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Navigating key news stories in pharma
Featured Stories
Despite its parent company facing scrutiny and potential sanctions from the U.S. government, WuXi AppTec continues to expand its contract research, development and manufacturing organization (CRDMO) services in its native China.
Since breaking ground in October 2022 and fresh from its IPO in September 2023, SCHOTT Pharma, the maker of drug containment solutions and delivery systems for injectable drugs, announced the culmination of a EUR 76 million investment with the opening of its new production facility in Lukácsháza, Hungary.
WuXi AppTec and WuXi Biologics saw significant stock gains (7% and 14%, respectively) after the BIOSECURE Act was unexpectedly excluded from the National Defense Authorization Act (NDAA). The Act, which targets foreign biotech companies over U.S. national security concerns, proposed cutting ties with certain Chinese firms by 2032.
With plenty of panels happening at BIO 2024, one convention discussion highlighted the transformative potential of gene therapy and the challenges of funding these high-cost, one-time treatments. Experts from bluebird bio, Vertex Pharmaceuticals, and other stakeholders emphasized the need for innovative payment models that reflect the long-term value of gene therapies.
Dealmaking
AstraZeneca says the acquisition will enhance its oncology portfolio with Fusion’s expertise in radioconjugates (RCs), a type of drug that combines radiation with a tumor-targeting agent.
South Korea's Lotte Biologics and Germany's Merck KGaA have signed a partnership to enhance biopharmaceutical production and process development as part of Lotte's "Bio Venture Initiative" at their Songdo Bio campus in South Korea.
Merck KGaA announced a definitive agreement to acquire Mirus Bio, strengthening its biopharmaceutical manufacturing and gene therapy capabilities.
Sanofi will make a $500 mn upfront to Novavax and take a sub-5% equity stake in the vaccines company $70 mn. The partners will co-develop and commercialize a combined flu and COVID-19 vaccine, and Sanofi will expand the reach of Novavax's protein-based COVID-19 vaccine.
Future Biopharma
Aizon has raised $20 million in Series C financing, with NewVale Capital leading the round with support from current backers. This funding boost is set to advance their AI-based platform for pharmaceutical manufacturing and aid in deploying their latest electronic batch record (eBR) system.
Sponsored by Expert Insights and Orientation Marketing, a panel of senior executives from the development and manufacturing partners charged with scaling and supplying medicines to patients were optimistic about 2024, but reflected on some of the challenges the industry will face too.
Brought to you by Orientation Marketing, hear thought-provoking views from five experienced c-level executives from leading development, technology, manufacturing, and bioprocessing partners.
The transformative impact of Artificial Intelligence (AI) on life sciences is indisputable. Join us on an exploration of AI’s potential within the pharmaceutical and healthcare industry. Hear two thought leaders discuss AI as a catalyst to create a more efficient and accessible healthcare future.
R&D
The latest product for automated lab integration, Heracell VIOS 250i AxD CO₂ Incubators feature automated door control for robotic handling and are designed to support optimal cell growth conditions and minimal contamination risk and support large-scale and automated cell therapy production for efficiency and safety.
Tourmaline Bio has dosed the first patient in its Phase 2 TRANQUILITY trial for TOUR006, an anti-IL-6 monoclonal antibody aimed at treating atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular conditions.
GRI Bio, Inc. has announced positive preclinical data for its lead program, GRI-0621, in treating Idiopathic Pulmonary Fibrosis (IPF).
Novo’s proposed acquisition of Catalent, with the immediate goal of adding capacity for its weight-loss drugs, has rarely been out of the news, whilst a raft of expansions elsewhere has been announced at Thermo Fisher, Alcami, Lonza and Vetter, to list but a few.
Expansion
Since breaking ground in October 2022 and fresh from its IPO in September 2023, SCHOTT Pharma, the maker of drug containment solutions and delivery systems for injectable drugs, announced the culmination of a EUR 76 million investment with the opening of its new production facility in Lukácsháza, Hungary.
A new report suggests that the global sterile injectable CDMO market is projected to reach $33.7 bn by 2034, driven by high demand for biologics, accelerated development timelines, and the shift towards end-to-end business models offering comprehensive services from API development to drug manufacturing.
Simtra BioPharma Solutions, the new name for Baxter International’s BioPharma Solutions (BPS), announced last week that work had started on constructing a 150,000 square foot extension to its facility in Bloomington, Indiana.
Despite its parent company facing scrutiny and potential sanctions from the U.S. government, WuXi AppTec continues to expand its contract research, development and manufacturing organization (CRDMO) services in its native China.
Strategy
With plenty of panels happening at BIO 2024, one convention discussion highlighted the transformative potential of gene therapy and the challenges of funding these high-cost, one-time treatments. Experts from bluebird bio, Vertex Pharmaceuticals, and other stakeholders emphasized the need for innovative payment models that reflect the long-term value of gene therapies.
GSK has secured a non-exclusive license to Elsie Biotechnologies' oligonucleotide discovery platform following a successful research collaboration.
Thermo Fisher Scientific has inaugurated a GMP-certified ultra-cold facility in Bleiswijk, Netherlands, to enhance its clinical trial network in Europe. This state-of-the-art facility supports the development of advanced therapies, including cell and gene therapies, biologics, and vaccines through comprehensive services, including ambient to cryogenic storage, clinical packaging, labeling, and distribution.
Kindeva Drug Delivery, the drug and device CDMO, is to expanding its facilities at its Charnwood campus in Loughborough, U.K. The expansion will support growth in demand for so-called green propellants, providing commercial-scale supply and doubling the company’s UK laboratory footprint.
Regulatory
WuXi AppTec and WuXi Biologics saw significant stock gains (7% and 14%, respectively) after the BIOSECURE Act was unexpectedly excluded from the National Defense Authorization Act (NDAA). The Act, which targets foreign biotech companies over U.S. national security concerns, proposed cutting ties with certain Chinese firms by 2032.
The U.S. Federal Trade Commission (FTC) has proposed a rule change that will require pharmaceutical companies to file all pre-institution patent settlements with the Patent and Trademark Office (USPTO), with the ruling aimed at enhancing the FTC's ability to detect anticompetitive settlements that delay generic drug competition and keep drug prices high.
The FDA has introduced guidance for platform technology designations that is designed to streamline regulatory processes for biotech companies using ‘well-understood and reproducible technology’, such as specific nucleic acid sequences, vectors or delivery methods, to expedite subsequent drug applications.
In response to President Biden’s Executive Order 14081, the EPA, FDA, and USDA have jointly unveiled a plan to streamline the regulation of biotech innovations in plants, animals, and microorganisms.
Upcoming Events
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The year 2024 has been considered the ‘coming of age’ era for antibody-drug conjugates, in great part due to the remarkable resurgence in drug development across the Asia-Pacific region. This part of the world is taking the ADC industry by storm with high-profile deals, multiple approvals, multiple ADCs moving into clinical trials, and novel targets being explored just to name some advancements.
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