- Medical Design Sourcing

GE CEO Larry Culp [Photo courtesy of GE]Medical device makers and suppliers seeking relief from the global semiconductor shortage will have to hold on a while longer.

GE (NYSE:GE) is warning investors that supply and labor shortages are squeezing its Healthcare business this quarter, and that the pressure won’t likely let up in 2021.

GE’s Healthcare business “largely is a supply chain story right now,” GE Chair and CEO Larry Culp said this week, specifically citing semiconductors, resin and logistics as supply chain barriers to meeting “strong, if not robust” demand.

Get the full story at our sister site, Medical Design & Outsourcing.

How Lilly Oncology is aiming to improve clinical trial diversity

Minorities tend to participate in clinical trials at far lower rates than their real-world demographics and prevalence of the disease, according to the American Society of Clinical Oncology. In addition, minorities often have worse outcomes for certain cancers than the broader public. For instance, the mortality rate for Black women with breast cancer is 40% higher than that of white women.

The pandemic, however, has highlighted persistent health disparities while offering potential strategies for improvement, according to Amy Davis, senior director of clinical development at Lilly Oncology.

The pandemic has popularized the use of decentralized trials. For instance, Lilly debuted decentralized capabilities in a recent breast cancer trial and will continue doing so for upcoming trials. “We are building in decentralized capabilities from the get-go — decreasing the number of in-person visits by half,” Davis said. The company is using remote data capture and offer…

GE warns of supply chain strain well into 2022

GE CEO Larry Culp [Photo courtesy of GE]

Medical device makers and suppliers seeking relief from the global semiconductor shortage will have to hold on a while longer.

GE (NYSE:GE) is warning investors that supply and labor shortages are squeezing its Healthcare business this quarter, and that the pressure won’t likely let up in 2021.

“It has been a bit of a whack-a-mole game in making sure we’ve got what we need to fulfill demand at the levels we’d like to. … We’re really engaging that challenge on a daily basis,” he said Tuesday at the Morgan Stanley Laguna Conference.

The Boston-based conglomerate recently warned those supply constraints “may impac…

What is Human AB Serum?

By Trevor Smith, MS MBA, Product Manager, Immune Cells

Human AB Serum is a staple in the biological research field, providing nutrients, vitamins and necessary growth factors in cellular culture and reliable controls in in vitro diagnostics. To truly understand serum, it is important to learn about its different production and processing methods.

Starting material for Human AB Serum is collected from healthy male donors with an AB blood type. A single gendered pool is used to reduce variation in the final product. The AB blood type means that donors have both A and B antigens on their red blood cells and therefore lack blood group antibodies. This guarantees that the serum will not react with other blood types, further minimizing immunoreactivity for researchers. Typical lots of Human AB Serum are produced from 150-250 donors and pooled together, but custom batches with fewer donors are available. BioIVT can produce Human AB Serum lots of less than 10 i…

Alfred E. Mann Foundation sells insulin infusion pump IP to Medtronic

The Alfred E. Mann Foundation for Scientific Research (AMF) today announced the sale of intellectual property to Medtronic (NYSE:MDT).

As part of the transaction of IP related to implanted infusion pumps, AMF will work with Medtronic to develop the technology into a next-generation implantable insulin pump for people living with hard-to-treat type 1 diabetes in Europe.

Get the full story at our sister site, Drug Delivery Business News.

Prenetics is going public through a SPAC deal

Genomic and diagnostic testing company Prenetics announced that it will merge with Artisan Acquisition Corp. and go public.

Artisan, a special purpose acquisition company (SPAC) will provide a business portfolio across retail, hospitality, healthcare, property and other strategic businesses for Prenetics to substantially expand its platform through the merger, according to a news release.

The transaction values Prenetics at approximately $1.25 billion with a combined equity value of approximately $1.7 billion. The Hong Kong- and UK-based diagnostics company says it projects 215% revenue growth year-on-year from $65 million last year to $205 million in 2021. Its 2025 revenue projections total more than $600 million.

Prenetics most recently launched Circle HealthPod in Hong Kong, a CE-IVD point-of-care diagnostic and at-home rapid detection health monitoring system for infectious diseases, starting with COVID-19. The R&D team is developing tests for in…

Catalent to make Phathom Pharmaceuticals stomach acid blocker if it wins FDA approval

Catalent announced today that it entered into a commercial supply agreement with Phathom Pharmaceuticals for its acid blocker.

The commercial supply agreement covers Phathom’s lead compound, vonoprazan, which is a novel, orally active-potassium competitive acid blocker (P-CAB) for treating gastrointestinal diseases, according to a news release.

Phathom currently has vonoprazan in late clinical-stage development for treating gastric acid-related diseases and disorders, including gastroesophageal reflux disease (GERD) and Helicobacter pylori (H. pylori) bacterial infection. The company owns rights for developing and commercializing vonoprazan in the U.S., Europe and Canada.

Under the agreement, Catalent will undertake the commercial manufacturing and packaging of the product at its large-scale oral solid dose manufacturing site in Winchester, Kentucky, should the drug receive FDA approval.

“As Phathom readies for the …

An inside look at Insmed

Many large drug developers employ individual groups or teams independently working on discrete steps in the drug development process.

Rare disease biopharma Insmed (NSDQ:INSM) differentiates itself through its focus on patients with rare diseases. To that end, the company works to ensure collaboration between various departments to consider questions related to the applicability of a given molecule and the potential impact it could have on patients.

The company has won FDA approval for Arikayce (amikacin liposome inhalation suspension), a novel treatment of Mycobacterium avium complex (MAC) lung disease in conjunction with an antibacterial drug regimen.

Dr. Martina Flammer

“Many companies speak about patient focus and patient-centricity,” acknowledged Dr. Martina Flammer, the company’s chief medical officer. But often, that focus can be intermittent or can begin midway through development.

…

Diabeloop joins corporate advisory partnership, seeks to develop business in U.S.

Diabeloop announced today that it set up a local and dedicated team to support its pursuit of entry into the U.S. market.

Paris-based Diabeloop develops an automated insulin delivery (AID) system that deployed throughout Europe this past year, making it commercially available in Germany, the Netherlands, Italy, Spain and Switzerland, with more countries to come. The interoperable controller can be used recombination with the Dexcom G6 CGM and Accu-Chek Insight insulin pump and will soon be available with ViCentra’s patch-like Kaleido pump.

Get the full story at our sister site, Drug Delivery Business News.

Theranos whistleblower testifies to blood analyzer inaccuracies in Elizabeth Holmes fraud trial

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]

One of Theranos’ whistleblowers testified on the inaccuracies in the blood analyzers that Theranos had touted to investors on the third day of Elizabeth Holmes’ federal fraud trial.

Erika Cheung, a former Theranos lab associate, testified yesterday that the machines the company was using to conduct patient blood tests had inaccuracies of quality control test results that would result in inaccurate patient tests, Silicon Valley News reports. She said that some 30% of prostate cancer tests were inaccurate and thyroid tests returned with a failure rate of more than 50%.

Cheung claimed that Theranos would throw out outlier data points to get the tests to pass quality control checks, The Washington Post reports. She said choosing those outliers was like …

Caresyntax brings Series C funding to $130M

Digital surgery platform developer Caresyntax announced today that it added a $30 million extension to its Series C funding round.

Boston-based Caresyntax’s $30 million extension brings its total Series C funding to $130 million, adding to the first stage announced in April 2021, according to a news release.

PFM Health Sciences led the extension, with selected investors including funds and accounts managed by BlackRock, as well as ProAssurance, Harmonix and existing investors such as the Relyens Group and IPF Partners. The overall Series C features investments from Optum Ventures, Intel Capital, Lauxera Capital Partners, Vesalius Biocapital III, Arno Capital, Rezayat Investments, and Surgical.AI.

Caresyntax said the funding will be used to continue developing its digital surgery platform, which uses proprietary software and AI to analyze large volumes of real-world data in and around the operating room to offer insights for immediate use by…

CMS aborts launch of MCIT payment program for breakthrough devices

CMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs.

CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar yesterday — three months before the rule was set to take effect on Dec. 15 — saying the rule “is not in the best interest of Medicare beneficiaries.”

Get the full story at our sister site, Medical Design & Outsourcing.

CMS aborts launch of MCIT payment program for breakthrough devices

CMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs.

CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar on Wednesday — three months before the rule was set to take effect on Dec. 15 — saying the rule “is not in the best interest of Medicare beneficiaries.”

CMS created the MCIT pathway in the last days of the Trump Administration, and it was among a host of regulations the Biden Administration immediately put on hold for further consideration.

“While the rule tried to address stakeholder concerns about accelerating coverage of new devices, significant concerns persist about the availability of clinical evidence on Breakthrough Devices when used in the Medicare population as well as the benefit or risks of these devices with respect to use in the Medicare population…

Pear Therapeutics touts real-world data for reSET-O prescription digital therapeutic

Pear Therapeutics today announced the publication of positive results from real-world data of its reSET-O prescription digital therapeutic.

Boston-based Pear Therapeutics evaluated its FDA-authorized reSET-O PDT in the treatment of opioid use disorder (OUD) on patients treated for 24 weeks, with real-world evidence demonstrating that the treatment is associated with improved outcomes, high levels of treatment retention and fewer hospital encounters compared to 12 weeks of the treatment.

Get the full story at our sister site, Drug Delivery Business News.

Theranos whistleblower testifies to blood analyzer inaccuracies in Elizabeth Holmes fraud trial

Theranos founder Elizabeth Holmes (center) arrives at federal court in San Jose, California on Aug. 31, 2021. [Photo by David Paul Morris/Bloomberg via Getty Images]One of Theranos’ whistleblowers testified on the inaccuracies in the blood analyzers that Theranos had touted to investors on the third day of Elizabeth Holmes’ federal fraud trial.

Cheung claimed that Theranos would throw out outlier data points to get the tests to pass quality control checks, The Washington Post reports. She said choosing those outliers was like “cherry-picking” and that the …

Philip Morris’ $1.2B offer for inhaled drug delivery tech developer becomes unconditional

Philip Morris (NYSE:PM) announced today that its offer to buy inhaled drug delivery technology developer Vectura has become unconditional.

Having received valid acceptances for or acquired 74.77% of Vectura shares, in excess of the 50% required under the acceptance condition, along with confirming that all other conditions to the offer have been satisfied or waived, the deal reached unconditional status.

Get the full story at our sister site, Drug Delivery Business News.

Amylyx Pharmaceuticals preps NDA filing for ALS drug AMX0035

Cambridge, Massachusetts–based Amylyx Pharmaceuticals intends to submit a New Drug Application (NDA) to FDA for AMX0035 (sodium phenylbutyrate and taurursodiol) to treat amyotrophic lateral sclerosis (ALS), which is also known as Lou Gehrig’s disease.

The company decided to file after a series of meetings with the FDA, including a pre-NDA meeting on July 15.

AMX0035 was the subject of the Phase 2 CENTAUR trial, which involved 137 participants with ALS. In that trial, the drug met its primary efficacy endpoint of slowing ALS based on the ALS Functional Rating Scale-Revised (ALSFRS-R).

A forthcoming Phase 3 trial will evaluate the safety and efficacy of the drug over 48 weeks.

Before reversing course, FDA had asked Amylyx to submit positive Phase 3 trial results before filing a New Drug Application.

To date, there are limited treatment options available for ALS. A 2020 paper in Neuropharmacology.

Concluded that the two drugs with…

A closer look at Urovant’s vibegron blood pressure study

In recent years, regulators including FDA have increased their focus on the potential of drugs to cause blood pressure increases. To that end, the agency asked Urovant (Irvine, California) to study the impact of the beta-3 adrenergic receptor agonist vibegron on blood pressure.

The study, recently published in the Journal of Urology, found no significant change in blood pressure among either vibegron or placebo recipients. There were 96 patients in the vibegron group. Another 101 received placebo. “The good news was that the changes in blood pressure were trivial — on average less than one millimeter of mercury,” said Dr. Michael A. Weber, a professor of medicine at SUNY Downstate College of Medicine in New York, who was involved in the study.

Weber recently summarized the results at the Annual Meeting of the American Urological Association.

FDA approved vibegron in late 2020. In addition, the agency approved another beta-3 adrenergic receptor agonist…

Hookipa Pharma announces oncology partnership with Merck

Immunotherapy-specialist Hookipa Pharma (NSDQ:HOOK) has announced a clinical collaboration and supply agreement with Merck (NYSE:MRK). Hookipa will test its immunotherapeutic HB-200 in conjunction with Merck’s blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), as first-line treatment for patients with advanced head and neck squamous cell carcinoma (HNSCC).

Last year, Merck raked in $14.5 billion in sales revenue from Keytruda.

“There remains considerable unmet treatment need for people with metastatic head and neck cancers, and we believe the combination of HB-200 and Keytruda may offer hope,” said Joern Aldag, Hookipa CEO, in a statement.

Hookipa reports that the company has seen early success with combining Keytruda and HB-200 in heavily pre-treated patients.

The company plans on launching a Phase 2 trialing the combination of HB-200 with Keytruda in 2022.

The company is developing a range of novel arenaviral immunotherapies for onc…

One of FDA’s top lawyers leaves to join Greenberg Traurig

James C. Fraser, Greenberg Traurig

Greenberg Traurig recently announced that James C. Fraser, a former associate chief counsel for litigation at the FDA, has joined its Litigation and Health Care & FDA practices in Washington, D.C.

Fraser left FDA in August. He has more than 16 years of experience in life sciences litigation and most recently worked in conjunction with the U.S. Department of Justice representing the FDA in civil litigation throughout the United States.

Robert P. Charrow recently returned to Greenberg Traurig as senior chair of the firm’s Health Care & FDA Practice after a stint as HHS general counsel.

“Having worked with Jim for several years, I am certain that his significant ability to successfully litigate complex matters concerning pharmaceuticals, medical devices, and other FDA-regulated products is of tremendous value to our clients,” Charrow said in a news…

Smiths Medical has a Class I recall over aluminum potentially leaking in fluid warmers

Smiths Medical is recalling the Normoflo irrigation fluid warmer and warmer sets due to the potential for aluminum ions leaching into warmed fluids.

The recall has been designated as a Class I recall — the most serious kind — by the FDA.

According to an FDA notice, when fluid circulates through a patient’s body, the patient can be exposed to high levels of aluminum. That exposure may not be easily recognized and could lead to serious adverse events, including death. No complaints, injuries or reports of death have been received to date.

The recall covers the Normoflo irrigation fluid warmer and Normoflo irrigation warming set. The company initiated the recall on Aug. 6, 2021, for devices manufactured between January 1994 and July 2021 and distributed between January 1994 and the present day. To date, Smiths Medical has recalled 520,163 devices in the U.S.

Normoflo fluid warming systems warm blood, blood products and intravenous solutions bef…

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