NTM | Jotup

MannKind Receives U.S. FDA Fast Track Designation for Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease

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måndag, maj 6, 2024

Fast track designation is intended to facilitate the development, and expedite the review, of medicines to treat serious conditions and fill an unmet medical need.

Key Points:

Fast track designation is intended to facilitate the development, and expedite the review, of medicines to treat serious conditions and fill an unmet medical need.
“We are pleased with the FDA’s decision to grant Fast Track designation for Clofazimine Inhalation Suspension, providing us an opportunity to accelerate our efforts to potentially bring an important medicine to patients living with NTM,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation.
The U.S. FDA previously designated Clofazimine Inhalation Suspension as both an orphan drug and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections.
NTM lung disease is more common in women over the age of 65, with a predominance in those of Caucasian and Asian descent.

CorMedix Inc. Announces Abstracts at Upcoming Society for Healthcare Epidemiology of America Conference

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torsdag, april 11, 2024

Mortality, Society, Gram-positive bacteria, Economics, Abstract, Bacteria, NTM, BSI, Patient, Gram-negative bacteria, CVC

BERKELEY HEIGHTS, N.J., April 11, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that two abstracts have been accepted for presentation at the Society for Healthcare Epidemiology of America (SHEA) conference being held in Houston, Texas, April 16 – 19, 2024.

Key Points:

BERKELEY HEIGHTS, N.J., April 11, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that two abstracts have been accepted for presentation at the Society for Healthcare Epidemiology of America (SHEA) conference being held in Houston, Texas, April 16 – 19, 2024.
The first abstract being presented examines in vitro antimicrobial activity of taurolidine against a set of recent clinical isolates representative of bacteria recovered from the LOCK-IT 100 trial and those commonly associated with CRBSI.
Based on these data, taurolidine demonstrated broad antimicrobial activity against all gram-positive bacteria, including non-tuberculosis Mycobacteria (NTM), gram-negative bacteria, and fungal isolates tested.
In addition, the activity of taurolidine was unaffected by resistance to common antibiotics.

Spero Therapeutics Announces Fourth Quarter and Full Year 2023 Operating Results and Provides a Business Update

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onsdag, mars 13, 2024

“2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.

Key Points:

“2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.
Top-line data from the Phase 2a proof-of-concept clinical trial in treatment-naive and treatment-experienced non-refractory NTM-PD patients is expected in 2H 2024.
Spero commenced enrollment in PIVOT-PO, a global, randomized, double-blind, Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including AP in December 2023.
Total revenue for the fourth quarter of 2023 was $73.5 million, compared with total revenue of $47.4 million for the fourth quarter of 2022.

AN2 Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business and Scientific Highlights

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torsdag, mars 28, 2024

Patients in the Phase 2 trial have reached the six-month mark, and we plan to report topline results this summer.

Key Points:

Patients in the Phase 2 trial have reached the six-month mark, and we plan to report topline results this summer.
Net loss: Net loss for the full year 2023 was $64.7 million, compared to $41.0 million in the prior year.
Net loss for the fourth quarter of 2023 was $16.9 million, compared to $11.8 million for the same period during 2022.
Cash Position: The Company had cash, cash equivalents, and investments of $134.5 million at December 31, 2023.

Vast Therapeutics Expands Leadership Team with Appointment of Dr. Paul Bruinenberg as Chief Medical Officer

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torsdag, mars 7, 2024

MORRISVILLE, N.C., March 7, 2024 /PRNewswire/ -- Vast Therapeutics today announced the addition of Paul Bruinenberg, MD, MBA as Chief Medical Officer. Dr. Bruinenberg brings over 30 years of experience as a clinical development executive in respiratory medicine and orphan diseases. This appointment and the recent addition of microbiologist and clinical diagnostics expert Chris Polage, MD, as Medical Director, significantly bolster the company's clinical development expertise in pulmonary infectious diseases and medical microbiology.

Key Points:

MORRISVILLE, N.C., March 7, 2024 /PRNewswire/ -- Vast Therapeutics today announced the addition of Paul Bruinenberg, MD, MBA as Chief Medical Officer.
"Paul's development experience will guide Vast Therapeutics as we successfully transition to a clinical-stage organization," said Nate Stasko, Chief Executive Officer at Vast Therapeutics.
"It is an amazing opportunity to join a company with an accepted IND for a novel treatment modality that shows promising efficacy against chronic infections caused by Pseudomonas aeruginosa and non-tuberculosis mycobacteria," commented Paul Bruinenberg, Chief Medical Officer at Vast Therapeutics.
Most recently, Dr. Bruinenberg served as the Senior Medical Officer of the TB Alliance leading clinical development against mycobacterial infections.

Beyond Air® Reports Financial Results for Third Quarter of Fiscal Year 2024

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måndag, februari 12, 2024

“In the third quarter of fiscal year 2024, we reported solid sequential revenue growth of more than 60% compared with the second quarter.

Key Points:

“In the third quarter of fiscal year 2024, we reported solid sequential revenue growth of more than 60% compared with the second quarter.
This increasing demand for our current LungFit PH system was seen even as we prepared to launch a key software update.
As our inventory of upgraded LungFit PH grows, we expect to be able to meet accelerating demand over the next several quarters.
General and administrative expenses for the three months ended December 31, 2023 and December 31, 2022 were $9.8 million and $8.9 million, respectively.

The macroeconomic effects of global supply chain reorientation

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lördag, februari 10, 2024

Bank, Control, Quarterly Journal of Economics, Literature, Deutsche Bundesbank, Reconstruction, COVID-19, Monetary policy, Medical classification, Aggregate, Interest, Hail, Motion, Organization, WT, Policy, Smith, Elasticity, American Economic Review, Information, CHiPs, Journal of Economic Perspectives, Reproduction, Tagliapietra, Culture, Journal of International Economics, Section 3, European Commission, Communication, B16, Shock, NTM, European Chips Act, SSC, PHT, B17, Classification, Common, Tradability, Bank of Italy, Congressional Research Service, NT, Central bank, Private, Exercise, NIU, Labour, PDF, Website, European Parliament, Terrorism, Employment, B10, SUBST, Agricultural economics, F62, RTK, Bank of England, European Central Bank, Calibration, Agriculture, Foreign policy, Semiconductor, International Monetary Fund, Research Papers in Economics, Outline, Council, Openness, Bias, Economic system, European Council, Public policy, Deutsch, Statistics, GDP, Real, American Economic Journal, Table, Journal, YT, EAGLE, Household, Grossman, Science, Conference, Journal of Comparative Economics, Horse, SSRN, TC, Consumption, REA, F13, Section 2, University, Section 5, Legislation, Money, NTD, Central Bank of Ireland, Language, Capital, University of Limerick, Intermediate, CBI, Caselli, Macroeconomics, Crowding, Technical report, B14, Tax, Civil service commission, Growth, Commission, UNCTAD, Optimism, Politics, PIM, PX, Work, Social science, JEL, Government, Automation, HTT, Quarterly Journal, Canadian International Council, ECB, XT, METRO, ELAS, Credit, Bolt, Research, European Communities, American Journal, ArXiv, Unilateralism, Lerner, Motivation, International, C6, Committee, Security (finance)

We analyse the macroeconomic

Key Points:

We analyse the macroeconomic
effects of supply chain reorientation through localisation policies, using a global dynamic
general equilibrium model.
While arguments about comparative advantage, the potential forgone benefits of international specialisation and industry- and product-specific disruptions are familiar, there is less
analysis on the macroeconomic effects of supply chain changes resulting from localisation policies.
The large sensitivity of the global economy to the recent supply chain shocks suggests that
the international trade reconfiguration implied by localisation policies could also have sizable
impacts on key macroeconomic variables such as output, employment and inflation.
Thus, localisation focuses on the
goods in our model most closely related to global supply chains.
Retaliation also attenuates any positive effects from
reshoring on output and implies a reduction in the volume of overall international trade.
This finding calls for limiting the scope of reshoring, such as by focusing on vital goods that are
most susceptible to supply chain disruptions.
Either that, or the economic costs are considered a worthwhile trade-off for an increase
in security of supply, for example.
While arguments about comparative advantage, the potential forgone benefits of international specialisation and industry- and product-specific disruptions are familiar, there is less
analysis on the macroeconomic effects of supply chain changes resulting from localisation policies.
Recent supply chain shocks have had large effects, with disruptions in 2021 estimated
to have reduced euro area GDP by around two percent and doubled the rate of manufacturing producer inflation (Celasun et al., 2022).
To analyse this issue, we simulate a (partial) reshoring of production back to Europe in
a global dynamic general equilibrium framework.
Thus,
localisation focuses on the goods in our model most closely related to global supply chains.3 We
model reshoring through a direct change to the export goods? production-function parameters.
Since reshoring
effectively shortens the supply chain, the sum of markups along the chain falls.
This means that imports that are at the end of the supply chain (i.e.
In particular, our work relates to papers examining the potential for countries to reduce
their exposure to global supply chains.
(2021) demonstrate that reduced reliance on foreign inputs does not mitigate pandemicinduced contractions in labour supply.
(2021) find no evidence of a relationship
between global value chain integration and macroeconomic volatility.
This dynamic, along with factors such as natural disasters, climate-change
induced volatility and terrorism mean that supply chain disruptions could be a new normal
(Grossman et al., 2021).
Our work contributes to the literature providing dynamic general equilibrium analyses of
protectionist policies, in particular those using global macroeconomic models to quantify trade
policy changes.
(2008) analyse the effect of a rise in protectionism in response
to rising global trade imbalances.
Linde? and Pescatori (2019) find that although the macroeconomic costs of a
trade war are substantial, a fully symmetric retaliation is the best response.
(2020) consider a rich input-output structure and demonstrate that closer integration amplifies
the adverse effects of protectionist trade policies.
Several recent studies have also examined the economic effects of a global trade fragmentation.
First, we modify a dynamic general
equilibrium model of the global economy in order to analyse the transmission of localisation
policies.
This allows for a comprehensive treatment of cross-border macroeconomic interdependences and spillovers between the different regions.
4
There is, however, substantial cross-country heterogeneity in terms of impact, with small open economies
(SOEs) reliant on global supply chains more affected.
ECB Working Paper Series No 2903
7

Second, we are able to assess both long-run effects and the transition dynamics of localisation
policies.
Our model contains a detailed monetary block and captures inflation dynamics, which is a key
concern for supply chain reorientation.
Overall, our paper contains a careful analysis of the key aspects of the localisation debate,
including effects of localisation on domestic competition and efficiency.
Section 2 provides a brief overview of the model, the modifications to examine
global supply chain reorientation, some key details on the calibration and a brief discussion of
the nature of our exercise.
(2020) for discussions of the relative strengths and weaknesses of
trade and macroeconomic models in assessing large economic shocks.
2.1
Supply chain reorientation

Our analysis focuses on imported inputs used to produce goods for export, as the introduction
of localisation policies is in response to recent disruptions to global supply chains.
Since reshoring
effectively shortens the supply chain, the sum of markups along the chain falls.
Further to
these effects, engagement with global firms provides an opportunity for knowledge spillovers to
local firms (Criscuolo et al., 2017).
This finding calls for limiting the scope of reshoring, such as by focusing on vital goods that are
most susceptible to supply chain disruptions.
(B12)
Adjusting the share of local inputs in export goods, of course, affects prices and quantities all
along the supply chain.

Leading Independent Proxy Advisory Firm ISS Recommends Consolidated Communications Shareholders Vote “FOR” the Proposed Transaction with Searchlight and BCI

Retrieved on:

fredag, januari 19, 2024

Consolidated Communications Holdings, Inc. (Nasdaq: CNSL) (the “Company” or “Consolidated”), a top 10 fiber provider in the U.S., today announced that a leading independent proxy advisory firm, Institutional Shareholder Services (“ISS”), has recommended that Consolidated shareholders vote “FOR” the proposed acquisition of the Company by affiliates of Searchlight Capital Partners, L.P. (“Searchlight”) and British Columbia Investment Management Corporation (“BCI”) (the “Proposed Transaction”).

Key Points:

Consolidated Communications Holdings, Inc. (Nasdaq: CNSL) (the “Company” or “Consolidated”), a top 10 fiber provider in the U.S., today announced that a leading independent proxy advisory firm, Institutional Shareholder Services (“ISS”), has recommended that Consolidated shareholders vote “FOR” the proposed acquisition of the Company by affiliates of Searchlight Capital Partners, L.P. (“Searchlight”) and British Columbia Investment Management Corporation (“BCI”) (the “Proposed Transaction”).
The Company’s special meeting of shareholders (the “Special Meeting”) to vote on the Proposed Transaction is scheduled for January 31, 2024.
Consolidated urges its shareholders to vote FOR the Proposed Transaction today.
Consolidated issued the following statement regarding the ISS recommendation to vote FOR the Proposed Transaction:
“We are pleased ISS recognizes that the Proposed Transaction maximizes the value our shareholders can receive by eliminating the risk they would bear should Consolidated remain a standalone company.

nShift: 88% of companies "not ready" for CSRD

Retrieved on:

tisdag, januari 9, 2024

CSRD, ISO, Network, NTM, Reliability, GLEC, Credibility, Medical imaging

LONDON, Jan. 9, 2024 /PRNewswire/ -- Companies are still under-prepared for the EU Corporate Sustainability Reporting Directive (CSRD), which will come into effect later this year.

Key Points:

LONDON, Jan. 9, 2024 /PRNewswire/ -- Companies are still under-prepared for the EU Corporate Sustainability Reporting Directive (CSRD), which will come into effect later this year.
The tool helps ecommerce companies and warehouses calculate, record, and analyze greenhouse gas emissions for every shipment.
It enables companies to comply with new incoming environmental reporting requirements and pinpoint opportunities for emissions reduction.
Mattias Gredenhag, CTO at nShift said, "The clock is ticking for companies when it comes to tracking and reporting emissions.

Airship AI Holdings Completes Business Combination with BYTE Acquisition Corp.

Retrieved on:

torsdag, december 21, 2023

Airship AI Holdings, Inc. (“Airship AI”), a robust AI-driven video, sensor and data management surveillance platform that provides complex automated monitoring, predictive event analysis and intelligence to large institutions operating in dynamic and mission-critical environments with rapidly increasing volumes of data and data sources, and BYTE Acquisition Corp. (NASDAQ: BYTS), a special purpose acquisition company (“BYTE”), have completed the previously announced business combination (the “Business Combination”).

Key Points:

Airship AI Holdings, Inc. (“Airship AI”), a robust AI-driven video, sensor and data management surveillance platform that provides complex automated monitoring, predictive event analysis and intelligence to large institutions operating in dynamic and mission-critical environments with rapidly increasing volumes of data and data sources, and BYTE Acquisition Corp. (NASDAQ: BYTS), a special purpose acquisition company (“BYTE”), have completed the previously announced business combination (the “Business Combination”).
In connection with the Business Combination closing, the combined company has been renamed “Airship AI Holdings, Inc.” (the “Company”).
The board of Airship AI would like to thank the team at BYTE for the successful completion of the Business Combination,” concluded Allen.
We thank the Airship AI team for their hard work and partnership in completing the Business Combination.”
1) Edge AI Hardware Market By Component, Valuates Reports
Roth Capital Partners served as exclusive M&A advisor to Airship AI.