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Ahead of Medtronic RDN’s FDA review panel, analysts place their bets

The Symplicity Spyral renal denervation system delivers radiofrequency energy via a catheter to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Analysts expect good news for Medtronic and its renal denervation (RDN) therapy for hypertension when the FDA review panel meets later this month.

RDN therapy could be a life-saver for millions of patients with high blood pressure — and a billion-dollar business for Medtronic if it wins FDA approval after two failed trials in the past decade.

The world’s largest medical device company is looking for a win after the latest RDN pivotal trial fell short of expectations, a disappointing result in a year with many other challenges. Medtronic’s revenue slipped 1% in fiscal 2023 (which ended on April 28, 2023), and net income dropped by 25% year-over-year as the company cut costs with early retirements, la…

Hologic stock dips on Q3 losses, questions over future margins

Hologic (Nasdaq: HOLX) + shares fell this morning despite third-quarter results that topped the consensus forecast.

Shares of HOLX dipped 4% at $76.29 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.6%.

The Marlborough, Massachusetts-based women’s health and diagnostics company posted losses of $40.5 million. That equals 16¢ per share on sales of $984.4 million for the three months ended July 1, 2023.

Hologic recorded a bottom-line slide into the red from profits of $228.4 million for the same period a year ago. It reported a sales decline of 1.8%, primarily driven by lower sales of COVID-19 assays compared to last year. Revenues still exceeded Hologic’s guidance for between $930 million and $980 million.

Adjusted to exclude one-time items, earnings per share came in at 93¢, landing 4¢ …

Fast Five: Abbott withdraws Trifecta valves from U.S. market, Augmedics buys Surgalign’s digital health assets

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, August 1, 2023.

Fast Five by MassDevice · Abbott withdraws Trifecta valves from U.S. market, Augmedics buys Surgalign’s digital health assets

The recent collaboration between Henry Schein and Medpod signifies an increased focus on telehealth solutions and the integration of diagnostic technologies. Fast Five hosts Danielle Kirsh and Sean Whooley discuss how the Medpac system serves as a telediagnostic offering and the benefits it offers patients and providers.

Inspire Medical recently appointed a former AppliedVR executive as its chief medical officer. The move highlights the significance of medical leadership in driving strategic decisions. Hear who is taking on the new clinical role and what their career experience is that supports the appointment.

The succe…

Gilead wins ruling against alleged counterfeiters in HIV drug case

A federal judge ruled against two defendants accused of selling counterfeit HIV medications, denying their motions to lift existing asset freezes obtained by pharmaceutical company Gilead Sciences in the ongoing lawsuit. Judge Ann M. Donnelly of the United States District Court for the Eastern District of New York converted the temporary asset freezes into preliminary injunctions, allowing Gilead to preserve funds for a potential award in the still undecided case. The judge had frozen the assets in 2022.

Gilead alleges the defendants were part of a counterfeiting ring that sold fake versions of its HIV medications. In the Gilead HIV drug case, the company obtained asset freezes against defendant Scripts Wholesale, a drug distributor and defendant Peter Khaim, a supplier.

Scripts and Khaim moved to lift the freezes. The court denied both motions. On Scripts’ motion, Judge Donnelly found Gilead showed a likelihood of success on its Lanham Act claims that Sc…

FDA approves another over-the-counter Naloxone nasal spray

The RiVive over-the-counter naloxone nasal spray. [Image from Harm Reduction Therapeutics]

Harm Reduction Therapeutics announced that it received FDA approval for its over-the-counter RiVive naloxone nasal spray.

Pittsburgh-based HRT designed the 3 mg naloxone HCl nasal spray for the emergency treatment of opioid overdose. Approval helps make free or low-cost OTC nasal spray widely available in the U.S.

The FDA first approved Narcan 4 mg OTC naloxone nasal spray in March of this year. A different opioid overdose therapeutic, the Opvee nalmefene hydrochloride nasal spray from Opiant Pharmaceuticals, received approval in May.

RiVive uses an easy-to-use standard dose unit system. Each nasal spray device contains one dose. HRT plans to offer it exclusively in twin packs containing two single-dose devices.

“We are grateful that FDA granted RiVive approval so we can now achieve what most thought i…

New HHS initiatives put spotlight on long COVID

The U.S. Department of Health and Human Services (HHS) recently announced two major initiatives to shed light on long COVID, a condition affecting millions. First, the agency plans to establish the Office of Long COVID Research and Practice. HHS is also set to launch new long COVID-19 clinical trials through its RECOVER initiative. Jointly, the long COVID drug development efforts highlight the need for therapies and create openings for pharmaceutical companies to drive research and drug development related to the condition.

HHS has earmarked $1.15 billion for the RECOVER Initiative to explore novel therapies for the condition estimated to have affected between 7.7 and 23 million Americans. To date, the RECOVER Initiative has enrolled more than 24,000 participants in observational studies on long COVID. New clinical trials, beginning enrollment in summer 2023, will test experimental therapies across five focus areas to identify therapies that can alleviate symptoms and…

Tivic Health reduces workforce as it may face Nasdaq delisting

Tivic Health (Nasdaq:TIVC) CEO Jennifer Ernst issued a letter to investors updating them on the current situation at the bioelectronic medicine developer.

Ernst’s letter included the announcement that the company took several measures to fortify its position. That includes a reduction in force and internal restructuring. The company did not disclose further details about the reduction or restructuring.

San Francisco-based Tivic filed an SEC Form 8-K pertaining to a notice of delisting from the Nasdaq market. The company received notice in January that its closing price fell below $1 for 30 consecutive trading days. It received a six-month grace period to regain compliance.

Tivic recommended a reverse stock split to remedy the issue, but failed to pass the measure at its annual meeting of stockholders in June. The company set a special stockholder meeting for Aug. 11 and urged investors to vote in favor of a reverse split.

Ernst relayed her c…

Court rejects Johnson & Johnson bankruptcy gambit over talc suits

[Image from Pixabay]

A U.S. bankruptcy judge in New Jersey has dismissed a Johnson & Johnson-created company’s bankruptcy filing to resolve talc-related lawsuits.

Judge Michael Kaplan’s ruling on July 28 was similar to a U.S. Court of Appeals for the Third Circuit ruling months ago, which failed to find immediate financial distress over the lawsuits. As recounted in media reports, Kaplan said: “In sum, this court smells smoke, but does not see the fire.”

Johnson & Johnson plans to appeal Kaplan’s ruling. It was previously seeking U.S. Supreme Court review of the Third Circuit ruling.

JNJ shares were down nearly 4%, at $167.58 apiece, by the afternoon today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down about 1%. The company’s financial performance has been somewhat volatile in r…

Court rejects Johnson & Johnson bankruptcy gambit over talc suits

[Image from Pixabay]A U.S. bankruptcy judge in New Jersey has dismissed a Johnson & Johnson-created company’s bankruptcy filing to resolve talc-related lawsuits.

Judge Michael Kaplan’s ruling on July 28 was similar to a U.S. Court of Appeals for the Third Circuit ruling months ago, which failed to find immediate financial distress over the lawsuits. As recounted in media reports, Kaplan said: “In sum, this court smells smoke, but does not see the fire.”

Johnson & Johnson (NYSE: JNJ) + plans to appeal Kaplan’s ruling. It was previously seeking U.S. Supreme Court review of the Third Circuit ruling.

JNJ shares were down nearly 4%, at $167.58 apiece, by the afternoon today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down about 1%. (Our sister site Pharmaceutical Processing World has an analysis of how talc …

MIT researchers build wearable ultrasound scanner for earlier breast cancer detection

This wearable ultrasound scanner could offer frequent, at-home imaging of breast tissue to spot tumors earlier and increase survival rates. [Photo courtesy of MIT]

A wearable ultrasound scanner developed by researchers at MIT could improve the survival rate of breast cancer patients.

The researchers 3D-printed a flexible patch that can attach to a bra using magnets. The patch has six openings where a miniaturized ultrasound scanner can contact the skin and image the wearer’s breast tissue from different angles.

The goal is to detect breast cancer earlier with more frequent screening for patients at high risk.

“We changed the form factor of the ultrasound technology so that it can be used in your home,” MIT Media Lab Associate Professor Canan Dagdeviren, who designed the miniaturized scanner, said in a news release. “It’s portable and easy to use, and provides real-time, user-frie…

Integra Lifesciences expects to resume manufacturing in Boston

Integra LifeSciences (NASDAQ: IART) recently announced that it plans to resume manufacturing in its Boston facility by the end of the fourth quarter.

Just two months before, Integra voluntarily recalled all tissue-related products made in Boston and distributed between March 1, 2018 and May 22, 2023. The recalled products included SurgiMend, PriMatrix, Revize and TissueMend. According to the company, an internal investigation found deviations with endotoxin testing. The result was a release of products with higher levels of endotoxins than permitted by the product specifications. Higher levels of endotoxins can induce an immune response, including a postoperative fever.

During a July 27 earnings call with analysts, CEO Jan De Witte said the company, over the past months, has strengthened its leadership and project management in Boston, made investments and brought in outside subject matter experts. A third-party auditor is assessing progress and key milestones …

Timeline: Navigating Johnson & Johnson’s talc lawsuits and their stock performance impact

Johnson & Johnson continues to face legal challenges over allegations that its talcum powder causes cancer. Recently, a judge dismissed the company’s latest attempt to settle thousands of lawsuits through bankruptcy, marking the second time J&J’s bankruptcy strategy has been rebuffed. We take a look at the timeline of the talc litigation below.

Johnson & Johnson is planning on spinning off its consumer unit, which will be known as “Kenvue.” The separation of the unit could happen later this year.

The company’s talc-related troubles started in 2009 when the first lawsuit was filed against J&J alleging its talc products caused a woman’s ovarian cancer. By 2016, J&J suffered its first significant legal defeat with a $72 million verdict. In 2018, a jury ordered the company to pay $4.69 billion to cancer victims.

Johnson & Johnson began selling its Baby Powder brand of talcum powder in 1894.

N…