HHS Secretary Robert F. Kennedy Jr.’s actions in recent months have raised concerns that he is taking a heavy-handed and unilateral approach to vaccine policy in the U.S.
Big Pharma executives have not been shy about their desire for deals, but companies have been battling macro headwinds alongside Trump’s policies on drug pricing and tariff threats.
The deal gets NextCure the rights to Simcere’s novel ADC for solid tumors outside of China.
At a satellite kickoff event to the annual BIO meeting, investment bankers and VCs gave reasons for optimism amid a ‘volatile’ period for the industry.
At 12 weeks, weight loss ranged from 2.6% to 11.3%, compared to a gain of 0.2% in the placebo group. Guggenheim analysts were also impressed by the tolerability profile.
Analysts at Jefferies give Roche and Prothena’s Phase III study just a 25% to 40% probability of success.
FEATURED STORIES
The next six months for the FDA are primed to be as groundbreaking as the first six, with Eli Lilly’s donanemab and Lykos Therapeutics’ MDMA-assisted PTSD therapy on the docket, among others.
The FDA is facing four big target action dates in the final week of June, including one label expansion for a bispecific antibody and another for an investigational gene therapy.
While GLP-1 drugs remain wildly popular and are a highly lucrative sector, data analytics firm GlobalData contends manufacturing and cost will remain overhangs on the obesity market.
Accurately diagnosing Alzheimer’s disease pathologies is becoming increasingly important, but the U.S. is facing imaging resource constraints.
The plethora of genes involved in obesity presents an intriguing opportunity for both gene silencing and ex vivo gene therapy approaches.
Although Massachusetts’ life sciences job growth increased by just 2.5% in 2023, the state continues to grow the industry, according to a new MassBioEd report.
LATEST PODCASTS
In this episode of Denatured, BioSpace’s head of insights Lori Ellis and Colin Zick, partner at Foley Hoag LLP, spend time discussing some of the points brought up in the Bioprocessing Summit last month. They explore the connections between hammers, AI, The Planet of the Apes and monoliths.
The White House is clamping down on pharma’s ability to buy new molecules from Chinese biotechs; Sanofi, Merck and others abandon the U.K. after the introduction of a sizeable levy; Novo CEO Maziar Mike Doustdar lays off 9,000 while the company presents new data at EASD; Capsida loses a patient in a gene therapy trial; and CDER Director George Tidmarsh walks back comments on FDA adcomms.
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
Job Trends
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Joseph Romanelli, president, Human Health International, is scheduled to participate in a fireside chat at the TD Cowen 44th Annual Health Care Conference on Tuesday, March 5, 2024, at 1:30 p.m. ET.
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SPECIAL EDITIONS
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.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
DEALS
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The Federal Trade Commission is asking for more information regarding Pfizer’s planned $43 billion acquisition of Seagen, according to the latter’s Securities and Exchange Commission filing on Friday. -
This week: Cancer license deals from J&J and BeiGene, a potential $7B acquisition by Roche and confirmed $1.9B Lilly buy, EU fine for Illumina, and more legal challenges to the Inflation Reduction Act -
Eli Lilly said Friday it plans to pay up to $1.925 billion to acquire Versanis and its lead asset, bimagrumab, a monoclonal antibody that aims to reduce fat mass without affecting muscle mass. -
The Swiss pharma is in talks to acquire Roivant Sciences’ RVT-3101, an anti-TL1A antibody that recently showed promising results in a Phase IIb ulcerative colitis trial, reports The Wall Street Journal. -
For closing its $8 billion acquisition of Grail without regulatory approval, the European Union has slapped Illumina with a record $476 million fine—the maximum sanction allowed under the EU’s rules.
WEIGHT LOSS
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Seeking a slice of the lucrative obesity market, Indian pharma companies are developing their own versions of Novo Nordisk’s blockbuster weight-loss drug Wegovy, Reuters reports. -
Two surprise companies, Vertex Pharmaceuticals and Regeneron Pharmaceuticals, made GlobalData’s list with 41.4% and 21.8% market capitalization growth, respectively. -
A week after Britain’s debut of the four-week Kwikpen, a European Medicines Agency panel is slated to review Eli Lilly’s multi-dose, pre-filled pen injector for diabetes drug Mounjaro. -
Novo Nordisk seems to believe it can do a better job managing troubled Catalent than the contract manufacturer. However, the Danish drugmaker has its work cut out for it. -
Studies presented Monday at the American Academy of Orthopaedic Surgeons annual meeting show semaglutide has positive impact on outcomes for total hip arthroplasty patients.
POLICY
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The BIOSECURE Act’s prohibition on doing business with China-based companies may have implications for biotech and biopharma markets on both sides of the Pacific. -
With the BIOSECURE Act likely to be voted on in Congress this year, WuXi AppTec’s U.S. revenue dropped 1.2% in the first half of 2024 while the Chinese company increased its lobbying efforts. -
The combination therapy is one step closer to becoming a potential new first-line standard of care for patients with unresectable or metastatic urothelial carcinoma in Europe. -
Despite their initial kicking and screaming, drugmakers seem confident the Inflation Reduction Act’s Medicare Drug Price Negotiation Program will not greatly impact their bottom lines. -
Executives from the three largest pharmacy benefit manager companies testified Tuesday before Congress that rising drug prices in the U.S. are due to pharma companies taking advantage of market exclusivities and excessive charges.
In the meantime, here are a few things you can do to fill your resume while you’re in between jobs.
Our recent article describing six prominent careers in the biopharma industry was well-received by both college students and current biopharma professionals. As the first installment in a six-part series, we present an in depth review of a rewarding career as a genetic counselor.
A well-written thank you letter after interview can help you make an impact on the interviewers. It can increase your chance of getting hired so learn how to write one.
The more you funnel the universe of employers into a laser-focused, precise, narrow segment of those who would love to hire you, the more successful you’ll be.
Background checks, especially at the executive level, have become routine in the recruitment process.
Here we outline how to figure out what your dream job is and how to find dream job among the hundreds of job listings out there. This guide will help organize your job search.
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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Coherus BioSciences and Junshi Biosciences’ PD-1 inhibitor Loqtorzi significantly boosted progression-free and overall survival in a late-stage study of patients with advanced hepatocellular carcinoma. -
The use of artificial intelligence in the development of cancer vaccines allows for individualized therapy, but the prospect of an ever-changing product poses new challenges for drug developers and regulators. -
AbbVie’s antibody-drug conjugate Elahere, developed by ImmunoGen, elicited a nearly 52% objective response rate in heavily pretreated patients with folate receptor-alpha-positive, platinum-sensitive ovarian cancer. -
BMS presented late-stage results on Tuesday at the ASCO annual meeting which showed the combination of Opdivo and Yervoy lowered the risk of death by 21% in patients with unresectable hepatocellular carcinoma, compared to two kinase inhibitors. -
In addition to missing the mark in overall survival, Gilead reported Thursday a higher number of deaths in the Trodelvy arm of the confirmatory metastatic urothelial cancer study.
NEUROSCIENCE
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For forms of Alzheimer’s, frontotemporal dementia and Parkinson’s caused by genetic defects, gene therapy could change the treatment landscape. -
To protect the central nervous system, the blood-brain barrier bars entry to around 98% of molecules—but approaches like Roche’s trontinemab could spell new hope in Alzheimer’s and beyond. -
While the biotech’s third-quarter revenue beat Wall Street expectations, its $7.3 billion acquisition of Reata Pharmaceuticals—which closed in September—negatively impacted 2023 per-share earnings. -
After winning traditional approval from the U.S. regulator, Eisai’s Alzheimer’s disease therapy Leqembi has seen a sharp increase in patient uptake, with a target of 10,000 patients by March 2024. -
A third-party audit found no integrity and reliability problems with data from BioXcel Therapeutics’ Phase III trial. The company intends to file a supplemental New Drug Application for its candidate BXCL501.
CELL AND GENE THERAPY
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Bluebird bio has re-emerged after a private equity buyout as Genetix Biotherapeutics, marking a return to its roots and a new path forward for manufacturing. -
The White House is clamping down on pharma’s ability to buy new molecules from Chinese biotechs; Sanofi, Merck and others abandon the U.K. after the introduction of a sizeable levy; Novo CEO Maziar Mike Doustdar lays off 9,000 while the company presents new data at EASD; Capsida loses a patient in a gene therapy trial; and CDER Director George Tidmarsh walks back comments on FDA adcomms. -
A new analyst survey suggests that doctors are still prescribing Sarepta’s Elevidys, even after a series of deaths in certain populations marred the gene therapy’s record. -
The patient-specific nature of autologous cell therapies presents unique challenges that can best be addressed by a middle path between on-site and centralized manufacturing. -
Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy.
