The FDA’s Oncologic Drugs Advisory Committee narrowly voted against the approval of Zusduri, citing the lack of a completely randomized study to back up the application.
Bioinformatics is on the rise, forecasted to grow by about $16 billion from 2024 to 2029 given its value to managing mass datasets critical to modern drug discovery and development. Two talent acquisition experts share how the field has evolved in the past few years and which skills are most in demand.
Novartis is falling farther behind AbbVie, which expanded its JAK inhibitor Rinvoq into giant cell arteritis in April.
RSV
Health Secretary Robert F. Kennedy Jr. endorsed the expanded use of RSV vaccines for people 50 through 59 years old who are at risk of severe disease.
While it trails Johnson & Johnson’s Tecvayli, Regeneron still hopes Lynozyfic can differentiate in terms of dosing convenience and efficacy.
An open letter signed by more than 50 industry executives blasts a “fundamentally, fatally flawed” report that urges greater restrictions on the abortion pill.
The women’s health focused company acquired the drug for up to $954 million in 2021 through the acquisition of Forendo Pharma.
FEATURED STORIES
A suit against Novartis and Vitaris by Henrietta Lacks’ estate hinges on questions about the morality and legality of using the line for biopharmaceutical research.
Multiple players are exploring whether modalities designed to combat B cell malignancies can be repurposed against lupus, myasthenia gravis and other conditions traced to misdirected immune response.
This year has seen several biopharma companies drop Alzheimer’s and Parkinson’s disease programs, but experts say plenty are still chasing these multi-billion-dollar markets.
While some of the initial excitement around immunotherapies has waned, companies—particularly smaller biotechs—are developing newer iterations that will take cancer care to the next level.
Lilly CEO Dave Ricks in Wednesday’s third-quarter earnings call acknowledged that the company is at the mercy of wholesaler stocking decisions.
Big-name venture capital firms are raising billions again, though funding a small number of de-risked companies. Meanwhile, smaller VC firms are catching the less flashy companies they think could be future pillars of the sector.
FROM BIOSPACE INSIGHTS
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. This webinar will show leaders how strategic insights and targeted outreach can turn awareness into high-converting leads. Watch now.
LATEST PODCASTS
How can startup leaders support long-term sustainable growth and investment? BioSpace’s Lori Ellis speaks with venture capital guests Ansbert Gadicke, Martin Gershon and Mike Goguen for their advice and recommendations on how biopharma startups should approach funding.
What needs to happen for funding in biopharma to bounce back? BioSpace’s Lori Ellis discusses the macroeconomic environment and biopharma funding outlook with venture capital guests Ansbert Gadicke, Martin Gershon and Mike Goguen.
FDA
This week, we discuss the two major FDA approvals for sickle cell from Vertex/CRISPR and bluebird bio; Axcella and the future of long-covid treatments, Vanda’s $100m purchase and AI regulatory developments in Europe.
Job Trends
Strategic collaboration to leverage BigHat’s AI/ML (Artificial Intelligence / Machine Learning) guided Milliner™ platform to design high-quality next-generation protein therapeutics.
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SPECIAL EDITIONS
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
DEALS
  1. Follow along as BioSpace keeps you up to date on the latest pharma and biotech M&As, from announcements to closings.
  2. Companies inked 204 deals in the fourth quarter of 2023 with venture capital funding slipping to $6.3 billion from $7.8 billion in the third quarter last year, according to market data firm Pitchbook.
  3. After oncology and neuroscience headlined biopharma investment in 2023, experts anticipate increased interest in the autoimmune and obesity spaces this year.
  4. Antibody-drug conjugates are a breakthrough in targeted cancer therapy and will continue to attract big pharma investment over the next few years, finds a new report from market intelligence firm Evaluate.
  5. After a slow start to 2023 in an uncertain economic climate, biopharma mergers and acquisitions are on the rise.
WEIGHT LOSS
  1. Second-quarter earnings season continues with Big Pharma beating Wall Street expectations, the author of an encrypted email sent to BioSpace has a proposal for Moderna and Merck, Roche and Viking seek quicker entry to the obesity market, and AAIC is in full swing.
  2. The regulator on Friday warned healthcare providers and patients about adverse events linked with dosing errors from compounded versions of Novo Nordisk’s weight-loss and diabetes drugs.
  3. Encouraged by the potential of the weight-loss candidates acquired from Carmot Therapeutics, Roche will speed up the development of its obesity programs, seeking to differentiate itself in the market.
  4. With promising Phase II data in hand, Viking Therapeutics is pushing its subcutaneous GLP-1/GIP receptor dual agonist into late-stage development, the company announced on Wednesday.
  5. Despite early 2024 optimism, BioSpace’s Job Market Trends report outlines a still sluggish situation in the biopharma industry, Novartis and J&J announce Q2 earnings, GLP-1 market leaders expand into China and the Cassava Sciences saga continues.
POLICY
  1. According to BMO Capital Markets, Medicare coverage of Lilly’s Zepbound opens the door to using secondary indications to secure CMS coverage for obesity drugs.
  2. Eli Lilly’s request to intervene in a suit filed by compounding pharmacies against the FDA reflects a belief the outcome could affect its business and that the FDA does not adequately represent its interests.
  3. Other notable greenlights this year include Bristol Myers Squibb’s Cobenfy, the first novel therapeutic for schizophrenia in 35 years, and Madrigal Pharmaceuticals’ Rezdiffra, the first-ever treatment for MASH.
  4. AbbVie’s blockbuster Humira held 105 patents, shielding the anti-inflammatory drug from biosimilar competition for more than 20 years. Proposed reforms could help prevent companies from extending exclusivity with such patent thickets.
  5. Now that they’ve received the go-signal from both U.S. and EU anti-trust regulators, Novo Holdings and Catalent expect to wrap up their deal in the coming days.
CAREER HUB
Let’s review the six tips for finding work during the coronavirus pandemic.
To help you kick off your yearly goal planning, we put together a series of prompts to get your brain mulling over achievable goals to set for 2021.
Use these ways to immediately make the a new co-worker feel at ease.
There are a few lessons from the pandemic about the work which everyone should learn to be more productive. We have compiled the list of them. So let’s take a look.
Think about why you are the best candidate for the position and sell yourself. Here are a few ways to do that.
How do you find success (and not feeling like you’re drowning) when you have to onboard to a new job virtually? We have a few ideas.
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
An interview with Philip Vanek, chief commercialization officer of the International Society for Cell & Gene Therapy (ISCT), reveals both promising developments and significant concerns shaping the advanced therapies sector’s trajectory through 2025 and beyond. This interview was conducted with support from Tozaro.
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. Thursday’s agreement with Orano Med is the second in as many months. Sanofi in September made its first foray into the radioligand space with a $110 million licensing deal with Orano Med and Texas biotech RadioMedix.
  2. Jazz Pharmaceuticals contends that its alkylating agent Zepzelca significantly improved both overall survival and progression-free survival in patients with extensive-stage small cell lung cancer, when used as a front-line maintenance therapy with Roche’s Tecentriq.
  3. Sales of Johnson & Johnson’s oncology drugs jumped nearly 19% in the third quarter, driven by cancer treatment Darzalex which brought in more than $3 billion.
  4. The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT inhibitor for use alongside insulin in type 1 diabetes and chronic kidney disease.
  5. FDA
    Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.
NEUROSCIENCE
  1. Active immune therapies hold promise for preventing or slowing disease onset, but some experts warn of potential safety risks.
  2. Eisai presented a plethora of data on the drug at the Alzheimer’s Association International Conference, including a study showing the consequences of pausing treatment.
  3. Sangamo and Pfizer’s hemophilia A gene therapy candidate scored a Phase III victory last week. However, with the genomic medicine company soon to run out of cash, Sangamo’s short-term prospects look bleak but not unsalvageable, analysts say.
  4. Cognitive function in the liraglutide cohort declined 18% slower than in the placebo arm over one year of treatment, researchers announced Tuesday at the Alzheimer’s Association International Conference.
  5. The European Medicines Agency’s Committee for Medicinal Products for Human Use found that Leqembi’s benefits do not outweigh the risks of severe side effects associated with the treatment.
CELL AND GENE THERAPY
  1. AAVs and accelerated approval are just two of the topics being discussed at ASGCT. Meanwhile, the race between Vertex and bluebird bio’s gene therapies Casgevy and Lyfgenia is heating up.
  2. The FDA is looking at four decision deadlines in the coming three weeks, including two for a CAR-T therapy and another for a hepatitis B vaccine.
  3. In a joint conference event on Monday, cell therapy pioneer Carl June revealed unpublished results showing that in around 1,500 patients treated with CAR-T therapies, no cases of secondary malignancy could be definitively linked to the treatment.
  4. BioSpace will be in attendance at the American Society of Gene & Cell Therapy’s 27th annual meeting, along with thousands of others. Stay with us for updates throughout the week.
  5. Cell and gene therapy company Cellectis announced Monday it has completed a $140 million investment from AstraZeneca that extends the biotech’s cash runway into 2026.