June 28, 2022

Recent Medical Breakthroughs to See a Change in the World

Research in different areas of therapy for various diseases has led to a wide range of treatments. Various diseases that were once thought to be incurable can be treated now. Medical industries like Medtronic, Bioscience, Transgene, etc. contribute to health promotion by fostering access to existing and new drugs, vaccines, and healthcare. 

How various companies are helping medical professionals to win a great victory against diseases?

FDA clears Medtronic’s PillCam system for remote endoscopy procedures

Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its PillCam Small Bowel 3 system for remote endoscopy procedures.

PillCam SB3 @Home program works with Amazon logistics to ensure timely and accurate results for patients undergoing remote endoscopy procedures from the comfort of their own homes, according to a news release.1

BioNTech’s skin cancer therapy wins FDA’s fast track designation

Germany’s BioNTech on Friday was awarded fast track designation by U.S. drugs regulators for the speedy review of a novel skin cancer therapy, which is based on RNA technology similar to the one that underpins its COVID-19 vaccine.

The U.S. Food and Drug Administration (FDA) granted the fast track status to the BNT111 infusion, which is designed to instruct the body to produce four proteins that are characteristic of melanoma cells and trigger an immune response against those cancer cells in the body.2

Cipla launches Spirofy

Currently, COPD remains the 2nd most common cause of death in India after heart diseases, where India alone bears 32% of the global COPD burden.

Cipla has announced the launch of Spirofy, India’s first pneumotach-based portable, wireless Spirometer, on World COPD Day. With this launch, the company intends to revolutionize Obstructive Airway Disease (OAD) diagnosis, in line with its ambition to strengthen its position as the lung leader in India. This is a part of the Company’s #LungAttack campaign that endeavors to drive awareness about COPD and encourage early diagnosis.

Cipla’s Spirofy ensures high result accuracy and individual patient safety using Bacterial Viral Filters. It is entirely wireless with good battery backup, making it suitable for use in outdoor camps, remote areas with power shortages, or simply providing physicians’ flexibility and ease of use. The device generates reports in real-time, which can be printed using a portable wireless thermal printer instantly, or a pdf version can be shared on the phone. Cipla will undertake the training of physicians in the interpretation of spirometry results.3

Roche launches more compact cobas 5800 analyzer for smaller European diagnostic labs

Roche’s cobas 5800 can pull from a menu of more than 25 assays that it shares with its larger siblings, the cobas 6800 and 8800, including PCR tests for COVID-19. 

Roche launched a relatively more compact addition to its mainstay cobas molecular diagnostic lineup with instruments that aim to bring automated testing to laboratories of all sizes.

Roche is initially releasing the system in Europe and countries accepting the CE mark, and it said in a statement it anticipates securing an FDA approval in the third quarter of next year. The new system is designed to help meet the explosion in demand for infectious disease testing seen since the start of the COVID-19 pandemic—including at smaller hospitals, clinics, and public health laboratories—as well as real-time PCR diagnostics for infections related to sexually transmitted diseases and transplant screening.4

Pfizer, Novartis sign on to accelerate gene therapies for rare diseases with US agencies

A cadre of big and small biotechs and pharmas, plus nonprofit organizations, have signed on to a new U.S. initiative to go after gene therapies for rare diseases.

Called the Bespoke Gene Therapy Consortium, or BGTC, the initiative is headed up by the FDA and the National Institutes of Health (NIH) and is designed to accelerate the development of gene therapies. The agencies are putting up $76 million over five years.

While the diseases are rare, the collective group could make an impact on conditions that affect 30 million Americans. Just two rare diseases out of the 7,000 recognized have approved gene therapies: Novartis’ Zolgensma in spinal muscular atrophy and Spark’s Luxturna for RPE65 mutation-associated retinal dystrophy.The BGTC, which is part of the NIH Accelerating Medicines Partnership program, will optimize and streamline the development process for gene therapies for rare diseases to help fill the unmet need.5

Takeda wins US approval for new CMV treatment

Transplant patients in the U.S. with a common infection now have a new treatment option, with this week’s approval of Takeda Pharmaceutical’s maribavir, which will be sold in the U.S. as Livtencity.

The Food and Drug Administration on Tuesday cleared the medicine for patients with cytomegalovirus, or CMV, infection that is resistant to other available antiviral treatments. To date, those patients haven’t had a fallback treatment option after older drugs stop working.6

ITC starts clinical trials of nasal spray for COVID-19 prevention

ITC starts clinical trials of nasal spray for COVID-19 prevention. Diversified entity ITC on Thursday confirmed that it is developing a nasal spray for COVID-19 prevention for which it has initiated clinical trials. Developed by scientists at ITC Life Sciences and Technology Centre (LSTC), Bengaluru, the company plans to market the nasal spray under the Savlon brand once it gets all the requisite regulatory approvals, according to sources.7

Insurtech startup Artivatic launches AI underwriting platform ‘AUSIS’

Insurance technology startup Artivatic has launched ‘AUSIS’, an AI underwriting platform for better risk and fraud analysis.

AUSIS is a smart, AI-based underwriting platform with personalized pricing, risk, and decisions too. It helps to process and digitize medical records, KYC, and application forms to verify and build personalized profiles in combination with historical data and business rules of the product.

This platform enables in-depth individual health-risk analysis and suggests the underwriting decision in less than 60 seconds.8

Santhera, ReveraGen announce positive topline results with vamorolone after completion of the VISION-DMD study

Santhera Pharmaceuticals, a Swiss specialty pharmaceutical company, and ReveraGen BioPharma, Inc announce new topline results after completion of the VISION-DMD study at week 48. As previously reported, the FDA considered the safety and efficacy data of vamorolone at 24 weeks (period 1) sufficient for an NDA filing. Efficacy assessments at the now reported completion at week 48 (period 2) included Time to Stand (TTSTAND) velocity, 6-Minute Walk Test (6MWT), Time to Run/Walk 10 meters (TTRW) velocity, and North Star Ambulatory Assessment (NSAA).9

Roche to present new data from an extensive hematology portfolio for people with blood disorders at ASH 2021

Roche announced that new data from its extensive hematology portfolio will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition from 11 to 14 December 2021. Roche molecules will be featured in more than 90 abstracts, including 17 oral presentations, showcasing new immunotherapies, unique treatment combinations, the application of novel endpoints, and fixed-duration regimens.10

Cadila Healthcare inks pact with Enzychem Lifesciences for Covid-19 vaccine

Cadila Healthcare Ltd (CHL) has entered into a manufacturing license and technology transfer agreement for its plasmid DNA based Covid-19 (ZyCoV-D) vaccine with Enzychem Lifesciences (Enzychem) of the Republic of Korea.11

Pfizer says former employee stole trade secrets on megablockbuster COVID-19 vaccine

Pfizer and other drugmakers go to great lengths to protect their proprietary information. When it comes to the world’s best-selling pharmaceutical product, the company’s BioNTech-partnered COVID-19 vaccine, Pfizer’s defense of trade secrets carries even more weight.12

Reference:

  1. https://www.massdevice.com/fda-clears-medtronics-pillcam-system-for-remote-endoscopy-procedures/?spMailingID=58548&puid=2421985&E=2421985&utm_source=newsletter&utm_medium=email&utm_campaign=58548 
  2. https://health.economictimes.indiatimes.com/news/medical-devices/cipla-launches-spirofy/87750415
  3. https://www.fiercebiotech.com/medtech/roche-launches-more-compact-cobas-5800-analyzer-for-smaller-european-diagnostic-labs?oly_enc_id=2782I7205556A9W
  4. https://www.fiercebiotech.com/biotech/pfizer-j-j-among-pharmas-and-biotechs-signing-to-us-agencies-new-rare-disease-gene-therapy?oly_enc_id=2782I7205556A9W      
  5. https://www.biopharmadive.com/news/takeda-cmv-fda-approval-livtencity-antiviral/610586/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202021-11-24%20BioPharma%20Dive%20%5Bissue:38231%5D&utm_term=BioPharma%20Dive
  6. https://health.economictimes.indiatimes.com/news/pharma/itc-starts-clinical-trials-of-nasal-spray-for-covid-19-prevention/87911126
  7. http://www.pharmabiz.com/NewsDetails.aspx?aid=144183&sid=2
  8. http://www.pharmabiz.com/NewsDetails.aspx?aid=144169&sid=2
  9. http://www.pharmabiz.com/NewsDetails.aspx?aid=144191&sid=2
  10. http://www.pharmabiz.com/NewsDetails.aspx?aid=144205&sid=2
  11. https://www.fiercepharma.com/pharma/pfizer-says-former-employee-stole-trade-secrets-megablockbuster-covid-19-vaccine?oly_enc_id=8564G5068334A2C

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