A new report found that 85% of pharma respondents are increasing their artificial intelligence investments, and 70% see AI as an immediate priority. Two experts discuss how biopharmas are implementing and adopting AI, including their increased use of external help with the process.
George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a second FDA division to his portfolio after Vinay Prasad’s sudden departure.
As analysts parsed news of Vinay Prasad’s ouster, worries over drug approval delays, cell and gene therapy impacts and more were top of mind.
Madrigal will study SYH2086 in combination with Rezdiffra for metabolic dysfunction-associated steatohepatitis, aiming for clinical trials in early 2026.
Long-term data presented at the Alzheimer’s Association International Conference show Leqembi can help patients stay in the earlier stages of Alzheimer’s disease as compared to the condition’s natural progression.
Monarez is the first CDC director to be confirmed by the Senate under a new 2023 law and will be the first person without a medical degree to assume leadership of the agency in more than 70 years.
FEATURED STORIES
The pharma industry is staring down the barrel of a widespread loss of exclusivity, with more than 190 products going off-patent between 2022 and 2030. Here are some strategies company are employing to manage the drop in revenue.
Four executives with collective decades spent at BMS, Roche, Astellas, Eli Lilly and more gave their insights on navigating a biopharma career during a Monday DIA panel in San Diego.
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.
LATEST PODCASTS
In this episode presented by Slone Partners, Leslie Loveless, Co-CEO and Managing Partner discusses how hiring and the building of executive teams has responded to the current biotech environment.
Pfizer seals the deal with Metsera for $10 billion after Novo Nordisk bowed out; President Donald Trump welcomes executives from Novo and Eli Lilly to the White House to announce that the companies’ GLP-1 medicines would be sold at a reduced cost; and the FDA grants the second round of priority review vouchers—primarily to already marketed drugs.
In this episode presented by PII, BioSpace’s head of insights discusses how to relieve clinical trial patients of technological burden to improve compliance with guests Oliver Eden and Travis Webb.
Job Trends
Sana Biotechnology, Inc., a company focused on changing the possible for patients through engineered cells, announced that it has commenced an underwritten public offering of $125.0 million of shares of its common stock.
Subscribe to GenePool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
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
-
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. -
A handful of biotechs and pharma companies have posted sizable IPOs in 2023, despite a tight economy. Still, the numbers are way down from last year. -
The companies have filed their own suit against the Federal Trade Commission, claiming the FTC’s attempt to legally block their $28 billion merger is unconstitutional. -
In its third acquisition this month, Eli Lilly is buying antibody-drug conjugates startup Emergence Therapeutics to bolster its cancer business. -
Eli Lilly announced Thursday it will acquire former collaborative partner Sigilon Therapeutics to deepen its diabetic foothold with a potentially functional cure for Type 1.
WEIGHT LOSS
-
Two Florida courts have sided with Novo Nordisk against Ekzotika and Effinger Health, agreeing that their compounded versions of semaglutide are against the law. The Danish pharma has reached confidential settlements with both companies. -
Biopharma’s latest earnings season was, in a word, predictable. Companies are consistently beating Wall Street earnings and revenue estimates as they set low expectations for investors. -
While analysts are bullish on Novo Holdings’ $16.5 billion acquisition of Catalent, they say it raises questions for companies that have contracted the CDMO for manufacturing.
-
Eli Lilly on Tuesday said it is already making manufacturing investments for orforglipron, its next-generation oral weight-loss candidate that recently moved into Phase III development.
-
Eli Lilly on Tuesday reported more than $9.3 billion in revenue in the fourth quarter of 2023, beating Wall Street expectations, thanks to demand for its weight-loss drug Zepbound and diabetes treatment Mounjaro.
POLICY
-
A federal judge ruled last week that the U.S. government can use its economic standing as a bulk purchaser to negotiate for better deals, handing Boehringer Ingelheim a loss in its legal challenge to the Inflation Reduction Act. -
President Joe Biden and Sen. Bernie Sanders in a Tuesday op-ed in USA Today called on Novo Nordisk and Eli Lilly to “stop ripping off Americans” with “unconscionably high prices” for their GLP-1 medicines. -
Despite an uncertain legislative path to becoming law, the BIOSECURE Act has already impacted the biopharma industry’s confidence in Chinese service providers and prompted efforts to diversify manufacturing partners. -
As congressional pressure increases on WuXi AppTec and other China-based companies over alleged ties to the Chinese government, India’s contract development and manufacturing organization sector could benefit. -
This week on Denatured, Head of Insights Lori Ellis and guests discuss the implications of not addressing the DE&I data gaps for the future.
Is your dream job with a large organization or a small company? It’s common for life sciences professionals to have a preference one way or the other when considering employment opportunities.
Have you ever considered relocating for your career? If you have, you aren’t alone. According to a recent BioSpace Community Survey, 78% of life science professionals would be open to relocation for the right job opportunity.
To navigate each step along the way from an interview to a final offer, you should have a clear understanding of a timeline of events. These job search tips can help you with that.
Have you thought about what benefits are important to you? Would you request certain benefits from your current employer, or during an interview for a new job?
Most people avoid networking connections due to uncomfortable situations. In contrast, strategic networking can be extremely beneficial for your career.
According to a recent BioSpace survey, 69% of employers indicated “finding quality talent” will be a significant challenge in 2019. Are you the quality talent life science employers are looking for? Don’t delay, apply now and show these employers you possess the quality skills they need!
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
-
The race is on to develop therapeutic cancer vaccines that could give immunotherapies an edge, and late-stage trials could soon provide more-robust data about candidates’ efficacy and safety. -
The new company, BridgeBio Oncology Therapeutics, is looking to advance two KRAS inhibitors and a blocker of the interaction between the RAS and PI3K pathways. -
Based on strong overall and progression-free survival data in its Phase III confirmatory study, Pfizer and Genmab’s antibody-drug conjugate Tivdak on Monday secured the FDA’s full approval for recurrent or metastatic cervical cancer that had progressed on or after chemotherapy. -
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu significantly improved progression-free survival in metastatic breast patients with low and ultralow HER2 expression levels who had received at least one line of systemic treatment. -
The FDA on Tuesday approved Day One Biopharmaceuticals’ type II RAF inhibitor Ojemda, which is designed to penetrate the blood-brain barrier, for the treatment of relapsed or refractory pediatric low-grade glioma.
NEUROSCIENCE
-
With a recent study yielding positive results, experts say GLP-1 drugs are making headway in treating Alzheimer’s and other neurodegenerative diseases. -
With new Alzheimer’s drugs receiving—and expected to receive—FDA approval, the market for diagnostic biomarker tests is set to expand. -
The companies partnered to develop the antibody transport vehicle in late 2021, but will continue their 2018 agreement to pursue other drugs in preclinical development. -
Amid a re-energized Alzheimer’s disease space, Quest Diagnostics offers what the company contends is the first direct-to-consumer blood-based biomarker test to assess disease risk. -
Biogen’s $7.3 billion Reata acquisition and layoffs dominated this week’s news, while BMS and Roche reported second-quarter earnings and BioSpace looked at 12 late-stage neuro companies.
CELL AND GENE THERAPY
-
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation. -
The plausible mechanism pathway “could accelerate gene therapy/editing development,” analysts at William Blair said Thursday, while adding that additional clarity is needed. -
MeiraGTx Holdings is licensing a genetic eye disease medicine to Eli Lilly in a deal worth up to $475 million. -
The FDA previously placed two clinical studies on hold, including the Phase III trial in which the liver toxicity occurred. Intellia is working with experts to create a risk management program for nex-z. -
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study.
