Fresenius SE & Co. KGaA

Fresenius Kabi is yanking a batch of another product in the U.S., shortly after initiating a separate recall tied to mislabeled pain medicine. Fresenius has issued a recall of its biosimilar Tyenne (tocilizumab-aazg) injection in 20 ml vials, after a company investigation found the product contained glass particles. It likely goes without saying that injecting medication contaminated with glass particulates can have unintended consequences. Doing so could cause irritation, pain or swelling at the infusion site, as well as potential inflammation of the veins, Fresenius said in a recall notice posted on the FDA’s website. In more serious cases, injected glass particles can cause blockage and clotting of blood vessels, stopping blood flow to organs and potentially leading to life-threatening clots in the lungs. At its worst, an adverse event from such a product could lead to permanent organ damage or death, the company warned. As of Aug. 12, Fresenius Kabi had not received any adverse event reports tied to the recall, a company spokesperson confirmed to Fierce. Tyenne is a biosimilar referencing Roche’s IL-6 receptor antagonist Actemra. It is used to treat certain adults with severely active rheumatoid arthritis, and those with giant cell arteritis. Fresenius’ drug is also cleared in pediatric populations for active polyarticular juvenile idiopathic arthritis and active systemic juvenile idiopathic arthritis, and in adults and kids with CAR T cell-induced severe or life-threatening cytokine release syndrome. Fresenius’ recall covers a single lot of Tyenne, which was distributed across the U.S. and carried an expiration date of August 2028. Glass particles shedding or otherwise turning up in vials of the drug have prompted multiple other product pulls in recent years. As recently as May, generics powerhouse Sun Pharma yanked one lot of a chemotherapy in the U.S. after the discovery of glass particles in some vials of the product—used to treat ovarian cancer, Kaposi sarcoma and multiple myeloma—during production. In 2024, Gilead Sciences recalled one batch of its COVID-19 med, Veklury, after detecting a glass particle in a vial, which was flagged by a customer complaint. And the issue also led to similar product pulls for GSK and Pfizer the year before that, to name just a few examples. As for Fresenius, the German-headquartered drugmaker publicized a separate U.S. recall last week focused not on particulate contamination, but labeling gone wrong. In that notice, Fresenius Kabi said it was pulling one lot of morphine sulfate injection that was mislabeled and could contain a prefilled syringe of the more potent opioid dilaudid. Editor's note: This story has been updated with a comment from a Fresenius Kabi spokesperson.

BD's third quarter earnings weren't just about beating expectations. They were about proving that the company's decision to spin off its entire Biosciences and Diagnostic Solutions business and merge it with Waters Corporation was a worthwhile strategic reset. The results suggest the bet is paying off, at least in the early innings. Revenue hit $5 billion, up 5.4% on a reported basis and 4.4% on a currency-neutral basis. Adjusted diluted earnings per share came in at $3.23, up 4.9% year-over-year and ahead of Wall Street's expectations. Cash generation surged, with year-to-date operating cash flow from continuing operations jumping 33.3% to $2.1 billion, while free cash flow increased 44.6% to $1.7 billion. "Our first full quarter as New BD demonstrates the early benefits of a more focused MedTech company," CEO Tom Polen said in a release, framing the results as validation of the company's transformation strategy. What "New BD" actually means The February 2026 spin-off of BD's Biosciences and Diagnostic Solutions business was one of the largest divestitures in recent MedTech history. The company shed its entire Life Sciences segment to focus exclusively on four core segments, including medical essentials, connected care, biopharma systems, and interventional. It was a dramatic reversal for a company that had spent years building a diversified healthcare portfolio. But BD's leadership concluded that the diagnostics and life sciences businesses operated under fundamentally different models than the company's medical device and drug delivery platforms, and that the market wasn't giving BD credit for the diagnostics unit's performance. It's the same logic Solventum used when it announced plans to spin off its Health Information Systems business less than two years after separating from 3M. The conglomerate discount is real, and MedTech companies are increasingly willing to break themselves apart to escape it. For BD, the separation meant walking away from roughly $3 billion in annual revenue. But it also meant shedding complexity, reducing capital intensity, and refocusing on businesses where BD has clearer competitive advantages and higher margins. The Q3 results suggest the strategy is working. Adjusted operating margin expanded, cash generation accelerated, and all four remaining segments posted solid growth. Segment performance: Growth across the board Medical Essentials, BD's largest segment, delivered $1.68 billion in revenue, up 4.5% on a reported basis and 3.2% on a currency-neutral basis. The segment includes medication management systems, infection prevention products, and vascular access devices. The standout product in the quarter was the BD CentroVena One Insertion System, which received a Vizient Innovative Technology contract. Connected Care posted $1.22 billion in revenue, up 4.9% reported and 4.4% currency-neutral. This segment includes infusion systems, medication management software, and smart pump technology. BioPharma Systems, which makes prefillable syringes, pen injectors, and self-injection devices for pharmaceutical companies, grew 6.6% on a reported basis and 5.2% currency-neutral, reaching $670 million. The segment continues to benefit from the GLP-1 boom. BD announced a collaboration with EMS, one of Brazil's leading pharmaceutical companies, to launch a semaglutide product using BD's Vystra Injection Pen platform. Interventional, which includes urology, surgery, and vascular products, delivered $1.41 billion in revenue, up 6.4% reported and 5.5% currency-neutral. The segment launched the Elyra Thulium Fiber Laser System for kidney stone treatment, expanding BD's urology portfolio and signaling the company's intent to move beyond commodity surgical products into higher-margin capital equipment. The cash flow story The most impressive number in BD's Q3 report wasn't revenue or earnings, but cash flow. Year-to-date operating cash flow from continuing operations increased 33.3% to $2.1 billion. Free cash flow, which subtracts capital expenditures, jumped 44.6% to $1.7 billion. That's a dramatic improvement, and it reflects two things: first, the separation of the diagnostics business removed a capital-intensive operation that required significant investment in manufacturing and R&D. Second, BD's operational efficiency initiatives—branded as "BD Excellence"—are starting to show up in the numbers. Strong cash generation gives BD flexibility. The company can pay down debt, fund acquisitions, invest in R&D, or return cash to shareholders through buybacks and dividends. Guidance raised, modestly BD raised its full-year fiscal 2026 guidance, but the increase was modest. The company now expects revenue growth "toward the high end" of its low single-digit range and raised the midpoint of its adjusted diluted EPS guidance to $12.67, up from $12.62. That's not a dramatic raise, but it reflects confidence that the momentum from Q3 will continue through the rest of the year. BD is benefiting from strong demand across its key growth platforms, continued margin expansion through operational efficiency, and favorable currency tailwinds. The company didn't provide specific guidance for fiscal 2027, but Polen's comments suggest BD expects to sustain mid-single-digit revenue growth and continue expanding margins as the benefits of the separation and BD Excellence initiatives compound over time. The competitive landscape BD operates in a very competitive environment. In vascular access, it competes with Teleflex and ICU Medical. In infusion systems, it faces Baxter and B. Braun. In BioPharma Systems, it's up against West Pharmaceutical Services, Gerresheimer, and Schott. In urology and surgery, it competes with Boston Scientific, Medtronic, and a host of smaller players. The advantage BD has is scale and breadth. The company delivers billions of products annually across multiple categories, giving it leverage with hospital systems and pharmaceutical companies that want to consolidate their supplier base. BD's installed base of infusion pumps, medication management systems, and vascular access devices creates switching costs and recurring revenue streams that are difficult for competitors to disrupt. BD needs to prove it can innovate at the same pace as more nimble competitors. The CentroVena One system and the Elyra laser are steps in the right direction, but BD will need a steady pipeline of differentiated products to sustain growth in mature markets. What happens next BD's Q3 results were strong, but the real test will be whether the company can sustain this momentum over the next 12 to 18 months. The separation from the diagnostics business is still fresh, and BD is still working through transition service agreements, technology separation, and the establishment of fully standalone corporate functions. The company also faces macroeconomic headwinds. Hospital capital budgets remain constrained, reimbursement pressures continue to squeeze healthcare providers, and currency volatility is creating unpredictability in international markets. But BD's leadership is betting that a more focused portfolio, stronger cash generation, and disciplined capital allocation will drive sustainable growth and higher valuations. The market seems to agree, with BD's stock outperforming the broader MedTech sector since the separation was announced. BD stock was up 3.84% at $177.06 per share on Thursday following the release of Q3 results. For now, "New BD" is off to a solid start. Whether it can maintain this trajectory will depend on execution, innovation, and the company's ability to prove that smaller really is better.

CALGARY, Alberta, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Marvel Biosciences Corp. (TSXV: MRVL | OTC: MBCOF ), and its wholly-owned subsidiary, Marvel Biotechnology Inc. (collectively the “Company” or “Marvel”), a drug discovery company developing novel therapeutics for autism spectrum disorder and related conditions, is pleased to announce positive results from its preclinical Fragile X study conducted through the FRAXA Drug Validation Initiative in collaboration with the FRAXA Research Foundation. This announcement represents another significant milestone in the continued de-risking of Marvel Biosciences' lead drug candidate, MB-204. By demonstrating statistically significant improvements in both behavioural and cognitive function in a Fragile X mouse model , including durable carry-over effects after treatment ceased, MB-204 has now generated compelling efficacy data across three independent preclinical models of autism spectrum disorder (ASD) , including Rett syndrome (Mecp2), the Oprm1 model of ASD, and now Fragile X syndrome (Fmr1). Collectively, these results further strengthen the scientific foundation supporting MB-204's advancement toward clinical trials while expanding its potential commercial opportunity across multiple orphan neurological indications with significant unmet medical need. Fragile X syndrome (FXS) is the most common inherited cause of intellectual disability and one of the most common single-gene causes of autism spectrum disorder. It is caused by mutations in the FMR1 gene on the X chromosome. As males have only one X chromosome, they are typically more severely affected than females. Current epidemiological studies estimate that FXS occurs in approximately 1 in 7,000 males and 1 in 11,000 females in the general population and as such it qualifies as an orphan disease in both the United States and Europe. The study was conducted through the FRAXA Drug Validation Initiative (FRAXA-DVI), an independent program that evaluates promising therapeutic candidates for Fragile X syndrome. The study evaluated MB-204, Marvel’s lead compound, in low- and high-dose treatment groups administered orally once daily in FMR1 knockout (KO) mice. FMR1 mice were treated for approximately two weeks and subjected to a standard battery of model-specific behavioural and cognitive tests, then retested two weeks after treatment ceased to study the carry-over effect of the drug. Overall, MB-204 restored every behavioural and cognitive endpoint studied in Fragile X mice toward wild-type (normal) levels , including improvements in novel object recognition (cognition), open-field test (locomotor activity), self-grooming (stereotypy), nesting (hippocampal dependent activity of daily living), hyphoneophagia (anxiety). Key highlights included: ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); After Two Weeks On Treatment: MB-204 produced clear dose-dependent behavioural effects in the Fmr1 knockout mouse on every endpoint, with the high-dose group showing the strongest and most consistent efficacy. Animals receiving the high-dose treatment generated response patterns statistically consistent with wildtype-like performance (WT) in open-field test activity, self-grooming, nesting and hyponeophagia (p<0.0001 vs KO vehicle), although nesting remained different from WT. The low-dose group produced significant but non-WT-like effects in open field, self-grooming and hyponeophagia (p<0.0001, p<0.017 and p<0.0001 vs KO vehicle, respectively) but had no detectable effect on nesting. Both treatment groups restored novel-object discrimination (p<0.0001 for both doses), demonstrating significant improvement in recognition memory, a key measure of cognitive function. After Two Weeks Off Treatment (Carry-Over Effect): The high-dose treatment group retained significant effects relative to KO vehicle in open field (p=0.003) and self-grooming (p=0.0015), although these responses were attenuated and no longer WT-like. The high-dose group also retained significant novel-object discrimination when tested with a completely different object set (p=0.0052), supporting a persistent recognition-memory effect rather than simple memory for the original objects. Overall, results support robust on-treatment efficacy and a measurable, though reduced, post-washout effect in the high-dose treatment group, while the low-dose treatment was insufficient to produce a durable post-treatment benefit. “This is now the third ASD model and second independent group that has demonstrated the potential of MB-204 to restore behavioural and cognitive function to near normal levels in mice regardless of the genetic cause of the neurodevelopmental disorder” commented Dr. Mark Williams, CSO of Marvel Biosciences . “We also confirmed a carry-over effect in a second model, suggesting MB-204 has a very attractive target product profile. We are very grateful to FRAXA for this collaboration and look forward to advancing MB-204 to the clinic”. This latest preclinical success in Fragile X syndrome marks the third autism-related model in which MB-204 has demonstrated the ability to restore behavioural and cognitive function toward normal levels, providing further validation of the drug's mechanism of action and strengthening the Company’s core investment thesis. Combined with previously reported positive results in the Rett syndrome (Mecp2) and Oprm1 ASD models, these findings continue to build a compelling preclinical package supporting the advancement of MB-204 toward clinical trials. The Company has also completed preclinical evaluation of MB-204 in a Shank3 model of Phelan-McDermitt syndrome and is awaiting final statistical analysis of the results. Marvel expects to report those results in a future announcement. About Marvel Biosciences Corp. Marvel Biosciences Corp. through its wholly-owned subsidiary Marvel Biotechnology Inc., is a Calgary-based biotechnology company developing new treatments for neurological diseases and neurodevelopmental disorders. Our lead drug candidate, MB-204, is a novel fluorinated derivative version of Istradefylline, an approved Parkinson’s drug and the only adenosine A2A receptor blocker currently on the market. Research shows that blocking the A2A receptor may help treat conditions such as autism, depression, and Alzheimer’s disease. Marvel is also exploring MB-204’s potential in rare disorders like Rett syndrome and Fragile X syndrome, aiming to bring new options to patients with few effective treatments. Contact Information: Marvel Biosciences Corp. J. Roderick (Rod) Matheson, Chief Executive Officer Email: rod@marvelbiosciences.com Dr. Mark Williams, President and Chief Science Officer Email: mark@marvelbiosciences.com Tel: 403 770 2469 Website: | Twitter/X | LinkedIn Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release. All information contained in this news release with respect to the Company and its subsidiary,(collectively, the "Parties") were supplied by Marvel, respectively, for inclusion herein and each parties' directors and officers have relied on each other for any information concerning such Party. This news release may contain forward-looking statements and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of the Company are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the expectations of the Company and include other risks detailed from time to time in the filings made by the Company under securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. As a result, the Company cannot guarantee that the above events on the terms will occur and within the time disclosed herein or at all. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by Canadian securities law.