Latest news with #Solid
Yahoo
20 hours ago
- Business
- Yahoo
Camfil APC Publishes Comprehensive Guide on Pharmaceutical Dust Collection Strategies for Oral Solid Dose Manufacturing
New Technical Resource Addresses Critical Safety, Compliance, and Operational Efficiency Challenges in OSD Pharmaceutical Production Dust Collection Strategies for Oral Solid Dose Manufacturing Jonesboro, AR, June 05, 2025 (GLOBE NEWSWIRE) -- Camfil APC, a leading manufacturer of industrial dust collectors, today announced the publication of a comprehensive technical guide addressing dust collection strategies for oral solid dose (OSD) pharmaceutical manufacturing. The resource, Pharmaceutical Dust Collection: Strategies for Oral Solid Dose Pharmaceutical Manufacturing, provides industry professionals with essential insights into managing potent compound containment, regulatory compliance, and operational efficiency through advanced air filtration technologies. Addressing Critical Industry Challenges The pharmaceutical manufacturing industry faces complex challenges in maintaining worker safety while ensuring product quality and regulatory compliance. This new guide specifically addresses the unique air quality management requirements of OSD production, where exposure to potent, toxic, and allergenic dusts presents significant risks to both personnel and product integrity. "OSD pharmaceutical manufacturers require specialized dust collection solutions that go beyond standard industrial applications," said Tony Galvin, Pharmaceutical Segment Manager, at Camfil APC. "Our new guide provides the technical depth and practical guidance that process engineers, facility managers, and safety professionals need to implement effective containment strategies." Comprehensive Technical Coverage The guide covers essential aspects of pharmaceutical OSD dust collection implementation, including: Regulatory Framework Navigation: OSHA, NFPA and EPA Designing a Dust Collection System for OSD Production Dust Capture and Conveyance Dust Collector Design and Orientation Primary Filtration Media Dust Containment Explosion Protection Measures for Dust Collection Systems Advanced Filtration Solutions for Pharmaceutical Applications The guide features information on Camfil APC's pharmaceutical OSD dust collection solutions, including: Gold Series Camtain® Dust Collector: Engineered for high-containment applications Quad Pulse Package Compact Dust Collector: Space-efficient solutions for facilities with limited mechanical room availability Each solution incorporates advanced HEPA filtration technology and specialized containment features designed to meet the stringent requirements of OSD pharmaceutical production environments. Industry Expert Insights The guide draws upon extensive experience in pharmaceutical manufacturing applications, providing real-world case studies and implementation examples. Content addresses the specific concerns of cross-functional teams typically involved in dust collection system selection, including process engineers, facilities managers, health and safety professionals, quality assurance teams, and maintenance personnel. "Effective dust collection in pharmaceutical OSD manufacturing requires understanding both the technical requirements and the operational realities of production environments," noted Tony Galvin, Pharmaceutical Segment Manager, at Camfil APC. "This guide bridges that gap by providing practical implementation strategies backed by proven engineering principles." Supporting Pharmaceutical Industry Innovation The guide reflects Camfil APC's ongoing commitment to supporting OSD pharmaceutical manufacturing excellence through advanced dust collection and air filtration technology. As the industry continues to evolve with new compounds, production methods, and regulatory requirements, effective dust collection strategies remain essential for maintaining competitive operations while ensuring worker safety and product quality. Technical Resource Availability The complete pharmaceutical OSD dust collection strategies guide is available immediately through Camfil APC's website at About Camfil APC Camfil APC is a leading manufacturer of dust, mist, and fume collection equipment for industrial applications. With decades of experience in air filtration technology, the company provides engineered solutions for challenging industrial environments, including pharmaceutical manufacturing, food processing, metalworking, and chemical production. Camfil APC's comprehensive product portfolio includes dust collectors, replacement filters, and complete system integration services. The company maintains manufacturing facilities in Jonesboro, Arkansas, and provides technical support, installation, and maintenance services across North America. Camfil APC is part of the global Camfil Group, recognized worldwide for innovation in air filtration technology and commitment to clean air solutions. For more information about Camfil APC's OSD pharmaceutical dust collection solutions, visit Media Contact: Lisa Goetz Schubert b2b 1-610-269-2100 x244 lgoetz@ Technical Contact: Tony Galvin Pharmaceutical Segment Manager Camfil APC 1-612-865-9377 Attachment Dust Collection Strategies for Oral Solid Dose Manufacturing
India Gazette
3 days ago
- Health
- India Gazette
CAQM issues strict directions to curb landfill fires, open waste burning in NCR
New Delhi [India], June 3 (ANI): The Commission for Air Quality Management (CAQM) has issued comprehensive directions on Tuesday to tackle one of the 'major contributors' to air pollution- open burning of Municipal Solid Waste (MSW), and curbing open biomass generating Particulate Matter and other harmful gaseous pollutants. According to a statement, the directions aim to eliminate fire incidents in Sanitary Landfill (SLF) sites, dumpsites, and open burning of Municipal Solid Waste (MSW)/ biomass across the National Capital Region (NCR). The Commission has directed the concerned agencies in the NCR to take appropriate actions under two broad categories with a view to prevent fire incidents and resultant high levels of air pollution. The agencies are directed to manage legacy waste at SLF and dumpsites, and also to manage fresh generation of MSW to prevent fire incidents. According to the official statement, the agencies are required to carry our proper identification, categorization, demarcation and fire risk assessment of all SLFs and dumpsites located in Delhi-NCR. Extensive bio-mining and bio-remediation are to be carried out in landfills and dumpsites to 'liquidate the legacy waste as per the targeted timelines already submitted to the Supreme Court,' with the Delhi government and state governments to review the action plans. CCTV cameras are also to be installed at these sites, with appropriate fencing arrangements along the boundary. Installation of Methane Gas Detectors at the SLFs and dumpsite are also required so that high methane concentration areas are identified and preventive measures are taken. Similarly, other fire-fighting arrangements are to be made available at all sites, with period mock drills to be conducted too, including quarterly audits for Fire Safety and hazardous emissions. The workers at the site are to be provided with proper safety gear and personal Protection Equipment (PPE) for safe handling of legacy waste. For dealing with new waste, CAQM has directed that agencies ensure collection, segregation, transportation and processing of waste in accordance with the Solid Waste Management Rules, 2016. There will be 'zero tolerance' towards burning of MSW at vulnerable points, intermediate dumps and collection centres, along with regular enforcement teams to be deployed for ensuring prevention of open burning of MSW. The CAQM directions also call for increasing the capacities of urban local bodies to process horticulture waste in parks, gardens, green belts, institutions, and roadside areas and intensifying collection during the autumn season. ZQM has also said that regular capacity-building programs should be incorporated for sanitation staff. 'All concerned agencies as mentioned under various statutes relating to solid waste management have been directed to ensure compliance with the Statutory Directions of the Commission,' CAQM's statement read. All State Pollution Control Boards (SPCBs)/ Delhi Pollution Control Committee (DPCC) have to submit a consolidated State wide report on prevention and control of sanitary landfill site and dumpsite fires and open Municipal Solid Waste/ Bio-mass burning in Delhi-NCR to the Commission in a prescribed format for the Quarterly Report, with the commission warning that non-compliance might invite penal action. (ANI)
Yahoo
15-05-2025
- Business
- Yahoo
Solid Biosciences Reports First Quarter 2025 Financial Results and Provides Business Updates
- : Participant dosing ongoing in the Phase 1/2 INSPIRE DUCHENNE trial; Solid on track to discuss accelerated pathways with U.S. FDA later in 2025 - - Dosing of first participant anticipated in the second half of 2025 - - FDA IND on track for submission first half of 2025 - - Company ended first quarter 2025 with $306.9 million in cash, cash equivalents, investments and available-for-sale securities; Solid has anticipated cash runway into the first half of 2027 - CHARLESTOWN, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the 'Company' or 'Solid'), a life sciences company developing precision, next generation, genetic medicines for neuromuscular and cardiac diseases, today reported financial results for the first quarter ended March 31, 2025, and provided a business update. Bo Cumbo, President and CEO of Solid, commented: 'The positive initial three patient, 90-day data in the INSPIRE DUCHENNE trial of SGT-003, our next-generation, investigational gene therapy to treat Duchenne muscular dystrophy, were a milestone in the development of a meaningful treatment candidate for this terrible disease. With the initial data demonstrating robust microdystrophin expression and improvements across biomarkers of muscle integrity and, excitingly, encouraging biomarkers of cardiac and liver health, we continue to dose participants as we prepare to engage with the FDA later this year on the potential for accelerated pathways. 'To our patient communities, we know that safety is a critical factor in choosing any medical therapy. SGT-003, utilizing our proprietary, rationally designed capsid, AAV-SLB101, contains the lowest dose of any Duchenne gene therapy currently marketed or in clinical development, and to date, has demonstrated an encouraging safety and tolerability profile. We look forward to the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) where, on Saturday, we will provide an interim safety update from the INSPIRE DUCHENNE trial during our late-breaking oral presentation. 'As an organization, we are intensely focused on driving innovation and advancing the C> field with the aspiration to make gene therapies safer, more effective, and truly accessible. These efforts originate with our differentiated and thoughtfully designed neuromuscular and cardiac therapeutic pipeline and expand to the development and broad out-licensing of next-generation delivery technologies, beginning with AAV-SLB101. We look forward to executing across these objectives over the coming quarters to drive meaningful value for all of our stakeholders,' Mr. Cumbo concluded. Company Updates Neuromuscular PipelineSGT-003 for Duchenne Muscular Dystrophy (Duchenne) As announced on February 18, 2025, the Company reported positive initial clinical data from the first three participants dosed in the Phase 1/2 INSPIRE DUCHENNE trial. SGT-003 has been well tolerated in all participants dosed to date, with no treatment emergent serious adverse events (SAEs) or AEs of acute liver injury observed. The INSPIRE DUCHENNE trial continues dosing participants across multiple cohorts, and the Company expects to dose approximately 20 total participants by year-end. The INSPIRE DUCHENNE trial now has eight active sites in the U.S., Canada and Italy, with additional sites expected to be activated by year-end. The Company plans to meet with the FDA later this year to share safety and efficacy results from additional treated participants in the INSPIRE DUCHENNE study and to discuss accelerated regulatory pathways. The Company expects the meeting to occur in the fourth quarter of 2025. SGT-212 for Friedreich's Ataxia (FA) As announced on January 7, 2025, the FDA has cleared the IND for SGT-212 for the treatment of FA. SGT-212 is the first gene therapy candidate for FA to utilize a dual route of administration that was designed to promote restoration of therapeutic levels of the frataxin protein to address neurologic, cardiac and systemic clinical manifestations of FA. The Company expects to initiate a first-in-human, open-label, Phase 1b clinical trial of SGT-212 in the second half of 2025. The trial is expected to enroll non-ambulatory and ambulatory adult participants living with FA across up to three cohorts and is designed to evaluate the safety and tolerability of systemic and bilateral IDN administration of SGT-212. Cardiac PipelineSGT-501 for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) IND-enabling Good Laboratory Practice (GLP) toxicology studies of SGT-501 in non-human primates were completed in the first quarter of 2025. The Company anticipates submitting an IND for SGT-501 for the treatment of CPVT in 1H 2025. Platform Technologies – Capsids & OtherCapsids & Promoters The Company is building multiple cardiac and neuromuscular next-generation capsid and promoter libraries with final capsid selection from the first cardiac capsid library anticipated in the fourth quarter of 2025. AAV-SLB101 is the Company's proprietary capsid used in SGT-003, which in the initial three participants dosed in the INSPIRE DUCHENNE study demonstrated rapid and robust levels of vector transduction, microdystrophin expression, and reduced liver targeting. Solid currently has partnership agreements with 19 academic labs, institutions and corporations for the use of AAV-SLB101, with additional partnerships expected to be executed over the coming quarters. First Quarter 2025 Financial Highlights Cash Position: Solid had $306.9 million in cash, cash equivalents, and available-for-sale securities as of March 31, 2025, compared to $148.9 million as of December 31, 2024. The Company expects that its cash, cash equivalents, and available-for-sale securities as of March 31, 2025, will enable it to fund its operational runway into the first half of 2027. Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2025 were $30.9 million, compared to $18.9 million for the first quarter of 2024. The increase of $12.0 million was primarily due to a $7.4 million increase in costs for SGT-003 primarily related to manufacturing, regulatory, and clinical costs, a $1.9 million increase in personnel-related expenses, a $1.3 million increase in other development program expenses primarily due to manufacturing costs, a $0.8 million increase in costs for SGT-212 primarily related to regulatory and clinical costs, and a $0.7 million increase in costs for SGT-501 primarily related to research, regulatory, and clinical costs. General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2025 were $9.1 million, compared to $8.0 million for the first quarter of 2024. The increase of $1.1 million was primarily due to a $1.7 million increase in personnel-related costs, partially offset by a $0.4 million decrease in other G&A expenses. Net Loss: Net loss for the first quarter of 2025 was $39.3 million, compared to $24.3 million for the first quarter of 2024. About Solid BiosciencesSolid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich's ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. The Company is also focused on developing innovative libraries of genetic regulators and other enabling technologies with promising potential to significantly impact gene therapy delivery cross-industry. Solid is advancing its diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted by Duchenne, Solid's mission is to improve the daily lives of patients living with devastating rare diseases. For more information, please visit Forward-Looking StatementsThis press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding future expectations, plans and prospects for the company; the ability to successfully achieve and execute on the company's goals, priorities and key clinical milestones; the company's SGT-003 and SGT-212 programs, including expectations for additional CTA filings, site activations, planned enrollment, planned regulatory interactions and the potential accelerated approval pathway for SGT-003; the company's expectations for submission of INDs; the cash runway of the company and the sufficiency of the Company's cash, cash equivalents, and available-for-sale securities to fund its operations; and other statements containing the words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'would,' 'working' and similar expressions. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the company's ability to advance SGT-003, SGT-212, SGT-501, SGT-601 and other preclinical programs, capsid libraries and other enabling technologies on the timelines expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies and early-stage clinical trials of the company's product candidates; obtain, maintain or protect intellectual property rights related to its product candidates; replicate preliminary or interim data from early-stage clinicals trials in the final data of such trials; compete successfully with other companies that are seeking to develop Duchenne, FA, CPVT and other neuromuscular and cardiac treatments and gene therapies; manage expenses; and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-003, SGT-212, SGT-501, SGT-601 and other candidates, achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the 'Risk Factors' section, as well as discussions of potential risks, uncertainties and other important factors, in the company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company's views as of the date hereof and should not be relied upon as representing the company's views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company's views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so. Solid Biosciences Investor Contact:Nicole AndersonDirector, Investor Relations and Corporate CommunicationsSolid Biosciences Media Contact:Glenn SilverFINN SOLID BIOSCIENCES INC. SELECTED FINANCIAL INFORMATION (UNAUDITED) CONDENSED CONSOLIDATED BALANCE SHEETS March 31, December 31, (in thousands, except share data) 2025 2024 Cash and cash equivalents $ 210,629 $ 80,235 Available-for-sale securities 96,289 68,685 Prepaid expenses and other current assets 6,491 8,382 Operating lease, right-of-use assets 23,720 24,295 Property and equipment, net 4,483 4,747 Other non-current assets 319 366 Restricted cash 1,973 1,952 Total Assets $ 343,904 $ 188,662 Accounts payable $ 6,439 $ 4,237 Accrued expenses and other current liabilities 14,576 19,852 Operating lease liabilities 1,868 1,787 Finance lease liabilities 1,096 1,231 Derivative liabilities 4,800 3,150 Operating lease liabilities, excluding current portion 20,662 21,159 Total stockholders' equity 294,463 137,246 Total Liabilities and Stockholders' Equity $ 343,904 $ 188,662 Common stock outstanding 77,492,959 40,468,141CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS Three Months EndedMarch 31, (in thousands, except per share data) 2025 2024 Operating expenses: Research and development $ 30,914 $ 18,873 General and administrative 9,138 7,989 Total operating expenses 40,052 26,862 Loss from operations (40,052 ) (26,862 ) Other income, net: Interest income 2,300 2,651 Interest expense (68 ) (95 ) Change in fair value of derivative liabilities (1,650 ) — Other income, net 188 3 Total other income, net 770 2,559 Net loss $ (39,282 ) $ (24,303 ) Net loss per share, basic and diluted $ (0.59 ) $ (0.64 ) Weighted average shares of common stock outstanding, basic and diluted 66,341,305 38,155,373 This press release was published by a CLEAR® Verified 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
Yahoo
30-04-2025
- Business
- Yahoo
Solid Biosciences to Participate at The Citizens Life Sciences Conference
CHARLESTOWN, Mass., April 30, 2025 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the 'Company' or 'Solid'), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, announced that Bo Cumbo, President and CEO, will participate in a fireside chat at The Citizens Life Sciences Conference on Wednesday, May 7, at 12:30 pm ET. A live webcast of the fireside chat will be available on the Events page of the Investors section of the Company website or by clicking here. The webcast replay will be archived for 30 days on the Events page. Institutional investors interested in meeting with management during the conference may reach out to their Citizens representative. About Solid BiosciencesSolid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich's ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. The Company is also focused on developing innovative libraries of genetic regulators and other enabling technologies with promising potential to significantly impact gene therapy delivery cross-industry. Solid is advancing its diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted by Duchenne, Solid's mission is to improve the daily lives of patients living with devastating rare diseases. For more information, please visit Solid Biosciences Investor Contact:Nicole AndersonDirector, Investor Relations and Corporate CommunicationsSolid Biosciences Media Contact:Glenn SilverFINN
Miami Herald
29-04-2025
- Business
- Miami Herald
Key banking brand filed unexpected Chapter 11 bankruptcy
Any time a brand gets branded (or brands itself) as the something of some other industry it takes a major risk. Calling yourself the Apple of the motorcycle industry or the Google of fishing, can simply be confusing. Using this type of designation helps company's raise money as it makes their business easy to understand. The problem is that this type of elevator pitch designation creates expectations. It's a lot to be the Chipotle or Mediterranean food or the Netflix of live concerts. Related: Fan favorite retail chain nears end after Chapter 11 bankruptcy in both cases, the shortcut description makes it easy to understand what the company wants to be. It also sets the actual brand for failure. Chipotle and Netflix have easy to understand business models which have failed hundreds of times when used by other companies. It turns out that serving via a line of already-prepared foods and delivering video via streaming are only part of the magic for those two companies. Don't miss the move: Subscribe to TheStreet's free daily newsletter Framing a business by comparing it to an unquestioned industry leader makes raising money and researching customers easier. But, if you do that and don't deliver, failure can come quickly. Solid, which used to be known as Wise, called itself the "AWS of fintech." That's a lot to live up to and a bit confusing as many people who use Amazon Web Services only vaguely understand what it does. A banking as a service (BaaS) company, Solid uses a more modest description of what it offers on its website. "Solid's platform enables banks and companies to offer embedded banking, payments, and card products, in a safe, secure and compliant way," it posted. Basically, Solid offers white label banking products. "With a single integration, build out your FinTech program on Solid, the most advanced and well-documented platform that helps you launch on budget, on time, on quality, and, most importantly, in full compliance," it added. That's a potentially huge category and the brand was much-heralded during its most recent fundraising round. More bankruptcies: Popular restaurant and bar chain files for Chapter 11 bankruptcyPopular athletic shoe chain files for Chapter 11 bankruptcyAward-winning cosmetics brand files for Chapter 11 bankruptcy The company, which was founded in 2018, raised over $80 million. Solid was valued at $330 million as of August 2022, according to PitchBook, when it announced a $63 million Series B round of funding led by FTV. Now, the company is fighting for survival as it has filed for Chapter 11 bankruptcy protection. Solid formally filed for Chapter 11 bankruptcy protection in the United States Bankruptcy Court for the District of Delaware on April 7. The filing made it clear that if its first-day motions were not approved, the company might not be able to continue operations. It also shared the three aspects of Solid's BaaS revenue model: Bank Partnerships: The debtor partners with regulated banks through Banking Services Agreements. These banks maintain custody of customer deposits,manage and execute money transmission, issue cards, and provide the underlying payments and compliance infrastructure required to operate compliant financial products. Technology Platform for Fintech Clients: The debtor offers a developer-friendly application programming interface ("API") platform (the "Solid Platform") that allows fintech companies to quickly launch and scale financial products. The debtor's offerings include connectivity between fintech clients and sponsor banks to open accounts, issue cards and initiate payment wrapped around compliance management and fraud Onboarding and Integration: The debtor signs up clients,usually fintech companies or platforms, that want to embed financial services. The debtor's clients then use the Debtor's API and dashboards to launch financial products. Solid has served 142 clients and worked with four banks. At the time of the filing, the company was owed $760,000 by clients and had $7 million in cash, only $5 million of which is liquid. Related: Big-name whiskey brand in Chapter 11 bankruptcy fights to survive As part of the Chapter 11 bankruptcy filing it plans to wind down or sell its business. As it pursues a sale, it will continue operating normally. The company, according to the Chapter 11 filing, faces "significant and costly litigation." The company is being sued by its own Series B investor FTV Capital which is seeking to get its $61 million investment back. The Arena Media Brands, LLC THESTREET is a registered trademark of TheStreet, Inc.
