Catalent, Inc.

iStock, Victor Golmer Wednesday’s update to the regulator’s drug shortage database is good news for Novo Nordisk, which has struggled to keep up with demand for the blockbuster GLP-1 drugs. All doses of Novo Nordisk ’s semaglutide—sold as Ozempic for type 2 diabetes and as Wegovy for obesity—are now available, according to a Wednesday update to the FDA’s drug shortages database. Still, the regulator’s webpage continues to list semaglutide’s status as “currently in shortage.” It is unclear if compounders will need to stop producing and marketing their remixed versions of semaglutide due to Wednesday’s supply update—or if the FDA will enforce action against these pharmacies. Earlier this month, the FDA announced that it was rethinking the shortage status of Eli Lilly’s tirzepatide brands Mounjaro and Zepbound—which the regulator had taken off its shortage list just days earlier—after a complaint from the Outsourcing Facilities Association (OFA). In its lawsuit, the trade group called the FDA “reckless” in declaring the end of the tirzepatide shortage, noting that the decision could “deprive patients of a vital treatment for type 2 and obesity.” Currently, the FDA still officially considers the tirzepatide shortage to be “ resolved ,” according to its website. It remains to be seen whether the OFA will similar complaint for semaglutide. Wednesday’s supply update comes after nearly a year of aggressive manufacturing investments from Novo. In November 2023, the pharma announced a $6 billion boost to its production capacity in Denmark, dedicated for a multi-product facility focused on active pharmaceutical ingredients. Novo in March 2024 also injected $556 million into its Chinese operation, following it up in June 2024 with a $4.1 billion commitment to its manufacturing footprint in North Carolina. Novo Holdings, the controlling shareholder of Novo Nordisk, announced in February 2024 its $16.5 billion acquisition of CDMO giant Catalent. In a related $11 billion deal, Novo Holdings plans to sell three of Catalent’s sites to Novo Nordisk to help expand production of its GLP-1 drugs. However, the Novo Holdings-Catalent buyout is facing opposition. Earlier this month, Sen. Elizabeth Warren (D-Mass.) urged Federal Trade Commission Chair Lina Khan to “carefully scrutinize” the Catalent deal which, if allowed to push through, will give Novo “unprecedented visibility into and control over its competitor’s production capacity, costs, and business practices.” Lilly CEO David Ricks said in a Q2 earnings call in August that the company remains concerned about the Novo-Catalent deal. “We’ve aired those concerns publicly and privately since the proposed transaction was announced, and we’re waiting to see what happens,” Ricks told analysts. Last week, Roche CEO Thomas Schinecker urged regulatory authorities to block Novo Holdings’ buyout of Catalent, arguing that the deal would have wide-ranging negative effects on the industry. “Limiting the competition in this space is not a good idea,” Schinecker said in a media call. However, he insisted that Roche would not be affected by the deal but it “could be a problem for other smaller players,” according to Reuters . Unions, consumer groups and public interest organizations have also raised concerns about the acquisition, noting in a letter to Khan that the merger “would be harmful to competition across various therapeutic areas.”

GHENT, Belgium, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Ardena, a specialist pharmaceutical Contract Development and Manufacturing Organisation (CDMO) with GMP facilities in Belgium, Spain, the Netherlands and Sweden, today announced a substantial expansion of its Bioanalytical Services in the Netherlands. This strategic investment includes establishing a brand new bioanalytical lab at Ardena’s Pivot Park facility in Oss, along with additional capacity and new GLP capabilities to its Bioanalytical Center of Excellence in Assen, aimed at meeting rising client demand for comprehensive, cutting-edge bioanalytical services. The new 3,000+ sqft lab in Oss, expected to be operational by Q1 2025, will provide advanced analytical testing services for both small and large molecules, employing LC-MS/MS and fluorometric detection assays, along with ELISA-based Gyrolab automated technology platform. Meanwhile, Ardena’s investments in Assen focus on expanding its capabilities in immunochemistry, flow cytometry, and qPCR platforms, increasing its LC-MS/MS capacity, and adding new Hamilton automated systems to enhance efficiency and address evolving bioanalytical challenges. The addition of the new Oss lab will complement Ardena’s current bioanalytical operations in Assen, providing greater flexibility in project timelines and faster turnaround times to meet client needs. “This expansion allows us to quickly scale our operations, leverage an additional pool of talented professionals, and bring enhanced efficiency and value to our clients, from discovery to late stage clinical phases,” explains Jeremie Trochu, Chief Executive Officer of Ardena. Ardena’s expanded bioanalytical services are designed to serve a broad spectrum of clients, from small biotech innovators to large pharmaceutical companies, through every phase of drug development, and across a broad range of modalities, including small molecules, therapeutic peptides and proteins, antibodies, antibody-drug conjugates, nanoparticles, oligonucleotides, mRNA, and cell and gene therapies. These investments come on the heels of Ardena’s recent announcement to acquire an advanced drug product manufacturing facility in the U.S. from Catalent. “Together, these investments demonstrate Ardena's focus on growth and innovation, reinforcing our strategy to assist clients navigate through an ever-increasing complex drug development process and bring life-changing therapies to patients worldwide faster,” added Mr. Trochu. About Ardena Ardena is a leading Contract Development and Manufacturing Organization in advanced drug development of new, innovative, and complex molecules. Ardena’s mission is to enable current and next-generation therapies to get into the clinic and to patients faster. Ardena assists biopharmaceutical companies in navigating through the drug discovery and development process to create effective and compliant drug substances and products for clinical trials, by providing integrated services including solid state chemistry, API, and nanomedicine development and manufacturing, analytical and formulation development, drug product manufacturing, bioanalytical and CMC regulatory services. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0ed97215-2202-4d7e-97dd-eb3e7fbaf21a

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here . It’s earnings season! Our reporters will be closely following announcements next week from Pfizer, Novartis, Eli Lilly, GSK, AbbVie, Merck and more. Stay tuned for the latest. — Nicole DeFeudis In a 74-page presentation, activist investor Starboard Value said this week the company’s board needs to “ hold management accountable ” after not being able to capitalize on what it described as one of the best pipelines in biopharma. Though Starboard did not call for changes to the board or Pfizer’s management team, it’s not unusual for activists to make such declarations to test the waters for a company’s response. Endpoints’ founding editor takes a look at some of 2024’s biggest industry trends as they stand at the end of the third quarter. Among the highlights: AI appears to be driving higher M&A figures, licensing deals are down, venture totals are up and IPOs have been a mixed bag. Check out John’s full analysis here . Intellia Therapeutics said this week that its experimental gene editing therapy reduced patients’ mean rate of monthly swelling attacks caused by hereditary angioedema by about 80%. Danny Cohn , a doctor who led the Phase 2 study, said he was “overwhelmed by the clinical response.” Ryan Cross has the details here . Just six months after launching with $100 million, Boston’s latest neuropsychiatry startup Seaport Therapeutics closed a $225 million Series C this week. The company spun out of publicly traded PureTech and is developing prodrugs of molecules that have already been tested or approved. Seaport is starting in depression, with a Phase 2b study expected for a prodrug version of allopregnanolone. Roche is taking a stance on Novo Holdings’ planned acquisition of Catalent . CEO Thomas Schinecker said on Wednesday that antitrust regulators shouldn’t clear the deal, citing concerns that it could limit competition from a broader industry perspective. Why would the company try to block the deal? Drew Armstrong unpacks the news here. The companies will no longer partner on a program called bepranemab . Roche and Genentech had ponied up $120 million upfront and promised up to $2 billion in milestones to team up back in 2020. It’s not the first Alzheimer’s deal Roche and Genentech have broken off this year: In January, the two ended a partnership with AC Immune after lackluster readouts. UCB regained global rights to the program. SPOTLIGHT Editas pivots away from ex vivo sickle cell therapy in favor of in vivo approach ‘It’s not right.’ Califf slams pharma over weight loss drug prices R&D FDA+ PHARMA FINANCING DEALS MANUFACTURING HEALTH TECH