Dive Brief The Food and Drug Administration has categorized an urgent medical device correction from Johnson & Johnson’s Megadyne as a Class I event. Megadyne contacted customers last month to restrict the use of four electrode products in children under the age of 12 years. The products are staying on the market with a narrower label. The J&J unit took the action after receiving reports of burn injuries that could be particularly harmful to children. Megadyne has received reports of 99 injuries and no deaths, according to the FDA’s Monday recall notice. Dive Insight The electrode pads help direct currents from certain instruments used during surgery through the patient’s body to prevent the risk of energy concentrating in one area and burning the patient, according to the FDA. Megadyne sent an urgent field safety notice about the burn risk in June, leading to a Class I notice from the FDA ...
Though GSK divested much of its oncology assets to Novartis in 2015, the company has built it back through a internal R&D and business development deals. GSK Senior Vice President, Global Head of Oncology, R&D Hesham Abdullah explained the company’s evolving cancer strategy in an interview during the J.P. Morgan Healthcare Conference in San Francisco. By FRANK VINLUAN GSK committed $270 million up front in recent months to gain access to early-stage assets in the class of cancer therapies known as antibody drug conjugates, or ADCs. The deals are part of a broad industry to acquire assets in this therapeutic modality, GSK’s top cancer executive Hesham Abdullah acknowledges. But for GSK, the deals are just one part of an evolving oncology strategy. The strategy has been years in the making. In 2015, GSK divested its oncology business, which Novartis acquired for $16 billion. Abdullah, who is GSK’s senior vice president, ...
Johnson & Johnson’s acquisition of antibody drug conjugate developer Ambrx Biopharma comes as Novartis and Merck also unveiled M&A deals on the first day of the J.P. Morgan Healthcare conference. In a report, the investment bank said big pharmas are looking for deals involving de-risked assets. By FRANK VINLUAN Big pharmaceutical companies splashed out big bucks in 2023 to acquire or license antibody drug conjugates, or ADCs. The trend is continuing into the new year with Johnson & Johnson reaching a $2 billion deal to acquire clinical-stage Ambrx Biopharma. According to deal terms announced Monday, J&J will pay $28 cash for each Ambrx share, which is a 105% premium to the biotech’s closing stock price on Friday. In other biopharma deal announcements, Merck is paying $680 million to acquire Harpoon Therapeutics, a developer of targeted cancer therapies, and Novartis is buying autoimmune disease drug developer Calypso Biotech for $250 ...
San Francisco—Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. On Monday, the Swiss pharma’s CEO Vas Narasimhan explained how he’s resisted the temptation. The answer is radioligand therapies, Narasimhan said Monday during the 2024 J.P. Morgan Healthcare Conference in response to a question from Fierce Pharma. “We have a long history within research of ADCs, but we have not been successful,” Narasimhan said. “To be clear, part of our focus strategy is looking at places where we think we can create long-term sustainable leadership. And we are investing in radioligand therapies.” ADCs and radioligand therapies are similar in that both technologies act as guided missiles. For ADCs, the guiding force is an antibody, and the cancer-killing payload is a chemotherapy. A radioligand therapy uses a ligand to target cancer cells and kills them with a therapeutic radioisotope. Radiotherapies may have a safety ...
The number of people getting tested over the last decade has increased by 133% The NHS has announced a new analysis showing its highest year on record for providing urgent cancer checks over the last year. Almost three million people in the UK received cancer checks between November 2022 and October 2023. In alignment with the health service’s goal of catching cancer earlier, the new analysis has shown a 133% increase in the number of people getting checked for cancer over the last decade. Between November 2022 and October 2023, over 2.9 million people were seen for urgent cancer checks, an increase of 147,960 people between 2021 and 2022. In October alone, the NHS saw the highest month on record for cancer checks, as well as 269,492 urgent referrals and 192,889 people who received an all-clear or definitive cancer diagnosis. In addition to this, the NHS has made major progress ...
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 ...
NFL players aim to boost awareness of Type 1 diabetes under a new charitable campaign. The “My Cause My Cleats” campaign will see NFL players wear custom-painted cleats during some football games to raise awareness and funds for charitable causes. In 2024, Type 1 diabetes has become a core theme, with Mark Andrews of the Baltimore Ravens, Orlando Brown Jr. of the Cincinnati Bengals, Blake Ferguson of the Miami Dolphins, Collin Johnson of the Chicago Bears, Chad Muma of the Jacksonville Jaguars, Nate Peterman of the Chicago Bears, and Kevin Radar of the Tennessee Titans, all lacing up for the cause. More than 1.4 million Americans are affected by Type 1 diabetes, an autoimmune disease that causes the pancreas to produce little or no insulin. The disease typically hits at a young age, and is separate from Type 2 diabetes, which typically affects adults and can be related to obesity. ...
Over the years, shareholders at the Interfaith Center on Corporate Responsibility (ICCR) have repeatedly voiced concerns on a variety of subjects to top pharma companies. Now, as 2023 comes to a close, the group is taking pharma giants to task over their patenting strategies and potential human rights shortfalls. In proposals to AbbVie, Eli Lilly, Gilead, Johnson & Johnson, Merck and Pfizer, the group is pushing the companies to review how add-on patents for medicines can affect patient access. Additionally, Bristol Myers Squibb, Pfizer and Eli Lilly face calls to review and update their human rights policies. While ICCR has voiced pharma-related complaints plenty of times in the past, its proposals haven’t been met with much enthusiasm by the companies’ larger pools of shareholders. In 2019, for instance, investors at several large pharma companies rejected the group’s proposals to study the potential link between CEO pay and drug prices. In ...
Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. And it is with cautious optimism that industry watchers see the trend continuing in 2024. Wielding plenty of firepower, drugmakers are more likely to make higher-value deals in the new year as they address growth challenges that loom later in the decade because of patent cliffs and the effects of the Inflation Reduction Act. “Executives will continue to deploy cash balances and seek out areas of innovation and clinical differentiation,” PricewaterhouseCoopers wrote in its Pharmaceutical and Life Sciences: U.S. Deals 2024 Outlook. “As regulators’ perspectives on key deal factors become better understood, there may be a return of larger deals, along with continued interest in the $5 billion to $15 billion deals to fill targeted strategic gaps.” Look no further ...
Dive Brief The Food and Drug Administration posted a draft guidance on Monday clarifying how it evaluates real-world data in its decisions to clear or approve medical devices. The draft is an update to a final guidance in 2017 and includes more detail on how the agency assesses the relevance and reliability of real-world data, study design elements and recommendations on documentation for FDA review. An omnibus spending bill passed at the end of 2022 required the FDA to issue a draft guidance on the use of real-world data in premarket submissions. Two years after the public health emergency ended, the law also requires the FDA to specify how many requests for clearance or approval it has received and how many of those applications were approved or denied when real-world evidence was submitted. Dive Insight The 21st Century Cures Act, signed into law in 2016, created a framework for the ...
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