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Invacare announces executive leadership changes after CEO steps down

Invacare (NYSE:IVC) today announced multiple leadership changes as CEO Matthew E. Monaghan has stepped down from the corner office.

Elyria, Ohio-based Invacare said in a news release that the changes were made to its senior management team and board of directors to advance its business transformation initiatives, address supply chain challenges and strengthen its financial performance.

Invacare named Geoffrey P. Purtill, who served as SVP and GM of EMEA and APAC, interim president and CEO to replace Monaghan, whose departure from his role as chair, president and CEO was made effective on Aug. 28. The board of directors commenced a search to identify and appoint a permanent CEO.

“After careful consideration, the board determined that now is the right time for a change in leadership to oversee the successful execution of Invacare’s business transformation,” said Cliff Nastas, Invacare’s lead independent director. “We welcome Geoff who has disti…

Incyte wins second FDA indication for FGFR inhibitor Pemazyre

FDA has approved the selective fibroblast growth factor receptor (FGFR) inhibitor Pemazyre (pemigatinib) to treat adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

The drug, developed by Incyte (Nasdaq:INCY), first won approval for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma.

The latest indication, MLNs with FGFR1 rearrangement, covers an extremely rare and aggressive form of blood cancer.

A 2019 article in Frontiers in Oncology noted that there had been approximately 100 cases of the cancer reported to date.

“The approval of Pemazyre represents an important treatment advancement for people living with MLNs with FGFR1 rearrangement who currently have limited treatment options,” said Hervé Hoppenot, Incyte CEO, in a news release. “These are complex hematologic malignancies with a range of presentations, and this approval highlights Incyte’s continued…

U.S. Adderall shortage continues

[Chemical structure model courtesy of PubChem]

Demand for the attention-deficit/hyperactivity disorder drug Adderall (mixed amphetamine salts) has skyrocketed in the past decade. In 2021, physicians prescribed the medication and its generic equivalents 41.4 million times.

Supplies of generic Adderall XR, however, remain scarce. Amneal Pharmaceuticals, Rhodes Pharmaceuticals, Par Pharmaceutical, Sandoz and Teva had the drug on backorder in late August, according to the American Society of Health-System Pharmacists (ASHP).

Labor shortages are partly to blame for the supply disruptions.

Initially marketed by Shire, Adderall is now part of Takeda’s drug portfolio. Takeda acquired Shire in 2019.

The drug’s patent expired in 2009. The drug first hit the U.S. market in 1996.

A 2015 review found psychostimulants such as Adderall led to cognition improvements in adults.

T…

Medical Design & Outsourcing recognized in TABPI awards

The 2022 Trade, Association, Business Publications International (TABPI) awards named Medical Design & Outsourcing‘s May 2021 edition as an honorable mention for best single issue.

TABPI’s Tabbie Awards honor local, regional, national, and international B2B publications.

The May 2021 edition of MDO featured mask manufacturers’ solutions to the N95 respirator shortage, our ranking of the 10 largest orthopedic device companies in the world, and analysis of how the biggest companies in medtech performed in the first year of the pandemic.

What a difference a year makes. Just today, the FDA announced the removal of N95 respirators from its medical device shortage list. We’ve also updated our list of the biggest orthopedic companies, and are currently conducting another analysis of medtech performance based on our new Medtech Big 100 ranking, which we’ll release in the coming weeks. (Sign up for our free newsletters to be amon…

N95 respirators removed from FDA medical device shortage list

An N95 mask made by Moldex. (Image courtesy of Moldex)

The FDA today removed N95 respirators from its medical device shortage list.

The agency credited increased domestic manufacturing of the face masks, new supply chain data from the industry and federal government, and approval from the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health (NIOSH) of new disposable N95s and reusable respirators.

The FDA did not announce any new additions to the device shortage list, but added two brands of needles and syringes (product code GAA) and two brands of viral transport media (product codes QMC and JSM) to its device discontinuance list.

The FDA last month identified new shortages of automated external defibrillators (AEDs), chest drains/suction canisters and autotransfusion systems.

Respirators were one of the first medical devices identified in c…

The data to solve many pharmaceutical research problems already exists. We just need to harness it.

[Image courtesy of ipopba via iStock Photo]

In searching for new therapies, pharmaceutical research teams worldwide are conducting experiments daily and generating knowledge. Thanks to this constantly expanding pool of scientific data, we are starting projects with access to more information than ever before.

Data is good. The right data is better. But finding the right data is no easy task. Inaccessible data sources, the growing complexity of search terms required to attain appropriate results, and the multitude of databases available means that finding data – and then applying it to inform research – is taking up more and more valuable researcher hours. As a result, 80% of researcher time is dedicated to acquiring and reformatting data; time that could be much better spent on analysis and developing scientific insights.

It is, however, essential. What’s needed are methods to accelerate the search …

Zimmer Biomet loses appeal on $3.5M hip implant suit verdict

[Image from Unsplash]A U.S. Court of Appeals denied an appeal from Zimmer Biomet (NYSE:ZBH) to move to a new trial after a $3.5 million hip implant lawsuit verdict.

In 2020, a federal jury in Iowa awarded $3.55 million to Lori Nicholson and her husband Willis for injuries sustained as a result of the company’s much-litigated M2a Magnum metal-on-metal hip implant. The jury found in Nicholson’s favor following the conclusion that the M2a Magnum was defectively designed. Around the same time as the Iowa lawsuit, a federal judge in Missouri signed off on a $21 million judgment regarding the M2A Magnum.

Zimmer Biomet moved for a new trial and renewed its motion for judgment as a matter of law, but the district court denied these motions and, in a decision filed Aug. 24, the U.S. Court of Appeals for the Eight Circuit affirmed that denial.

The appeals court found that the district court did not err in denying Zimmer Biomet’s motion for judgment as a …

Study shows workplace productivity improvements with One Drop type 2 diabetes tech

[Image from One Drop]One Drop today announced positive results from a trial of its digital health platform for people with type 2 diabetes.

Employees using the One Drop digital diabetes management platform experienced significant productivity and functioning gains and were less likely to experience presenteeism at follow-up compared to control groups.

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

Moderna says Pfizer-BioNTech COVID vaccine infringed its patents

Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer and its COVID-19 vaccine partner BioNTech over patent infringement in U.S. and German courts.

Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany.

The suits could pit three of the most significant COVID-19 vaccine makers against each other in an IP battle with billions of dollars potentially at stake. COVID-19 vaccine revenue boosted Pfizer to the top of the list among the Pharma 50 largest pharmaceutical companies on Drug Discovery & Development. Moderna and BioNTech also joined the Pharma 50 for the first time in the most recent edition.

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” Moderna CEO…

Dentsply Sirona taps BD executive as new CEO

Simon Campion is leaving BD to take over the corner office at Dentsply Sirona [Image courtesy of Dentsply Sirona]Simon Campion will be the new CEO of Dentsply Sirona (Nasdaq:XRAY) as it wraps up an internal investigation into potentially iffy financial practices.

Campion will join the Dentsply Sirona board on Sept. 12, according to a news release out yesterday. He takes over for interim CEO John Groetelaars, the former Hillrom CEO who has led the dental tech company since the removal of former CEO Don Casey in April. (Previous CFO Jorge Gomez soon left his new job at Moderna.)

At BD, Campion has most recently led the company’s Medtech segment. He joined BD through its $24 billion acquisition of Bard in 2017, leading BD’s Interventional segment through the integration.

Eric K. Brandt, chairman of the Dentsply Sirona board, described Campion as a high-integrity, transformational leader. “In his 25 years in the medical device industry, Simon …

MindMed launches Phase 2b to study LSD in generalized anxiety disorder

Psychedelic medicine firm MindMed (OTCMKTS:MMDCF) has dosed the first patient in a Phase 2b dose-optimization trial of MM-120, a pharmaceutically optimized form of lysergic acid diethylamide (LSD).

The study will test the potential of LSD to treat general anxiety disorder (GAD), which affects about 3% of the population.

While LSD emerged as the definitive psychedelic compound of the 1960s, psilocybin has more recently emerged as a more popular recent focus of clinical trials. LSD arguably has seen more cultural backlash than psilocybin.

Unravelling psychedelic mysteries

Evidence is mixed regarding LSD’s potential to treat mood disorders. Some LSD users report obtaining life-changing insights from their experiences. For instance, the actor Cary Grant reported experiencing an “immeasurably beneficial cleansing of so many needless fears and guilts” after ingesting LSD an estimated 100 times in a therapeutic setting from 1958 to 1961. Conve…

Medtronic recall of HeartWare HVAD batteries is Class I

Medtronic’s HVAD [Image courtesy of Medtronic]The FDA today issued a notice deeming the recall of the Medtronic (NYSE:MDT) HVAD batteries as Class I, the most serious kind.

Medtronic recalled the HeartWare Ventricular Assist Device (HVAD) batteries (model number 1650DE) because they may experience electrical faults that cause them to fail unexpectedly. Such an occurrence means the batteries may be unable to power the controller, unable to accept a charge from the battery charger or appear to remain charged when in use.

If the battery fails and the patient is unable to replace the failed battery with a charged, working battery or with AC or DC power, the HVAD may stop working, leading to serious injury or death, according to the FDA notice.

The medtech giant has recalled 23,372 devices, distributed from Jan. 1, 2009, to the present day, after initiating the recall on June 28, 2022. To date, Medtronic has reported 1,159 complaints, six injuries and one …