FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly’s tirzepatide and Novo’s semaglutide “regularly or in inordinate amounts” at a site with “insanitary conditions.”
Analysts were keen to see a new modality compete with Roche’s approved drug Lucentis in the late-stage trial but new safety issues could complicate the future for Merck’s candidate.
The weekly insulin Onswik will now be available to U.S. patients after initial approvals in Europe, Mexico and Japan.
Basecamp Research joins the growing group of AI-forward biotechs that in recent months have brought in notable sums from investors, including Isomorphic Labs and Enveda.
The new partnership follows Roche’s recent R&D expansion in Boston focused on development for cardiovascular, renal and metabolic diseases.
InnoCare Pharma is the latest addition to Eli Lilly’s dealmaking spree, which includes some of the biggest acquisitions this year: up to $7 billion for Kelonia Therapeutics in April and up to $7.8 billion for Centessa Pharmaceuticals in March.
After imeroprubart failed to demonstrate sufficient efficacy in lupus during a Phase 2b trial, Immunovant is moving on from the indication and looking to other high priority programs for the drug in neurology, endocrinology and rheumatology.
FEATURED STORIES
Kyverna Therapeutics’ miv-cel showed improved mobility and a favorable safety profile at one year in patients with stiff person syndrome, further derisking an upcoming FDA application, William Blair said on Thursday. The biotech plans to file for priority review this year.
IPO
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
As molecule complexity rises, advanced cell line development platforms are giving biopharma companies new tools to overcome expression challenges, improve stability and reach the clinic faster.
After achieving clinical validation earlier this year, ReCode Therapeutics has called up a new CEO to take on the mission of advancing programs for cystic fibrosis and primary ciliary dyskinesia through the clinic.
As Chinese companies push beyond “me-too” drugs and the country lays out a new five-year plan targeting a $522 billion–strong biotech industry by 2030, experts say more predictable funding and regulation could help the U.S. maintain its edge.
With a trillion-dollar market cap and a wildly successful GLP-1 portfolio, Eli Lilly isn’t resting on its laurels. At the Psych Congress 2026, the company presented early-stage data that could support the potential of its next-gen GLP-1 and GIP receptor agonist to treat diseases far beyond obesity.
FROM BIOSPACE INSIGHTS
This guide explores the evolving role of podcasts, webinars, and thought leadership programs in biopharma and provides practical recommendations for public relations agencies, corporate communications teams, and commercial marketers looking to elevate their visibility and influence.
UPCOMING EVENTS
LATEST PODCASTS
In this episode of Denatured presented by Curium, Jennifer Smith-Parker speaks to Mike Patterson, CEO North America and Professor Sabine Brookman-May, vice president and head of Global Clinical Development. We look at the momentum behind radioligand therapy and how its diagnostic and therapeutic capabilities are improving care for more than 14 million patients worldwide.
FDA
Novo plans to hit $23B in revenue by 2035, has further reduced its workforce by 4,000 and is boosting manufacturing capacity for its Wegovy pill, but investors are unconvinced it will be enough to turn things around; Viking Therapeutics and Roche report positive results for their weight loss assets; Ultragenyx snags FDA approval for its Sanfilippo syndrome gene therapy; IPOs keep on coming.
In this episode of Denatured, you’ll hear Philip Jacob Rosenfeld, professor of Ophthalmology at the University of Miami Health System and Bascom Palmer Eye Institute, and Wesley Jackson, chief science officer at Valitor. We talk about the eye condition call wet age-related macular degeneration (AMD), the limits of anti‑VEGF therapy and the push for true durability to change a patient’s life.
Job Trends
Follow along as BioSpace tracks job cuts and restructuring initiatives.
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SPECIAL EDITIONS
As Big Pharma adds AI technology to bolster drug development, a cadre of new, upstart biotechs are pushing drug discovery to new heights.
BioSpace takes stock of the psychedelic therapeutics space, which is once again on the cusp of its first FDA approval.
Job postings increase and competition dips, according to BioSpace data.
DEALS
  1. Tech darling Enveda has raised a total of $845 million in the past six years. The latest funding round is intended to pave the way for an IPO someday.
  2. Amgen is awaiting another Phase 3 readout for the investigational Sjögren’s disease therapy, set for later this year. William Blair anticipates that at least two trials will be needed to support an FDA application.
  3. Novartis is the current radiopharma leader with two FDA-approved therapies in Pluvicto and Lutathera.
  4. Envisagenics’ platform makes use of AI to screen and detect cancer-specific RNA alterations, which Boehringer Ingelheim wants to target through various precision treatment modalities, including multi-specific antibodies, antibody-drug conjugates and T cell engagers.
  5. Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
WEIGHT LOSS
  1. FDA
    Novo plans to hit $23B in revenue by 2035, has further reduced its workforce by 4,000 and is boosting manufacturing capacity for its Wegovy pill, but investors are unconvinced it will be enough to turn things around; Viking Therapeutics and Roche report positive results for their weight loss assets; Ultragenyx snags FDA approval for its Sanfilippo syndrome gene therapy; IPOs keep on coming.
  2. Viking Therapeutics’ VK2735 met Truist’s “best-case scenario,” with robust weight loss that was largely maintained when patients transitioned to less frequent dosing. Viking’s stock popped more than 30% on Tuesday.
  3. With sales of the oral GLP-1 medicine rising quickly, executives reassured investors that Novo has secured production capacity to support continued growth.
  4. The mid-stage readout is one link in a chain of catalysts that analysts were watching for this year from Roche’s metabolic pipeline, which features assets from the $2.7 billion acquisition of Carmot Therapeutics as well as partner Zealand Pharma.
  5. Novo has “gone shopping” to fill pipeline gaps, with a focus on obesity and diabetes, plus an expansion in blood and endocrine disorders, liver diseases and cardiovascular conditions.
POLICY
  1. Inspection access is not “an administrative footnote,” leaders of key FDA divisions wrote in an editorial on Wednesday vowing to expand oversight of foreign clinical trial sites.
  2. CSL Vifor holds the marketing authorization for Tavneos in the U.K., where the drug is marketed as Avacopan Vifor. It continues to be sold on the U.S. market by Amgen despite concerns raised by the FDA.
  3. Astellas Pharma, BridgeBio, BeOne Medicines and six other large biotechs join the 17 Big Pharmas that previously signed on to President Donald Trump’s Most Favored Nation (MFN) drug pricing program, representing some 89% of the branded drug market.
  4. The U.S. is scrambling to compete with a strategically positioned China on the biotech stage as the Asian country surpasses America in biomedical research and clinical trials. So far, China is winning.
  5. The current classifications of vaccine recommendations could imply that not all shots require the consent of patients or their parents, according to Health Secretary Robert F. Kennedy Jr.
CAREER HUB
Newly permanent CBER and CDER directors Karim Mikhail and Michael Davis are widely expected to continue the FDA’s efforts toward an adaptive framework for rare disease therapies. If approved by the Senate, will commissioner nominee Heidi Overton stay the course?
A career setback can teach you something useful—or teach you the wrong lesson. Executive coach Angela Justice explains how one difficult experience can quietly shape the choices that follow.
Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you.
With U.S. data science jobs projected to grow 35% over the next decade, a recruiter and talent strategy director discuss the qualifications, technical skills and mindset needed to land these coveted positions.
Funding announcements can signal future hiring activity, giving biotech professionals a chance to build relationships before positions are posted. Industry experts share how to identify the funding events, milestones and company indicators most likely to lead to new jobs.
An executive who is rarely short on ideas needs someone to pull their big ideas through to implementation. Kaye/Bassman’s Michael Pietrack explains why this person, who he calls the implementer, may be the most important hire in the building.
A missed promotion can feel like a verdict on your potential. But people and organizations do not always develop at the same pace. Executive coach Angela Justice breaks down what a missed promotion is actually telling you—and what it isn’t.
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
Aside from its manufacturing and distribution footprint, ITM Isotope Technologies Munich will give Telix Pharmaceuticals the late-stage ITM-11, being developed for gastroenteropancreatic neuroendocrine tumors. The asset was rejected by the FDA last month for manufacturing concerns.
REPORTS
Gain the latest insights into the biopharma hiring landscape with BioSpace’s Biopharma Job Market Report Q2 2026. Explore the trends shaping talent acquisition, from rising job postings and sustained R&D hiring to the market activity signaling stronger hiring demand ahead.
Opportunities increased by the end of the first quarter, according to BioSpace data.
In this whitepaper, BioSpace reviews the major trends impacting the CDMO sector and the evolving relationship between sponsors and providers. We examine the key qualities pharma and biotech should consider in CDMO selection, and how the macroeconomic and macrodevelopment factors affecting the space play a role in this selection.
CANCER
  1. In this episode of Denatured presented by Curium, Jennifer Smith-Parker speaks to Mike Patterson, CEO North America and Professor Sabine Brookman-May, vice president and head of Global Clinical Development. We look at the momentum behind radioligand therapy and how its diagnostic and therapeutic capabilities are improving care for more than 14 million patients worldwide.
  2. FDA
    Citing the urgent unmet need for patients with advanced biliary tract cancer, Compass Therapeutics will continue to seek an approval path for its drug after the FDA recommended the biotech conduct a new clinical study.
  3. Bristol Myers Squibb acquired the degrader-antibody conjugate from Orum Therapeutics in 2023 for $100 million upfront and the possibility of up to $80 million more in milestones.
  4. FDA
    The FDA held a public forum on Monday to discuss the future of psychedelic therapeutics, followed by a meeting on Wednesday regarding recommendations for reauthorizing the Prescription Drug User Fee Act the day after launching its TrialBlazer initiative. Meanwhile, Definium Therapeutics notched another late-stage trial win for its LSD drug, and Novartis continues to reel from the company’s triple asset stumble.
  5. A growing number of biotechs are entering the market with newly launched medicines, a pattern indicative of “improving capital markets,” according to Jefferies’ Andrew Tsai.
NEUROSCIENCE
  1. ALS
    Ulefnersen, an RNA-targeted therapy being developed by Ionis Pharmaceuticals and Otsuka Pharmaceutical, improved measurements of functional impairment and survival in patients with a rare, genetic ALS subtype in a Phase 3 trial. The partners plan to approach the FDA with the results to determine potential pathways for approval.
  2. As Xenon Pharmaceuticals announced that azetukalner has reached the FDA for focal seizures, the company also disclosed the emergence of psychosis adverse events in psychiatric trials of the drug, triggering a temporary pause.
  3. Novartis stands alongside Big Pharma peers that have similarly invested in technologies to penetrate the blood-brain barrier, including GSK, Roche and Eli Lilly.
  4. ALS
    The TREM2 stabilizer failed to show efficacy in a Phase 2 trial of patients with early-stage ALS. This development follows two late-stage trial failures reported by Novartis last week, plus the news that the pharma has paused multiple CAR T cell trials following patient deaths.
  5. Positive topline results from a second straight study in generalized anxiety disorder shift the narrative for Definium Therapeutics’ DT120 to commercialization, Jefferies analysts said Monday, while Stifel wrote that the asset is moving towards an FDA submission.
CELL AND GENE THERAPY
  1. The market approval for Fayuvi, which was rejected in 2025 due to manufacturing problems, comes shortly after Ultragenyx got the FDA nod for its first gene therapy last month.
  2. Blood centers have the donors, resources and community footprint drug sponsors need to solve supply chain issues around cell and gene therapies.
  3. Encoded Therapeutics’ lead asset ETX101 is a gene therapy being tested for Dravet syndrome. Phase 1/2 data showed substantial reductions in seizures.
  4. In this episode of Denatured, sponsored by SK pharmteco, Jennifer Smith-Parker speaks to Arvind Singh, vice president and global head of supply chain. In this episode, we explore how CDMOs are reshaping supply‑chain strategy for a new generation of complex modalities.
  5. FDA
    September has been a rough month already for Novo Nordisk, which canned two more late-stage trials of its embattled IL-6 inhibitor, and Novartis, which took Phase 3 hits in both cardiovascular and muscular dystrophy indications; Ultragenyx’s big bet in Angelman syndrome failed to yield benefit in Phase 3 but Ionis’ Pharmaceuticals nabbed the first targeted approval for Alexander disease; and on the business side, biopharma investment is back in a big way.