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This week on "The Top Line," we dive into the biggest clinical trial failures of 2024 and discuss what the industry can learn from these setbacks. [ABSTRACT FROM AUTHOR]

This week on "The Top Line," we zoom in on a Fierce JPM Week panel of industry experts discussing what it takes to pull off a successful biotech IPO. [ABSTRACT FROM AUTHOR]

Each year, we dive into the world of biotech closures and layoffs, tracking the industry's pulse as companies navigate [ABSTRACT FROM AUTHOR]

The article deals with a clinical trial to be conducted by New York City-based Synchron to test its Stentode implant technology developed to restore communication for people with severe paralysis. Topics include the amount raised by the company from a series B funding round to start the trial, the implication of a possible U.S. Food and Drug Administration (FDA) approval of Stentode for both medicine and technology and the components of this brain-computer interface device and how it will work.

IMPORTANCE: Aesthetic outcomes are key determinants of psychosocial functioning among surgically treated patients with head and neck cancer (HNC); however, long-term aesthetic outcomes after microvascular free tissue transfer (MFTT) are not well described. OBJECTIVE: To examine risk factors for impaired long-term aesthetic satisfaction and appearance-related psychosocial functioning after HNC ablation with MFTT. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional, web-based survey was conducted at an academic tertiary care center. A total of 228 individuals who underwent MFTT between January 1, 2015, and December 31, 2019, for treatment of HNC were included. The study was conducted from November 1, 2020, through January 15, 2021. EXPOSURES: Head and neck cancer ablation with MFTT. MAIN OUTCOMES AND MEASURES: Patient-reported outcomes were assessed via Aesthetic FACE-Q scales. The primary objective was aesthetic satisfaction determined by the Satisfaction With Facial Appearance scale. Secondarily, the Appearance-Related Psychosocial Distress, Psychological Function, and Social Function scales were used to assess appearance-related psychosocial functioning. Patients were stratified by demographic, disease, surgical, and postoperative characteristics. Survey scores on a 100-point scale were compared and subjected to univariable and multivariable linear regression. RESULTS: A total of 124 of 228 patients (54.4%) completed surveys a median of 34.4 months after MFTT (interquartile range, 22.6-48.8). Most responders (79 [63.7%]) were men with advanced cancer of the oral cavity or skin, reconstructed with anterolateral thigh or osteocutaneous fibula free flaps. Nonresponders had no significant differences in baseline characteristics. The Satisfaction With Facial Appearance score was independently lower among patients who received osteocutaneous flaps (regression coefficient, −10.6 points, 95% CI, –20.4 to –0.8 points) and/or adjuvant (chemo)radiotherapy (regression coefficient, –6.9 points; 95% CI, –13.8 to –0.1 points). Impaired appearance-related psychosocial functioning was independently associated with female sex, a history of anxiety or depression, osteocutaneous flaps, prolonged tube feeding requirements, and any recurrent or persistent disease. After adjustment for covariates, each 1-point increase in the Satisfaction With Facial Appearance score independently estimated improved appearance-related psychosocial functioning as determined by the Appearance-Related Psychosocial Distress scale (regression coefficient, –0.5 points; 95% CI, –0.7 to –0.4 points), Psychological Function scale (regression coefficient, 0.4 points; 95% CI, 0.3 to 0.5 points), and Social Function scale (regression coefficient, 0.4 points; 95% CI, 0.3 to 0.6 points). CONCLUSIONS AND RELEVANCE: The findings of this cross-sectional, web-based survey study suggest that osteocutaneous reconstruction and adjuvant therapy independently increase the risk of poor patient-reported long-term aesthetic satisfaction, which correlated with impaired appearance-related psychosocial functioning. Aesthetic outcomes appear to be a priority to address in patients with HNC undergoing MFTT.

Purpose: Essential tremor (ET) is a common movement disorder with disability in voluntary actions such as eating and writing. First-line treatment involves pharmacological agents, although efficacy is limited by side effects. In these patients, functional neurosurgery can be considered. Magnetic resonance imaging-guided focused ultrasound (MRgFUS) thalamotomy offers a non-invasive solution for treatment. This paper examines an original cohort of ET patients undergoing MRgFUS thalamotomy and discusses the anesthetic management of these cases. Methods: We retrospectively reviewed the anesthetic records of all MRgFUS thalamotomy cases from 15 May 2012 to 16 July 2015 at our centre (Sunnybrook Health Sciences Centre, Toronto, Canada) to expand a data set provided by the focused ultrasound system manufacturer (Insightec, Tirat Carmel, Israel) from a prior phase-II regulatory approval study. Specific drug and procedural details were listed including aspects of the patients’ experience. Results: A total of 82 patients were included in the analysis, 78 from a phase-II trial (16 were from the local site) and four local non-trial cases. No patient required general anesthesia and only 29% of cases required sedation to tolerate the procedure. The most frequent medications required were antiemetics and analgesics. Headache (31%) was the most frequent perioperative symptom. Transient intra-procedural paresthesia symptoms were a common occurrence (32%). Conclusions: The use of MRgFUS for thalamotomy provides a non-invasive and well-tolerated method for treating ET, which usually only requires monitored anesthesia care sedation. Nevertheless, there are several predictable side effects that require contingency planning including the personnel and means to resolve them.

IMPORTANCE: The fibula free flap donor site is associated with both short-term and long-term morbidity. Split-thickness skin graft (STSG) loss can lead to long delays in donor site healing and is associated with significant adverse sequelae. Patients may experience initial good STSG uptake after bolster removal but may have subsequent partial or total loss related to contact pressure or shearing. OBJECTIVE: To determine if increased duration of bolster use is associated with increased STSG uptake rates following fibula free flap reconstruction. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included patients 18 years and older undergoing fibula free flap reconstruction following head and neck extirpative surgery at a tertiary care academic medical center from May 2013 to March 2019. The donor sites were photographed 4 weeks postoperatively, and areas of graft uptake were measured using image processing software. The baseline demographic, comorbidity, and operative characteristics were also collected. INTERVENTIONS: A fine mesh gauze with 3% bismuth tribromophenate and petrolatum blend bolster was sutured over leg STSGs placed on fibula free flap donor sites intraoperatively, and the ankle and lower leg were immobilized for 5 days in a plaster splint. Bolsters were either removed on postoperative day 5 or 14. Thereafter, the STSGs were covered with a petroleum and bismuth gauze and a cotton dressing. MAIN OUTCOMES AND MEASURES: Rates of donor site infection and STSG percentage uptake at 4 weeks. RESULTS: Of the 42 included patients, 31 (74%) were male, and the mean (SD) age was 62.1 (13.1) years. A total of 20 patients were included in the 5-day group, and 22 were included in the 14-day group. The 14-day bolster group had a higher mean percentage skin graft uptake rate compared with the 5-day bolster duration group (77.5% vs 59.9%), with an effect size of −0.632 (95% CI, −1.260 to −0.004). Patients with Adult Comorbidity Evalution-27 scores of 3 had poorer rates of STSG uptake compared with patients with Adult Comorbidity Evalution-27 scores of 0 to 2 (65.9% vs 82.9%), with an effect size of 0.599 (95% CI, −0.191 to 1.389). No donor site infections were noted in either group. CONCLUSIONS AND RELEVANCE: Fourteen-day bolster application to the fibula free flap donor site was associated with better STSG uptake rates than 5-day bolster application.

Metabolic disorder biotech lands industry vet as CMO. MaaT welcomes ex-Autolus leader. Former Seagen execs take Shape. [ABSTRACT FROM AUTHOR]

Cardiometabolic biotech Marea unveils C-suite. Ashibio exits stealth with newly appointed leaders. Arvinas CSO steps into new role after 5 years. [ABSTRACT FROM AUTHOR]

J&J exec to retire after 17 years. Bayer's top biotech leader departs. Former Kite exec takes the reins of new biotech. [ABSTRACT FROM AUTHOR]

Three Sanofi leaders hit the exit. Lilly bids farewell to CFO, hello to new quality exec. Amarin undergoes CEO shake-up again. [ABSTRACT FROM AUTHOR]

Roche bids adieu to pharma vet Sabry. Vir fills vacant CMO spot. Neurocrine maps out CEO succession plan. [ABSTRACT FROM AUTHOR]

CRISPR Tx plucks Sanofi leader for CMO spot. Novartis taps leader for newly created innovation role. Cour finds permanent CMO in Acelyrin alum. [ABSTRACT FROM AUTHOR]

Ousted former Stanford president to lead new billion-dollar biotech. Fresh off BMS buy, Karuna's ex-CEO to helm Anthos. CureVac names new CBO. [ABSTRACT FROM AUTHOR]

Two Bayer pharma execs add new roles. BioNTech hires ex-Novartis' radioligand head. Arvinas taps former BMS hematology leader as CMO. [ABSTRACT FROM AUTHOR]

As Medtronic and Axonics' legal battle over alleged similarities between their sacral neuromodulation devices drags on, the ITC is getting involved. [ABSTRACT FROM AUTHOR]

Shortly after OK'ing Neuralink's first human trial last year, the FDA reportedly found quality control issues related to the company's animal tests. [ABSTRACT FROM AUTHOR]

The FDA put out a safety communication Tuesday warning about the possibility of "serious complications" tied to the use of Hologic's BioZorb devices. [ABSTRACT FROM AUTHOR]

Fresh off earning an updated FDA nod for its neurostim device, Mainstay Medical has closed an equity financing round to expand its global presence. [ABSTRACT FROM AUTHOR]

In the wake of the FDA's recent reminder that it has yet to OK any noninvasive glucose sensors, Know Labs is ramping up its efforts to change that. [ABSTRACT FROM AUTHOR]

Less than three years after debuting on the New York Stock Exchange in an initial public offering, Agiliti is leaving the public market. [ABSTRACT FROM AUTHOR]

A new AI algorithm may be able to replace the bulky and often expensive equipment typically used to produce accurate diagnoses of sleep disorders. [ABSTRACT FROM AUTHOR]

The FDA first alerted patients and healthcare providers to Nurse Assist's voluntary recall of several of water-based medical products last fall. [ABSTRACT FROM AUTHOR]

According to CEO Jim Hollingshead, that increase represents Insulet's "eighth consecutive year of 20-plus percent revenue growth." [ABSTRACT FROM AUTHOR]

If you see a smartwatch claiming to offer noninvasive glucose tracking, the FDA wants you to know it had nothing to do with it, thank you very much. [ABSTRACT FROM AUTHOR]

In the wake of a full-year earnings sheet that showed an 8% year-over-year drop in revenues, QuidelOrtho is making some changes at the top. [ABSTRACT FROM AUTHOR]

After nearly a decade in the role, Agilent Technologies CEO Mike McMullen is stepping down. [ABSTRACT FROM AUTHOR]

Years after Medtronic wrapped up its $1.6 billion buyout of Mazor Robotics, a former Mazor employee is still grappling with the aftermath of the deal. [ABSTRACT FROM AUTHOR]

In much the same way that Cagent Vascular's flagship device opens up blocked arteries, a recent round of funding will widen its commercial reach. [ABSTRACT FROM AUTHOR]

More than a year after laying out a plan to divest its patient monitoring and respiratory interventions businesses, Medtronic is reworking the reorg. [ABSTRACT FROM AUTHOR]

"Progress is good, and the patient seems to have made a full recovery, with no ill effects that we are aware of," the Neuralink founder said Monday. [ABSTRACT FROM AUTHOR]

Roche has participated in all of Freenome's past funding rounds and was also solely responsible for a $290 million contribution at the start of 2022. [ABSTRACT FROM AUTHOR]

After operating at a slow-and-steady pace for a little over a decade, Adagio Medical is preparing to move to a new rhythm. [ABSTRACT FROM AUTHOR]

Only about a year after earning its first FDA nod, Wandercraft's Atalante X robotic exoskeleton has broadened that clearance. [ABSTRACT FROM AUTHOR]

The rumors are true: A week after reports first surfaced that Invitae was on the brink of filing for bankruptcy, it has done exactly that. [ABSTRACT FROM AUTHOR]

After a successful limited rollout of its newest insulin pump in the U.S., Tandem Diabetes Care is picking up the pace. [ABSTRACT FROM AUTHOR]

As Philips reaches an agreement with the FDA that will suspend its sales of sleep therapy devices in the U.S., ResMed is ramping up its offerings. [ABSTRACT FROM AUTHOR]

Amid rumors that Apple is in the process of adding a sleep apnea detection feature to its namesake wearables, Samsung has beat it to the punch. [ABSTRACT FROM AUTHOR]

Masimo released new study data about a week after the FDA convened a meeting to discuss strategies for reducing racial biases in pulse oximetry tech. [ABSTRACT FROM AUTHOR]

A mounting wave of recent research argues that high-volume hemodiafiltration may significantly improve outcomes compared to standard hemodialysis. [ABSTRACT FROM AUTHOR]

Echoing a previous $50 million fundraising, the new proceeds bring Unlearn's lifetime total to more than $130 million. It will be used to build out its staff, computing power and long-term R&D projects. [ABSTRACT FROM AUTHOR]

Mere weeks after announcing the first insulin pump partner for its FreeStyle Libre 2 Plus CGM, Abbott has found a second such tie-up across the pond. [ABSTRACT FROM AUTHOR]

With the number of healthcare workers experiencing burnout at an all-time high, Ambience Healthcare is betting on AI as a potential solution. [ABSTRACT FROM AUTHOR]

A rising tide lifts all boats, and so too is a new FDA clearance expanding the reach of all of Boston Scientific's WaveWriter spinal cord stimulators. [ABSTRACT FROM AUTHOR]

While the original Dexcom One shared the same sensor as the G6 CGM, the Dexcom One+ system takes a step forward by incorporating the G7's sensor. [ABSTRACT FROM AUTHOR]

After losing a patent infringement lawsuit last year that ended with an order to pay $31 million in damages, NanoString is plotting a new way forward. [ABSTRACT FROM AUTHOR]

An app developed by Cedars-Sinai for use with Apple's new spatial computing headset is putting a new spin on the concept of virtual care. [ABSTRACT FROM AUTHOR]

As clinical trials of its brain-computer interface progress, Synchron is laying the groundwork for the technology's eventual commercial rollout. [ABSTRACT FROM AUTHOR]

Revvity's first several months as a standalone company haven't all been smooth sailing. [ABSTRACT FROM AUTHOR]

Though both Philips and the FDA have agreed to the terms of the decree, it's still in the process of being finalized and approved. [ABSTRACT FROM AUTHOR]