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Novo Nordisk has agreed to acquire Inversago for up to $1.075 billion in cash if certain development and commercial milestones are achieved, the company announced on Aug. 10, 2023. The acquisition of the latter includes the company’s lead development asset INV-202, an oral CB1 inverse agonist which is designed to block the receptor protein CB1. According to the press release, CB1 plays an important role in metabolism and appetite regulation in the peripheral tissues, like the kidneys and liver.

INV-202 will continue to be investigated under Novo Nordisk as a potential treatment for obesity and obesity-related complications.

“The acquisition of Inversago Pharma will further strengthen our clinical development pipeline in obesity and related disorders,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk, in a press release. “This promising class of medicine pioneered by the Inversago team could lead to life-changing new treatment options for those living with a serious chronic disease and, in particular, may offer alternative or complementary solutions for people living with obesity.”

François Ravenelle, chief executive officer of Inversago Pharma, emphasized the delight he feels in joining forces with a global leader in the obesity and metabolic disorder space. “We believe this combination will help unlock the full medical potential of our CB1 blockers and may one day expand treatment options for people living with metabolic syndrome, obesity and related complications,” he said in a press release. “Novo Nordisk has world-class research facilities, significant global reach and a rich culture of collaboration seeking to bring our therapeutic treatments to market.”

The closing of the acquisition is expected to happen before the end of 2023, according to the press release.

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The acquisition of the latter includes the company’s lead development asset INV-202, an oral CB1 inverse agonist which is designed to block the receptor protein CB1. 

Novo Nordisk to Acquire Inversago Pharma

Feliza Mirasol is the science editor for 

Eli Lilly and Company (Lilly) has announced the completion of several previously announced acquisitions: Versanis Bio (Versanis), Sigilon Therapeutics (Sigilon), and DICE Therapeutics (DICE), all of which were concluded in August 2023.

The Versanis acquisition includes that company’s lead asset, bimagrumab, a monoclonal antibody currently in Phase IIb development for treating obesity. Under the agreement, Versanis shareholders stand to receive up to $1.925 billion in cash, which includes an upfront payment and subsequent payments based on the achievement of certain development and sales milestones, according to an Aug. 14, 2023 company press release. Lilly had announced its intent to acquire Versanis Bio in July 2023 (1).

"Combining our current incretin portfolio, including tirzepatide, with activin receptor blockers such as bimagrumab, could be the next major step in innovative treatments for those living with cardiometabolic diseases, [such as] obesity," said Ruth Gimeno, group vice-president, diabetes, obesity, and cardiometabolic research, Lilly, in the company press release. "The wealth of knowledge that our new colleagues from Versanis will bring to Lilly will propel our research and development efforts forward, ultimately benefiting patients around the world."

The Sigilon acquisition, first announced by Lilly in June 2023 (2), boosts Lilly’s R&D capabilities in encapsulated cell therapies for treating type 1 diabetes and includes a lead candidate, SIG-002. According to a company press release, Lilly offered $14.92 per share of Sigilon common stock, an aggregate of approximately $34.6 million (2).

Finally, the $2.4 billion ($48 per share) DICE acquisition, 

 (3), expands Lilly's immunology portfolio. It adds DICE's novel oral therapeutic candidates for treating chronic diseases in immunology, including oral interleukin-17 (IL-17) inhibitors, to Lilly’s pipeline. The IL-17 inhibitors are currently in clinical development, according to a company press release.

1. Eli Lilly and Company, Lilly to Acquire Versanis to Improve Patient Outcomes in Cardiometabolic Diseases. Press Release, July 14, 2023.
2. Eli Lilly and Company, Lilly to Acquire Sigilon Therapeutics. Press Release, June 29, 2023.
3. Eli Lilly and Company, Lilly to Acquire DICE Therapeutics to Advance Innovation in Immunology. Press Release, June 20, 2023.

The completion of three acquisitions of Versanis Bio, Sigilon Therapeutics, and DICE Therapeutics boosts Eli Lilly and Company’s product pipeline in obesity, diabetes, and immunology.

Lilly Completes Spate of Acquisitions

Rakuten Medical, a US-based biotechnology company specializing in cell targeting therapies, announced on Aug. 10, 2023 that it has signed an exclusive licensing and commercialization agreement with Hikma Pharmaceuticals (Hikma), a UK-based pharmaceutical company that serves the Middle East and North Africa (MENA) region as well as Europe.

Under the agreement, Hikma gains an exclusive license to commercialize products in Rakuten Medical’s oncology pipeline to all of Hikma’s MENA markets. Rakuten Medical’s oncology pipeline was developed using its proprietary photoimmunotherapy technology platform, Alluminox. These therapies are not currently approved in MENA for investigational or commercial use. Outside of Japan, they are investigational treatments, according to a company press release.

“We are already developing Alluminox treatment in several countries and regions, including the United States, Japan, Taiwan, and India, and this agreement further accelerates our global expansion. With Hikma’s strong regional footprint and medical expertise, we expect the Alluminox platform to make significant progress in MENA,” said Mickey Mikitani, co-CEO of Rakuten Medical, in the company press release.

“This agreement allows us to work with an excellent global partner to strengthen our growing portfolio in oncology and biotechnology. Most importantly, this allows us to bring a potentially transformative technology to cancer patients in MENA, helping to put better health within reach, everyday,” said Mazen Darwazah, executive vice-chairman and president of MENA, Hikma, in the release.

Under the exclusive agreement, Hikma will commercialize products in Rakuten Medical’s pipeline for cancer treatment in the Middle East and North Africa region.

Rakuten Medical Signs Exclusive Licensing Agreement with Hikma for Cancer Treatments in MENA

, a biotech start-up focused on regenerative medicines. In this candid discussion with Grant Playter, associate editor, Luis discusses his company’s regenerative bone therapy, how it evolved from his experiences in Iraq, how Theradaptive secured funding in a lukewarm venture capital market, and more.

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Luis Alvarez, PhD, founder of Theradaptive, candidly discusses how his regenerative therapy start-up evolved and secured start-up funding.

Unpacking Regenerative Medicines and Start-Up Funding with Luis Alvarez

The United Kingdom Bioindustry Association recently released new data surrounding UK biotech funding in the second quarter. According to the report, venture capital investments rose from £258 million in the first quarter to £338 million in the second, whereas public funding rose from £37 million to £44 million. This represents an overall quarter-over-quarter uptick of 29%, putting it en route to approximately match the £1.21 billion raised over the course of 2022. However, both years totals are set to lag significantly behind 2021, which saw approximately £2.52 billion in total financing.

According to findings from the report, the average size of venture capital investments in the second quarter was £13 million, the same as the first. The report also noted that there was a “healthy spread” of funding between early- and late-stage companies.

The report summary stated that public markets remain challenging, with no new market launches or lackluster follow-on funding, a trend noted as in-line with international trends; no UK biotech company raised money via initial public offering (IPO) in this quarter, mirroring the first quarter. This is in stark contrast to 2021, which saw approximately $1.3 billion raised via IPO over the course of the year. However, due to the positive momentum of the quarter and overall stability in attracting capital, as well as upcoming UK government policy initiatives set to bolster funding, the overall findings were deemed positive by the members of the UK Bioindustry Association.

“Amidst the current challenges facing the UK’s biotech sector, we are encouraged by the 29% growth in investment quarter-on-quarter, and the positive policy progress from UK Government that bodes well for a rapid rebound.” said Steve Bates, CEO, Bioindustry Association, in the report.

The summarized findings of the report can be read 

A report from the UK Bioindustry Association report indicated that biotech venture and public financing rose from £295 million in the first quarter to £382 million in the second quarter.

United Kingdom Biotech Report Finds 29% Uptick in Funding

Cytomos, a Scottish life science company focused on developing new approaches to analyzing cells, announced on Aug. 9, 2023, that it had secured £4 million (approximately $5 million) to scale-up market testing of its technology platform Cytomos Dielectric Spectroscopy (CDS). According to a company press release, CDS is designed to provide high-speed, scalable, and low-cost cell analysis relative to existing systems.

The investment round was led by existing investors Archangels, as well as participation from Old College Capital, Scottish Enterprise, and new investor British Business Bank. According to the release, the new investment will allow Cytomos to significantly advance the development of CDS and expand its team. The company is targeting platform commercialization in 2024.

“On the back of a very successful year for Cytomos, this new funding will now allow us to scale up our engagement with industry partners,” said David Rigterink, CEO, Cytomos, in the release. “We truly believe that, through our CDS technology, we offer a powerful platform which will help the scientific community bring novel therapies to market faster and radically reduce costs by making better informed, game-changing decisions a lot earlier.”

“As a highly innovative, Scottish early-stage life science company with global horizons, Cytomos is an excellent fit for our investment portfolio,” said Sarah Hardy, director and head of new investments, Archangels, in the release.  “Its ambitious vision to improve real time cell analysis in formats to better suit the end users will revolutionize the development and commercialisation of products in the bioprocessing and cell and gene therapies spaces.  We’re looking forward to working with David and the team as they drive the business forward, making smarter, faster and more accurate cell analysis finally more accessible.”

Cytomos will use the £4 million in funding to develop its dielectric spectroscopy technology.

Cytomos Secures £4 Million to Develop Spectroscopy Platform

Astellas Pharma and Poseida Therapeutics announced on Aug. 10, 2023 a strategic investment to further support the development of cell therapies for cancer . According to a press release, Astellas will be investing a total of $50 million and a one-time $25 million payment for a right of exclusive negotiation and first refusal to license one of Poseida’s clinical-stage programs, P-MUC1C-ALLO1, which is an allogeneic chimeric antigen T cell (CAR-T) cell therapy in development for multiple solid tumor indications.

Additionally, Poseida has approved Astellas as a board observer seat, which gives Astellas the right to attend Poseida’s scientific advisory board meetings and certain notice rights related to any potential change of control over Poseida.

“By leveraging our extensive expertise, experience in cancer biology, and unique technologies, we are focused on reinvigorating the immune system’s ability to discover, disarm, and destroy cancers in more patients,” said Adam Pearson, chief strategy officer, Astellas, in a press release. “We believe that this investment fits strategically with our long-term vision of expanding our capability in immuno-oncology and will ultimately lead to the development of new therapeutics for patients in need of cancer immunotherapy.”

"This investment further validates the potential of our proprietary genetic engineering technology platform and cell therapy approach, and we look forward to working with Astellas to advance our shared vision and explore future opportunities for collaboration to further unlock that potential," said Mark Gergen, Poseida's chief executive officer, in a press release.

Astellas and Poseida Therapeutics Plan to Invest in Redefining Cancer Cell Therapy 

On Aug. 11, 2023, Novartis announced the completion of its acquisition of Chinook Therapeutics, a US-based clinical-stage biopharmaceutical company focused on developing and producing precision medicines for kidney diseases. The transaction included a $3.2 billion upfront payment, with a total deal value of up to $3.5 billion. Stockholders in Chinook are expected to receive up to $44.00 per Chinook share through a contingent value right, which represents a potential added $300 million in aggregate contingent consideration.

In a company press release, Novartis identified two key late-stage assets in development at Chinook: atrasentan and zigakibart (BION-1301). Both assets are being developed to treat Immunoglobulin A nephropathy (IgAN). Atrasentan, an oral endothelin A receptor antagonist, is in Phase III development for IgAN and has shown notable decreases in proteinuria. It is also in early development for other rare kidney diseases. Zigakibart (BION-1301), a subcutaneously administered anti-a proliferation-inducing ligand (APRIL) monoclonal antibody, entered Phase III development for IgAN in July 2023.

“We are excited to complete this important transaction and look forward to leveraging our combined resources and expertise to further advance the development of these promising treatments for the benefit of patients with rare, severe chronic kidney diseases,” said Vas Narasimhan, CEO of Novartis, in the press release. “We welcome the Chinook team to Novartis as we expand our renal portfolio and continue our journey to reimagine medicine.”

Novartis has completed its acquisition of biopharma company Chinook Therapeutics.  

Novartis Finalizes Chinook Therapeutics Acquisition in Deal Worth Up to $3.5 Billion

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On Aug. 4, 2023, FDA released a guidance document, 

Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs)

. The guidance gives both applicants and manufacturers of drugs recommendations for estimating the mutagenic and carcinogenic potential of NDSRIs that could be in drug products and gives acceptable intake (AI) limits for NDSRIs.

NDSRIs are a subcategory of nitrosamine impurities that share structural similarity to the API in drug products; NDSRIs often lack the compound-specific mutagenicity and carcinogenicity data necessary for informed safety assessments. FDA wrote in the guidance document that this guidance “provides a recommended methodology for AI determination that uses structural features of NDSRIs to generate a predicted carcinogenic potency categorization and corresponding recommended AI limit that manufacturers and applicants can apply, in the absence of other FDA-recommended AI limits, in their evaluation of potential impurities in their drug products.”

FDA wrote that it will provide updated NDSRI-specific information on 

 to be viewed in tandem with the guidance. The updated information will include suggested AI limits for specific NDSRIs based on “compound-data or read-across analysis from a surrogate”, suggested interim AI limits for NDSRIs, suggested testing methods for corroborative testing of specific NDSRIs, and suggested safety testing methods for NDSRIs. It will also include suggested AI limits for specific NDSRIs based on “predicted carcinogenicity potency categorization listed by APIs that hypothetically could be at risk of forming such NDSRIs.” 

The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.

FDA Releases Guidance on Intake Limits for Nitrosamine Drug Substance-Related Impurities

On Aug. 4, 2023, FDA approved zuranolone (Zurzuvae), an oral medication to treat postpartum depression (PPD) in adults from Sage Therapeutics, a US-based biopharmaceutical company. According to an agency press release, zuranolone is the first oral treatment approved for PPD.

The approval was based on two studies that showed zuranolone’s effectiveness as a treatment for PPD. Patients who took zuranolone showed noticeably more improvement compared to those in the placebo groups, and the effect remained four weeks after the last dose of zuranolone.

PPD is a major depressive episode that usually occurs after childbirth, although it can also start in the later stages of pregnancy. As with other forms of depression, PPD can cause sadness, lethargy, and loss of interest in previously enjoyable activities. Symptoms include feelings of sadness or inadequacy, loss of energy, cognitive impairment, and suicidal ideation. Until this approval, PPD treatment was only available via intravenous injection given by a health care provider in a health care facility. FDA granted the application for Zurzuvae priority review and fast track designation.

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” said Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in FDA’s press release. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

The new drug could be a powerful tool for patients suffering depressive symptoms after birth.

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Behind the Headlines Episode 27

Ask the Expert

Drug Digest September 2025

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

Top Trends Reshaping Pharma R&D