; future competitive or other market factors that may adversely affect the commercial potential for YUTREPIA; and our ability to execute on our strategic or financial initiatives, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Despite the approval of YUTREPIA by the FDA, it is possible that commercialization of YUTREPIA may be blocked or delayed in connection with legal proceedings that have been initiated or that may in the future be initiated, or we may be required to pay damages, including royalties, in connection with our commercial launch, as a result of these legal proceedings. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'would,' and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks discussed in our filings with the SEC, as well as a number of uncertainties and assumptions. Moreover, we operate in a very competitive and rapidly changing environment and our industry has inherent risks. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Nothing in this press release should be regarded as a representation by any person that these goals will be achieved, and we undertake no duty to update our goals or to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Information Investors:Jason Adair 919.328.4350 Media: Patrick Wallace 919.328.4383 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Time of India
20-05-2025
- Science
- Time of India
Narlikar inspired young minds, guided aspiring scientists with cosmic storytelling
Nagpur: Internationally-acclaimed astrophysicist and science communicator, Jayant Narlikar , maintained strong ties with the scientific, academic, and literary scenario in Nagpur and Vidarbha. Though Narlikar was based in Pune, where he breathed his last on Tuesday, his frequent interactions and visits with regional science forums and his ability to communicate science in Marathi made him a respected figure in the region. Dr Narlikar's tryst with Nagpur dates back to the 1980s when he visited the Govt Science College to guide aspiring scientists. Over the years, he continued to inspire young minds through engagements at institutions like Shri Shivaji Science College, where he participated in the INSPIRE programme — always emphasising the need to blend scientific inquiry with ethical clarity and cultural consciousness. As news of his demise spread, leading personalities from Nagpur and Maharashtra paid heartfelt tributes to the late scientist. Chief minister Devendra Fadnavis said, "A brilliant mind who illuminated India's scientific image and established the importance of astronomy has departed. Dr Narlikar's contribution to Indian science is unmatched." Union minister Nitin Gadkari, expressing deep sorrow, tweeted, "The nation has lost a celestial beacon in the world of astrophysics. Dr Narlikar simplified complex scientific ideas for the common man and was tireless in his efforts to spread scientific thinking." Dr Prakash Amte called it "a deeply sad moment," recalling Narlikar's decades-long commitment to research and science communication : "He utilised every medium — books, articles, lectures — to make astronomy understandable for the masses," said Amte. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Click Here - This Might Save You From Losing Money Expertinspector Click Here Undo Vidarbha Sahitya Sangh (VSS) president Pradip Date highlighted Narlikar's impact on science fiction in Marathi: "He gave Marathi literature a taste for science storytelling. He used to say that if science is bitter, fiction is the sugar coating that helps people absorb it." Ashish Shelar, minister of cultural affairs, said, "Dr Narlikar's work on the origin of the universe and his efforts to democratise science are lighthouses for current and future generations." MLC Sandip Joshi paid tribute, calling Narlikar "an inspiring writer and science communicator whose work gave Indian science a global platform". "A brilliant star has set," he said. MLC Dr Parinay Fuke stressed Dr Narlikar modernised Indian astronomy and scientific thought. "He made science part of common discourse through his simple yet powerful writing," said Fuke. Academicians, scientists, social workers, and literature lovers also paid glowing tributes to Narlikar.
Business Insider
18-05-2025
- Business
- Business Insider
Applied announces INSPIRE Phase 2/3 trial primary endpoint not significant
Applied Therapeutics (APLT) presented full 12-month clinical results and new topline data from 18 and 24 months from the INSPIRE Phase 2/3 trial of govorestat for the treatment of Sorbitol Dehydrogenase Deficiency, a subtype of Charcot-Marie-Tooth disease, in an oral presentation at the Peripheral Nerve Society 2025 Annual Meeting, being held May 17-20, 2025 in Edinburgh, Scotland. A reverified, interim analysis of 49 patients evaluable for efficacy as of February 2024, conducted at 12 months of active treatment. Full clinical results from 12 months include: Statistically significant correlation between absolute reduction in sorbitol and change in the 10MWRT and the CMT-FOM Lower Limb domain were observed. The primary endpoint, the 10MWRT, was not statistically significant. Since initiation of the INSPIRE study, the 10MWRT was removed from the CMT-FOM, which now only consists of 11 components. Govorestat treatment demonstrated a statistically significant improvement on key secondary endpoint, CMT-HI at 12 months. A statistically significant correlation between percent change in sorbitol and change in CMT-HI was observed at 12 months for the total score as well as in the mobility and balance domains. Statistically significant lowering of blood sorbitol levels were observed. Govorestat continued to be generally safe and well tolerated, with similar incidence of adverse events between active and placebo-treated groups Confident Investing Starts Here:
