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Nalu Medical raises $65M for neurostim tech

BY SEAN WHOOLEY Nalu Medical announced today that it closed a $65 million equity financing to support its minimally invasive neurostimulation product. Carlsbad, California–based Nalu had its round led by new investor Novo Holdings. All existing significant investors — including Gilde Healthcare, MVM Partners, Endeavor Vision, Decheng Capital, Longitude Capital, Advent Life Sciences, Pura Vida and Aperture Venture Partners — participated, too. Nalu plans to use the proceeds to accelerate commercial growth and expand clinical and health-economic evidence. It also wants to use the funds to continue product development and scale operations. The company’s FDA-cleared spinal cord stimulation and peripheral nerve stimulation technology treats patients with chronic neuropathic pain. It delivers gentle electrical pulses to the nervous system to modulate pain signals before they reach the brain. Nalu system includes a fully featured, battery-free, miniaturized implantable pulse generator (IPG). An externally worn therapy disc wirelessly powers the IPG and ...
- Source: drugdu
- 177
- January 6, 2024
FDA Grants Fast Track, Breakthrough Designations to CG Oncology Inc’s Cretostimogene Grenadenorepvec

Pharmaceutical Executive Editorial Staff Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors. The FDA granted Fast Track and Breakthrough Therapy designations to CG Oncology Inc’s cretostimogene grenadenorepvec (CG0070) for the treatment of patients with high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without Ta or T1 tumors.1 The novel, intravesically delivered oncolytic immunotherapy is currently being evaluated in the Phase III BOND-003 and the Phase II CORE-001 clinical trial in combination with pembrolizumab (Keytruda) in the same indication. An investigator-sponsored clinical trial is evaluating cretostimogene grenadenorepvec in combination with nivolumab (Opdivo) for the treatment of muscle invasive bladder cancer. The regulatory action was based on data from an ongoing clinical trial program, including the Phase III BOND-003 trial (NCT04452591), which ...
- Source: drugdu
- 149
- January 6, 2024
Lilly makes website to simplify access to obesity drug Zepbound, plus diabetes and migraine meds

Eli Lilly has created a website to make it easier for patients to access medicines including its hot obesity drug Zepbound. The website, LillyDirect, combines telehealth and pharmacy services to provide access to Lilly’s portfolio of diabetes, migraine and obesity medicines. Companies including the weight loss program providers Noom and WeightWatchers have begun offering telehealth services to help people access Lilly’s Zepbound and Novo Nordisk’s Wegovy. Drugmakers have kept in their lane, though, developing and manufacturing medicines without getting into the business of connecting patients to physicians and delivering products to their homes. LillyDirect marks a shift in strategy, at least for Lilly. The website features sections to help people access healthcare, either remotely or in person, and details of how to send prescriptions to LillyDirect Pharmacy Solutions to get home deliveries of Lilly drugs. Lilly CEO David Ricks set out the thinking behind LillyDirect in a statement, framing the ...
- Source: drugdu
- 160
- January 6, 2024
Thermo Fisher to cut the lights at California plastics plant, lay off 74

After pumping millions into its manufacturing capacity to keep up with COVID-related demand and bolster longer-term efforts during the pandemic, Thermo Fisher is winding down operations for good at its Petaluma, California, plant and letting go of 74 employees in the process. The 74 layoffs will take effect on February 1, according to the state’s recent Worker Adjustment and Retraining Notification (WARN) update. The site itself will close its doors in July, a company spokesperson confirmed over email. Thermo Fisher’s ten-year lease on the property ends that month, according to the North Bay Business Journal. The decision to not renew the lease aligns with the company’s “ongoing effort” to “continuously evaluate its global operations to identify opportunities to improve efficiency and effectiveness in meeting our customers’ needs,” the spokesperson said. “Decisions that impact colleagues and their families are never taken lightly,” Thermo Fisher’s spokesperson added. “All impacted colleagues will receive ...
- Source: drugdu
- 96
- January 6, 2024
Inbound HCP communication channels double digital engagement, Veeva finds

Biopharma companies that provide healthcare professionals (HCPs) with compliant chat channels benefit from increased engagement, according (PDF) to Veeva Systems. Analyzing interactions captured in its customer relationship management platform, Veeva found HCPs start 30% of conversations with reps when a compliant chat channel is available. The software provider framed the use of the channels by HCPs in light of the rise of precision therapies, saying the focus on smaller patient populations means physicians have questions when they come to start patients on drugs. Inbound channels offer HCPs a way to get answers to questions about reimbursement, site certification and more. Veeva found that, on average, reps can respond to queries in compliant chat channels in less than five minutes and use the medium to arrange samples for new patient starts and schedule meetings. Text messaging and standalone chat apps may also support timely responses but in the view of Veeva, ...
- Source: drugdu
- 94
- January 6, 2024
Bluebird bio’s Lyfgenia launch progresses with 2nd major outcomes-based coverage deal

Despite competitive pressure from a buzzy CRISPR therapy, bluebird bio keeps striding forward with its sickle cell disease gene therapy Lyfgenia. The Massachusetts biotech has signed a second outcomes-based reimbursement agreement for Lyfgenia, according to a securities filing. The deal pushes Lyfgenia’s coverage range to nearly 200 million people in the U.S., up from the previous 100 million when bluebird signed the first agreement three weeks ago. Bluebird pulled off the feat within a month of winning FDA approval for Lyfgenia in SCD patients who have a history of the painful blood flow blockade episodes known as vaso-occlusive events. And it comes despite the company pricing Lyfgenia at a wholesale acquisition cost that’s about 40% higher than Vertex and CRISPR Therapeutics’ rival gene therapy Casgevy. Under these outcomes-based agreements, bluebird is offering a discount if a patient is hospitalized because of vaso-occlusion events within three years after treatment. In addition ...
- Source: drugdu
- 86
- January 6, 2024
Novo Nordisk, Eli Lilly’s weight-loss drugs under FDA scrutiny for suicidal thoughts, hair loss

Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus, which can be life threatening. Could cautions about more common side effects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro? On Tuesday, the FDA revealed that it is investigating patient reports of suicidal thoughts and hair loss from the use of the blood sugar-modulating products. The U.S. regulator also is looking into cases of aspiration, a condition often associated with surgery in which people breathe food, liquids, vomit or saliva into their lungs. The investigation was triggered by information gathered on the FDA Adverse Event Reporting System (FAERS), a database that allows the regulator to track potential problems by collecting side effect reports from patients and healthcare providers. Each quarter, the FDA posts a list of drugs that ...
- Source: drugdu
- 92
- January 6, 2024
CVS Caremark to kick AbbVie’s Humira off some formularies in favor of cheaper biosimilars

This year, CVS Health plans to employ the classic “out with the old, in with the new” mantra when it comes to AbbVie’s Humira. Come April 1, the branded drug will be replaced by cheaper biosimilars across the company’s major commercial formularies nationwide. The move is part of CVS Caremark’s efforts to expand the adoption of biosimilars. As it stands, the U.S. biosimilar market is expected to grow from less than $10 billion in 2022 to more than $100 billion by 2029, CVS Caremark cited in a recent press release. The company is “committed” to ramping up adoption of the cheaper biologic drugs and enabling customer choice, CVS Health’s executive vice president and president of CVS Caremark David Joyner noted in a statement. “By preferring biosimilars that have a significantly lower list price than their reference product, CVS Caremark is putting our customers in the driver’s seat to best meet ...
- Source: drugdu
- 141
- January 6, 2024
Wearing hearing aids could extend people’s lifespan

Hearing loss affects approximately 40 million American adults, yet only one in 10 people who need hearing aids use them, research shows. Those who don’t use hearing aids but should may want to make wearing them one of their New Year’s resolutions, according to a new study from Keck Medicine of USC published today in The Lancet Healthy Longevity.  Janet Choi, MD, MPH, an otolaryngologist with Keck Medicine and lead researcher of the study said, “We found that adults with hearing loss who regularly used hearing aids had a 24% lower risk of mortality than those who never wore them. These results are exciting because they suggest that hearing aids may play a protective role in people’s health and prevent early death.” Previous research has shown that untreated hearing loss can result in a reduced life span (as well as other poor outcomes such as social isolation, depression and dementia). ...
- Source: drugdu
- 169
- January 5, 2024
AI Tool Rapidly Analyzes Gene Activities in Medical Images to Highlight Hidden Cancers

A novel artificial intelligence (AI) tool, designed to interpret medical images with exceptional clarity, is set to revolutionize the way clinicians approach disease diagnosis and image analysis. This advanced tool, named iStar (Inferring Super-Resolution Tissue Architecture), was developed by researchers at the Perelman School of Medicine at the University of Pennsylvania (Philadelphia, PA, USA). It can assist healthcare professionals in diagnosing and treating cancers that might otherwise remain undetected. iStar offers an in-depth view of individual cells and a broader look at the full range of human gene activity, potentially revealing cancer cells that were nearly invisible earlier. This tool could play a crucial role in confirming whether cancer surgeries have fully removed malignancies and provide automatic annotations for microscopic images, marking a significant leap toward molecular-level disease diagnosis. One of the standout capabilities of iStar is its automatic identification of crucial anti-tumor immune formations known as “tertiary lymphoid structures,” ...
- Source: drugdu
- 94
- January 5, 2024

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