Latest news with #Chemistry
Business Upturn
a day ago
- Business
- Business Upturn
Lipella Pharmaceuticals Re-signs Manufacturing Collaboration Agreement with Cook MyoSite to Support LP-310 Clinical Development
PITTSBURGH, June 04, 2025 (GLOBE NEWSWIRE) — Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ('Lipella' or the 'Company'), a clinical-stage biotechnology company focused on developing therapies for diseases with significant unmet need, today announced that it has re-signed its manufacturing collaboration agreement with Cook MyoSite, Inc. ('Cook MyoSite') to support Chemistry, Manufacturing and Control (CMC) documentation supporting our clinical products LP-10 and LP-310. Dr. Jonathan Kaufman, Chief Executive Officer and Co-Founder of Lipella, said, 'We are pleased to renew our collaboration with Cook MyoSite, a trusted partner with a strong track record in high-quality manufacturing. This CMC collaboration is increasingly valuable to Lipella as our clinical pipeline matures toward commercializable assets.' Ryan Pruchnic, Managing Vice President of Cook MyoSite and a member of Lipella's Board of Directors, added, 'Our team is committed to ensuring high standards of safety, quality and execution, to support Lipella's clinical progress.' About Cook MyoSite Cook MyoSite is dedicated to the development and subsequent commercialization of technology related to the collection, selection and expansion of human skeletal muscle cells for the treatment of various disorders. In addition to operating several regulated clinical studies, Cook MyoSite provides a range of custom services, including modified cell samples to contract manufacturing arrangements, procurement and processing of muscle cells from specific donor populations, custom media formulations, CMO/CDMO arrangements and QC analytical testing and assay development. Learn more about Cook MyoSite at . About Lipella Pharmaceuticals Inc. Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating active agents in existing generic drugs and optimizing these reformulations for new applications. Lipella targets diseases with significant unmet needs, where no approved drug therapies currently exist. The company completed its initial public offering in 2022. Learn more at and follow us on X and LinkedIn. Forward-Looking Statements This press release includes certain 'forward-looking statements.' All statements, other than statements of historical fact, included in this press release regarding, among other things, our strategy, future operations, financial position, prospects, clinical trials, including the statistically significant safety and efficacy data presented above for LP-310, regulatory approvals, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. Forward-looking statements can be identified by words such as 'may,' 'will,' 'could,' 'continue,' 'would,' 'should,' 'potential,' 'target,' 'goal,' 'anticipates,' 'intends,' 'plans,' 'seeks,' 'believes,' 'estimates,' 'predicts,' 'expects,' 'projects' and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding future events and financial trends that we believe may affect among other things, market and other conditions, our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore, against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, risks related to the current clinical trial for LP-310, general capital market risks, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other risks that may be included in the periodic reports and other filings that the Company files from time to time with the U.S. Securities and Exchange Commission. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal and related matters concerning the matters described herein. CONTACT:Jonathan KaufmanChief Executive OfficerLipella Pharmaceuticals Inc. [email protected] 1-412-894-1853
NDTV
a day ago
- General
- NDTV
Maharashtra Common Entrance Test 2025 Result To Be Declared On June 16
MHT CET 2025 Final Answer Key: Maharashtra Common Entrance Test (MHT CET) final answer key has been released. The Physics, Chemistry, Biology (PCB) group provisional answer key was issued on May 19. Candidates who appeared in the examination can access their results by visiting the official website - Reportedly, over 7.64 lakh candidates appeared across both streams - PCB and PCM. For the PCB group, 3,01,072 candidates registered and 2,82,737 appeared, while for the PCM group, 4,64,263 candidates registered and 4,22,863 appeared. This year, the MHT CET exams were conducted from April 22 to April 30 for the PCB group, and from May 2 to May 17 for the Physics, Chemistry, Mathematics (PCM) group. According to the official notice, the MHT CET PCB and PCM results will be declared on June 16, 2025. Apart from the MHT CET result date, the tentative result dates for several other courses have also been released. Results for BBCA/BBA/BMS/BBM-CET and LLB 5-Year CET will be declared on June 4. The B Design CET result will be announced on June 9, while the LLB 3-Year CET result is scheduled for June 17. MHT CET Result 2025: Here's How To Check Go to the official website - Select the relevant course link. You'll be directed to a new page where you must enter your login credentials. After submitting the details, your result will appear on the screen. Check, download, and save your result. Take a printout for future reference. After the MHT CET 2025 result is announced, the counselling process will begin for admissions to various state colleges in engineering, pharmacy, agriculture, and other courses. In 2024, the final answer keys for MHT CET PCB and PCM were released on June 3 and June 5, respectively.
India.com
2 days ago
- Lifestyle
- India.com
Bloom in Style: Must-Have Floral Dresses on Myntra's EORS
If you want to add some fresh, flower-like beauty to your wardrobe, now is the time! Myntra's End of Reason Sale continues from the 31st of May to the 12th of June, providing you with thrill-ending deals on your most desired fashion items. In the summer, you should go for dresses with flared and layered sleeves, cotton dresses, and nice flower-print dresses. Don't miss out—shop smart while the sale is on! PURVAJA Floral Print Round Neck Flared Maxi Dress Image Source- Order Now This PURVAJA maxi dress is your day-time chic favorite. Featuring a stunning floral print and flared hem, it falls nicely and gives comfort throughout the day. Round neck and loose fabric make it ideal for brunches, beach walks, or family dinners. Style with heels or flats and look effortlessly stylish. Key Features: Maxi length that flows with a flared hem Colorful all-over floral print Lightweight, breathable polyester fabric Round neck design for time-tested appeal Sleeveless design, perfect for hot summer days The material tends to wrinkle easily if not well taken care of. MANOJAVA Floral Cotton Print Flared Sleeve Layered Fit & Flare Dress Image Source- Order Now Turn heads in the super-fashionable MANOJAVA layered fit & flare dress. With its cotton print, floral, and dramatic flared sleeves, the dress is ideal for any day-out escapade. The layered hemming adds a touch of glamour, while the cotton fabric brings softness and comfort. A must-have for those who adore fusion fashion. Key Features: Soft and cozy cotton build Glamorous flared sleeves Layered silhouette for style and drama Pretty floral print Crossover relaxed fit to wear every day Sheer may require a slip to wear under. HIBIKI Floral Print Cotton Empire Dress Image Source- Order Now Stylish and glowing, the HIBIKI empire dress is both elegant and comfortable. Lightweight cotton is used to create the lovely floral design and empire waist for a fashionable fit. Whether you are going out for a coffee or a night out, the dress provides that effortless chic without the nervousness while being super comfy. Key Features: Cotton material is perfect for everyday usage Empire waist provides a chic fit Floral design provides a feminine touch Easy to plan with sandals or sneakers Light and travel-friendly Limited availability of sizes on the internet. Chemistry Black & Rust Orange Floral Print Wrap Dress Image Source- Order Now Smart and sophisticated, the Chemistry wrap dress boasts a distinctive arrangement of rust-orange and black floral print. Wrap style is flattering for any figure and the perfect fashionable option for dinner dates or an uptown brunch. Key Features: Wrap-around design to complement your style Statement black & rust-orange floral print Ideal for semi-formal occasions Soft viscose rayon material with a slight stretch Tie-up waist enhances the silhouette Requires ironing to maintain a crisp look. All of these floral dresses can add their unique look to your fashion, with their organic flow from PURVAJA, layered style from MANOJAVA, comfy design from HIBIKI, or smart elegance from Chemistry. They make you feel good, look trendy, and were made for summer outfits. You can find these beautiful outfits at Myntra End of Reason Sale, from 31st May to 12th June, and enjoy stylish updates without spending too much. Brunch or outing or casual get-together, these dresses make you flower with confidence, poise, and economy. Shop now and let your flower story unfold. Disclaimer: At IDPL, we help you stay up-to-date with the latest trends and products. It should not be construed as an endorsement to buy. IDPL may make a very small commission from its sale if one chooses to buy the product from any of the links in this article.
Yahoo
27-05-2025
- Business
- Yahoo
Savara Receives Refusal to File (RTF) Letter From the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for MOLBREEVI* to Treat Patients With Autoimmune Pulmonary Alveolar Proteinosis (autoimmune PAP)
LANGHORNE, Pa., May 27, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that the Company received an RTF letter from the FDA for the BLA of MOLBREEVI as a therapy to treat patients with autoimmune PAP. Upon preliminary review, the FDA determined that the BLA submitted in March 2025 was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC). The RTF was not the result of safety concerns, and the FDA did not request or recommend additional efficacy studies. Within the next 30 days, the Company intends to request a Type A meeting with the Agency. Typically, Type A meetings are granted by the FDA within 30 days of the request. "The requested CMC data outlined in the RTF letter are currently being generated, and we look forward to meeting with the FDA to align on next steps," said Matt Pauls, Chair and Chief Executive Officer, Savara. "Based on our understanding of the letter, we are confident we can thoroughly address the Agency's request and expect to resubmit our BLA in the fourth quarter of 2025. We remain highly confident in our program for autoimmune PAP and believe that our clinical data demonstrate that MOLBREEVI improves pulmonary gas transfer and respiratory health-related quality of life in this rare disease." Pauls continued, "As outlined in our Annual Report, we are working to establish a redundant supply chain. Pursuant to that strategy, we remain on track to complete the technology transfer with our second-source drug substance contract manufacturer in the fall. We have completed three upstream process performance qualification (PPQ) batches, are in the process of completing our downstream PPQ campaign and have begun our analytical comparability analysis." The RTF does not impact previous designations granted by regulators for MOLBREEVI in autoimmune PAP. MOLBREEVI in autoimmune PAP has been granted Fast Track and Breakthrough Therapy Designations by the FDA, Orphan Drug Designation by the FDA and the European Medicines Agency (EMA), as well as Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA). About Autoimmune Pulmonary Alveolar Proteinosis (autoimmune PAP) Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at and LinkedIn. *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements related to the Company's intention to request a Type A meeting with the FDA, our confidence in our ability to thoroughly address the Agency's request, our expectations regarding the resubmission of the BLA and the timing of the resubmission, our belief that our clinical data demonstrate that MOLBREEVI improves pulmonary gas transfer and respiratory health-related quality of life in autoimmune PAP, and that we remain on track to complete the technology transfer with our second-source contract manufacturer in the fall. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; the occurrence and outcome of the planned Type A meeting with the FDA; our ability to address the FDA's request and successfully meet the requirements for resubmission; our ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara's operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K, and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. View source version on Contacts Media and Investor Relations Contact Savara Johnson, Executive Director, Corporate Affairsir@ Error 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
Gizmodo
13-05-2025
- Science
- Gizmodo
computer simulations
Science Physics & Chemistry Gravity Could Be Proof We're Living in a Computer Simulation, New Theory Suggests Gravity may not be a fundamental force of nature, but a byproduct of the universe streamlining information like a cosmic computer.
