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The standing ovation for Keytruda and Padcev in metastatic bladder cancer at the 2023 European Society for Medical Oncology (ESMO) Congress still echoes, and, now, the pair from Merck & Co., Pfizer and Astellas has pulled off similarly showstopping results in certain patients with muscle-invasive bladder cancer (MIBC). The combination of Merck’s Keytruda and Pfizer and Astellas’ Padcev reduced patients' risk of death by a whopping 50% when used before and after bladder removal surgery in those with MIBC who are not eligible for or declined cisplatin-based chemotherapy compared with surgery alone, according to results to be presented at the 2025 ESMO Congress. The PD-1/antibody-drug conjugate combo also significantly improved event-free survival (EFS) by 60% versus surgery alone. A negative event includes progression of disease that precludes surgery or failure to undergo surgery, gross residual disease left behind during surgery, cancer recurrence or death.

AstraZeneca and Daiichi Sankyo’s star drug Enhertu has delivered a double knockout, showing its ability to stave off early breast cancer in two pivotal clinical trials. First, in another major head-to-head win against Roche’s rival antibody-drug conjugate Kadcyla, Enhertu significantly pared down the risk of invasive disease recurrence or death by 53% when used as an adjuvant therapy after surgery in HER2-positive early breast cancer. The patients had residual invasive disease following neoadjuvant treatment and are considered at high risk of recurrence. At the time of the analysis, 12.5% of patients who got Kadcyla have developed invasive disease or died, versus 6.2% among Enhertu takers. The data, from the Destiny-Breast05 study, will be presented during a presidential symposium at the 2025 European Society for Medical Oncology Congress.

Novo Nordisk (NOVOb.CO), opens new tab has appointed U.S. pharmaceutical executive Greg Miley as its new head of corporate affairs, as the obesity drugmaker faces growing pressure from U.S. President Donald Trump on drug pricing. Miley recently served as senior vice president of government affairs at U.S. pharmaceutical giant AbbVie (ABBV.N), opens new tab. He posted a statement on LinkedIn on Friday and Novo Nordisk shared the statement with Reuters. Novo is turning to an American executive with deep U.S. pharmaceutical experience to help navigate political risks under the Trump administration in the United States, its largest market. NEW HIRE TO FOCUS ON RELATIONS WITH TRUMP ADMINISTRATION The appointment comes as new CEO Mike Doustdar tries to revive investor confidence through a restructuring to sharpen Novo's focus in a fierce obesity drug battle against U.S. rival Eli Lilly (LLY.N), opens new tab. The overhaul includes cutting 9,000 jobs, with 5,000 positions being eliminated in Denmark and layoffs underway across multiple U.S. departments. "In this new role, I see great potential to strengthen our Global Communication and Public Affairs efforts," Miley wrote on LinkedIn, adding that he would begin his new role next month and would relocate to Denmark, Novo's home market. Miley's urgent priority will...

Shares of weight-loss drug makers Novo Nordisk and Eli Lilly fell on Friday after U.S. President Donald Trump said that the price of Novo's popular Ozempic treatment would be lowered. Although Ozempic is approved to treat diabetes, it shares the same active ingredient - semaglutide - as the Danish drugmaker's blockbuster obesity treatment Wegovy. In the United States, Ozempic has been frequently used as a so-called off-label treatment for obesity and often served as a generic reference to weight-loss drugs. Since taking office in January, Trump has been striving to narrow the gap between U.S. and foreign drug prices. Under its "most favored nation" policy, the U.S. government will require drugmakers to charge patients in the U.S. no more than in other wealthy nations. INVESTORS BRACED FOR PRICE CUTS Novo's shares fell to a near three-week low of 342.3 crowns and were last down 6% at 344.7 crowns. Shares in rivals dropped as well, with Eli Lilly down 4% and Zealand Pharma down 5%. In U.S. pre-market trading, Viking Therapeutics was down nearly 6%, and Altimmune down 1%. BMO Capital markets analyst Evan Seigerman said that the market reaction to Trump's comments seemed exaggerated. Trump's made the comments during a White House event on Thursday,...

Medical device maker Boston Scientific said on Friday it will buy the remaining equity in privately held Nalu Medical for about $533 million in cash, expanding its portfolio of treatments for chronic pain. Boston Scientific has been a strategic investor in Carlsbad, California-based Nalu Medical since 2017, supporting its development of neurostimulation technologies for chronic pain. The deal gives Boston Scientific access to Nalu's neurostimulation device, designed to deliver targeted relief to adults living with chronic pain in areas such as the shoulder, lower back and knee, through peripheral nerve stimulation (PNS). PNS is used primarily to treat chronic pain that has not responded well to other treatments, like medication or physical therapy. The therapy uses mild electrical impulses to interrupt pain signals before they reach the brain and features a miniaturized, battery-free implantable pulse generator, powered wirelessly by a small, externally worn therapy disc and controlled via a smartphone app. Nalu's device received the U.S. Food and Drug Administration's clearance in 2019. In a late-stage trial, 79% of the patients using the system reached an average pain relief of 64% at six months. Nalu's "Medical technology complements our existing therapies — including spinal cord stimulation, basivertebral nerve ablation and radiofrequency ablation — enabling us...

Roche (ROG.S), opens new tab on Thursday launched direct-to-consumer U.S. sales of its influenza antiviral pill Xofluza at a discounted cash price of $50, following similar moves by rivals as they scramble to address pressure from the Trump administration to lower prescription drug prices paid by Americans. The Xofluza cash price, offered by Roche's U.S. biotech unit Genentech at 70% below list price, will be available to insured and uninsured patients from Alto Pharmacy and Mark Cuban Cost Plus Drug Company. Same-day delivery will be available via Alto Pharmacy. Major U.S. pharmacy chains like CVS (CVS.N), opens new tab will not be involved, Roche confirmed. The administration of U.S. President Donald Trump has said it plans to launch, likely early next year, a website called TrumpRx that aims to help consumers buy some medicines directly from the manufacturers. Roche said its new program will not be accessible through TrumpRx, but that it will continue to evaluate its options. Few people in the U.S. pay cash for prescription medications. Most have insurance - either commercial or federal plans like Medicare - that charge them a fixed co-pay or percentage of a drug cost. Insurers typically receive confidential discounts or rebates directly from drug...

Chinese biotech Hansoh Pharma said on Friday it had signed a licence agreement worth up to $1.45 billion with Roche for an investigational treatment of colorectal cancer and other solid tumours. Hansoh Pharma units Shanghai Hansoh Biomedical and Changzhou Hansoh Pharmaceutical will grant Roche subsidiary F. Hoffmann-La Roche an exclusive worldwide licence to develop, manufacture and commercialise the product. The licence excludes rights in the Chinese Mainland, Hong Kong, Macau and Taiwan. The licensors will receive an upfront payment of $80 million and be eligible to receive up to $1.45 billion in milestone payments associated with the development, regulatory approval and commercialisation of the product, among others.

Danish drugmaker Novo Nordisk and Omeros have signed a licensing deal worth up to $2.1 billion for the U.S.-based company’s experimental drug, which is being developed for rare blood and kidney disorders, they said on Wednesday. Omeros shares more than doubled to $9.90 in morning trading. As part of the agreement, Novo gains exclusive global rights to develop and commercialize Omeros’ drug zaltenibart, designed to inhibit MASP-3 — a protein that acts as a key activator of the alternative pathway of complement. The complement pathway is a system of proteins in the blood that enhances the immune system’s ability to fight infections. Omeros is eligible to receive up to a total of $2.1 billion, including $340 million upfront and near-term milestone payments. The company had said in March it began enrollment for late-stage trials studying the drug for paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder in which part of the immune system attacks and damages the red blood cells and platelets. Zaltenibart has shown several potential advantages over other alternative pathway inhibitors currently in development or on the market, the companies said. The drug was safe and well tolerated in the trials. After the deal closes, expected in the fourth quarter of 2025, Novo aims to...

U.S. biotech firm Nabla Bio said on Tuesday it has signed a second major research partnership with Japanese drugmaker Takeda Pharmaceutical, deepening their use of artificial intelligence to accelerate drug discovery. Under the new multi-year agreement, which builds on an earlier collaboration launched in 2022, Nabla will receive upfront and research cost payments in double-digit millions. The company is also eligible for success-based payments worth more than $1 billion. The move underscores growing momentum across the pharmaceutical industry to harness AI in drug development, with hopes of significantly reducing timelines and costs in the coming years. Nabla said it would use its proprietary AI platform, Joint Atomic Model (JAM), to design protein-based therapeutics for Takeda's early-stage pipeline. The companies will focus on hard-to-treat diseases and include multi-specific drugs and other custom biologics. Comparing to how ChatGPT answers text questions, Nabla CEO Surge Biswas said JAM responds to molecular queries by designing antibodies from scratch that bind targets with desired properties. The company claims to maintain "probably the fastest feedback loop in the industry", with a turnaround of three to four weeks from design to lab testing. "We are basically working on whatever the most pressing problems in Takeda's discovery portfolio is at any given time,...

Johnson & Johnson on Tuesday raised its 2025 sales forecast after reporting quarterly earnings that topped Wall Street expectations, and announced plans to spin off its orthopedics business into a standalone company. The healthcare conglomerate now expects product revenue of $93.5 billion to $93.9 billion, about $300 million higher than its prior forecast and above analysts' expectations of $93.4 billion, according to LSEG data. Alongside the upbeat forecast, J&J said it plans to separate its orthopedics business into a standalone company named DePuy Synthes within the next 18 to 24 months, marking its second major spinoff since 2023. J&J's orthopedics unit, which makes hip, knee, and shoulder implants, surgical instruments, and other products, generated around $9.2 billion last year, or about 10% of total revenue. J&J in 2023 announced a two-year restructuring program for its orthopedics business, saying it planned to exit certain markets and stop selling some products, after having recently spun off its $15 billion consumer unit into Kenvue. The company said it planned to focus on high-growth, high-margin areas as part of its separation plans, such as oncology, immunology, neuroscience, surgery, vision care, and cardiovascular. J&J Chief Financial Officer Joe Wolk said the company was exploring multiple paths for the separation, with...