The Fourth Circuit’s ruling follows a Supreme Court verdict that also allowed the Trump administration to move forward with its mass layoffs at federal agencies.
Known as the home of big-name companies including Johnson & Johnson, New Jersey has become a destination for more and more small and midsize life sciences businesses. Choose New Jersey, Grace Therapeutics and Onyx Equities executives discuss the state’s life sciences scene.
Analysts suggested that the tariffs will have little effect on reshoring manufacturing and will likely decrease patient drug access and increase costs.
The National Security Commission on Emerging Biotechnology recommends at least a $15 billion investment into biotech over the next five years.
The FDA approved the use of Opdivo with Yervoy in front-line colorectal cancer, while a Manhattan court junked a class action complaint over the blood cancer drug Pomalyst.
Jazz is being accused of anti-competitive practices regarding its narcolepsy drug, as generic competitors emerge on the market.
FEATURED STORIES
CEO Pascal Soriot on Tuesday heralded a “new era of growth” for AstraZeneca with plans to launch 20 new medicines in six years. He’s delivered before but can he do it again?
Patent cliffs and other factors may lead other large drugmakers to embrace similar cost-cutting measures, experts tell BioSpace.
Approaches and targets for depression and other mental health illnesses have remained stagnant for decades. With several readouts for novel therapies on the horizon, that could be changing.
Despite weathering a difficult year, biopharma continues to see massive pay gaps between CEOs and their median employees, with top executives often earning hundreds of times more.
Until compelling surface targets for lung cancer are developed, antibody-drug conjugates will fail to treat most patients with lung cancer, experts told BioSpace.
The insights AI affords can potentially boost sustainability, but it’s unclear whether these gains outweigh the technology’s environmental cost.
FROM BIOSPACE INSIGHTS
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
LATEST PODCASTS
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis discusses key themes from BIO and DIA, including the funding environment, with Rich Daly, CEO of Catalyst Pharmaceuticals, Peter Ronco, CEO of Emmes Corporation, and Phil Vanek, founder of Redline Bio Advisors.
Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the year, M&A is back with one deal for a gene editing biotech reinvigorating that sector; and RFK Jr. installs a suite of new vaccine board members who share his skeptical views on vaccines.
HHS Secretary Robert F. Kennedy Jr. made waves this week, firing the remaining members of the CDC’s Advisory Committee on Immunization Practices; Metsera’s amylin drug produced weight loss of 8.4% at 36 days; and FDA leaders gathered last week to discuss the future of cell and gene therapy, a sector that has been in turmoil since the ousting of CBER Chief Peter Marks.
Job Trends
Merck today announced positive data from multiple Phase 3 studies evaluating V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine, at the 13th Meeting of the International Society of Pneumonia and Pneumococcal Diseases (ISPPD) in Cape Town, South Africa.
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SPECIAL EDITIONS
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.
A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
DEALS
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An increase in funding share and available lab space helps to keep the Bay State’s biotech and pharma sectors strong. -
The European Commission on Thursday ordered Illumina to divest Grail, opening the next chapter in the years-long regulatory saga. Illumina is reviewing the order, Reuters reported. -
From Statera Biopharma and Sorrento Therapeutics to Aceragen and Infinity Pharmaceuticals, 2023 has seen a record high 28 bankruptcies in the biotech space so far. Here’s why. -
Following rumors last week of a potential acquisition by Sanofi, Bristol Myers Squibb on Sunday announced that it paid $4.8 billion to gain access to Mirati Therapeutics’ oncology-focused portfolio. -
Though data became an issue in two separate meetings, the FDA’s Oncologic Drugs Advisory Committee made a potentially precedent-setting decision by voting in favor of US WorldMeds’ neuroblastoma treatment.
WEIGHT LOSS
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Oprah Winfrey this week shone the spotlight on these transformative GLP-1 medications. Now, it’s time for Medicare to cover them and expand access to millions of Americans. -
Following its label expansion earlier this month, Medicare on Thursday said it will now cover the use of Novo Nordisk’s Wegovy in patients with overweight or obesity who have preexisting cardiovascular disease. -
A new analysis from the Congressional Budget Office predicts that Novo Nordisk’s semaglutide will likely be subjected to Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act. -
The recent FDA decision will likely mean more Medicare patients gain access to the blockbuster weight loss drug, experts say. Meanwhile, results continue to roll in for GLP-1 agonists for conditions beyond diabetes and obesity. -
Novo Nordisk’s investment of more than half a billion dollars is meant to expand its production capabilities in China and help it meet the global drug demand.
POLICY
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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. -
PTC Therapeutics said Thursday the FDA has lifted a partial clinical hold on its Huntington’s disease candidate PTC518 after displaying favorable clinical trends in a mid-stage study. -
Eli Lilly on Thursday said it is again suing spas and clinics over compounded and counterfeit forms of tirzepatide, the active ingredient in blockbusters Mounjaro and Zepbound, which the pharma says can cause harmful side effects. -
The Federal Trade Commission is supporting the U.S. Patent and Trademark Office’s proposed new rules requiring parties to a patent dispute to disclose all settlement agreements, including pharmaceutical drug settlements. -
National Institutes of Health researchers in a Phase Ib/II study found a five-drug combination elicits strong remission rates in diffuse large B-cell lymphoma patients without using chemotherapeutic agents.
Here’s how smart prospective interviewees can optimally prepare for success in online interviews.
This article offers suggestions for how to be camera-ready for a virtual interview.
Many people are wondering how they can make meaningful connections and grow their professional network in a time when large group meetings are discouraged.
Once you’ve made initial meaningful contact with a hiring manager – through an interview, online or phone inquiry, informational interview or networking experience – the best way to turn that encounter into opportunity is through sustained follow-up.
Here are four ways to improve your productivity while working from home!
You can apply these career-planning and goal-setting techniques to establish career goals that are just as exciting as those you dreamed about as a kid.
HOTBEDS
IN CASE YOU MISSED IT
China continues to be a source of innovation as Pfizer strikes biggest pact yet; HHS provides more info on Trump’s Most Favored Nation executive order; FDA Commissioner Marty Makary and CBER director Vinay Prasad reveal new COVID-19 vaccine strategy following Novavax approval; ODAC underway after chaotic planning; more.
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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AbbVie and Genmab on Wednesday announced the FDA has expanded the label of their bispecific antibody Epkinly, allowing it to be used in patients with relapsed or refractory follicular lymphoma. -
One patient died of respiratory failure in a Phase I study of Lyell Immunopharma’s investigational CAR-T therapy. The company on Wednesday said it has not definitively linked the fatality to the treatment. -
AstraZeneca’s PD-L1 inhibitor failed to significantly improve disease-free survival in patients with non-small cell lung cancer, but hit its primary endpoint in a late-stage trial in muscle-invasive bladder cancer. -
The FDA’s calendar is relatively light in July, with only five major deadlines, including one for a PD-1 blocker and another for an opioid overdose drug. -
G1 Therapeutics on Monday reported Phase III study results showing its drug Cosela did not demonstrate a statistically significant effect in overall survival in triple-negative breast cancer patients.
NEUROSCIENCE
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After showing some unfavorable results for its data, AC Immune on Monday announced it will be getting back its Alzheimer’s disease candidates from Roche’s Genentech. -
With recent scientific advances, milestone approvals and increased dealmaking, the future of treatment for neurological diseases looks brighter—but continued investment, collaboration and patient-focused efforts are key. -
The deal, announced late Wednesday, will provide AbbVie with access to Cerevel Therapeutics’ pipeline of clinical-stage and preclinical candidates for psychiatric and neurological diseases. -
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.
CELL AND GENE THERAPY
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While BMO Capital Markets said that zimislecel is “highly encouraging” for type 1 diabetes, questions regarding its target population and Vertex’s execution hang over the cell therapy’s commercial potential. -
The well-respected director of the FDA’s cell and gene therapy office was seen as a stabilizing and trustworthy voice inside the quickly reshaping FDA, especially since the late-March exit of CBER Director Peter Marks. -
Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the year, M&A is back with one deal for a gene editing biotech reinvigorating that sector; and RFK Jr. installs a suite of new vaccine board members who share his skeptical views on vaccines. -
The pending deal was rumored overnight after a report from the Financial Times, spurring analysts to speculate that if true, the entire gene editing space would see a boost at the markets. -
Analysts at Truist Securities called J&J’s CAR T readout “compelling,” noting that the efficacy figures could position the cell therapy as a formidable competitor to the current standard of care, Gilead’s Yescarta.
