FDA Head Says OxyContin Was Approved Illegally. Now What?
Hi, it's Sam in New York. Earlier this year, I wrote about the FDA's role in igniting the opioid epidemic. More on why this is back in the news in a moment, but first …
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Business Insider
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- Business Insider
KalVista says FDA will not meet PDUFA goal date for Sebetralstat NDA
KalVista (KALV) Pharmaceuticals nnounced that the U.S. Food and Drug Administration has notified the company that it will not meet the PDUFA goal date for the New Drug Application for sebetralstat, the company's investigational oral on-demand treatment for hereditary angioedema. The FDA notified the company on June 13, 2025, that the previously disclosed June 17, 2025 PDUFA goal date will not be met due to heavy workload and limited resources. The FDA indicated that it expects to deliver a decision within approximately four weeks. The FDA has not requested additional data or studies and has not raised any concerns regarding the safety, efficacy or approvability of sebetralstat. KalVista has addressed all prior information requests in a timely manner, and the company believes the only remaining item under FDA review is the finalization of the labelling. 'We are disappointed by this delay, most importantly because we know how much people living with HAE are looking forward to an oral on-demand option to treat their HAE attacks,' said Ben Palleiko, CEO of KalVista. 'At the same time, we remain confident in the near-term approval of sebetralstat. We are continuing to work closely with the FDA to support the completion of their review. Our commitment to bringing this important therapy to people living with HAE remains unwavering.'
Miami Herald
an hour ago
- Miami Herald
Lilly's experimental obesity drug shows promise in early study
An experimental weight-loss drug from Eli Lilly & Co. helped patients lose weight with few side effects, according to the summary of a small study that suggests the company has another foothold in the obesity market. The drug, called eloralintide, helped some patients lose more than 11% of their body weight in three months, according to an abstract posted Friday ahead of the American Diabetes Association conference in Chicago. The drug is moving to the next stage of development and researchers will present details on dosing and safety at the conference next week. "The data look particularly strong, and should push the program back into investor conversations," Cantor Fitzgerald analyst Prakhar Agrawal wrote in a note to investors. Lilly has shared few details about eloralintide before now, as it's still in the early stages of testing. It's part of a class of drugs that mimic the hormone amylin, which slows digestion and makes people feel full longer. They're thought to be a gentler option for losing weight than currently available injections like Zepbound and Wegovy, which often have side effects like nausea and vomiting. The study enrolled 100 patients who were given different doses of the experimental drug or a placebo for 12 weeks. Weight loss ranged from 2.6% to 11.3%, according to the abstract. Gastrointestinal side effects were relatively minimal, with about 10% of patients experiencing diarrhea and 8% vomiting. Few details were provided, however, including information on risks and benefits based on dose. The promise of drugs that are easier to take than blockbusters like Lilly's Zepbound and its rival Wegovy, from Novo Nordisk A/S, has drawn increasing interest from companies hoping for a piece of pharma's hottest market. In March, Roche Holding AG entered into a $5.3 billion deal to co-develop and commercialize Zealand Pharma A/S' amylin drug, called petrelintide. It is seen as the one to beat in the amylin class, with early trials showing patients lost as much as 8.6% of their body weight in four months, with less nausea than Lilly and Novo's current therapies. AbbVie Inc. agreed to pay as much as $2.2 billion in March for an amylin drug from Danish biotech Gubra A/S, marking its first foray into the obesity market. New York-based startup Metsera Inc. is developing a related compound that may be taken less frequently than weekly shots like Zepbound and Wegovy. Lilly is already a leader in the obesity market, where Zepbound is capturing the majority of new prescriptions. The company has several promising next-generation products in the late stages of development, including a pill called orforglipron and an experimental shot that's thought to be even more effective for weight loss. The company is studying eloralintide alone and in combination with Zepbound - similar to the approach Novo is taking with its next-generation drug CagriSema, which combines an amylin component with semaglutide, the backbone of Wegovy and the diabetes drug Ozempic. Copyright (C) 2025, Tribune Content Agency, LLC. Portions copyrighted by the respective providers.
Associated Press
an hour ago
- Associated Press
Notification of Data Security Incident
LAS VEGAS, June 13, 2025 /PRNewswire/ -- Effortless Office Enterprises, LLC ('Effortless Office') has learned of a data security incident that may have involved personal and/or protected health information of certain employees and patients of Nevada Heart and Vascular ('NHV'). Notice of this incident has been sent to certain affected current/former employees, patients, and/or associated parties and provided resources to assist them. Upon learning of suspicious activity temporarily within its computer network, Effortless Office promptly took steps to secure the environment and began an investigation to determine the nature and scope of the issue. In addition, they began working to restore impacted systems as quickly as possible and engaged digital forensics specialists to conduct an investigation. The investigation determined that unauthorized access occurred at certain times between May 9, 2024 and July 23, 2024. After determining that personal information may have been impacted, Effortless Office completed a comprehensive programmatic and manual review to identify what personal information was impacted and to whom it belonged. On May 12, 2025, Nevada Heart & Vascular Center, LLP learned that certain personal information was impacted in connection with the incident. The following information may have been affected as a result of the incident: Social Security number, taxpayer identification number, driver's license or state identification, passport number, date of birth, account number, routing number, security code, payment card number, payment card pin, payment card expiration date, health insurance information, medical information, and biometric data. On June 13, 2025, a notification letter was mailed to affected individuals, for whom address information was available. A toll-free call center has been established to answer questions about the incident and address related concerns. Call center representatives are available Monday through Friday from 9:00 am to 9:00 pm Eastern Time and can be reached at 1-855-200-7910. The privacy and protection of personal and protected health information is a top priority for Effortless Office, which deeply regrets any inconvenience or concern this incident may cause. View original content: SOURCE Effortless Office Enterprises, LLC
