Navigating key news stories in pharma

Featured Stories

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Activist Investors Eyeing Big Pharma: What It Means for the Industry
Strategy
Activist Investors Eyeing Big Pharma: What It Means for the Industry
Strategy

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?

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Strategy
News
Matica Bio and KaliVir Partner to Advance Oncolytic Virus Manufacturing for Cancer Therapies
Strategy
Matica Bio and KaliVir Partner to Advance Oncolytic Virus Manufacturing for Cancer Therapies
Strategy

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.

Strategy
FDA Removes Wegovy from Shortage List as Novo Nordisk Resolves Supply Issues
Regulatory
FDA Removes Wegovy from Shortage List as Novo Nordisk Resolves Supply Issues
Regulatory

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.

Regulatory
Celltrion Secures $73 Million CDMO Deal
Dealmaking
Celltrion Secures $73 Million CDMO Deal
Dealmaking

Korean biopharmaceutical company, Celltrion, has secured a $72.8 mn contract with TEVA Pharmaceuticals International for the development and manufacturing of the migraine treatment Ajovy.

The contract – which only runs until July 30, 2025 - represents 4.6% of Celltrion’s 2023 revenue but plans to establish a fully owned CDMO subsidiary by the end of 2024, with facility expansion set for next year.

Dealmaking
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Dealmaking

Featured
Celltrion Secures $73 Million CDMO Deal
Celltrion Secures $73 Million CDMO Deal

Korean biopharmaceutical company, Celltrion, has secured a $72.8 mn contract with TEVA Pharmaceuticals International for the development and manufacturing of the migraine treatment Ajovy.

The contract – which only runs until July 30, 2025 - represents 4.6% of Celltrion’s 2023 revenue but plans to establish a fully owned CDMO subsidiary by the end of 2024, with facility expansion set for next year.

CDMO Samsung Biologics Bags $1.2B Contract, Boosting 2024 Value to Over $3.3B
CDMO Samsung Biologics Bags $1.2B Contract, Boosting 2024 Value to Over $3.3B

Samsung has locked down a $1.2 bn contract with an unnamed Asia-based pharmaceutical company that’s expected to run through December 2037.

The manufacturing project, which will be carried out at Samsung’s biomanufacturing site in the Songdo area of Incheon, South Korea, brings the company’s total new contract value for the year to more than $3.3 bn.

In addition, the company is on track to complete its fifth production plant in Korea by the end of 2024 - a dedicated ADC facility in Incheon - which will add 180 kL to its existing 784 kL capacity and expected to go online in April 2025.

SpectronRx Announces Collaboration for European Radiotherapy Isotope Manufacturing Facility
SpectronRx Announces Collaboration for European Radiotherapy Isotope Manufacturing Facility

Radiopharmaceutical CDMO, SpectronRx, and Belgian Nuclear Research Centre, have announced advanced plans to establish a European radiopharmaceutical CDMO (rCDMO) facility, on the Belgian Nuclear Research Center premises in Mol, Belgium.

The collaboration will see both companies working together to meet the rising demand for radioisotopes, particularly Actinium-225, which plays a crucial role in targeted radiotherapies for cancer treatment. The facility will offer end-to-end solutions, from isotope production to radiopharmaceutical development and manufacturing, and strengthen Europe's position in the radiotherapy market.

Sanofi and Orano Partner to Develop Next-Generation Radioligand Cancer Therapies
Sanofi and Orano Partner to Develop Next-Generation Radioligand Cancer Therapies

Pharma multinational, Sanofi, and pioneers in targeted alpha therapies in oncology, Orano Med, have entered a partnership to develop next-generation radioligand therapies (RLTs) using lead-212 alpha-emitting isotopes, which follows a recent announcement between Orano Med, RadioMedia and Sanofi to advance RLTs in rare cancers, focusing on one late-stage project, AlphaMedix™.

Targeted alpha therapy relies on combining the ability of biological vectors to target cancer cells with the short-range and highly energetic cell-killing capabilities of alpha-emitting radioisotopes. The vector directs the radioisotope to the target cancer cells expressing the specific marker. This unique mechanism of action aims to damage or destroy target cancer cells, while limiting impact on nearby healthy cells.

Future Biopharma

Featured
Aizon Secures $20M for AI-Based Pharma Manufacturing & Next-Gen Electronic Batch Record Systems 
Aizon Secures $20M for AI-Based Pharma Manufacturing & Next-Gen Electronic Batch Record Systems 

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.

Getting Your Molecule Thru the Clinic in these Challenging Times – a View from your CDMO Partners
Getting Your Molecule Thru the Clinic in these Challenging Times – a View from your CDMO Partners

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.

Panel: Getting Your Molecule Thru the Clinic in these Challenging Times- a View from Partners’ C-Suite
Panel: Getting Your Molecule Thru the Clinic in these Challenging Times- a View from Partners’ C-Suite

Brought to you by Orientation Marketing, hear thought-provoking views from five experienced c-level executives from leading development, technology, manufacturing, and bioprocessing partners.

Unlocking AI’s Potential in Pharma
Unlocking AI’s Potential in Pharma

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

Featured
AI Study Expands Potential for GLP-1 Use in Cardiovascular Care
AI Study Expands Potential for GLP-1 Use in Cardiovascular Care

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 Cachexia Drug Shows Positive Results in Mid-Stage Trials
Pfizer’s Cachexia Drug Shows Positive Results in Mid-Stage Trials

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.

GLP-1 Discovery Award Recognition
GLP-1 Discovery Award Recognition

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's MariTide to Face Phase 3 Trials in Targeting Liver and Kidney Diseases
Amgen's MariTide to Face Phase 3 Trials in Targeting Liver and Kidney Diseases

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

Featured
Piramal Pharma Commits $85 Million for Capacity Expansion and Growth
Piramal Pharma Commits $85 Million for Capacity Expansion and Growth

Following an all-time high price, Indian drug discovery company, Piramal Pharma, has announced plans to allocate approximately $85 mn for the current fiscal year to expand capacity and address maintenance and de-bottlenecking at its CDMO sites.

Chairperson Nandini Piramal stated that around $30 mn has already been invested in the first half of the fiscal year, with plans to expand its sterile injectables facility in Lexington, Kentucky, by FY27 as the company aims to surpass $2 bn in revenue by FY30.

NorthStar Medical Radioisotopes Opens New Radiopharmaceutical CDMO Facility
NorthStar Medical Radioisotopes Opens New Radiopharmaceutical CDMO Facility

Radiopharmaceutical CDMO, NorthStar Medical, has inaugurated a 52,000-square-foot Radiopharmaceutical CDMO facility in Beloit, Wisconsin, to become the only U.S.-based company housing commercial scale radioisotope production and CDMO services at the same facility.

The new facility will develop and manufacture key medical radioisotopes - including Ac-225, Lu-177, Cu-64, Cu-67, and In-111 - as the company plans to support biopharmaceutical companies in advancing diagnostic and therapeutic radiopharmaceuticals, particularly for cancer treatment.

MilliporeSigma Invests $76 mn to Triple ADC Production Capacity
MilliporeSigma Invests $76 mn to Triple ADC Production Capacity

MilliporeSigma, the life sciences division of Merck KGaA in the U.S. and Canada, is investing $76 mn to expand its ADC production facility in St. Louis, which will triple the site's current capacity, improve process and analytical development labs, and include new manufacturing spaces, labs, and cold storage, creating 170 new jobs in the process.

The announcement follows a similar investment in 2022, where the company invested $65 mn at its Verona, Wisconsin facility, as it looks to expand production capabilities to meet the ever-growing demand for its services.

Rentschler Biopharma to Build State-of-the-Art Buffer Media Station in Laupheim
Rentschler Biopharma to Build State-of-the-Art Buffer Media Station in Laupheim

Leading CDMO for biopharmaceuticals, Rentschler Biopharma SE, has announced plans to commence construction of a new buffer media station at its headquarters in Laupheim, Germany, from next year.

The facility, spanning 3,400 square meters and expected to be operational by 2028, will enhance production efficiency and modernize the site to meet evolving client and patient needs. The four-story building will house advanced equipment, including media and buffer tanks, ensuring high standards of hygiene, safety, and automation, whilst also supporting Rentschler's sustainability goals and improving employee ergonomics.

Strategy

Featured
Matica Bio and KaliVir Partner to Advance Oncolytic Virus Manufacturing for Cancer Therapies
Matica Bio and KaliVir Partner to Advance Oncolytic Virus Manufacturing for Cancer Therapies

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.

ROVI Retains CDMO Business – Rejecting 5 Offers for Sale
ROVI Retains CDMO Business – Rejecting 5 Offers for Sale

Laboratorios Farmacéuticos Rovi, the Spanish headquartered pharmaceutical manufacturer, CDMO and R&D company, has decided to retain its CDMO business after evaluating several non-binding offers and deciding that continuing with its current strategic plan will maximize value for its existing shareholders.

Rovi had previously explored the potential of a sale of its CDMO segment - which includes manufacturing COVID-19 vaccines for Moderna – but rejected all five offers from potential buyers.

Jim Petrilla Joins Vernal Biosciences as CEO
Jim Petrilla Joins Vernal Biosciences as CEO

Vernal Biosciences has appointed Jim Petrilla as CEO and Board Member, as the company focuses on strategic growth as an mRNA and lipid nanoparticle (LNP) manufacturing leader.

With over 25 years in biopharma and clinical research, Petrilla brings a wealth of operational excellence expertise in leadership roles at major biopharma firms such as Bristol-Myers Squibb and Becton Dickinson, where he spearheaded transformative projects, achieved substantial revenue growth, and led a global NDA filing.

Petrilla succeeds founder Christian Cobaugh, Ph.D., who will now focus on his role as Chief Scientific Officer within the company.

CDMO and API Sectors Set to Fuel Strong H2 Growth at Laurus
CDMO and API Sectors Set to Fuel Strong H2 Growth at Laurus

Dr Satyanarayana Chava, CEO of pharmaceutical company Laurus Labs', is predicting robust growth for his company in the latter half of 2024/25, primarily driven by CDMO and active API segments.

Already this year, the company has reported a 40% increase in CDMO revenue, attributing the growth to substantial investments in CDMO capabilities with planned deliveries set to boost revenues further in Q3 and Q4. However, Chava was clear to point out that the 16% dip in API revenue in Q2 - due to planned facility modifications - is back on track and aligned with upcoming contractual needs as it looks to expand its expertise in oncology and other specialized therapeutic areas.

Regulatory

Featured
FDA Removes Wegovy from Shortage List as Novo Nordisk Resolves Supply Issues
FDA Removes Wegovy from Shortage List as Novo Nordisk Resolves Supply Issues

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.

UK's Labour Party Unveils £520 Million Innovative Manufacturing Fund in Life Science-Heavy Budget
UK's Labour Party Unveils £520 Million Innovative Manufacturing Fund in Life Science-Heavy Budget

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.

Zealand Pharma Faces Second FDA Rejection Due to CDMO Inspection Issues
Zealand Pharma Faces Second FDA Rejection Due to CDMO Inspection Issues

Danish biotech, Zealand Pharma, has faced its second FDA rejection for its hypoglycemia drug - dasiglucagon - which is tied to manufacturing issues uncovered during a CDMO inspection. Despite the setback, Zealand said it remains committed to resolving the issues and pursuing approval for the drug, which is designed to treat severe low blood sugar in diabetic patients.

Further Opposition Voiced on Novo Holdings’ Catalent Acquisition, While Catalent Sells Facilities
Further Opposition Voiced on Novo Holdings’ Catalent Acquisition, While Catalent Sells Facilities

Several U.S. consumer groups and labor unions have asked the FTC to block Novo Holdings planned $16.5 bn acquisition of Catalent, amidst concerns that the potential deal could stifle competition in the market for GLP-1 receptor agonist drugs.

The groups argue that the acquisition would further solidify Novo Nordisk's leading position - dominated by Ozempic and Wegovy – and that this could potentially lead to higher prices and reduced access to these critical medications. They also contend that the deal could give Novo Nordisk control over Catalent's production facilities, and thus limit its rivals' ability to manufacture competing drugs. The move comes amid growing scrutiny from lawmakers - including the U.S. Senator Elizabeth Warren - who has also raised concerns about the merger’s potential to reduce competition. Senator Warren has asked the FTC to closely investigate the deal.

Upcoming Events

Featured
World ADC San Diego 2024

Returning as industry’s definitive ADC forum from early discovery to late-phase manufacturing, the 15th World ADC San Diego is the world-leading, largest, and most comprehensive ADC-focused conference to maximize the therapeutic window of ADCs. Whether you have just ventured into the ADC space or are an ADC guru, you’ll leave this meeting with the insight and connections needed to overcome your challenges and make impactful strides in your work.

PEGS Europe Summit 2024

Network with 1,500+ colleagues at PEGS Europe, the largest protein & antibody engineering event in Europe, which has been described as "the best biologics technology meeting in Europe." New this year is expanded coverage of AI/ML, multispecific antibodies, antibody-drug conjugates, and an entire stream devoted to Oncology.

Global Pharma and Biotech Summit 2024

The Global Pharma and Biotech Summit is the essential annual event for you to stay on top of the latest trends and innovations in life sciences. Industry leaders and experts will discuss what’s new in areas such as drug discovery, clinical trials, market access and patient engagement.

ASHG Annual Meeting 2024

Over the course of 5 days, the meeting will cover a broad spectrum of topics including new technologies, applications, and research to showcase the most compelling genetics and genomics science of the year. It is a perfect place to present or learn about cutting-edge research findings while uncovering new insights as we continue to advance the field.