Featured Stories
Roche Earns CE Mark for AI-Enabled Medical Device
Roche has received CE mark approval for its AI-enabled Accu-Chek SmartGuide continuous glucose monitoring (CGM) system, designed for adults with type 1 and type 2 diabetes on flexible insulin therapy. The system, which features a 14-day wear time and a one-step application process, uses predictive AI to provide real-time glucose predictions and assess hypoglycemia risk with clinical evaluations showing high accuracy, with 99.8% of glucose values within acceptable zones.
Thermo Fisher to Acquire Swedish Proteomics Firm
Thermo Fisher Scientific has announced plans to acquire Sweden-based Olink Holding AB for approximately $3.1 bn in order to leverage Olink’s validated protein biomarker targets and advanced proteomics solutions, including its Proximity Extension Assay (PEA) technology. The transaction is expected to close by mid-2024, subject to regulatory approvals and customary conditions.
Novartis Announces Closure of its San Diego Research Facility
Pharmaceutical Multinational, Novartis, has filed notice to close its San Diego R&D facility by mid-2025, eliminating 100 jobs. The facility, which is currently being used for oncology, neuroscience and immunology R&D, will be moved to other existing U.S. locations. The company says it plans to maintain a presence in San Diego.
MedPharm and Tergus Pharma Merge to Form Topical & Transepithelial CDMO
MedPharm and Tergus Pharma have announced a merger to create a leading CDMO specializing in topical and transepithelial pharmaceuticals, and will continue to operate using the MedPharm name.
The merger allows the new company to offer comprehensive drug development and manufacturing services.
Lotte Biologics to Invest $3 Billion in Songdo Biomanufacturing Expansion
South Korean CDMO, Lotte Biologics, has acquired land in Songdo, South Korea, to construct three biomanufacturing plants to increase production capacity to 360,000L, and in the process is expected to create 37,000 jobs.
Aptamer Group and AstraZeneca Announce siRNA Delivery Collaboration
Aptamer Group and AstraZeneca have announced a strategic collaboration following promising initial results with Aptamer's fibrotic liver delivery vehicles.
The partnership will focus on addressing the challenges of precise siRNA delivery, with the hope of revolutionizing therapeutic applications with Aptamer’s Optimer® technology.
CordenPharma to Invest €900 Million to Meet GLP-1 Drug Demand
CordenPharma has announced that it is investing €900 mn (c.$982 mn) over the next three years to expand its peptide manufacturing capacity in the U.S. and Europe, driven by rising demand for GLP-1 drugs. The Swiss CDMO plans to build a third facility and add new manufacturing lines to its Boulder, Colorado site, and construct a new large-scale manufacturing facility elsewhere in Europe.
Lonza Group Welcomes New CEO
Wolfgang Wienand has been announced as the new CEO of Lonza Group (starting July 1), succeeding Albert M. Baehny, who served as interim CEO since October 2023 and was Chairman of the Board until May 2024.
Samsung Biologics Secures $1.06 Billion Manufacturing Deal with US Pharma
Samsung Biologics voluntarily disclosed that it has secured a six-year deal with an unnamed U.S.-based pharmaceutical company, having secured a letter of intent signed in June. The contract runs through to the end of 2030.
Global CMO & CDMO Market Valuation Predicted to Reach $40 Billion by 2033
A recently published report from Future Market Insights highlights significant potential for global CMO/CDMO market growth; with projections suggesting a significant increase in value from $22.5 bn in 2023 to $39.4 bn by 2033.
Ginkgo Bioworks Expands Layoffs to 400 Job Cuts
Following a previous announcement just a few days earlier that it would layoff 158 of its workers, Ginkgo Bioworks, the cell programming company, expanded the number of people affected to 400, or around 35% of its workforce.
FDA Issues Complete Response Letter for AbbVie’s Parkinson’s Treatment... Again
The FDA has issued a Complete Response Letter (CRL) to AbbVie for its Parkinson’s treatment ABBV-951 due to issues with a third-party manufacturer. The regulator did not highlight safety or efficacy concerns with the drug or its administration device.
Formation Bio Secures $372 Million for AI-Driven Drug Development
Formation Bio has raised $372mn in series-D funding to enhance its drug development pipeline and expand its AI-driven platform, with plans to deploy the new capital to continue acquiring and in-licensing clinical stage assets from biotech and pharma partners.
Lilly Looks to AI in Fight Against Drug-Resistant Bacteria
Eli Lilly has announced a partnership with OpenAI to leverage generative AI to invent novel antimicrobials to address drug-resistant pathogens and their worldwide impact on antimicrobial resistance.
The collaboration comes through the initiative of Lilly’s Social Impact Venture Capital Portfolio, with $100mn committed to provide patients with two to four new antibiotics by 2030.
Abzena and Argonaut Partner to Promise Accelerated Drug Development Support
Two CDMOs, Abzena and Argonaut Manufacturing Services, have announced a strategic partnership to provide an integrated drug substance and product manufacturing solution for biopharmaceutical companies to streamline drug development from early discovery to commercial manufacturing.
NeuroBo Announces Successful Pre-Clinical Results, Raises $70 Million in Shares Sale for GLP-1
NeuroBo has recently announced pre-clinical data for its drug candidate DA-1726, demonstrated superiority in weight loss, retention of lean body mass, and lipid-lowering effects compared to Boehringer Ingelheim’s survodutide, in pre-clinical models.
Zealand Pharma Raises $1 Billion to Develop Obesity Drugs
Zealand Pharma has sold $1bn worth of new shares as it sets out to invest in the development of obesity pipeline candidates including amylin analogue petrelintide and the GLP-1/GLP-2 receptor dual agonist dapiglutide.
Novo Nordisk Secures Approval in China for Obesity Drug Wegovy
Novo Nordisk has gained approval from China’s National Medical Products Administration (NMPA) for its obesity drug Wegovy, which will be marketed as NovoCare in China and consisting of the same compound, semaglutide, as that used in Ozempic.
FDA Expands Label for Sarepta’s Duchenne Gene Therapy
The FDA has broadened the label for Sarepta Therapeutics’ Elevidys - a gene therapy for Duchenne muscular dystrophy (DMD). The therapy is now approved for all DMD patients aged 4 and older after the therapy showed meaningful clinical benefits in secondary measures, despite the trial missing its primary endpoint.
Lupin Appoints CEO of New API CDMO Subsidiary
Indian multinational pharmaceutical company, Lupin, has expanded into the CDMO market.
The company has appointed Abdelaziz Toumi as the CEO of its newly established subsidiary, Lupin Manufacturing Solutions (LMS) which will focus on developing, manufacturing, and selling APIs while expanding into the CDMO market.