Search Results for “FDA” – Page 26 – media

Nanowear gets FDA clearance for undergarment that estimates blood pressure

Dive Brief Nanowear has received 510(k) clearance for AI-enabled software that allows its wearable undergarment to estimate blood pressure. The Food and Drug Administration decision covers software that processes electrocardiogram (ECG) data, heart sounds and thoracic impedance captured by the Simplesense wearable device to monitor blood pressure at home, in healthcare facilities and during medical research. Nanowear is pitching the software as the “first non-invasive, cuffless, continuous blood pressure monitor, and diagnostic.” The company cited Biobeat Technologies’ wrist and chest monitor as a predicate blood pressure device in its 510(k) filing. Dive Insight Simplesense is a cloth-based undergarment that wraps around the wearer’s torso and over one shoulder. The medical device features two ECG leads, plus sensors for recording heart sounds and activity, and for measuring respiration rate through thoracic impedance. Nanowear made the device to enable physicians and researchers to remotely capture data on patients without disrupting their lives. ...
- Source: drugdu
- 174
- January 9, 2024
FDA Authorizes Florida’s Drug Importation Program

Today, the U.S. Food and Drug Administration authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada. Through this pathway, the FDA may authorize section 804 importation program (SIP) proposals from states or Indian tribes to import certain prescription drugs from Canada if the SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety. President Biden’s Executive Order on Promoting Competition in the American Economy directed the FDA to work with states and Indian tribes on these plans to reduce costs to American consumers while supporting public health and safety. Florida’s SIP is authorized for two years from the date the FDA is notified of the first shipment of drugs ...
- Source: drugdu
- 84
- January 9, 2024
BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod

By PharmaCompass BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod This week’s Phispers is a double bill with news from last week and the first days of the New Year. Bristol Myers Squibb (BMS) and AstraZeneca have been on year-end shopping sprees with the former picking up Karuna Therapeutics for a whopping US$ 14 billion and the latter expanding its already dominant presence in China through an acquisition and a deal. Novo Nordisk is investing over US$ 2 billion, this time in Ireland, to meet the skyrocketing demand for its blockbuster diabetes and weight-loss drugs, Ozempic and Wegovy. In drug approvals, AstraZeneca and Ionis Pharmaceuticals’ drug Wainua became the first self-administered treatment in the United States for a rare nerve damage disease. In trial news, a potential first-in-class small molecule that was on course to becoming the first new drug approved in 20 years ...
- Source: drugdu
- 123
- January 8, 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
- 147
- 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
- 89
- January 6, 2024
FDA Fast Tracks Candel Therapeutics’ Novel Treatment for Pancreatic Ductal Adenocarcinoma

Pharmaceutical Executive Editorial Staff Study results show an estimated 71.4% survival rate after both 24 and 36 months with aglatimagene besadenovec (CAN-2409) in combination with valacyclovir for the treatment of patients with pancreatic ductal adenocarcinoma compared with 16.7% in the control group. The FDA granted Fast Track Designation to Candel Therapeutics, Inc’s aglatimagene besadenovec (CAN-2409) in combination with valacyclovir for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC).1 The novel off-the-shelf therapy is administered by a localized injection that is believed to provide a safety benefit compared with standard systemic administration in this patient population. “We are pleased with the FDA’s decision to grant fast track designation for CAN-2409 in pancreatic cancer,” said Paul Peter Tak, MD, PhD, FMedSci, president and chief executive officer of Candel Therapeutics, in a press release.1 “This milestone follows our first interim data report from the randomized Phase II clinical trial in patients with ...
- Source: drugdu
- 174
- January 5, 2024
After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer

In 2022, fueled by its powerhouse COVID products, Pfizer became the first company in the history of the biopharma industry to top $100 billion in annual revenue. What would the New York drugmaker do for an encore? In 2023, Pfizer went from generating the most sales in the industry to gaining the most approvals. With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approached what Pfizer accomplished in 2023. Pfizer’s splurge included four approvals in a dizzying five weeks in May and June. And all but one of the seven products has been pegged by analysts as a potential blockbuster. Two of the newly approved Pfizer treatments were acquired ...
- Source: drugdu
- 224
- January 4, 2024
FDA clears neurovascular aspiration, access catheters from Perfuze

BY SEAN WHOOLEY The Millipede catheter. [Image courtesy of Perfuze] Perfuze announced today that the FDA cleared its Millipede 070 aspiration catheter and second-generation Millipede 088 access catheter. Galway, Ireland-based Perfuze developed Millipede 070 to address critical unmet needs in ischemic stroke treatment. It aims to remove clots rapidly and safely through a novel, unique catheter. Millipede 070 has a unique design with a rib-and-recess surface architecture to improve navigability and reduce tip stiffness while maintaining durability. The design features superior deliverability and high procedural efficiency, enabling a more refined approach for restoring blood flow to the brain during endovascular thrombectomy procedures. The company currently has enrollment underway for its MARRS pivotal clinical study to support future regulatory submissions. “Perfuze aims to provide neurovascular interventionists with innovative thrombectomy solutions, to maximize their opportunity to completely restore blood flow to the brain on their first attempt,” said Wayne Allen, CEO. “The ...
- Source: drugdu
- 174
- January 2, 2024
Amgen’s request for full approval of Lumakras in lung cancer denied by FDA

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California pharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod. Lumakras was granted accelerated approval in May 2021 to treat second line KRAS G12C-mutated NSCLC. The company was asked by the FDA to launch a confirmatory trial and a dose optimization study to gain a full approval. The therapy faced an advisory committee meeting in October where a panel was asked to consider whether the primary endpoint for the phase 3 CodeBreak 200 trial could be reliably interpreted in Amgen’s study. The committee voted 10-2 against the measure, suggesting that they were unimpressed with Amgen’s trial design. Despite the negative vote, the agency was not expected to remove Lumakras from the market, but instead request another confirmatory trial. Amgen now says that’s exactly ...
- Source: drugdu
- 220
- January 1, 2024
Boston Scientific initiates new Farapulse trial, expects FDA approval in 2024

BY SEAN WHOOLEY The Farapulse PFA system. [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX)+ announced today that it initiated the AVANT GUARD clinical trial to evaluate its Farapulse pulsed-field ablation (PFA) system. The company also says it now anticipates FDA approval for Farapulse in the first quarter of 2024. AVANT GUARD looks at the safety and effectiveness of Farapulse as a first-line treatment for persistent AFib. Boston Scientific says this makes it the only trial studying the use of PFA as a frontline therapy in patients with this form of AFib. Farapulse is already a known commodity in the competitive PFA space. The nonthermal treatment uses electric fields to selectively ablate heart tissue. Boston Scientific bought Farapulse for nearly $300 million in 2021. The company shared its high hopes for the technology at its Investor Day event earlier this year, with analysts projecting FDA approval and rapid adoption in ...
- Source: drugdu
- 188
- December 30, 2023

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