Alkermes, Inc.

Most life sciences manufacturers that run into trouble during an inspection already have the programs that pharmaceutical EHS compliance calls for. There is a hazard communication plan, a waste contingency plan and a corrective action procedure. The finding tends to land somewhere else: in the step where a record should have changed and didn't, because the work passed from one team to another and nobody owned the handoff. An EHS gap in pharmaceuticals is the distance between what a site's procedures require and what its records can show on the day someone asks. The four gaps below turn up again and again in OSHA citation data, EPA settlements and FDA observations, and each one starts as an ordinary workflow problem. 1. Safety data sheets for in-house APIs and intermediates Hazard Communication was the second most cited OSHA standard in fiscal year 2026, with 1,961 violations recorded between October 1, 2025 and August 31, 2026, according to preliminary figures released with the National Safety Council in September 2026. Most of those citations go to ordinary employers with missing labels or thin training records. Drug manufacturers carry an extra duty on top of that. Under 29 CFR 1910.1200(g)(1), a chemical manufacturer has to author a safety data sheet (SDS) for each hazardous chemical it produces, which is usually done by SDS creation software . This EHS gap in pharmaceutical manufacturing comes from a split in ownership between the data and the document. Toxicology and occupational exposure band data for a new compound sit with development, while the SDS sits with EHS or regulatory affairs. When a new study changes the hazard picture, the SDS often stays as it was, even though the standard gives the preparer three months to add significant new hazard information once they become aware of it. OSHA's 2024 update to the standard, with the four-month extension announced in January 2026, set these compliance dates: Who must comply Substances Mixtures Manufacturers, importers and distributors (SDSs and labels) May 19, 2026 November 19, 2027 Employers (workplace labels, written program, training) November 20, 2026 May 19, 2028 The substance deadline for manufacturers has already passed. Any in-house compound still on an SDS written to the old format is out of date under the rule. Some manufacturers now run SDS Authoring in-house, generating the document from the same composition and hazard data the process team maintains, so the two records can't drift apart. 2. Hazardous waste records that lag behind the process EPA's June 9, 2026 settlement with Nitto Denko Avecia shows how waste gaps build up at a working drug manufacturing site. The company agreed to pay $858,889 to resolve federal RCRA and Massachusetts hazardous waste violations at two facilities in Milford, Massachusetts. EPA's list of problems covered five areas: - Hazardous waste air emissions. - Design and installation of hazardous waste tank systems. - Equipment inspections. - Labeling of waste and storage areas. - Contingency planning. None of these is exotic. The corrective measures the company put in place, including a leak detection program, daily tank inspections, and updated emergency response plans, are routine tasks for any site that generates hazardous waste. There is a structural reason these tasks slip. Waste streams change every time a process is scaled up, a solvent is swapped, or a new product goes into a suite. The waste determination, the tank inspection log, and the contingency plan rarely sit in the same change request as the process update, so they fall behind by one revision, then two. 3. Corrective actions closed without an effectiveness check Corrective action is where EHS and quality systems look most alike, and it is where EHS programs tend to be weaker. ISO 45001, the occupational health and safety standard many manufacturers certify to, requires an organization to review the effectiveness of any corrective action it takes. Also, it requires keeping documented information on the results, including whether the action worked. Many EHS teams track the action and close it when the task is done. The guard goes on, the procedure is revised, the training is delivered. Nobody comes back 60 or 90 days later to confirm the original hazard is gone. FDA observations show how regulators treat the same pattern on the quality side. Citations under 21 CFR 211.192, the production record review rule that requires investigation of unexplained discrepancies, rose 171% from 2023 to 2024 in Form 483 observations issued to sterile drug manufacturers, according to an analysis published by Pharmaceutical Online. The EHS version of that finding is a repeat incident at a workstation that already has a closed corrective action against it. The record shows the investigation stopped at a symptom. The fix is mostly about where the follow-up lives. EHS CAPA Management Software can hold the effectiveness check as a dated, assigned task, so the action can't be marked closed until someone confirms the fix held. A spreadsheet can do the same in principle, though the follow-up column is usually the one left blank. 4. Process changes that skip EHS review Scale-up, technology transfer and new equipment introduce more new hazards in a shorter time than anything else a drug manufacturing site does. ISO 45001 clause 8.1.3 requires a process for implementing and controlling planned temporary and permanent changes that affect health and safety performance. Most GMP change control systems already route changes to quality, regulatory, and validation reviewers. EHS is often an optional reviewer, or gets copied at the end. The consequences are visible in OSHA's fiscal 2026 list. Lockout/Tagout ranked third with 1,863 violations and Respiratory Protection sixth with 1,608. A process change touches both directly. New equipment needs its own energy control procedure, and a compound with a lower exposure band can move an operation from local exhaust ventilation to respirator use, which brings fit testing and medical evaluation with it. Making EHS a required approver on change controls, with a short checklist covering new chemicals, new energy sources, new waste streams, and changed exposure levels, is a small addition to a process most sites already run, and it closes one of the more common EHS gaps in pharmaceutical manufacturing. Closing the EHS gap in pharmaceuticals before the next inspection Each gap above sits between two teams: development and EHS for safety data sheets, operations and EHS for waste, quality and EHS for corrective actions and change control. Companies that publish their EHS approach tend to describe it as a single system. Alkermes, for example, describes a program built on an enterprise-wide risk management framework and aligned with ISO 14001 and ISO 45001. A practical place to start is one recent process change, traced end to end. Check whether the SDS, the waste determination, the energy control procedure, and any related corrective action all updated with it. Where one didn't, the gap is already on record.

iStock, aprott With sales of the oral GLP-1 medicine rising quickly, executives reassured investors that Novo has secured production capacity to support continued growth. Novo has vowed to expand its oral Wegovy manufacturing capacity to serve 10 times more patients by the end of the decade. Speaking at the company’s Capital Markets Day on Monday, Novo CEO Maziar Mike Doustdar said about 1.5 million people are currently on the Wegovy pill. Sales of the oral GLP-1 receptor agonist have risen quickly since Novo launched the product in January, outpacing the growth of Eli Lilly’s rival oral drug, Foundayo, that was launched a few months later. Doustdar allayed concerns that the amount of peptide in oral Wegovy will start throttling growth. “We will scale our oral manufacturing to 10 times more than the patients we serve today, so you don’t have to worry anymore about, ‘Can they actually drive this through with their orals?’” Doustdar said. Across all Novo’s products, the CEO continued, “we will go from 46.5 million patients we serve today to more than 60 million if our calculation holds.” Novo has secured capacity for the 10-fold expansion both in the U.S. and overseas. Speaking alongside Doustdar at the Capital Markets Day, Kasper Bødker Mejlvang, EVP, global manufacturing and supply at Novo, cited investment in an ex-Alkermes plant in Ireland and scale-up of a facility in Durham, North Carolina, as actions supporting the goal. He noted that Novo supplies the U.S. market for oral Wegovy with five domestic production sites, Third-party manufacturing plants could accelerate scale-up if needed, Mejlvang said. Novo is “exploring and developing further partnerships externally that will give us the flexibility to scale rapidly depending on how demand is evolving over the coming couple of years.” C-suite Novo’s plan to hit $23B in revenue by 2035 leaves investors wanting Novo has “gone shopping” to fill pipeline gaps, with a focus on obesity and diabetes, plus an expansion in blood and endocrine disorders, liver diseases and cardiovascular conditions. September 21, 2026 · 5 min read · Annalee Armstrong Read more The expanding manufacturing footprint will support Novo’s continued global rollout of the Wegovy pill. Novo has launched the product in Germany, the United Kingdom and the United Arab Emirates, markets that account for about one-third of the international opportunity, Emil Kongshøj Larsen, EVP, international operations at Novo, said at the Capital Markets Day. Mexico is next on Novo’s launch roadmap. Novo plans to launch in more than 20 markets by the end of next year, covering two-thirds of the market. “We do have plans . . . to reach two-thirds of our potential going forward. And that’s basically because our global manufacturing colleagues these days keep bringing good news in terms of how we crank up volumes in product supply,” Larsen said. The company’s goal for 2028 and beyond is to serve most of the obesity market. Novo will keep its margins “broadly stable” while expanding output, Doustdar said. Prior manufacturing investments are starting to protect margins in the back half of the 2020s, BMO Capital Markets analysts said in a Sept. 21 note to investors. Novo invested significant sums in manufacturing in the past few years and now expects capital expenditure as a percentage of sales to fall, the analysts said.

Today, a brief rundown of news involving Alkermes and Cue Biopharma, as well as updates from Eli Lilly, AbbVie and Johnson & Johnson that you may have missed.A new kind of sleep drug has shown early signs it may help treat attention-deficit hyperactivity disorder, or ADHD. Known as ALKS 7290 and discovered by Alkermes, the drug is one of several in clinical testing that amplify the protein orexin-2 and are initially being developed for narcolepsy. Alkermes said Monday that ALKS 7290 demonstrated proof of concept in an early-stage trial in ADHD, with treatment leading to dose-dependent, clinically meaningful improvements on exploratory measures evaluating the severity of symptoms. The findings are promising but not that surprising, wrote Leerink Partners analyst Marc Goodman. The key question is how well they will work, given the widespread availability of effective generics, he added. A Phase 2 study is underway, with results expected in 2027.Cue Biopharma said Sunday that a newly in-licensed drug had succeeded in a Phase 2 trial in chronic spontaneous urticarias in China. When compared to a placebo after 12 weeks, all three doses of Cues drug CUE-221 helped a higher proportion of patients eliminate their urticarias, or hives. The results also suggested CUE-221s effects might last beyond their final dose at 16 weeks, too, supporting differentiation compared to the widely used therapy Xolair, wrote Jefferies analyst Maury Raycroft. Still, Cue shares lost nearly a quarter of their value on Monday in a sell-off that Raycroft described as unwarranted. Cue grabbed rights to the therapy in an April deal with China-based biotech Ascendant Life Sciences.The Food and Drug Administration has expanded use of Eli Lillys breast cancer pill Inluriyo, the company said Friday. The agency originally approved Inluriyo as a monotherapy in a subgroup of adults whose metastatic, estrogen receptor-positive, HER2-negative breast cancer has progressed after at least one hormone therapy. On Friday, the FDA greenlit use of Inluriyo alongside another Lilly medication, Verzenio, in a similar setting. Both clearances were based on results from the same trial, EMBER-3, in which the Inluriyo-Verzenio combination delayed tumor progression by 11.1 months compared to 5.5 months for standard hormone-suppressing therapies in people with so-called ESR1 mutations.Caplyta, a psychiatric medicine Johnson & Johnson acquired in a nearly $15 billion deal last year, has succeeded in another late-stage study. When compared to a placebo, the drug reduced the rate of manic symptoms after three weeks in people with bipolar I disorder. Improvements were seen in as soon three days, and Caplytas safety was consistent with whats been observed in previous testing, according to J&J. Originally developed by Intra-Cellular Therapies, Caplyta is approved to treat schizophrenia, bipolar depression and major depressive disorder. Its not yet cleared to treat manic episodes, the sudden behavioral swings that are a defining feature of bipolar I disorder. A second Phase 3 study is underway.AbbVie will work with Iambicto unearth new small molecule medicines for cancer, immune diseases and neurological conditions.AbbVie didnt provide specific financial details in a Monday statement, but said that the multiyear partnership will involve using Iambics AI capabilities to accelerate the discovery of therapies with first-in-class and best-in-class potential. In addition to the AbbVie deal,Iambic has recently formed alliances with Takeda, Bayer, Lundbeck and Jazz Pharmaceuticals. '