Navigating key news stories in pharma
Featured Stories
Last month, hedge fund Starboard Value acquired a $1 bn stake in Pfizer, at the same time, sharply criticizing the company's management for recent underperformance and strategic missteps. According to Starboard, Pfizer has seen at least $20 bn in value evaporate since 2019.
This move is a textbook example of activist investing. Investors - individuals or institutions - buy a significant stake in a company to influence its management and strategy with the aim of boosting the company’s value and, ultimately, profit from their investment.
But why target Pfizer? And why now?
GSK has entered a partnership with Vesalius Therapeutics to develop treatments for neurodegenerative diseases, including Parkinson's disease and another unspecified neurodegenerative condition. Utilizing its proprietary platform, Vesalius will lead the drug discovery efforts, while GSK will have development and commercialization rights to the preclinical small molecule targeting Parkinson's, along with options to advance other programs.
BioNTech has announced plans to acquire clinical-stage biotechnology company, Biotheus, as the company looks to enhance its oncology strategy. This acquisition will grant BioNTech full global rights to BNT327/PM8002 - and investigational bispecific antibody targeting PD-L1 and VEGF-A - which has shown encouraging clinical activity in various tumor types.
Biotech startup, Metsera, has secured USD 215 mn in a Series B funding round which the company will use to continue developing its portfolio of obesity treatments, including long-acting GLP-1 drug, MET-097i, injectable amylin analog, MET-233i, and oral GLP-1 peptide, MET-002, with plans to explore combination therapies.
Dealmaking
GSK has entered a partnership with Vesalius Therapeutics to develop treatments for neurodegenerative diseases, including Parkinson's disease and another unspecified neurodegenerative condition. Utilizing its proprietary platform, Vesalius will lead the drug discovery efforts, while GSK will have development and commercialization rights to the preclinical small molecule targeting Parkinson's, along with options to advance other programs.
BioNTech has announced plans to acquire clinical-stage biotechnology company, Biotheus, as the company looks to enhance its oncology strategy. This acquisition will grant BioNTech full global rights to BNT327/PM8002 - and investigational bispecific antibody targeting PD-L1 and VEGF-A - which has shown encouraging clinical activity in various tumor types.
UK-based, gene-to-GMP company, Ascend Advanced Therapies, has announced a partnership with EW Healthcare Partners as it targets enhanced U.S. operations and infrastructure. As part of the collaboration, Advanced BioScience Laboratories (ABL), a CDMO based in Rockville, Maryland, and a portfolio company of EW Healthcare Partners, will be integrated into Ascend and combining over three decades of development and manufacturing experience, whilst also expanding Ascend's GMP capacity for adeno-associated virus (AAV) production and fill/finish services.
Biologics CDMO, Avid Bioservices, Inc., has announced its acquisition by GHO Capital Partners LLP and Ampersand Capital Partners in an all-cash transaction totalling approximately USD 1.1 bn.
Nick Green, president and CEO of Avid, emphasized the benefits of partnering with experienced investors who bring expertise, networks, and capital to strengthen Avid’s foundation, with the new owners aiming to unlock Avid’s potential through expanded offerings, talent investment, and geographic reach, building on recent capacity upgrades and its exemplary team for sustained growth.
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
An AI proof-of-concept study from Dandelion Health has identified an additional 44 million lower-risk cardiovascular patients who could benefit from a GLP-1 treatment. Using inclusion criteria similar to the Novo Nordisk-sponsored trial that helped convince the FDA that Wegovy had heart benefits, Dandelion examined whether GLP-1 use might reduce the risk of major adverse cardiac events such as heart attack or stroke in overweight and obese patients in lower-risk patients that didn’t have severe pre-existing cardiovascular disease.
Pfizer’s experimental drug, ponsegromab, has shown promising results in a Phase 2 clinical trial aimed at treating cancer cachexia - a serious condition characterized by muscle and weight loss. Presented at the 2024 ESMO conference, the candidate achieved weight gains of up to 5.6% in patients suffering from cachexia due to lung, pancreatic, or colorectal cancer, surpassing the 5% threshold deemed clinically significant. Pfizer is planning to commence Phase 3 trials by 2025, and aims to provide the first FDA-approved treatment for this life-threatening condition, which currently relies on nutritional support and anti-inflammatory treatments.
The 2024 Lasker Award, given to the living person or persons considered to have made the greatest contribution to medical science, has been awarded to scientists Joel Habener, Jens Juul Holst, and Dr. Gojko Mojsov for their discovery of GLP-1 (glucagon-like peptide-1). Their groundbreaking work has paved the way for life-changing treatments for diabetes and obesity, revolutionizing the management of these conditions through drugs like Ozempic and Wegovy, resulting in a wave of new medications entering the market.
Amgen is advancing its next-generation obesity drug, MariTide, into a Phase 3 clinical program aimed at addressing obesity in conjunction with other weight-related conditions such as heart, liver, and kidney diseases. The injectable therapy, which activates the GLP-1 receptor while blocking the GIP receptor, demonstrated a 14.5% reduction in body weight during Phase 1 trials.
Expansion
Biotech startup, Metsera, has secured USD 215 mn in a Series B funding round which the company will use to continue developing its portfolio of obesity treatments, including long-acting GLP-1 drug, MET-097i, injectable amylin analog, MET-233i, and oral GLP-1 peptide, MET-002, with plans to explore combination therapies.
AstraZeneca has announced a USD 3.5 bn investment to enhance its biopharmaceutical research and manufacturing capabilities in the U.S. by 2026, creating over 1,000 high-skilled jobs whilst targeting growth within the U.S. biopharmaceutical sector.
Eurofins CDMO Alphora Inc. has announced plans to construct a state-of-the-art GMP biologics facility in Mississauga, Ontario. Scheduled for completion in April 2026, the 50,000-square-foot facility will be part of a new 112,000-square-foot building on Eurofins CDMO Alphora's 14-acre campus within the Sheridan Research Park.
SEKISUI Diagnostics' microbial CDMO business - BioProduction by SEKISUI - has announced it has completed its USD 20.7 mn cGMP capacity expansion for clinical-grade drug substance manufacturing at its site in Kent, UK. Upon license approval, the company will be able to expand manufacturing capabilities for common drug types, with microbial fermentation and purification suites that will accommodate production scales up to 1,000L.
Strategy
Novo Nordisk has announced plans to gradually discontinue the production of human insulin pens worldwide, transitioning to offering human insulin exclusively in vial form. The strategic move comes as the company focuses on expanding manufacturing for its popular obesity and diabetes injections, such as Wegovy and Ozempic.
Thermo Fisher Scientific is restructuring its viral vector services, resulting in the closure of its Cambridge, Massachusetts facility and the elimination of 160 jobs, as part of a broader strategy to consolidate operations and enhance efficiency in viral vector manufacturing.
If you were to launch a biopharma startup today, where would you find the skills, talent, and space to bring your vision to life? Biopharma incubators are usually the answer.
These facilities provide an essential foundation for emerging companies, hosting the vital resources and support needed to drive the development of groundbreaking therapies. Programs like JLABS, BioLabs, and LabCentral provide startups with fully equipped labs, cutting-edge technologies, and access to networks of investors, mentors, and industry experts who can help turn ideas into reality.
Viral vector development CDMO, Matica Biotechnology Inc, has signed a Letter of Intent to allow U.S.-based biotech, KaliVir Immunotherapeutics, to develop advanced cancer therapies using Matica Bio’s Vaccinia Enhanced Template (VET™) platform.
The collaboration aims to accelerate the development of KaliVir's oncolytic virus therapies by focusing on a new manufacturing process using Matica Bio’s proprietary MatiMax™ cell line for the process.
Regulatory
The possible appointment of Robert F. Kennedy Jr. to a cabinet position has ignited fierce controversy in the U.S.; raising questions that could reshape the pharmaceutical industry and challenge the direction of federal scientific agencies.
With a well-publicized history of being a vaccine sceptic, Kennedy’s track record suggests a blend of reformist zeal and controversial positions that could redefine the role of agencies he is likely to oversee – the FDA, NIH and CDC.
Earlier this year, the FTC requested additional information regarding Novo Holdings’ proposed acquisition of Catalent, but now, the EU antitrust regulators have announced they are probing the deal for anti-competitiveness impacts surrounding injectables, pre-filled syringes, orally dissolved pills and soft gels.
The FDA has removed Novo Nordisk's weight-loss drug, Wegovy, from its drug shortage list, indicating that all dose strengths are now available, as Novo Nordisk's efforts to increase production meet the high demand for GLP-1 therapies like Wegovy and Ozempic.
The FDA's action comes shortly after removing Eli Lilly's tirzepatide-based drugs, Mounjaro and Zepbound, from the shortage list.
The UK government has pledged up to £520 mn through the Life Sciences Innovative Manufacturing Fund (LSIMF) to drive economic growth and enhance the National Health Service (NHS). The fund will support capital investments across the life sciences sector - providing grants for the manufacture of human medicines, including active pharmaceutical ingredients (APIs) and finished products, medical diagnostics for disease identification and monitoring, and MedTech products related to human health.
The initiative aims to strengthen the UK’s position in life sciences while simultaneously ensuring the NHS is equipped for future healthcare needs, as well as to support innovation and expand manufacturing capabilities across the UK.
Upcoming Events
In light of Anavex Life Sciences’ promising drug candidate (ANAVEX3-71), coupled with Mission Therapeutics’ recent fundraising of £25.2 million to advance their mitophagy program (MTX325), there has been growing evidence of interest towards broader disease groups with underlying pathogenesis from mitochondrial dysfunction.
This November, we will reunite 60+ C-Level, Biologist, Preclinical, Translational and Innovation-Scouting Leaders who are building on from the industry’s latest setbacks to innovate mitochondria-targeting approaches and expand novel therapeutic opportunities.
The Biomanufacturing World Summit is a premier gathering of industry leaders, biomanufacturing executives, and experts dedicated to exploring innovative strategies, emerging trends, and best practices in the dynamic world of biomanufacturing.
BMWS gathers Senior Manufacturing Executives, Technical Operations Quality Executives, and Biomanufacturing Executives to share insights, foster innovation, and build invaluable connections. Dive into a thoughtfully curated environment that brings together thought leaders, allowing you to explore new ideas and engage in meaningful discussions.
AMP appreciates the support and commitment that you show to the molecular diagnostics community and the patients we serve. We were delighted to welcome so many of you to Salt Lake City, Utah in November 2023. The AMP 2023 Annual Meeting & Expo was a resounding success for exhibitors, attendees, and speakers and we cannot wait to do it again!
I would like to personally invite you to join us in celebrating our 30th Anniversary at the AMP 2024 Annual Meeting & Expo, November 19-23rd, 2024. For the first time ever, this event will be held outside of the United States and we couldn’t be more excited to welcome you to Vancouver, British Columbia, Canada.
The 21st Annual #bioProcessUK conference is back and taking place on 19-21 November 2024 in Liverpool!
As in previous years, the event will include pre-conference drinks, a two-day conference, a dinner at the end of the first conference day, an exhibition, awards, student posters and one-to-one partnering.
At the conference, you will have the opportunity to make or strengthen important business connections, hear the latest bioprocessing news and learn from high profile speakers, and take part in some interactive voting for the best student poster.