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Healthcare
Neurotech International’s FDA Setback: Orphan Drug Status Denied for NTI164
October 04, 2024 10:19 AM AEST| By Team Kalkine MediaHighlights:,Neurotech International (,ASX:NTI,) was denied orphan drug status by the FDA for NTI164, citing concerns over the rarity of its target conditions.,The FDA questioned the distinction between PANDAS and PANS, and the prevalence data provide...
CSL Ltd's 2024 Performance and Sector Overview
October 04, 2024 10:06 AM AEST| By Team Kalkine MediaHighlights,CSL Ltd share price shows slight increase in 2024.,The Healthcare sector offers consistent revenue growth potential.,CSL operates in essential services, with a focus on long-term growth.,The share price of CSL Ltd,(ASX:CSL),, a global biot...
Lumos Diagnostics Secures $3M Funding from BARDA for FebriDx FDA Expansion
October 03, 2024 06:02 PM AEST| By Team Kalkine MediaHighlights,Lumos Diagnostics secures nearly $3 million in funding from BARDA.,The funds will support the FebriDx test’s CLIA waiver study and US FDA application.,The FebriDx test aids in distinguishing between bacterial and non-bacterial infections.,...
Island Pharma Raises $3.5M, Radiopharm Preps US Trial, Truscreen Gets WHO Nod
October 03, 2024 05:49 PM AEST| By Team Kalkine MediaHighlights,Island Pharmaceuticals raises $3.5M for its dengue fever study.,Radiopharm,Theranostics,prepares for a US cancer trial with FDA support.,Truscreen,Group receives recognition in,WHO,report for cervical cancer screening.,Island Pharmaceutica...
Cyclopharm Signs Interim Agreement with U.S. Veterans Health Administration for Technegas Supply
October 03, 2024 04:32 PM AEST| By Team Kalkine MediaCyclopharm Limited (ASX:CYC) has announced an Interim Agreement (IA) to supply the U.S. Veterans Health Administration (VA) with pharmaceutical and consumable components of Technegas. This deal marks an important milestone for Cyclopharm as it paves...
Lumos Diagnostics (ASX:LDX) Secures US Government Backing for FebriDx Test
October 03, 2024 01:42 PM AEST| By Team Kalkine MediaHighlights,Lumos Diagnostics secures US government funding for,FebriDx,test development.,Nearly US$3 million from BARDA to support clinical study and FDA submission.,FebriDx,aims to improve antibiotic use by distinguishing bacterial from non-bacteria...
4D Medical’s US Breakthrough, Clinuvel’s Global Push, and Biome’s Revenue Surge
October 01, 2024 02:54 PM AEST| By Team Kalkine MediaHighlights,4D Medical expects its first revenue from a US distribution deal with Philips this year.,Clinuvel Pharmaceuticals seeks Canadian approval for its skin disorder drug Scenesse.,Biome Australia reports record revenue growth in the latest quar...
Paragon Care (ASX: PGC) Shows Resilience Despite Unusual Profit Setback
October 01, 2024 02:39 PM AEST| By Team Kalkine MediaHighlights,Paragon Care shows strength despite lower reported profits.,AU$5.5 million in unusual items impacted the recent profit figures.,Future profit performance may improve as unusual expenses are not expected to recur.,Paragon Care Limited,(ASX:...
Sigma Healthcare (ASX:SIG) Shares Surge on Merger Update with Chemist Warehouse
October 01, 2024 02:12 PM AEST| By Team Kalkine MediaThe Sigma Healthcare Ltd (ASX:SIG) share price is experiencing a notable surge on Tuesday morning, climbing 12% to reach a 52-week high of AUD 1.62. This increase in investor interest comes on the heels of significant developments regarding Sigma's p...
ResMed Projects High Single-Digit Revenue Growth Until 2030
October 01, 2024 11:44 AM AEST| By Team Kalkine MediaHighlights:,ResMed (ASX: RMD) projects high single-digit revenue growth through 2030, supported by innovation and new product launches, including insomnia treatments.,The company dismisses concerns that weight-loss drugs like Ozempic will significant...
Sigma Healthcare's (ASX: SIG) Merger with Chemist Warehouse and Data-Sharing Provisions: A Closer Look
October 01, 2024 11:36 AM AEST| By Team Kalkine MediaHighlights:,Data-Sharing Rules:,Sigma Healthcare (ASX: SIG) has proposed data-sharing restrictions to prevent Chemist Warehouse from accessing confidential pharmacy data and potentially harming competition in the pharmaceutical market.,Franchisee Ter...
Pro Medicus (ASX:PME) Shares Surge with Strong Healthcare Performance
October 01, 2024 09:39 AM AEST| By Team Kalkine MediaHighlights,Pro Medicus Limited shares have surged 85.1% since the start of 2024,.,Pro Medicus offers radiology IT software that enhances healthcare services globally,.,The healthcare sector, including PME, benefits from consistent revenue and,strong...
EBR Systems Advances Towards FDA Approval for WiSE Technology
September 30, 2024 06:35 PM AEST| By Team Kalkine MediaHighlights,EBR Systems has received FDA acceptance of its PMA application for the WiSE device, moving to a substantive review.,The FDA expedited the review process, completing its confirmation in just 30 days.,EBR anticipates FDA approval in Q1 2025,...
Anteris Technologies Adjusts Timeline for Nasdaq Listing
September 30, 2024 04:10 PM AEST| By Team Kalkine MediaHighlights,Anteris extends Nasdaq listing schedule.,Scheme meetings rescheduled to October or November 2024.,Focus,remains,on re-domiciliation and structural heart innovations.,Anteris Technologies Ltd,(ASX:AVR),has announced a revised timeline for i...
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Polynovo (ASX:PNV): A Week of Gains Amid Market Fluctuations
September 30, 2024 02:45 PM AEST| By Team Kalkine MediaPolynovo Limited (ASX:PNV), Australia's fourth-largest pharmaceuticals and biotechnology company by market capitalization, has had a noteworthy week. The company's share price increased by 7.3% to close at AU$2.64. This rise stands in contrast to the...
Biome Australia Targets Significant Sales Growth Amid Industry Developments
September 30, 2024 12:51 PM AEST| By Team Kalkine MediaHighlights,Biome Australia aims to significantly increase sales over the next three years.,Anteris Technologies delays US IPO plans while progressing towards its goal.,Artrya,submits FDA application for its AI-based coronary disease detection product...
Mesoblast (ASX:MSB) Secures Funding Deal with Major Shareholder
September 30, 2024 12:47 PM AEST| By Team Kalkine MediaHighlights,Mesoblast secures AUD$72.7 million from top shareholder.,Funding will support marketing strategy for,Ryoncil,upon FDA approval.,Shares,rise,over 3% following the announcement.,Mesoblast (ASX:MSB), a developer of innovative therapies for in...
Pacific Smiles Rejects Genesis Bid Amid Competitive Offerings
September 30, 2024 10:50 AM AEST| By Team Kalkine MediaHighlights:,Pacific Smiles Group Ltd (,ASX:PSQ,) board,indicates,key shareholders intend to reject Genesis,Capital’s,$1.90 per share bid,,deeming,it below NDC,BidCo’s,offer of $2.05.,Genesis Capital holds a 19.9% interest in Pacific Smiles but has no...
ECS Botanics Holdings Shows Promising Gains Amid Ongoing Challenges
September 27, 2024 06:02 PM AEST| By Team Kalkine MediaHighlights,ECS Botanics Holdings Ltd has gained 38% in the last month.,The stock remains down 14% over the past year despite recent gains.,A low price-to-earnings ratio of 12.1x raises questions about future performance.,ECS Botanics Holdings Ltd (AS...
Healthcare Sector Sees Major Developments: Healius, Sigma, and Percheron Therapeutics in Focus
September 27, 2024 04:00 PM AEST| By Team Kalkine MediaHighlights,Healius sells Lumos Imaging to Affinity Equity Partners for $965m.,Sigma Healthcare awaits ACCC decision on Chemist Warehouse merger.,Percheron Therapeutics advances Phase 2B trial for Duchenne muscular dystrophy.,This week, the healthcare...
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