Latest news with #CGMP
Yahoo
5 hours ago
- Business
- Yahoo
Neurogene Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
NEW YORK, June 06, 2025--(BUSINESS WIRE)--Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced that the Compensation Committee of the Company's Board of Directors approved the grant of non-qualified stock options to purchase an aggregate of 39,345 shares of the Company's common stock to four new employees (the "Inducement Grants") on June 5, 2025 (the "Grant Date"). The Inducement Grants have been granted pursuant to the Company's 2025 Inducement Plan (the "Plan"). The Inducement Grants were granted as an inducement material to these individuals entering into employment with Neurogene in accordance with Nasdaq Listing Rule 5635(c)(4). The Inducement Grants have an exercise price per share that is equal to the closing price of Neurogene's common stock on the Grant Date. The Inducement Grants will vest over four years, with 25 percent vesting on the first anniversary of the vesting commencement date and thereafter in equal portions upon the lapse of each three-month period over the following 36-month period, subject to the employee's continued employment with Neurogene through the applicable vesting dates. About Neurogene The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company's novel and proprietary EXACT™ transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. For more information, visit View source version on Contacts Company Contact: Cara MayfieldVice President, Corporate Investor Contact: Melissa ForstArgot PartnersNeurogene@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
6 hours ago
- Business
- Yahoo
Neurogene Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
NEW YORK, June 06, 2025--(BUSINESS WIRE)--Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced that the Compensation Committee of the Company's Board of Directors approved the grant of non-qualified stock options to purchase an aggregate of 39,345 shares of the Company's common stock to four new employees (the "Inducement Grants") on June 5, 2025 (the "Grant Date"). The Inducement Grants have been granted pursuant to the Company's 2025 Inducement Plan (the "Plan"). The Inducement Grants were granted as an inducement material to these individuals entering into employment with Neurogene in accordance with Nasdaq Listing Rule 5635(c)(4). The Inducement Grants have an exercise price per share that is equal to the closing price of Neurogene's common stock on the Grant Date. The Inducement Grants will vest over four years, with 25 percent vesting on the first anniversary of the vesting commencement date and thereafter in equal portions upon the lapse of each three-month period over the following 36-month period, subject to the employee's continued employment with Neurogene through the applicable vesting dates. About Neurogene The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company's novel and proprietary EXACT™ transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. For more information, visit View source version on Contacts Company Contact: Cara MayfieldVice President, Corporate Investor Contact: Melissa ForstArgot PartnersNeurogene@
Yahoo
13-05-2025
- Health
- Yahoo
Thousands of eye care products sold nationwide are being recalled: See the list of impacted items
Be wary of what you put in your peepers: Nearly 76,000 cases of eye care products have been voluntarily recalled by their manufacturer following an audit by the U.S. Food and Drug Administration. BRS Analytical Service, LLC, is voluntarily recalling several of its eye drop products, according to a notice from pharmaceutical distributor AvKARE. While no specific health issues have been reported, the recall was prompted by 'manufacturing CGMP deviations' — meaning the products may not meet FDA quality standards. It's unclear whether these deviations pose a risk to users, so the company is recalling the products as a precaution. The affected products include artificial tears and other lubricating eye solutions and were first shipped between May 26, 2023, and April 21, 2025. They have expiration dates that range from April 2025 to March 2027 — meaning it's possible these items are still being used by customers. You can find specific information about what products are recalled on the FDA's website. Below are the products that are recalled: Artificial Tears Ophthalmic Solution Drug Code: 50268-043-15 13,872 cases recalled Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Drug Code: 50268-066-15 1,610 cases recalled Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Drug Code: 50268-068-15 32,876 cases recalled Lubricant Eye Drops Solution (Polyethylene Glycol 400 / Propylene Glycol) Drug Code: 50268-126-15 13,104 cases recalled Polyvinyl Alcohol Ophthalmic Solution 1.4% Drug Code: 50268-678-15 14,333 cases recalled If you find that you have one of these products, stop using it immediately. Consumers who want a refund can fill out a recall form and send it to AvKARE by fax or email, after which they'll receive instructions to return the product and get a full refund, including shipping. This is not the first time in recent years that certain eye products have been the subject of scrutiny by the FDA. In October 2023, the FDA warned consumers about 26 over-the-counter eye care products, including eyedrops available at stores like CVS and Target, which came with the 'potential risk of eye infections that could result in partial vision loss or blindness.' At the time, the FDA discovered that the manufacturing facility had poor sanitation practices and that the products tested positive for bacteria, proving they weren't sterile as advertised. And in September 2023, the FDA issued warning letters to eight companies for illegally marketing unapproved eye products that claim to treat conditions like pink eye, cataracts and glaucoma, some of which had sterility issues and/or contained silver, which can cause long-term health issues. The news came one month after the FDA warned consumers not to use Dr. Berne's and LightEyez MSM eye drops due to contamination risks and the use of an unapproved ingredient. There was also an earlier wave of eye drop recalls in 2023, including one linked to EzriCare Artificial Tears that caused infections in dozens of people, resulting in hospitalizations, vision loss and at least one death, according to the FDA.
Yahoo
13-05-2025
- Automotive
- Yahoo
Cooler recall expanded over amputation and crushing hazard
Igloo has expanded a recall of its coolers due to numerous reported injuries. In February, Igloo recalled 1,060,000 of its 90 Qt. Flip & Tow Rolling Coolers because the 'tow handle can pinch consumers' fingertips against the cooler, posing fingertip amputation and crushing hazards.' The recall came after 12 reports of fingertip injuries, including fingertip amputations, bone fractures, and lacerations due to the coolers. On May 9, the U.S. Consumer Product Safety Commission (CPSC) announced in a press release that Igloo was recalling 130,000 more of these rolling coolers. Since the initial recall was announced in February, Igloo has received 78 reports of fingertip injuries, 26 of which resulted in fingertip amputations, bone fractures, and lacerations. The additional recalled coolers were sold at Costco, Target, Academy, Dick's, and other stores nationwide and online at and other websites. They were sold from January 2019 through January 2025, and cost anywhere between $80 and $140. The affected products were manufactured before January 2024, with the manufacturing date on the bottom of the cooler in a circular pattern. There's also an arrow on the bottom of the cooler that points at the month of manufacture and the last two digits of the year of manufacture inside the circle. Coolers have a tow handle and the company's logo, 'IGLOO,' printed on the side. Products were also sold in many body and lid color combinations. The additional recalled coolers can be identified by one of these three SKU numbers: 34692, 34785, 34790. You can find the initial list of recalled coolers, with the SKU number, description, and date codes here. In addition, 20,000 coolers in Canada and 5,900 in Mexico are being recalled. Consumers should stop using the recalled coolers immediately. They can also contact Igloo for a free replacement handle. Many other popular products in the U.S. have been recalled in the last few months. This week, BRS Analytical Service, LLC announced an urgent recall of five eye care products, healthcare distributor AvKARE shared in a recent press release. The recall comes after a Food and Drug Administration (FDA) audit identified violations of Current Good Manufacturing Practice (CGMP). CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, and packing of a drug product. Although it's unclear what health risks may be posed, CGMP deviations could lead to 'unacceptable quality' of the recalled eyecare solutions, and it's 'not possible to rule out patient risks resulting from use of these products,' according to AvKARE. According to the FDA, the recall was issued due to a 'lack of assurance of sterility' in these products. The recall affects more than 1.8 million cartons of eye drops. Earlier this month, popular wellness brand Optimal Carnivore issued a voluntary recall on 1,500 bottles of their Bone & Joint Restore capsules, after they were distributed nationwide through major retailers, such as Amazon. The capsules, which contain bone marrow and bones from cows, were recalled due to potential salmonella contamination. Salmonella infection is a common bacterial disease that can affect the intestinal tracts and occurs after drinking contaminated water, eating raw meat, poultry, eggs, or unpasteurized milk.
Yahoo
13-05-2025
- Automotive
- Yahoo
Cooler recall expanded over amputation and crushing hazard
Igloo has expanded a recall of its coolers due to numerous reported injuries. In February, Igloo recalled 1,060,000 of its 90 Qt. Flip & Tow Rolling Coolers because the 'tow handle can pinch consumers' fingertips against the cooler, posing fingertip amputation and crushing hazards.' The recall came after 12 reports of fingertip injuries, including fingertip amputations, bone fractures, and lacerations due to the coolers. On May 9, the U.S. Consumer Product Safety Commission (CPSC) announced in a press release that Igloo was recalling 130,000 more of these rolling coolers. Since the initial recall was announced in February, Igloo has received 78 reports of fingertip injuries, 26 of which resulted in fingertip amputations, bone fractures, and lacerations. The additional recalled coolers were sold at Costco, Target, Academy, Dick's, and other stores nationwide and online at and other websites. They were sold from January 2019 through January 2025, and cost anywhere between $80 and $140. The affected products were manufactured before January 2024, with the manufacturing date on the bottom of the cooler in a circular pattern. There's also an arrow on the bottom of the cooler that points at the month of manufacture and the last two digits of the year of manufacture inside the circle. Coolers have a tow handle and the company's logo, 'IGLOO,' printed on the side. Products were also sold in many body and lid color combinations. The additional recalled coolers can be identified by one of these three SKU numbers: 34692, 34785, 34790. You can find the initial list of recalled coolers, with the SKU number, description, and date codes here. In addition, 20,000 coolers in Canada and 5,900 in Mexico are being recalled. Consumers should stop using the recalled coolers immediately. They can also contact Igloo for a free replacement handle. Many other popular products in the U.S. have been recalled in the last few months. This week, BRS Analytical Service, LLC announced an urgent recall of five eye care products, healthcare distributor AvKARE shared in a recent press release. The recall comes after a Food and Drug Administration (FDA) audit identified violations of Current Good Manufacturing Practice (CGMP). CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, and packing of a drug product. Although it's unclear what health risks may be posed, CGMP deviations could lead to 'unacceptable quality' of the recalled eyecare solutions, and it's 'not possible to rule out patient risks resulting from use of these products,' according to AvKARE. According to the FDA, the recall was issued due to a 'lack of assurance of sterility' in these products. The recall affects more than 1.8 million cartons of eye drops. Earlier this month, popular wellness brand Optimal Carnivore issued a voluntary recall on 1,500 bottles of their Bone & Joint Restore capsules, after they were distributed nationwide through major retailers, such as Amazon. The capsules, which contain bone marrow and bones from cows, were recalled due to potential salmonella contamination. Salmonella infection is a common bacterial disease that can affect the intestinal tracts and occurs after drinking contaminated water, eating raw meat, poultry, eggs, or unpasteurized milk.
