Imlifidase, an IgG-destroying enzyme, could receive FDA approval in the second half of 2026 and hit peak sales of $306 million, according to William Blair.
Phase III data showed that Inluriyo improves progression-free survival versus standard endocrine therapy.
Companies that have broken ground on or are actively constructing manufacturing facilities in the U.S. are exempted from the tariffs, according to President Donald Trump’s social media post on Thursday.
Though details remain scant, the pending order is expected to be the latest effort in President Donald Trump’s campaign to bring drug prices down to the same level as economically similar countries.
The regulatory greenlight was backed by two Phase III trials that showed normalized growth hormone levels in patients with the rare pituitary condition. It’s the first approval for Crinetics Pharmaceuticals and something CEO Scott Struthers predicted “will transform people’s lives.”
Looking for a biopharma job in Pennsylvania? Check out the BioSpace list of six companies hiring life sciences professionals like you.
FEATURED STORIES
Drug pricing, budget cuts, tariffs and other shifts under the Trump administration undermine the biopharma and healthcare ecosystem.
The Inflation Reduction Act includes an exemption for orphan drugs for a single indication, but experts say this is far from sufficient to maintain momentum in the rare disease space.
In advance of this week’s CDC vaccine advisory meeting, HHS Secretary Robert F. Kennedy Jr. restacked the committee, claiming problematic industry ties within the previous group. Experts say ACIP had long navigated COIs appropriately and that the new appointees risk the apolitical nature of membership.
On the sidelines of BIO2025, Julie Gilmore, head of Lilly Gateway Labs, shares her thoughts on the $1.3 billion Verve Therapeutics buy, where Lilly’s therapeutic puck is potentially going and how the company is leveraging its unprecedented success in obesity to support young biotechs.
EY’s 2025 Biotech Beyond Borders report provides a sobering snapshot of the industry’s financial health, with more and more companies facing cash runways of less than one year. The analyst firm’s leaders urge a return to basics for biotech.
Industry watchers responded mostly positively to the commissioner’s new voucher program, but worries remain over staffing cuts at the agency.
LATEST PODCASTS
Novartis, Eli Lilly and more put on their deal-making caps, Bristol Myers Squibb targets $2 billion in savings through 2027, sales continue to soar for Lilly and Novo Nordisk’s GLP-1s and Regeneron sues Sanofi over an alleged failure to provide adequate information about Dupixent sales.
Robert F. Kennedy Jr.’s HHS nomination moves to a full Senate vote; Donald Trump’s tariff war sparks China-related concerns for biopharma; Pfizer, Merck and more announce Q4 and 2024 earnings; and the non-opioid painkiller space heats up as FDA approves Vertex’s Jounavx.
In this episode, presented by the Genscript Biotech Global Forum 2025, BioSpace’s Head of Insights Lori Ellis talks to Tom Whitehead, co-founder of the Emily Whitehead Foundation, about how standard care, cell and gene therapies and their impact on patients.
Job Trends
Acquisition includes two pre-clinical bispecific antibodies targeting proven disease pathways, offering the potential to transform the treatment paradigm for patients living with atopic dermatitis and other immune-mediated diseases.
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SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
In this deep dive, BioSpace explores the next big thing in obesity.
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
DEALS
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Sanofi’s jump in earnings comes with an increased emphasis on R&D and vaccines, plus an eye cast toward M&A to shore up its pipeline.
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The J.P. Morgan Healthcare Conference started off with a flurry of deals that reinvigorated excitement across the biopharma industry. Johnson & Johnson moved to acquire Intra-Cellular Therapies for $14.6 billion, breaking a dealmaking barrier that kept Big Pharma’s 2024 biotech buyouts to under $5 billion.
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Donald Trump continues to make waves in biopharma; Sage rejects Biogen’s unsolicited takeover offer; the obesity space sees more action with new company launches, IPOs and fresh data; and experts get ready for an important era in the Duchenne muscular dystrophy space.
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Following a lawsuit filed last week, Sage has officially rejected Biogen’s unsolicited buyout offer, which valued the embattled biotech at just $469 million.
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Protein degradation–focused Neomorph nabs its third Big Pharma deal of around $1.5 billion in less than a year.
WEIGHT LOSS
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Deloitte urged pharma executives to “be bold” in a new report tracking the top 20 pharmaceutical companies’ R&D performance.
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Eli Lilly and Novo Nordisk are in a global battle for dominance in the weight loss space. BioSpace takes a look at the territory covered and what’s to come.
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With crucial lessons learned from the manufacturing shortages of injectable GLP-1s, experts say securing adequate supply of the upcoming oral options will be the sector’s next great challenge.
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Novo will license UTB251, a triple hormone receptor agonist that in mid-2023 achieved 24% weight reduction at 48 weeks in a mid-stage study.
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The explosion of GLP-1 weight loss drugs is reminiscent of the early days of PD-1 inhibitors, but key market differences suggest history may not repeat itself.
POLICY
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In an open letter addressing the Trump administration’s proposed budget cuts to HHS, the executives urged Congress to continue “robust federal funding” for scientific research, which they say will help maintain U.S. biotech leadership globally.
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The revamped and “more anti-vax skewed ACIP committee” at the CDC “has a bone to pick with mRNA vaccines,” according to Truist Securities analysts. Meanwhile, the FDA moves forward on having Pfizer/BioNTech and Moderna update labels for their COVID vaccines.
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Susan Monarez, already acting director of the CDC, said during her confirmation hearing that she sees no causal link between vaccines and autism.
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Without providing further context, HHS Secretary Robert F. Kennedy Jr. says that Gavi needs to “start taking vaccine safety seriously” by considering “the best science available.”
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The newly appointed members of the CDC’s influential vaccine committee meet Wednesday and Thursday under an unusually rapid timeline, with unexpected topics on the agenda.
In this job market report we’re reviewing life sciences job market movement in Q3 and what to expect for Q4 and beyond.
With 88% of life sciences organizations using or planning to use AI in recruitment and/or hiring, AI regulation is a priority for the industry.
Despite a government report showing that hiring slowed over the month of June, job postings on BioSpace’s life sciences-focused job board saw a marked increase.
Here are 10 career paths to consider that don’t include bench work, along with role descriptions and links to jobs available now on BioSpace’s job board.
Here are the top biotech companies in California hiring now on BioSpace’s life sciences–focused job board.
To be self-employed in the life sciences, you must have a strong network and background and experience in a relevant area.
HOTBEDS
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
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After losing its powerhouse partner, IGM Biosciences closed “most” of its labs and offices and initiated a strategic review of potential strategic alternatives and options for the business.
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The cell engineering company, co-founded by oncologist and writer Siddhartha Mukherjee, does not see a path forward for its pipeline of early-stage cell therapies for two different types of cancer.
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The Massachusetts biotech will focus its efforts and resources into cemsidomide, an oral drug candidate being trialed for multiple myeloma and non-Hodgkin lymphoma.
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Keytruda is set to lose exclusivity in 2028, meaning Summit may face competition from cheaper biosimilars. Meanwhile, other branded drugmakers are also seeking to improve on the blockbuster checkpoint inhibitor.
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BNT327, a PD-L1/VEGF therapy, is still currently being manufactured in China, but BioNTech is working to establish a diversified supply chain, executives said during the company’s Q1 investor call.
NEUROSCIENCE
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Wegovy and Zepbound are just the latest drug dyads to face-off in the competitive pharma market, continuing a legacy of rivalry that includes blockbuster drugs Keytruda, Humira and Eliquis.
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Stifel analysts were bullish on the data, which showed a 16.5% drop in body-mass index among patients with damage to the hypothalamus taking Rhythm Pharmaceuticals’ Imcivree.
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GSK is paying to access ABL Bio’s Grabody-B platform, which potentially enables therapies to cross the blood-brain barrier.
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Analysts at BMO Capital Markets said Centessa’s orexin receptor agonist has “best-in-class” potential for narcolepsy, putting the company in a strong position in the $15 billion market.
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Sangamo, which has been having cash problems, will receive $18 million upfront in licensing fees for its AAV capsid that in preclinical studies has shown the ability to cross the blood-brain barrier.
CELL AND GENE THERAPY
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Last month, Deerfield Management accused Alcon of obstructing Aurion’s IPO plans so it could acquire the startup “at a discount.”
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Adaptimmune is rolling out its T cell therapy Tecelra for synovial sarcoma, recording $1.2 million in sales since its approval in August 2024. Nevertheless, it is pausing development of two oncology assets to save money.
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After Sarepta reported the death of a patient who had recently taken the gene therapy Elevidys, patient advocacy group Parent Project Muscular Dystrophy stepped up—as they always do.
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The biotech is exploring opportunities for a reverse merger or other business combinations. CFO and now interim CEO Anup Radhakrishnan will take charge of these negotiations.
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After a patient taking the Duchenne muscular dystrophy gene therapy Elevydis died of liver injury, Sarepta will update the label to reflect the safety signal.