Merilog’s approval comes as the insulin space has over the past year suffered several setbacks, including strong calls for price caps and, potentially, the rise of the mammoth GLP-1 market.
In the third podcast in a special series focused on BioSpace’s NextGen Class of 2025, Senior Editor Annalee Armstrong speaks with Mark McKenna, CEO of Mirador Therapeutics.
Under the terms of the agreement, OPKO will accept 60% of the development costs, while Entera will shoulder 40%.
Monday was a busy day for AstraZeneca, which also paid up to $1 billion to acquire Belgian biotech EsoBiotec and its cell therapy pipeline and technology.
The gene therapy world is in turmoil, but Arbor, armed with more than $1 billion in partnerships and raises, is going forward.
Japan-based Taiho Pharmaceutical has worked with Araris Biotech since 2023 developing antibody-drug conjugates for the oncology space.
AstraZeneca has recently been investing heavily in the cell therapy space, including two acquisitions for TeneoTwo and Gracell Biotechnologies.
FEATURED STORIES
Novo Holdings’ acquisition of Catalent has ignited concerns from industry stakeholders, who fear that the consolidation could limit competition, but there is also the possibility that the deal could represent an opportunity for smaller-scale CDMOs to find new partners.
BioSpace takes a look at the headlines across a heavy earnings week for biotechs, checking in on Allogene, Rapport and more.
CEO Roberto Iacone admitted in an interview that the market remains tough, even for a biotech in the red-hot ADC world. But Alentis is targeting an IPO as early as 2025.
LATEST PODCASTS
In this episode of Denatured, presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses how AI transformation can help organizations navigate a rapidly evolving regulatory environment with senior director of regulatory innovation and technology, Michelle Gyzen.
Sanofi and BMS paid big money for rare disease and cancer assets, while Regeneron got in the obesity game; AstraZeneca, Gilead and Amgen shone at ASCO; RFK Jr. and the CDC appeared to disagree over COVID-19 vaccine recommendations and several news outlets are questioning the validity of the White House’s Make America Healthy Again report.
HHS Secretary RFK Jr. removes the COVID-19 vaccine recommendation for healthy kids and pregnant women—the latest in a string of changes to vaccine policies; judge issues an order to halt HHS’ reorganization and mass layoff plans; Rocket Pharmaceuticals’ pivotal Danon disease trial is on hold after a patient death; and President Trump has named Mehmet Oz to spearhead his Most Favored Nation drug pricing policy.
Job Trends
Merck, known as MSD outside of the United States and Canada, announced that Jannie Oosthuizen, president, Human Health U.S., is scheduled to participate in a fireside chat at the Barclays 26th Annual Global Healthcare Conference on Tuesday, March 12, 2024, at 3:05 p.m. EDT.
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SPECIAL EDITIONS
A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
Year-over-year BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the first quarter of 2025.
DEALS
  1. In its third acquisition this month, Eli Lilly is buying antibody-drug conjugates startup Emergence Therapeutics to bolster its cancer business.
  2. Eli Lilly announced Thursday it will acquire former collaborative partner Sigilon Therapeutics to deepen its diabetic foothold with a potentially functional cure for Type 1.
  3. Despite a challenging economic climate and gloomy forecast, 2023 has still notched some mega-deals for biopharmas. BioSpace highlights the biggest deals in the industry this year.
  4. The acquisition of the privately-held company will bring its novel, investigational beta-lactamase inhibitors and other antimicrobials into the Japanese pharma’s pipeline.
  5. Banking on its lead antibody APG777 for atopic dermatitis, Apogee Therapeutics is filing an initial public offering for an as-yet-undisclosed value.
WEIGHT LOSS
  1. While GLP-1 drugs have exploded in popularity, they don’t work for everyone, and experts say phenotyping based on a greater understanding of the disease is the future of obesity treatment.
  2. Over the past year, obesity treatments have become the focus of intense media attention and discussion in healthcare — with increased focus on Wegovy and Zepbound. This attention has highlighted the need to address the global obesity epidemic.
  3. Eli Lilly has signed a multi-year contract with animal genomics biotech Fauna Bio to use its artificial intelligence platform to discover drug targets for obesity in a deal worth nearly half a billion dollars.
  4. A GLP-1-based drug from Structure Therapeutics shows clinical promise but not enough for some on Wall Street.
  5. The study found only 19% of nearly 2,000 patients were still taking their prescribed anti-obesity medication at 12 months, compared to 40% that continued with Novo Nordisk’s Wegovy.
POLICY
  1. The PR departments of Chinese CDMOs affected by the BIOSECURE Act and their U.S. partners must step up to ensure proposed legislation doesn’t squash innovation.
  2. Following its recent about-face on the BIOSECURE Act, designed to combat China’s influence in the biopharma industry, lobbying group Biotechnology Innovation Organization in a realignment is laying off 30 employees.
  3. FDA
    The regulator on Monday approved two interchangeable biosimilars to Regeneron’s Eylea, providing additional competition for the pharma’s blockbuster as key patent protections are set to expire.
  4. The European Patent Office last week upheld one of Moderna’s key patents, handing the biotech an important victory in its protracted COVID-19 vaccine battle with Pfizer and BioNTech.
  5. Pfizer’s Wyeth unit notched a legal victory over AstraZeneca on Friday as a federal jury found the British-Swedish company violated two key patents in developing and marketing its lung cancer drug Tagrisso.
CAREER HUB
Here is how you can land a job at one of the biggest pharmaceuticals in the world.
Interview practice will help you reduce interview anxiety, improve your interview skills, and in many cases, gain important feedback about how you interview.
While many job seekers are unnerved by the “Tell me about yourself” request, it’s actually an opportunity to shine and take control of the interview.
What will it take to motivate the employer to hire you, or at least invite you back for a second interview?
Experts differ on how direct job seekers should be in closing the sale. Some say candidates miss opportunities if they don’t come right out and ask for the job. Others say a hard sell doesn’t work in this situation.
Here are a few ways to amplify your job search that can help you make significant progress.
Be ready by anticipating and countering objections the employer might raise.
HOTBEDS
Where are the Best Places to Work in life sciences? BioSpace’s annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace - find out who made the list this year.
IN CASE YOU MISSED IT
On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s oral cancer drug for a pair of rare tumors.
REPORTS
In this Employment Outlook report, BioSpace explores current workforce sentiment, job activity trends and the prospective job and hiring outlook for 2025, particularly as it compares to the previous year.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
CANCER
  1. 2024 began with several biopharma players posting positive Phase III data that could mean new market share for the companies and longer survival times and quality of life for patients.
  2. Following disappointing Phase III results in less aggressive non-small cell lung cancer, AstraZeneca on Friday announced that Imfinzi improved progression-free and overall survival in patients with limited-stage small cell lung cancer.
  3. Seeking a potential slice of the challenging KRAS market, Merck has launched a Phase III NSCLC trial of its oral G12C inhibitor MK-1084, in combination with Keytruda, in pursuit of Amgen and Bristol Myers Squibb.
  4. Following clearer overall survival data from the PSMAfore trial, Novartis on Thursday affirmed plans to file for a prostate cancer label expansion for its targeted radioligand therapy Pluvicto later this year.
  5. Genmab announced Wednesday it is buying ProfoundBio and its pipeline of next-generation antibody-drug conjugates being developed for gynecologic cancers and other solid tumors.
NEUROSCIENCE
  1. After an FDA advisory committee unanimously recommended Leqembi’s full approval, questions linger around amyloid-related imaging abnormalities and a potentially cumbersome patient registry.
  2. Neurologist David Weisman, with financial ties to the companies, was removed from the FDA’s upcoming advisory committee meeting slated to consider Leqembi’s traditional approval.
  3. The FDA has three high-profile events this week, including one target action date and two advisory committee meetings—one to discuss potential traditional approval for Alzheimer’s drug Leqembi.
  4. While donanemab showed impressive results in Phase III TRAILBLAZER-ALZ 2, concerns regarding its safety remain compared with Biogen’s and Eisai’s Leqembi.
  5. The amyloid plaque targeting therapy met primary endpoint and all secondary endpoints, which Lilly will use in its submission to the FDA this quarter.
CELL AND GENE THERAPY
  1. Avidity has been given the go-ahead by the FDA to request accelerated approval of delpacibart braxlosiran—potentially the first disease-modifying treatment for facioscapulohumeral muscular dystrophy—with an application in the second half of 2026.
  2. In a roundtable event on Thursday, HHS Secretary Robert F. Kennedy Jr. said his office will work to eliminate barriers that keep cell and gene therapies from the market.
  3. Interim results from a small group of children in a Phase I/II trial are essentially in line with that of Elevidys, according to BMO Capital Markets analysts.
  4. The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug development and review process, particularly for rare diseases.
  5. J&J has a multi-year head start, but Gilead believes it can win market share by delivering a drug with better safety and at least as good efficacy.