Tactile Medical Announces Acquisition of AffloVest

 

• Further expands the Company’s position as a leader in treating patients with underserved chronic conditions in the home

• Transaction aligns with Tactile Medical’s growth & margin goals, including 20%+ revenue growth, gross margins above 70% and expanding adjusted EBITDA margins

Tactile Systems Technology, Inc. (“Tactile Medical” or the “Company”) (Nasdaq: TCMD), a medical technology company focused on developing medical devices for the treatment of underserved chronic diseases at home, today announced it has acquired the assets of the AffloVest respiratory therapy business from International Biophysics Corporation, a privately-held company which developed and manufactures AffloVest.

AffloVest is a portable, wearable vest that treats patients with chronic respiratory conditions such as COPD-associated breathing conditions like bronchiectasis, or conditions resulting from neuromuscular disorders and cystic fibrosis, by managing airway clearance. AffloVest is the first truly portable, battery-powered, High Frequency Chest Wall Oscillation (HFCWO) device. Its use has been shown to reduce antibiotic use, emergency room visits and hospitalizations.

https://finance.yahoo.com/news/tactile-medical-announces-acquisition-afflovest-200500350.html

Phathom Pharmaceuticals Submits 2 NDAs for Vonoprazan Combinations

 Phathom Pharmaceuticals Inc. said it has submitted two new drug applications to the U.S. Food and Drug Administration for the use of vonoprazan in combination with amoxicillin and clarithromycin and vonoprazan in combination with amoxicillin as a treatment for Helicobacter pylori infection in adults.

The biopharmaceutical company said that if approved, vonoprazan-based treatments will offer two new therapeutic options that have demonstrated superior eradication rates as compared to standard of care lansoprazole-based triple therapy.

If approved, the company expects to launch the treatments in the U.S. in the second half of 2022.

The new drug applications are based on positive data previously announced from Phathom's Phase 3 trial for H. pylori, the company said. The study evaluated eradication rates of H. pylori infection using vonoprazan triple therapy and vonoprazan dual therapy compared to lansoprazole-based triple therapy. Vonoprazan triple therapy and vonoprazan dual therapy successfully met the study's primary non-inferiority endpoints and all secondary endpoints, demonstrating superior eradication rates versus lansoprazole-based triple therapy among all patients including in patients with clarithromycin resistant strains of H. pylori.

The FDA has previously designated vonoprazan triple therapy and vonoprazan dual therapy as qualified infectious disease products and awarded them fast track designation.

https://www.marketscreener.com/quote/stock/PHATHOM-PHARMACEUTICALS-69788315/news/Phathom-Pharmaceuticals-Submits-2-NDAs-for-Vonoprazan-Combinations-36372999/

Novartis's Sandoz Enters Commercialization Agreement for Oncology Medicine

Novartis AG said Wednesday that its generics division Sandoz has entered into a commercialization agreement with biopharmaceutical company Bio-Thera Solutions, Ltd. for oncology medicine biosimilar bevacizumab.

The Swiss pharmaceutical company said it will have the right to commercialize the medicine upon approval in the U.S., Europe excluding Russia, and Canada among other countries, while Bio-Thera Solutions will be in charge of development and manufacturing.

Bevacizumab is used for the treatment of multiple types of cancer.

Under the agreement, Bio-Thera Solutions will receive upfront and milestone payments and will also be entitled to receive profit share payments in the partnered territory, Novartis said.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Novartis-s-Sandoz-Enters-Commercialization-Agreement-for-Oncology-Medicine-36372570/

InflaRx to Proceed With Skin-Disease Drug Study After FDA Meeting

 InflaRx NV said it would proceed with its study of the use of vilobelimab to treat hidradenitis suppurativa, a skin disease, following a meeting with the Food and Drug Administration about its development program.

In the meeting, the FDA's response to InflaRx's proposals for the study's design supported a primary efficacy endpoint that would measure three types of lesions: inflammatory nodules, abscesses and draining tunnels. The study program would focus on patients with active draining tunnels, a symptom that accompanies HS.

The disease brings inflammation of hair follicles on the body, leading to pus formation.

InflaRx said it is still discussing final study-design details with the FDA.

https://www.marketscreener.com/quote/stock/INFLARX-N-V-38607083/news/InflaRx-to-Proceed-With-Skin-Disease-Drug-Study-After-FDA-Meeting-36372526/

Smiths Group Divests Its Medical Division To ICU Medical In $2.4B Deal

 

• ICU Medical Inc (NASDAQ: ICUI) has agreed to acquire Smiths Group plc's Medical division in a transaction that will create an IV therapy company and simplify customer workflow.

• The Smiths Medical business includes syringe & ambulatory infusion devices, vascular access, and vital care products.

• When combined with ICU Medical's existing businesses, the combined entity will generate estimated pro forma revenues of approximately $2.5 billion.

• Smiths will receive 2.5 million newly issued ICU Medical shares, currently valued at approximately $500 million, and $1.85 billion in cash.

• Smiths will own approximately 10% of ICU Medical. It is also eligible to receive a contingent earn-out consideration of $100 million in cash.

• The transaction is expected to close in 1H of 2022. In addition, at closing, a Smiths designee will be appointed to the ICU Medical board of directors.

https://finance.yahoo.com/news/smiths-group-divests-medical-division-113539210.html

Gain: Positive Topline Data in Treatment for Gaucher, Parkinson's Disease

 GT-02287and GT-02329 compounds display positive effects on GCase activity

and related parameters

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Study results demonstrate an increase in GCase protein levels with transport to the lysosomes and decrease of glucosylceramide and <ALPHA>-synuclein-p129 levels

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Comprehensive study results to be presented at Michael J. Fox Foundation's upcoming Innovating from Drug Discovery to the Clinic: Novel Approaches to PD Therapeutic Development webinar

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IND-initiating study planned for Q4'21

Gain Therapeutics, Inc. (Nasdaq: GANX) ("Gain", or the "Company"), a biotechnology company focused on identifying and optimizing allosteric binding sites never before targeted in neurodegenerative diseases and lysosomal storage disorders, today announced topline data from the Company's study, conducted at the University of Maryland School of Medicine (UMSOM). The study, evaluating two lead Structurally Targeted Allosteric Regulators (STARs) compounds -- GT-02287 and GT-02329 -- for the treatment of Gaucher and GBA1 Parkinson's Disease, demonstrated positive effects on all tested phenotypes.

Ricardo Feldman, Ph.D., Associate Professor of Microbiology and Immunology at the University of Maryland School of Medicine, stated, "Our laboratory is using human induced pluripotent stem cells (iPSC) derived from patients with GD and GBA-associated Parkinson's disease to test the efficacy of the two lead STAR chaperones developed by Gain Therapeutics. Our studies in iPSC-derived cortical and dopaminergic neurons from neuronopathic Gaucher Disease patients show that these compounds increase the levels of GCase protein, its transport to the lysosome, and its enzymatic activity. In dopaminergic neurons, the two lead STAR chaperones also decrease the levels of <ALPHA>-synuclein-p129, demonstrating their potential to treat GBA1-associated Parkinson's Disease."

"These data are extremely exciting, as it further demonstrates the potential of GT-02287 and GT-02329 and expands the body of evidence supporting our Site-Directed Enzyme Enhancement Therapy (SEE-Tx(TM)) drug discovery platform," said Eric Richman, Chief Executive Officer of Gain. "We plan to fully evaluate the results of this study and present a complete data set on the upcoming Michael J. Fox Foundation's Innovating from Drug Discovery to the Clinic: Novel Approaches to PD Therapeutic Development webinar. In addition, we anticipate initiating IND-enabling studies for Gaucher / Parkinson's Disease in the fourth quarter of this year."

Gain identified the two lead STAR candidates (GT-02287 and GT-02329) through its proprietary SEE-Tx(TM) platform. The compounds were characterized in assays to potentially help Parkinson's patients with GBA1 gene mutations as well as patients whose glucocerebrosidase (GCase) protein is misfolded due to ageing cellular processes. This previous work was supported through grants from The Michael J. Fox Foundation (MJFF) and the Silverstein Foundation for Parkinson's with GBA.

Mutations in GBA1, the gene encoding the lysosomal enzyme GCase, are among the most commonly known genetic risk factors for the development of Parkinson's Disease and related synucleinopathies. GBA1 mutations are causative for the rare autosomal storage disorder Gaucher Disease and may lead to degradation of the protein, disruptions in lysosomal targeting and diminished performance of the enzyme in the lysosome. Patients with Gaucher Disease including heterozygous carriers are at increased risk of developing Parkinson's Disease and Dementia with Lewy Bodies.

The study conducted in collaboration with Ricardo A. Feldman, Ph.D., Associate Professor of Microbiology and Immunology at UMSOM and lead investigator, is using human induced pluripotent stem cells (iPSC) for Gaucher and Parkinson's Disease modeling and drug discovery. Gain's candidate molecules GT-02287 and GT-02329 have been initially assessed in this unique "disease-in-a-dish" iPSC model derived from Gaucher type 2 and 3 patient cells.

https://www.marketscreener.com/quote/stock/GAIN-THERAPEUTICS-INC-120780704/news/Press-Release-Gain-Therapeutics-Inc-Announces-Positive-Topline-Data-in-Patient-derived-iPSC-Stud-36373493/

Majority of parents believe children fell behind with distance learning: poll

 A majority of parents believe their children have fallen behind due to distance learning that was widely adopted during the pandemic, according to a new poll.

The survey, conducted by USA Today and Ipsos, found that 55 percent of parents believe online or distance learning caused their children to fall behind, which was up from the 46 percent of respondents who felt the same way last year.

Sixty-seven percent of respondents said their children will eventually be able to make up any lost ground, which was down slightly from 73 percent in 2020.

On the topic of educators, 60 percent of respondents said teachers have struggled to help support their children’s online or distance learning, which was an increase from the 52 percent who said the same last year.

The percentage of adults who believe their school districts prepared their children well for online or distance learning during the pandemic dropped significantly from 2020, falling from 65 percent to 50 percent in the recent poll.

The numbers regarding distance learning come as students across the nation are beginning to return to the classroom to begin the fall semester after a year and a half marked by remote learning.

Education Secretary Miguel Cardona told The Washington Post in a recent interview that the pandemic worsened achievement disparities among students, and contended that the best way to close the gap is through in-person learning.

However, parents remain divided over where students should be learning. According to survey released last week from the Centers for Disease Control and Prevention and National Parent Teacher Association, 43 percent of parents support in-person classes, while 40 percent prefer hybrid learning.

And efforts to return the classroom are still being stymied by the pandemic.

At least 90,000 students in 19 states had to quarantine or isolate in the beginning weeks of the school year after contracting COVID-19 or coming into contact with someone who tested positive for the virus.

The USA Today/Ipsos poll also found that roughly two in three parents of children under the age of 18 say they support mask mandates for teachers and students amid a rise in pediatric COVID-19 infections.

The poll, which was conducted online between Aug. 30 and Sept. 1, surveyed roughly 2,000 adults, about a fifth of whom are parents of schoolchildren. The credibility interval is plus or minus 2.5 percentage points.

https://thehill.com/policy/healthcare/571152-majority-of-parents-believe-children-have-falling-behind-with-distance