Catalent Pharma Solutions’ Post

As we head into the Advent season, our latests edition of #brusselsajour is looking at #dgcomp's antitrust enforcement in the #pharma sector. The #europeancommission's recent Teva decision (devisional patents, disparagement strategies), and Luxembourg's Servier and Teva cases (on pay-for-delay) are reminders that the industry remains under strict scrutiny. On the merger control side, the industry is facing headwinds when it comes to "below the threshold" deals and dgcomp's focus on potential competition and innovation spaces. Just a few days ago, the bloc's antitrust regulator released a study on (alleged) #killeracquisitions in the #pharmaceutical sector (are there REALLY there any???)... See for yourself. Thanks to Dr. Caroline Beyersdorf, Dr. Sebastian Dworschak and Philipp Heuser for taking the lead on this edition. #antitrust #competitionlaw #eumr

🚨 Novo Holdings' $16.5B Catalent Deal Faces FTC Scrutiny 🚨 Novo Holdings A/S’s proposed acquisition of Catalent Inc. has caught the eye of the US Federal Trade Commission (FTC) due to antitrust concerns. This case could set a new precedent for vertical mergers under the Biden administration. Key Highlights: FTC Focus: The deal is seen as a test case for updated merger review guidelines aimed at preventing market monopolies. Antitrust Concerns: The FTC is investigating potential impacts on competitors' access to essential manufacturing services and drugs like Ozempic. Broader Implications: Reflects a broader effort to address high drug prices and market consolidation in the pharmaceutical industry. The outcome could reshape industry dynamics and antitrust enforcement. What are your thoughts on this landmark case? https://lnkd.in/e_rS44Wh #Pharma #Antitrust #MergersAndAcquisitions #BusinessNews

#News: Shortly after Novo Holdings parent company elected to resubmit paperwork around the investment firm’s proposed $16.5 billion buyout of #CDMO giant Catalent Pharma Solutions , the U.S. Federal Trade Commission (FTC) has teed up a further extension on the deal’s review period. #Catalent and the Novo Nordisk Foundation on Thursday received requests for additional documents and information on the proposed deal from the FTC as part of what’s known as a “second request,” Catalent said in a Friday securities filing. The #NovoNordiskFoundation acts as parent to both #NovoHoldings and drugmaker #NovoNordisk. The FTC’s second request imposes an additional waiting period of up to 30 days for the agency to review the deal from the time the Novo Nordisk Foundation and Catalent submit the required information. Novo and Catalent also have the option to further extend the waiting period themselves if they so choose. Both Catalent and the Novo Nordisk Foundation are currently gathering information to appease the FTC’s request “as expeditiously as possible,” the securities filing shows. Catalent says it still expects the buyout to close toward the end of 2024 as planned Read more from Fierce Pharma 👇🏽 https://lnkd.in/e7XPCSAR

Mankind Pharma has recently announced a strategic move to transfer its OTC (Over-the-Counter) business to a newly established subsidiary. This realignment is designed to enhance operational efficiency and streamline the company's focus. From a legal perspective, this transfer will necessitate rigorous adherence to regulatory compliance, meticulous management of intellectual property, and careful renegotiation of existing contracts with stakeholders. The transition must be managed with precision to avoid potential legal pitfalls and ensure smooth integration. This strategic realignment highlights several critical learnings for the pharmaceutical industry. Companies must remain agile, adapting their strategies in response to market demands and operational needs. Legal readiness is crucial, particularly in handling complex regulatory requirements and safeguarding intellectual property. Effective communication with all stakeholders, including employees, partners, and investors, is essential to maintain transparency and trust throughout the transition process. Looking ahead, Mankind Pharma should focus on closely monitoring the subsidiary’s performance and adapting strategies as needed based on market feedback. Strengthening IP management and assessing potential synergies between the subsidiary and the parent company will be vital for optimizing business performance. This move not only positions Mankind Pharma for enhanced efficiency but also serves as a strategic case study for navigating business realignments in the pharmaceutical sector. https://lnkd.in/ekUJBsRj #PharmaStrategy #LegalImplications #BusinessRealignment #MankindPharma #OTCBusiness #IndustryInsights #corporatelaw

Thoughts on this? >> Catalent sells New Jersey plant to Belgian CDMO, plans moving HQ elsewhere >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #productmarketing #pharmaceutical #pharma #healthcare

𝐓𝐡𝐞 𝐒𝐭𝐞𝐞𝐩 𝐂𝐥𝐢𝐦𝐛 𝐨𝐟 𝐆𝐞𝐧𝐞𝐫𝐢𝐜 𝐃𝐫𝐮𝐠 𝐔𝐬𝐞𝐫 𝐅𝐞𝐞𝐬: 𝐀𝐫𝐞 𝐖𝐞 𝐑𝐞𝐚𝐜𝐡𝐢𝐧𝐠 𝐭𝐡𝐞 𝐓𝐢𝐩𝐩𝐢𝐧𝐠 𝐏𝐨𝐢𝐧𝐭? The new Generic Drug User Fees for FY 2025 are here, and the spotlight is on the surging ANDA submission fees. 𝘈𝘴 𝘸𝘦 𝘣𝘳𝘢𝘤𝘦 𝘧𝘰𝘳 𝘢 $69,467 𝘩𝘪𝘬𝘦 𝘱𝘦𝘳 𝘈𝘕𝘋𝘈 𝘴𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯, 𝘵𝘩𝘦 𝘳𝘢𝘤𝘦 𝘪𝘴 𝘰𝘯 𝘵𝘰 𝘧𝘪𝘭𝘦 𝘣𝘦𝘧𝘰𝘳𝘦 𝘖𝘤𝘵𝘰𝘣𝘦𝘳 1𝘴𝘵, 𝘵𝘩𝘦 𝘴𝘵𝘢𝘳𝘵 𝘰𝘧 𝘍𝘠 2025. With #ANDA submissions projected to hit a historic low of 651, this year's submissions scramble will be one for the books. The FDA's projection of 651 ANDA submissions for FY 2025—the lowest since the inception of the Generic Drug User Fee Act (#GDUFA)—highlights the challenges ahead. This drop in submissions signals potential hurdles for generic drug manufacturers, particularly for smaller firms. All user fees are on the rise, with program fees also seeing substantial hikes due to mergers and acquisitions. Sponsors transitioning to higher program fee categories will likely voice their concerns, as these fees now account for 36% of the GDUFA program's required funding. The FDA’s data shows a reduction in the number of applicants across all tiers for FY 2025. Small businesses are particularly vulnerable, with their numbers projected to drop from 241 to 194. #GenericDrugUserFees

What's happening? In Italy, 3 Italian pharmaceutical carriers were acquired in a short period of time. Specific business with stable demand 😐. 1. France's Walden Group has completed its acquisitions, announced last year, of XCM Healthcare, a healthcare warehouse logistics specialist, and Unitex, a temperature-controlled last-mile chain specializing in pharmaceuticals and medical supplies. Both companies were previously owned by the Italian Marzano family, who also founded the Farmacia S. Catarina group, and Gaetano Colella CEO of XCM and Unitex. Read more at: https://lnkd.in/dYYvzXus 2. Belgian transport company H.Essers announced the acquisition of Italian transport company Romano Trasporti. Romano Trasporti, headquartered in southern Italy, provides both domestic and international transport. The carrier employs approximately 120 people, including 95 drivers, and operates a modern fleet of 95 trucks, as well as 100 temperature-controlled trailers. Its services are reported to be used by "several leading players" in the healthcare industry. Read more at: https://lnkd.in/dDyjYPRs

Big news!! JRC is now based in Raleigh/Durham NC and excited to connect with the life sciences companies here in the RTP region. Do you have a product in your pipeline nearing the critical phase of approval and commercialization planning? Together, we can ensure this process is successful! JRC offers over 19 years of commercial supply planning experience with a focus on commercialization and supplier relationships. Please reach out if you would like to have a discussion about your upcoming launch activities. Let's make your launch a success! #supplysuccess #supplychain #commercialization #launchplanning #pharma #patientneeds

Find out more about the key benefits of outsourcing to a CDMO. From expertise and efficiency, access to technology, and accelerated development and commercialisation, the benefits are numerous. Read the full article below. #CDMOLive #CDMO #Pharmaceuticaldevelopment #contractmanufacturing

Thoughts on this? >> J&J and Emergent settle Covid contract dispute; Siegfried names new CEO >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #biotech #healthcare #productmarketing #pharma