In an opinion issued late Thursday night, U.S. District Judge Susan Illston wrote that the president and department agency heads do not have the authority to reorganize the government without Congress’ input.
The seven new members of the CDC’s influential Advisory Committee on Immunization Practices recommended Merck’s new anti-RSV monoclonal antibody, discussed mRNA vaccine technology while injecting misinformation into the debate, heard updates on the upcoming flu season and, finally, voted to remove thimerosal from all flu vaccines.
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.
Eli Lilly’s tirzepatide is expected to be worth $62 billion annually by 2030, according to Evaluate. That valuation would be three times larger than what AbbVie’s blockbuster Humira ever achieved.
Gilead is betting up to $750 million on Kymera’s anti-CDK2 molecular glue for solid tumors, while Sanofi elected to move forward with another protein degrader from the biotech, designed to target immune-mediated diseases.
The FDA is assessing the need for “further regulatory action” on Sarepta’s Duchenne muscular dystrophy gene therapy in the aftermath of two patient deaths, though the regulator has not yet specified what action this could be.
FDA
Mike Davis previously worked as clinical team leader at the FDA’s Division of Psychiatry before serving as chief medical officer for Usona Institute, a research organization advancing psychedelic science.
FEATURED STORIES
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.
Biogen recently bolstered its pipeline with a potential $1.8 billion acquisition of Human Immunology Biosciences, following other big players looking to cash in on a global immunology market estimated to grow to $257 billion by 2032.
Despite a surge in the financial markets, multiple Big Pharma companies have announced hundreds or even thousands of cuts. Experts hope for a better second half of the year.
FROM BIOSPACE INSIGHTS
Building and scaling biopharma workforces can go beyond recruiting permanent employees to include fractional workers and consultants. A Slone Partners executive discusses how these blended workforces operate, highlighting the strategic benefits.
UPCOMING EVENTS
LATEST PODCASTS
In this episode presented by PII, BioSpace’s head of insights discusses with guests Oliver Eden and Travis Webb how autoinjectors offer opportunities to improve delivery systems, patient compliance and clinical trial processes.
M&A headlined for a second straight week as Genmab acquired Merus for $8 billion; Pfizer strikes most-favored-nation deal with White House; CDER Director George Tidmarsh caused a stir with a now-deleted LinkedIn post; GSK CEO Emma Walmsley will step down from her role; and uniQure’s gene therapy offers new hope for patients with Huntington’s disease.
The FDA is hoping to repurpose GSK’s Wellcovorin for cerebral folate deficiency; Pfizer acquired fast-moving weight-loss startup Metsera for nearly $5 billion after suffering a hat trick of R&D failures; psychedelics are primed for M&A action and Eli Lilly may be next in line; RFK Jr.’s revamped CDC advisory committee met last week with confounding results; and Stealth secured its Barth approval.
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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
  1. Despite a challenging economic climate and gloomy forecast, 2023 has still notched some mega-deals for biopharmas. BioSpace highlights the biggest deals in the industry this year.
  2. The acquisition of the privately-held company will bring its novel, investigational beta-lactamase inhibitors and other antimicrobials into the Japanese pharma’s pipeline.
  3. Banking on its lead antibody APG777 for atopic dermatitis, Apogee Therapeutics is filing an initial public offering for an as-yet-undisclosed value.
  4. Citing anti-trust issues, six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—are joining the FTC’s legal challenge to Amgen’s nearly $27.8 billion buyout of Horizon.
  5. Under the merger announced Thursday, Tourmaline shareholders will own nearly 80% of the new company, which will retain its name and continue to focus on developing its anti-IL 6 antibody.
WEIGHT LOSS
  1. 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.
  2. 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.
  3. Phase I results published Monday suggest Amgen’s investigational weight-loss drug MariTide produces longer-lasting effects than GLP-1s currently on the market.
  4. The investment arm of the Novo Nordisk Foundation is acquiring contract development and manufacturing organization Catalent to help meet high demand for Ozempic and Wegovy.
  5. The biotech is taking a synergistic approach to obesity with two muscle-preserving antibodies set to enter a Phase II study in mid-2024 in combination with existing incretin-based treatments.
POLICY
  1. 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.
  2. 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.
  3. 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.
  4. Allarity Therapeutics announced Monday that the Securities and Exchange Commission has made a preliminary determination recommending an enforcement action against the company for alleged violations of federal securities laws.
  5. The Department of Health and Human Services’ Office of the Inspector General found that bluebird bio’s fertility support program for its gene therapies could potentially violate federal anti-kickback statutes.
Do you wake up every morning dreading going to work? If this happens to you even once a week, it may be time to start looking for a new gig.
Here are three reasons why you need to boast a little, and ways to do just that.
The following tips from a seasoned recruiter can reduce serious ATS-related errors and help increase the value of the time investment.
For new graduates with limited experience, as well as career-changers whose experience is outside the area they now wish to pursue, fighting the underqualified label is tough
To find out more about career transitions within the life sciences, we interviewed Modu Feyisitan, MPH. Modu provided insight regarding her move from a role as an Epidemiologist within county government into private healthcare. She shares what motivated her to make a job change.
Not only can we humanize with storytelling; we can use stories to connect.
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
Based on new data, argenx expects to file for the expansion of Vyvgart’s label into patients with generalized myasthenia gravis who are negative for antibodies against the AChR marker—an indication William Blair analysts called the broadest option in this disease space.
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
  1. Johnson & Johnson’s radiopharma candidate JNJ-6420 returned mixed results in an early-stage study, demonstrating strong biochemical and radiographic response but also resulting in four patient deaths.
  2. Until compelling surface targets for lung cancer are developed, antibody-drug conjugates will fail to treat most patients with lung cancer, experts told BioSpace.
  3. Pfizer’s Wyeth unit notched a legal victory over AstraZeneca on Friday as a federal jury found the British-Swedish company violated two key patents in developing and marketing its lung cancer drug Tagrisso.
  4. FDA
    Bolstered by promising response data from its Phase II study, Amgen announced Thursday it got the FDA’s green light for its first-in-class bi-specific T-cell engager Imdelltra for extensive-stage small lung cancer.
  5. FDA
    Following back-to-back approvals in lymphocytic leukemia, Bristol Myers Squibb’s CAR-T therapy Breyanzi on Wednesday won the FDA’s green light for relapsed or refractory follicular lymphoma.
NEUROSCIENCE
  1. 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.
  2. Subcutaneous injections of Eisai and Biogen’s Leqembi led to numerically greater amyloid removal than the intravenous version of the Alzheimer’s disease therapy, though risks of brain swelling and bleeding remained.
  3. While the trial was designed to test safety and not efficacy, patients treated with Araclon Biotech’s experimental ABvac40 vaccine saw a 38% drop in disease progression compared to placebo.
  4. While sensitive and specific biomarkers for Alzheimer’s disease have recently taken a leap forward, the Parkinson’s space has lagged behind. Neurofilament Light Chain could change that.
  5. The biopharma’s data manipulation controversy continues with a recently leaked City University of New York report, which found signs of “egregious” and “deliberate” misconduct by a company advisor.
CELL AND GENE THERAPY
  1. Rocket Pharmaceuticals’ strategic realignment initiative in July pulled funding from fanca-cel, which the biotech was developing for Fanconi anemia.
  2. The centerpiece of the collaboration is the gene editor ABO-101, being developed for primary hyperoxaluria type 1, a rare disease that leads to severe kidney stones.
  3. As industry leaders gather at the annual event in Phoenix, the cell and gene therapy space remains in a state of flux, with M&A activity and regulatory support signaling momentum while commercialization challenges continue to hinder broader investor interest.
  4. Smarter design through targeted delivery and human-relevant testing can save the industry from costly safety failures.
  5. Following up on previous, dimly received issuances, a new set of ideas published by the FDA to streamline regulatory pathways for cell and gene therapies ‘for small populations’ is receiving a warmer welcome—but experts warn it will take more to turn the tide for the fraught therapeutic space.