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6 Steps for Winning at Life Sciences Bid Management

By Bob Steller, Industry Principal – Life Sciences

Discover the secret to success for planning, executing—and winning—profitable bids

Did you know that 85% of revenue in the medical technology market comes through bids and tenders? For Life Sciences companies like yours, one key to building and expanding your business is mastering the art and science of bid management.

Bid preparation takes time and resources, and with so much riding on the results, it’s important to get it right. Having an effective process, as well as the right tools, ensures you get the results you want.

The 6 key steps in an end-to-end integrated approach to managing bids and offers.

Plan What’s your strategy? Whether you want to penetrate new markets, build market share or just protect your position, you need to gather all the basic data about your bids and understand your full landscape.

Evaluate Study the bids and select the ones for response. Use pri…

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Gilead gains ground in HIV drug counterfeit litigation

A New York federal judge has frozen the assets of several individuals and entities for their alleged role in distributing counterfeit versions of Gilead Science’s (Nasdaq:GILD) HIV medications.

Presiding over the U.S. District Court for the Eastern District of New York, Judge Ann M. Donnelly also denied the defendants’ motion to dismiss the case for lack of personal jurisdiction and improper venue and permitted the case to proceed.

The defendants in the case are suppliers, distributors and pharmacies accused of operating an HIV drug counterfeiting ring. The lawsuit accuses three companies of involvement in the counterfeit ring, including Synergy Group Wholesalers, Cesar Castillo Wholesalers and DNS Distributor. It also states that Julio Martin Gonzalez assisted in the scheme.

According to recently unsealed court documents, Lazaro Roberto Hernandez and Armando Herrera were cited as the two kingpins involved in the scheme to market counterfeit …

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Janssen sees Blood Cancer Awareness Month as an opportunity to close the clinical trial diversity gap

Janssen (NYSE:JNJ) is working to highlight the importance of cancers such as leukemias, lymphomas and multiple myeloma for Blood Cancer Awareness Month in September.

Some 1.5 million people in the U.S. are currently living with or in remission from blood cancers, according to the Leukemia & Lymphoma Society. Roughly 35,000 people are diagnosed with multiple myeloma each year, according to the American Cancer Society.

In addition to highlighting the incidence of hematologic malignancies, Blood Cancer Awareness Month offers an opportunity to provide education about the need for improved clinical trial diversity. While the industry has made strides recently, people of color continue to be underrepresented in clinical trials. According to FDA data, in 2020, three-quarters of trial participants were white, while only 8% were Black. That same year, 11% of clinical trial participants were Hispanic.

According to the U.S. Census Bureau, 13.6% of the U.S. popu…

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New medical device user fees agreement passes Congress

[Image from Unsplash]The U.S. Congress today sent a stopgap funding bill to President Joe Biden’s desk that includes the reauthorization of FDA user fees programs through 2027.

“I am delighted to say that Congress has passed legislation reauthorizing the four user fee programs that provide critical funding to the FDA for its human medical products activities,” FDA Commissioner Dr. Robert Califf said on Twitter.

He later tweeted: “It means that we will not need to begin the notification process for user fee-funded staff.”

The reauthorization generally maintains the existing fee structure, but it includes a new mechanism where the FDA will be able to increase fees in later years if it meets goals related to timely review of submissions.

Trade group AdvaMed also applauded the passage of the fifth iteration of the Medical Device User Fee Amendment (MDUFA V).

“The bipartisan passage of this historic five-year agreement…

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Real-world data begin to emerge for the Jynneos vaccine in monkeypox outbreak 

[Photo by Artem Podrez from Pexels]

Until recently, CDC had warned that it remained uncertain how effective the Jynneos vaccine from Bavarian Nordic A/S (OMX:BAVA) and the ACAM2000 vaccine from Emergent BioSolutions (NYSE:EBS) were at guarding against the current monkeypox outbreak. 

The CDC, however, has begun to release data related to the former vaccine. The agency found unvaccinated patients were approximately 14 times more likely to become infected with the virus based on early real-world effectiveness data. 

In the week of August 28, monkeypox incidence was 230 per 100,000 for unvaccinated individuals. Among those who received at least one dose of the Jynneos vaccine in the same period, 15 per 100,000 became infected. 

Although the U.S. government has made the ACAM2000 vaccine available for use against monkeypox, it remains unclear how protective it is in the current outbreak. 

Because…

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Invacare receives notice of noncompliance on NYSE share price listing rule

Invacare (NYSE:IVC) announced today that it received notice from the New York Stock Exchange (NYSE) that it is not in compliance with certain rules.

Elyria, Ohio-based Invacare’s non-compliance involves Section 802.01C of the NYSE Listed Company Manual. The average closing price of the company’s common shares came in under $1 per share over a consecutive 30-day trading period.

According to a news release, the notice does not result in immediate delisting for the compnay.

Invacare plans to notify NYSE by Oct. 7 that it intends to cure its stock price deficiency and return to compliance. It can regain compliance any time within the six-month period following the receipt of notice. This rings true if on the last day of trading of any calendar month during that period, Invacare closes with shares reaching at least $1 apiece and an average closing price of at least $1 over the 30-day trading period ending on the last trading day of that month.

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Philips shareholders approve new CEO

Roy Jakobs is slated to become Philips’ president and CEO, effective October 15. [Image courtesy of Royal Philips]Roy Jakobs has cleared a final hurdle to become Philips’ next CEO, winning shareholder approval during a special meeting today.

The Dutch medtech giant — the fourth-largest in the world according to MassDevice and MDO‘s Big 100 report — announced plans in August for Jakobs to move into the corner office. His appointment is effective October 15.

Jakobs succeeds Frans van Houten, who has been CEO more than 11 years. As CEO, van Houten successfully carved out Philips’ lighting, television, audio and video, and domestic applicants businesses. Along with acquisitions such as the more than $1 billion acquisition of Volcano in 2015, the moves focused Philips on medtech. But as Philips wrestled with a deadly recall that involves more than a million CPAPs, ventilators and other respiratory devices, the company’s supervisory board d…

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In vivo electroporation is an engineering solution for drug and gene delivery

Electroporation involves using an external electrical device to apply a prescribed electric field to tissue. This transiently opens pores in cell walls, allowing transport of drugs, DNA, and gene therapies. [Photo courtesy of Minnetronix Medical]

Why the new buzz about an old technique? Harness the potential of an existing technology for modern medicine.

Daniel Friedrichs, Minnetronix Medical

Reversible electroporation is the use of an electric field to open pores in a cell wall, allowing transport of drugs, DNA or other “cargo” into a cell — in particular, allowing delivery of chemically large molecules and transport of DNA vaccines and customized gene therapies.

In the 40 years since its invention, electroporation has become a mainstay technique in biological sciences, but only recently has wide interest in in vivo (human clinical) electroporation taken hold. Compared to other delivery vectors and …

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FDA Modernization Act to end animal testing requirement passes U.S. Senate

[Image courtesy of Pixabay]

Today, the U.S. Senate passed the FDA Modernization Act 2.0, S.5002, without dissent.

Introduced by Senators Dr. Rand Paul (R-KY) and Cory Booker (D-NJ), the bill, if enacted, would curb animal testing in the coming years. A total of 10 other cosponsors backed the bill, which would end the mandate to test new drugs and biosimilars on animals.

The bill was based on S.2952, the FDA Modernization Act of 2021.

“This is the biggest policy development in Congressional history on the fight to replace animal testing with morally and scientifically superior methods,” said Dr. Paul in a statement. “The FDA Modernization Act 2.0 will accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science, and I’m proud to have led the charge with our fellow cosponsors.”

“Thanks to modern scientific innovat…

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FDA approves Amylyx ALS drug Relyvrio 

Amylyx Pharmaceuticals (Nasdaq:AML) has won FDA approval for Relyvrio (AMX0035; sodium phenylbutyrate and ursodoxicoltaurine), notching the first win for amyotrophic lateral sclerosis (ALS) in five years.

The drug received Health Canada approval in June. The drug is known as Albrioza in that country.

In a summary, FDA reviewers note that the limited clinical data available for the drug have resulted in “in a degree of residual uncertainty about the evidence of effectiveness” of the drug. The agency notes that the lack of clarity is acceptable given the significant disease burden of ALS.

“This approval provides another important treatment option for ALS, a life-threatening disease that currently has no cure,” said Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, in a news release. “The FDA remains committed to facilitating the development of additional ALS treatments.”

AML shar…

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FDA clears next-gen deep learning MRI software from GE Healthcare

[Image from GE Healthcare]GE Healthcare (NYSE:GE) announced today that it received FDA 510(k) clearance for its AIR Recon DL for 3D and Propeller imaging sequences.

Air Recon DL’s benefits extend to nearly all magnetic resonance imaging (MRI) clinical procedures. The platform covers all anatomies, enabling better image quality, shorter scan times and improved patient experience.

GE Healthcare said in a news release that the solution’s compatibility expands from 2D to 3D imaging sequences. This allows physicians to diagnose patients with an improved signal-to-noise ratio (SNR) and sharpness. Meanwhile, it said the 3D imaging provides for more clinical efficiency by eliminating the need for multiple 2D acquisitions. This potentially leads to faster diagnosis.

The platform is also compatible with Propeller motion-insensitive imaging sequencing. Propeller holds particular importance for anatomies susceptible to motion such as respiration during MRI …

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An inside look at Reunion Neuroscience’s psychedelic strategy for treating depression

Greg Mayes, the new CEO of Reunion Neuroscience (TSX:REUN, Nasdaq:REUN), has a more traditional drug development background than many executives in the psychedelic space. He had a successful foray into epilepsy at a company known as Engage Therapeutics. Founded in 2017, Engage was picked up by UCB in 2020. 

While Mayes’ background in pharma dates back to 2001 when he was senior counsel at AstraZeneca, his interest in Engage was more personal. “The whole reason I founded that company was because of my son’s epilepsy diagnosis,” Mayes said in a recent interview. “The most common comorbidity associated with epilepsy is depression and anxiety.”

In a recent conversation, Mayes and his colleague, Reunion’s Chief Scientific Officer Nathan Bryson, open up about the company’s strategy and how they foresee the psychedelic market evolving in the coming years. 

Could you share more about what inspired you to join Reunion?…
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FDA and VA Ventures Innovation Institute partner on new medical device testing tools

Dr. Beth Ripley is the medical device testing collaboration’s project manager for the VA. [Photo courtesy of the Department of Veterans Affairs]

The Department of Veterans Affairs’ VA Ventures Innovation Institute in Seattle will host up to a dozen FDA staffers in a new collaboration to develop and share new tools for medical device testing safety and efficacy.

The agencies intend to provide developers of devices and new technology with off-the-shelf tools that can help streamline regulatory review and get products to patients faster. FDA staff from the Center for Devices and Radiological Health (CDRH) will focus on regulatory science. Their partners at the VA’s Veterans Health Administration (VHA) will provide clinical context for test development and provide hands-on training and other immersive experiences for innovators wishing to utilize the tools.

RELATED: FDA issues draft guidanc…

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Analysts high on AtriCure following Converge AFib procedure update

[Image from AtriCure]Analysts have a positive outlook on AtriCure (Nasdaq:ATRC) following an investor webinar discussing the company’s Convergent procedure.

Convergent uses the company’s EPi-Sense system. Its epicardial-sensing electrodes allow both electrophysiologists (EPs) and cardiothoracic surgeons to sense and record cardiac signals. It can be used for the coagulation of cardiac tissue using radiofrequency (RF) energy.

According to BTIG analyst Marie Thibault, both EPs on Wednesday’s webinar — Dr. Zayd Eldadah from MedStar Heart & Vascular Institute in Washington, D.C. and Dr. Eric Buch from UCLA Health — believe the patient population for the procedure is large and can extend beyond its current use for long-standing persistent AFib. The FDA approved EPi-Sense for treating long-standing persistent AFib in April 2021.

Thibault said it may take time to start and ramp a program but the EPs expect volume to increase “significan…

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Why Algernon is investigating DMT in stroke rehabilitation

The clinical-stage company Algernon Pharmaceuticals (CSE:AGN; Frankfurt:AGW0; OTCQB: AGNPF) has received approval to run a Phase 1 clinical study of an IV formulation of AP-188.

The study will explore the drug candidate’s potential, a formulation of the classic psychedelic N,N-dimethyl tryptamine or DMT, to treat stroke patients in the Netherlands.

The Stichting Beoordeling Ethiek Biomedisch Onderzoek (“BEBO”), an independent medical research ethics committee, will manage the study.

Algernon decided to investigate the potential of DMT in human studies for ischemic stroke after reviewing data from independent studies demonstrating that DMT can mitigate tissue damage while promoting neurogenesis and neuroplasticity.

To learn more about Algernon’s plans to explore the potential of DMT as a therapy for ischemic stroke, we spoke with Christopher J. Moreau, the company’s CEO.

What led to your interest in DMT as a potent…
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Align Technology launches AI-powered home monitoring for Invisalign clear teeth aligners

[Image from Invisalign]Align Technology (Nasdaq:ALGN) announced that it launched the Invisalign Virtual Care AI remote monitoring solution.

Tempe, Arizona-based Align designed the next-generation platform to streamline workflows for doctors and their staff. Features include patient enrollment, setup, and review directly on the Invisalign Doctor Site. This eliminates the need to use separate standalone solutions.

Assisted by artificial intelligence (AI), the solution helps doctors remotely monitor Invisalign treatment progress. They base progress on their own pre-approved clinical settings and AI-assisted algorithms for automatic assessment. AI-assisted automated notifications — based on doctor settings — guide patients through the stages of their treatment. Patients send photos with every aligner change and receive progress notifications on the mobile app.

“Align is committed to continuous innovation in digital orthodontics and I am very excited about our n…

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FDA clears Nexpowder endoscopic hemostasis system from Medtronic

The Nexpowder system. [Image from Medtronic]Medtronic (NYSE:MDT) announced that it received FDA clearance for its Nexpowder endoscopic hemostasis system.

Nexpowder uses a noncontact, nonthermal and nontraumatic hemostatic powder. The powder sprays through a catheter that features a proprietary powder-coating technology for minimized clogging.

The Nexpowder design provides improved visibility and control in the treatment of upper gastrointestinal (GI) nonvariceal bleeding. According to a news release, upper GI bleeding accounts for 75% of all acute GI bleeding cases.

“We are very excited to bring the innovative, Nexpowder system to gastroenterologists. We considered the potential impact on physicians and patients alike, by meeting a clear need to reduce mortality from upper GI bleeding, a condition that causes death for one out of every 1,000 people while also reducing rebleeding, which happens in 20% of all upper GI bleeding cases,” said Gio Di Napoli, pres…

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How Boston Scientific is managing labor shortages with cobots and Spanish

Boston Scientific Global Operations EVP Brad Sorenson [Photo courtesy of Boston Scientific]

Boston Scientific (NYSE: BSX) executives said two labor-shortage strategies are paying off in a big way for the medical device maker, which has around 41,000 employees across the globe.

Collaborative robotics and Spanish-speaking shifts are helping Boston Scientific deal with a global labor shortage that’s been especially acute in the U.S.

That’s according to Global Operations EVP Brad Sorenson and Supply Chain VP Paudie O’Connor, who recently spoke with DeviceTalks Editorial Director Tom Salemi about the difficulty of hiring workers.

“It’s hit us everywhere. Part of that was just general wage inflation. Although we don’t like the cost of that per se, that’s relatively easy to deal with, right? You give people raises and at least the supply continuity problem goes away,&#…

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Reunion Neuroscience names new CEO to guide development of psychedelic depression therapy

Formerly known as Field Trip Discovery, Reunion Neuroscience (TSX:REUN, Nasdaq:REUN) has announced the appointment of Greg Mayes as its new president and CEO.

Mayes will first focus on completing the company’s Phase 1 clinical trial of its lead asset, RE-104 (formerly FT-104), for postpartum and treatment-resistant depression.

Mayes had held several senior executive roles at pharma companies, including a stint as president, CEO and founder of Engage Therapeutics from 2017 to 2020. From December 2020 to September 2022, he served as president and CEO of the clinical-stage biopharma Antios Therapeutics. At Antios, he led Series B financing worth more than $100 million.

In a LinkedIn post, Mayes described the new role at Reunion as an “ideal opportunity.” “I will be returning to my area of greatest interest and passion – the brain – where we successfully developed a rapid epileptic seizure treatment at Engage Therapeutics through Phase 2 and ultimately sold …

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Johnson & Johnson names proposed consumer health spinoff ‘Kenvue’ 

Johnson & Johnson (NYSE:JNJ) has announced that it will name its consumer health division ‘Kenvue.’

Earlier this year, GSK (NYSE:GSK) made a similar move by naming its consumer healthcare segment ‘Haleon.’ That moniker fuses the old English word ‘hale’ with the name ‘Leon.’ The first word means ‘healthy’ while the second refers to ‘strength.’

Haleon became a separate unit in July 2022.

Similarly, Kenvue brings together the words ‘ken,’ meaning ‘knowledge,’ and ‘vue,’ meaning ‘sight.’

Johnson & Johnson has signaled its intent to spin off Kenvue by November 2023.

The remaining company, headquartered in New Brunswick, New Jersey, would continue to focus on its drug and device businesses.

“Unveiling the Kenvue brand is a defining moment for our stakeholders and an important part of the planned separation,” said Thibaut Mongon, CEO Designate, Kenvue, in a news release. “We breathe life into some of the world’s most iconic and belo…

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This robotic capsule could deliver large-protein drugs like insulin

A new drug capsule developed at MIT can help large proteins such as insulin and small-molecule drugs be absorbed in the digestive tract.[Image from Felice Frankel/MIT]Researchers at the Massachusetts Institute of Technology (MIT) developed a new drug capsule with a robotic cap for improved drug delivery.

Large-protein drugs generally can’t pass through the mucus barrier that lines the digestive tract. Insulin and most other “biologic drugs” with proteins or nucleic acids thus must be injected or administered in a hospital, according to MIT’s news website.

The researchers believe the new drug capsule developed at MIT could one day replace those injections. It features a robotic cap that spins. This helps it tunnel through the mucus barrier when it reaches the small intestine. Thus, drugs carried by the capsule can pass into the cells lining the intestine.

Get the full story at our sister site, Drug Delivery…

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