Eli Lilly said its experimental gene therapy restored hearing in a boy born with profound hearing loss. The results for this experimental treatment come three months after Regeneron Pharmaceuticals reported early but encouraging data for its hearing loss gene therapy. By FRANK VINLUAN Gene therapy made its first breakthroughs slowing vision loss from inherited eye disorders. Eli Lilly is making the ear this therapeutic modality’s next proving ground, and the pharmaceutical giant now has some encouraging early clinical trial results showing it can work. An 11-year-old boy with profound hearing loss experienced restored hearing within 30 days of receiving the gene therapy, AK-OTOF, Lilly announced Tuesday. These are results for just one patient—the first in a clinical trial that could enroll up to 150 participants. But this early result is a promising sign for the therapy, which Lilly gained in 2022 through the $487 million acquisition of its developer, Akouos. ...
Xi’an Beilin Pharmaceutical Co., Ltd. (西安碑林药业股份有限公司, Xi’an Beilin), a subsidiary of Grand Pharmaceutical Group Limited (Grand Pharma, 0512.HK), recently entered into the second acquisition agreement with Chongqing Duoputai Pharmaceutical Co., Ltd. (重庆多普泰制药股份有限公司). Xi’an Beilin is to acquire 63% equity interest in Chongqing Duoputai Pharmaceutical Technology Co., Ltd. (重庆多普泰医药科技有限公司, Duoputai Pharmaceutical Technology) at a consideration of RMB442.26 million following the fulfillment of the relevant conditions. With the completion of the acquisition agreement, Xi’an Beilin will hold a 90% equity interest in Duoputai Pharmaceutical Technology, which will become a subsidiary of Grand Pharma to further consolidate the Group’s market position in the field of cerebro-cardiovascular disease treatment. https://www.grandpharm.com/en/news/grand-pharma-strategically-controls-duoputai-pharmaceutical-technology-strengthening-the-strategic-plan-in-field-of-cerebro-cardiovascular-disease-treatment
Bayer is launching a sweeping business overhaul as the German conglomerate sees “no viable alternative.” Bayer on Wednesday unveiled a restructuring of its organization that will “come at the expense of many managerial employees,” according to chairwoman of the executives committee on Bayer’s supervisory board, Barbara Gansewend. The job cuts will begin in the coming months and will end in 2025, the company said without providing a specific number for the jobs impacted. But the reductions will be “significant” at the group in Germany, the company said. Bayer declined to comment on the scale of the layoff or the functions involved. Reducing bureaucracy is the “central component” of the adjustments, a Bayer spokesperson told Fierce Pharma. The company’s new operating models are developed with customers at the center. “For this reason, there are no top-down targets and we will only gradually know what scale is really realistic here,” the spokesperson ...
Pfizer is still hungry for ADC opportunities, including in the Far East. Astellas’ impressive phase 3 data for its gastric cancer candidate couldn’t garner an approval because of manufacturing issues. Takeda’s 2022 TYK2 buy from Nimbus was highly competitive, an exec said. And more. 1. JPM24: Even after Seagen buyout, Pfizer oncology chief still eyes ADC deals As Pfizer continues its prowl for antibody-drug conjugate (ADCs) deals, the company is keeping an eye on opportunities around the globe. In an interview, Pfizer’s new oncology chief Chris Boshoff, Ph.D., said the company is looking for opportunities in China, which he said “is important in this whole area, especially ADC development.” The company is “not currently looking for big acquisitions,” Boshoff added. 2. Astellas’ gastric cancer candidate rejected by FDA because of manufacturing issues After running two phase 3 trials, Astellas’ near-term approval ambitions for its zolbetuximab have been dashed because of ...
Astellas Pharma’s zolbetuximab was on track to become the first gastric cancer drug that targets claudin 18.1, a protein found on cancerous stomach cells. Others with clinical-stage programs addressing this this target include AstraZeneca and Bristol Myers Squibb. By FRANK VINLUAN Astellas Pharma’s path to winning the first drug approval for a particular promising gastrointestinal cancer target has hit a detour. The FDA turned down the drugmaker’s application, citing manufacturing issues for the therapy, zolbetuximab. Astellas announced the FDA action earlier this week. The company did not go into detail about the problems spotted by the regulator, but described them as “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab.” Astellas added that the agency did not raise any concerns about the safety or efficacy of the drug, nor is it asking for additional clinical data. Zolbetuximab was developed as a treatment for patients with locally ...
Mike Hollan While the industry as a whole still faces challenges, there are positive trends appearing for pharmaceutical and medical device companies. Anyone hoping for good news for the financial state of the healthcare industry may have to wait until mid-2024. S&P Global released its annual healthcare industry outlook, providing a thorough analysis of the state of the industry. The last few years have been a rollercoaster for the industry, with it seeing unbelievable highs during the pandemic, only to watch most of that enthusiasm (and the money that came with it) fade in 2023. According to S&P Global’s report, its ratings outlook for the pharmaceutical and medical device subsectors is stable. However, it notes that the ratings outlook for the industry remains negative. This is due to lower end companies, which are typically sponsor-owned, struggling to maintain positive cash flow. There are a variety of factors that play into ...
3M Health Care’s Medical Solutions Division has received a $34.2m award to improve the treatment of traumatic wounds from point of injury to hospital. Provided by the US Army Medical Research Acquisition Activity, the funding will enable 3M to spearhead a programme that focuses on treatment strategies to be used in harsh settings, especially those related to delayed evacuation situations and mass casualties – the development of which is a Department of Defense Combat Casualty Care Capability Assessment objective. The programme’s scope includes developing solutions for infection prevention, wound management and healing. It will support the development of four product solutions, encompassing prototype creation, formulation development and the completion of two clinical studies for product registration. 3M’s collaboration involves partners such as the University of Minnesota Medical School, the 59th Medical Wing Science and Technology Office of the Chief Scientist, the Naval Medical Research Unit, San Antonio, and the University ...
Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. Morgan Healthcare Conference on Monday, the company’s CEO, Albert Bourla, spoke bluntly about the hits the company took, and he acknowledged the underperformance of certain key launches. But 2024 represents a fresh opportunity for the pharma giant, Bourla said. “In essence, you should expect 2024—after all the changes in the setup that we did in year ’23—to be a year of execution,” he told the JPM audience. Pfizer will attempt to execute, in part, by leveraging its recent $43 billion buyout of antibody-drug conjugate specialist Seagen, Bourla explained. Further, the company hopes to advance its presence in respiratory syncytial virus (RSV), where Pfizer recently launched its vaccine Abrysvo. Still, Bourla was frank about the challenges Pfizer faced in 2023. “The year for us, we missed our internal projections. And also we missed the expectations ...
The word has gained greater urgency in recent years as the consumer trend in healthcare has forced payers, providers and all other kinds of healthcare stakeholders to swear by it. By ARUNDHATI PARMAR In a space of five minutes in the roughly 12:30-minute presentation on CVS Health at the 42nd annual J.P. Morgan Healthcare conference in San Francisco on Monday, Karen Lynch said a version of the word “transparency” six times. No surprises for guessing they were all largely in the context of pharmacy benefit management and pharmacy reimbursement models. “… we introduced CVS Caremark TrueCost, which is a new PBM model that will be available to our customers and our clients that strives for greater transparency for our consumers and offers a simplified pricing model,” Lynch said, underscoring what concrete steps the company is taking amidst withering scrutiny of PBMs. CVS Caremark expects to launch the TrueCost model for ...
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, ...
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