Roche Pauses Shipments of Contested Gene Therapy Outside the US
The Swiss drugmaker said the pause effective today applies to new orders of Elevidys in countries outside the U.S. that base their approvals off Food and Drug Administration decisions. It covers all patients with Duchenne muscular dystrophy regardless of their ability to walk. It's voluntary and temporary, the company said in an emailed statement.
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CNN
an hour ago
- CNN
5 things to know for July 25: Thailand-Cambodia, France, AI, Sanctuary city lawsuit, Skydance-Paramount merger
In addition to telling time, smartwatches can track your steps, heart rate, blood pressure and sleeping patterns. Now, a smartwatch has helped search and rescue teams locate a small plane after it crashed into the dense forests near West Yellowstone, Montana. Here's what else you need to know to get up to speed and on with your day. More than 100,000 civilians have been displaced following a second day of violence along the disputed 500-mile land border between Thailand and Cambodia. At least 16 people were also reportedly killed, officials from both countries said. Tensions between the Southeast Asian neighbors have been boiling for months. Around 4:30 a.m. local time on Friday, clashes broke out with Cambodian troops using small arms and heavy weapons and Thai troops responding with artillery fire. On Thursday, when Thailand deployed fighter jets to attack Cambodian military targets, Cambodia vowed to 'respond decisively.' French President Emmanuel Macron said on Thursday that France will recognize a Palestinian state in an announcement at the UN General Assembly in September. France will be the first member of the UN Security Council and the G7 nations to do so. 'We must build the state of Palestine, ensure its viability, and ensure that by accepting its demilitarization and fully recognizing Israel, it contributes to the security of all in the Middle East. There is no alternative,' he wrote on X. Macron also called for an immediate ceasefire, access to humanitarian aid for the population of Gaza, the release of all hostages and the demilitarization of Hamas. Secretary of State Marco Rubio said the US 'strongly rejects' Macron's plan. The Department of Health and Human Services (HHS) has started using artificial intelligence, and behind the scenes, the practice has caused some alarm. An AI project known as Elsa is supposed to help speed up drug and medical device approvals at the FDA, a division of HHS. Six current and former FDA officials told CNN that Elsa can be useful for generating meeting notes and summaries, or email and communique templates, but it also invented studies and misrepresented research. In at least one instance — when an employee asked Elsa to generate something for a project — it insisted that the research area was not in the FDA's purview, even though it was. Elsa also cannot help with the lengthy assessment process that agency scientists undertake to determine whether drugs and devices are safe and effective because it can't access many of the files needed to answer basic questions. The Justice Department has filed a lawsuit against New York City over its so-called 'sanctuary city' policies. The move comes just days after the Trump administration blamed those policies for the shooting of an off-duty US Customs and Border Protection officer in an apparent robbery gone wrong. As part of the administration's widespread crackdown on undocumented immigrants, similar lawsuits have also been filed against Colorado, Illinois, Los Angeles, New York state, the city of Rochester, New York, and several New Jersey cities, the DOJ said in a statement. NYC Mayor Eric Adams said the city will review the lawsuit. 'Keeping New Yorkers safe also means making sure they feel safe, and we have been clear: no one should be afraid to dial 911, send their kids to school or go to the hospital, and no New Yorker should feel forced to hide in the shadows,' Adams said in a statement. The FCC approved the pending merger between Skydance Media and Paramount Global on Thursday. Voting 2-1 along party lines, the commissioners gave the go-ahead to the $8 billion deal, which has been mired in allegations of political interference stemming from President Trump's scathing criticism and his lawsuit against Paramount's CBS News division. But on July 1, Paramount agreed to pay $16 million toward Trump's future presidential library to resolve his legally dubious suit about an edit made to a '60 Minutes' interview with then-Vice President Kamala Harris before the November presidential election. Although Paramount and the FCC both insisted that the payout was unrelated to the merger review process, many likened it to a 'bribe.' GET '5 THINGS' IN YOUR INBOX If your day doesn't start until you're up to speed on the latest headlines, then let us introduce you to your new favorite morning fix. Sign up here for the '5 Things' newsletter. Amy Sherald, who gained national fame for her official portrait of former first lady Michelle Obama in 2018, was told that the museum had 'concerns' about one of her paintings. The head of human resources at the New York-based tech company and her boss were seen embracing on the 'kiss cam' during a Coldplay concert. Video of the encounter quickly went viral. The 12-year-old baseball player faced suspension for what he did last week after hitting a game-winning home run. High cocoa costs are prompting a major confectionery company to hike prices for chocolate candy. 'What have you done?' Victoria Beckham, the soccer star's wife, asked when she saw it. Legendary jazz musician Chuck Mangione diesThe noted flugelhorn player, trumpeter and composer became known for his signature tune 'Feels So Good,' which spent 25 weeks on the Billboard Hot 100 chart, peaking at #4 in 1978. Throughout his six-decade career in music, Mangione received 14 Grammy nominations and won the award twice. He also made recurring appearances on the Fox animated series 'King of the Hill,' where he played a tongue-in-cheek version of himself. Which city may soon become the first modern capital in the world to run completely out of water?A. Kabul, AfghanistanB. Mexico City, MexicoC. Baghdad, IraqD. Sanaa, Yemen Take me to the quiz! $250That's how much the US plans to charge international visitors for a new 'visa integrity fee.' The provision was included in President Trump's recently enacted domestic policy bill. 'Crazy!! My House got Home Invaded Saturday While I was in Indianapolis performing for the WNBA all star game & instead of Focusing on finding the Suspects, they focus on some cannabis.' — GloRilla on X. The Grammy-nominated rapper is facing felony drug charges after police responded to her Georgia home following a separate report of a burglary in progress. 🌤️ Check your local forecast to see what you can expect. This Swiss river is so clean that locals use it to commute to their jobs. Today's edition of 5 Things AM was edited and produced by CNN's Andrew Torgan.
Bloomberg
an hour ago
- Bloomberg
Sarepta-Roche Gene Therapy Fails to Get EU Regulator Approval
Roche Holding AG's gene therapy Elevidys failed to get the backing of European regulators. The European Medicines Agency's drug advisory committee recommended against Elevidys for children with Duchenne muscular dystrophy, the agency said Friday. The medicine had been intended for children aged 3 to 7 years who are able to walk.
Yahoo
an hour ago
- Yahoo
ImmunityBio, Inc. Announces Execution of $80 Million Equity Financing from Multiple Institutional Investors
CULVER CITY, Calif., July 25, 2025--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that it has executed financing to provide further working capital and support its ongoing business operations. The Company entered into a securities purchase agreement for a registered direct offering with two institutional investors, providing for the issuance of common stock of ImmunityBio as well as warrants for the purchase of additional shares of common stock of ImmunityBio that is expected to result in gross proceeds at closing of approximately $80 million before deducting placement agent fees and other offering-related expenses, subject to customary closing conditions. If fully exercised, the warrants could result in additional gross proceeds of up to approximately $96 million. Piper Sandler & Co. is acting as the exclusive placement agent for the registered direct offering. The securities to be sold by the Company are offered under its automatic shelf registration statement on Form S-3 (Registration No. 333-278770). A final prospectus supplement, which contains additional information relating to the offering, will be filed with the SEC and will be available on the SEC's website at Electronic copies of the prospectus supplement may be obtained for free by contacting Piper Sandler & Co., 350 North 5th Street, Suite 1300, Minneapolis, MN 55402, Attention: Prospectus Department, or by telephone at (800) 747-3924, or by email at prospectus@ Before investing in this offering, interested parties should read the prospectus supplement, the accompanying prospectus and the other documents that are incorporated by reference in such prospectus supplement and the accompanying prospectus in their entirety. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About ImmunityBio, Inc. ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit (Founder's Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding the timing and size of the proposed offering, the potential exercise of the warrants being offered and resulting additional proceeds to the Company, the anticipated closing of the equity financing described herein and use of proceeds to be received from such financing, the application of the Company's science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that reduce or eliminate the need for standard high-dose chemotherapy. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as "anticipates," "believes," "continues," "goal," "could," "estimates," "scheduled," "expects," "intends," "may," "plans," "potential," "predicts," "indicate," "projects," "seeks," "should," "will," "strategy," and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio's management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio's statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) whether the equity financing transaction described herein will close on the timeline anticipated, if at all, (ii) those related to the regulatory submission, filing and review process and the timing thereof, (iii) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (iv) whether clinical trials will result in registrational pathways, (v) whether clinical trial data will be accepted by regulatory agencies, (vi) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (vii) potential delays in product availability, regulatory approvals, and reimbursement decisions, (viii) ImmunityBio's ability to retain and hire key personnel, (ix) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (x) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xi) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xii) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiii) ImmunityBio's ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio's business are described under the heading "Risk Factors" in the Company's Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and the Company's Form 10-Q filed with the SEC on May 12, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. View source version on Contacts Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 Media Sarah Singleton ImmunityBio +1 Sign in to access your portfolio
