Traditionally carrying a dire prognosis, the treatment paradigm for multiple myeloma is changing, with CAR T therapies, bispecifics and more contributing to multifaceted regimens unique to each patient’s needs.
The funding, which follows the $176 million the government awarded Moderna in June 2024, aims to get mRNA vaccines ready before bird flu strains currently circulating in the wild and on farms can potentially cause human outbreaks.
In this bonus episode, BioSpace’s vice president of marketing ⁠Chantal Dresner⁠ and careers editor ⁠Angela Gabriel⁠ take a look at Q4 job market performance and what we expect to see ahead.
BioSpace has revealed its 2025 Hotbed Maps, showcasing nine regional hot spots for life sciences activity.
Datroway, formerly known as Dato-DXd, significantly improved median progression-free survival in a Phase III study but failed to do so for overall survival.
IPO
While some analysts expect the 2025 IPO market to be relatively cool in the near-term, others anticipate more bids than in 2024.
FDA
The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the 15 products to be subject to IRA-prescripted price negotiations for Medicare this year.
FEATURED STORIES
As the year gets underway, analysts and biotech executives highlight cell therapy’s pivot from oncology to autoimmune diseases, a continued appetite for next-generation obesity drugs and an increased focus on neuromuscular, kidney and cardiovascular diseases.
Even before the FDA’s recent approval of Dato-DXd in breast cancer, analysts predicted sales of the antibody-drug conjugate could hit $5.9 billion in 2030. However, the asset faced a series of setbacks in 2024.
There are currently no treatments available for celiac disease beyond a gluten-free diet. Several late-phase companies aim to change the paradigm and deliver hope and progress soon.
FROM BIOSPACE INSIGHTS
Eli Lilly and Company has invested more than $20 billion in its manufacturing capabilities since 2020 to help meet high demand for its medicines. Its recently announced Lilly Medicine Foundry—which will support research and development efforts—is just the latest example of the ability to research new ways of producing medicines, while also scaling up manufacturing of medicines for clinical trials.
LATEST PODCASTS
In this bonus episode, BioSpace’s vice president of marketing ⁠Chantal Dresner⁠ and careers editor ⁠Angela Gabriel⁠ take a look at Q4 job market performance and what we expect to see ahead.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis talks to Dr. Peter Marks, Director, CBER about his thoughts on the future of cell and gene therapies.
J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference. Meanwhile, Biogen proposes to acquire struggling neuro partner Sage, and obesity dominates discussions as Pfizer goes “all in.”
Job Trends
2024 was a tough year for the biopharma industry, with several companies cutting hundreds or even thousands of employees. Follow along as BioSpace tracks job cuts and restructuring initiatives throughout 2025.
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SPECIAL EDITIONS
In this deep dive BioSpace explores the opportunities and challenges presented by the FDA’s accelerated approval program.
Year-over-year BioSpace data shows there are fewer job postings live on the website and far more competition for them.
On election day, Tuesday, November 5, Americans will choose between former President Donald Trump and current Vice President Kamala Harris for their next president. The election will also see the rearrangement of Congress.
DEALS
  1. Biopharma executives make their predictions for the year ahead, from a bold forecast for the return of the megadeal to a plea for the slow, healthy recovery of the industry at large.
  2. While investors and analysts push for a deal, Biogen CEO Chris Viehbacher and Head of Development Priya Singhal refuse to make one out of desperation.
  3. J.P. Morgan kicked off with a flurry of deals, with Eli Lilly, GSK and Gilead all announcing deals potentially worth more than $1 billion while J&J committed $14.6 billion to buy Intra-Cellular. These moves have reinvigorated sentiment across the biopharma industry.
  4. In exchange for its investigational gene therapies, Regenxbio will receive $110 million upfront and up to $700 million in milestones. After hitting an all-time low of $6.95 at close of business yesterday, the stock surged on the news by nearly 20% before markets opened Tuesday.
  5. The multi-billion deal, in which Eli Lilly will acquire Scorpion Therapeutics’ STX-478 program, is a shot in the arm for PI3K treatments, which have had a mixed history over the past few years.
WEIGHT LOSS
  1. The data suggest the high dose nearly closes the efficacy gap with Zepbound.
  2. JPM25 is in full swing as several pharma powerhouses—including Merck, Lilly and Amgen—detail their strategies for growth in the coming year.
  3. The updated guidance, which was largely driven by lower-than-anticipated sales of GLP-1 blockbusters Mounjaro and Zepbound, sent Eli Lilly’s shares cratering by as much as 8% Tuesday, even as the company forecasted robust 2025 revenue.
  4. Biopharma executives were busy Monday, striking high-value deals and providing updates on cancer, obesity and vaccine pipelines.
  5. Obesity continues to grab attention at the J.P. Morgan Healthcare Conference in San Francisco, with both Pfizer and Kailera Therapeutics outlining their plans in the space moving forward.
FDA
  1. The Phase III CodeBreaK 300 study returned disappointing overall survival data for Lumakras plus Vectibix in metastatic colorectal cancer, but in its approval announcement, the FDA pointed to significant improvements in progression-free survival, calling it the “major efficacy outcome” of the trial.
  2. Atara Therapeutics’ Ebvallo, already marketed in Europe for a transplant-related blood cancer, will not hit the U.S. market just yet, forcing the company to “significantly reduce expenses.”
  3. After a series of strongly worded letters—one of which was addressed directly to Commissioner Robert Califf—the FDA has publicly laid out its reasoning for rejecting Vanda Pharmaceuticals’ gastroparesis drug candidate tradipitant.
  4. Omvoh’s label expansion is important progress for Eli Lilly as it works to diversify its portfolio beyond obesity, according to analysts from BMO Capital Markets.
  5. An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena.
CAREER HUB
Job postings in California took a dip in December during the holiday period, but activity is expected to pick up in January.
Businessman and entrepreneur Mark Cuban recently discussed leadership with Leadership Lab columnist Michael Pietrack. The three lessons that came out of that conversation start with one word: caring.
When hiring job candidates to work on cell and gene therapies, companies look for more than just technical skills. Talent acquisition executives from Bristol Myers Squibb and Intellia Therapeutics offer an inside look at what they want in an employee.
Learn how to leverage your end-of-year downtime to document achievements, update your professional presence and prepare for a successful 2025.
Based on how President-elect Donald Trump’s first administration handled immigration, experts are concerned about how his second term will impact foreign-born biopharma professionals. Two immigration attorneys discuss what may be ahead, including increased difficulty getting work visas.
At Drexel University’s Graduate School of Biomedical Sciences and Professional Studies, graduate students and active professionals can take interdisciplinary, career-oriented programs designed to help launch their careers and take them to the next level.
Massachusetts’ increased investment in the life sciences industry includes boosting its life sciences tax incentive program by $10 million annually, aiding job creation in the state.
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
Drugmakers will have until the end of February to decide whether they want to participate in the second round of Medicare negotiations or not. CMS has until June 1 to send an initial offer for the adjusted prices.
REPORTS
This report investigates anticipated job search activity and hiring outlook for the remainder of 2024.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
BioSpace’s 2024 Salary Report explores the average salaries and salary trends of life sciences professionals.
CANCER
  1. In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis talks to Dr. Peter Marks, Director, CBER about his thoughts on the future of cell and gene therapies.
  2. Annemarie Hanekamp has overseen some of the most transformative changes in oncology over her years in Big Pharma. Now, she will oversee BioNTech’s transition from a COVID-19 vaccine maker to an “end-to-end organizational oncology powerhouse.”
  3. The positive trial results could help Regeneron cushion the blow of its disappointing fourth-quarter sales for Eylea, which exceeded the consensus by a modest 1% and are bogged down by the slow conversion of patients to the high-dose formulation.
  4. On the heels of an FDA approval for its monoclonal antibody Bizengri, Merus will generate three novel cancer-targeting antibodies that it will pass over to Biohaven to link into antibody drug-conjugates.
  5. The first major deal of JPM 2025 will give GSK a promising small molecule drug for gastrointestinal stromal tumors.
NEUROSCIENCE
  1. AbbVie and Gilead are going back to their roots and leaning on their established areas of expertise to set themselves up for sustainable success in 2025.
  2. Amidst a “renaissance” of interest in neuropsychiatry, Seaport’s executive team is taking nothing for granted.
  3. J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference. Meanwhile, Biogen proposes to acquire struggling neuro partner Sage, and obesity dominates discussions as Pfizer goes “all in.”
  4. Lykos Therapeutics is currently working out ways to fund an additional Phase III study for its MDMA-assisted PTSD therapy following an FDA setback last year.
  5. The FDA accepted Biogen and Eisai’s BLA for a subcutaneous administration of the anti-amyloid antibody Monday as the partners await the regulator’s decision on a new intravenous regimen following an underwhelming launch riddled with coverage and accessibility barriers.
CELL AND GENE THERAPY
  1. Along with its gene editing therapy Casgevy, Vertex is offering fertility preservation support for its patients—a program that the HHS claims violates anti-kickback statutes.
  2. Sarepta Therapeutics’ Duchenne muscular dystrophy therapy Elevidys handily beat analysts’ expectations in the fourth quarter of 2024, reflecting the biotech’s “world-class” execution, according to BMO Capital Markets analysts.
  3. Benefiting from technological and conceptual groundwork and positive early data, gene therapies are advancing in the clinic for cardiovascular diseases including congestive heart failure, chronic refractory angina and cardiomyopathy.
  4. FDA
    Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming particularly in the oncology and neurosciences spaces.
  5. In this short teaser, BioSpace’s Head of Insights Lori Ellis talks to CBER Director Peter Marks and Tom Whitehead, Co-Founder of the Emily Whitehead Foundation about anticipated discussions at the upcoming GenScript Biotech Forum.