Susan Monarez, already acting director of the CDC, said during her confirmation hearing that she sees no causal link between vaccines and autism.
Jefferies analysts called the proxy filing, which is a standard disclosure after a merger agreement, “much more intriguing than normal” given the regulatory turmoil it revealed.
Minovia’s lead product is MNV-201, an autologous hematopoietic stem cell product that is enriched with allogeneic mitochondria.
Flagship Pioneering’s ProFound Therapeutics will use its proprietary technology to mine the expanded proteome for novel cardiovascular therapeutics. Novartis has promised to pay up to $750 million per target, though it has not specified how many targets it will go after.
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.”
Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said the agency’s new risk-based COVID-19 vaccine framework contradicts the current administration’s push for transparency and gold-standard science.
FEATURED STORIES
Last month, Vertex said sickle cell patients had not yet received infusions of its gene therapy Casgevy. That’s now changed, as the company races with bluebird bio’s Lyfgenia.
Launched in 2020 to more quickly bring to market an effective medicine for amyotrophic lateral sclerosis, the HEALEY Platform Trial has generated disappointing results for many but also continuing programs from Clene and Prilenia.
The potential of mRNA vaccines was established during the COVID-19 pandemic. Now, a new wave of candidates could soon hit the market for cancer, influenza and more.
The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions.
It’s time for Congress to step up and fund America’s supply chain independence from Chinese companies by bolstering our domestic manufacturing capabilities.
Analysts expressed skepticism about plans detailed by Moderna’s R&D chief Stephen Hoge to trim research spending in preparation for the launch of up to 10 new products.
FROM BIOSPACE INSIGHTS
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. This webinar will show leaders how strategic insights and targeted outreach can turn awareness into high-converting leads. Watch now.
LATEST PODCASTS
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.
In this episode presented by Taconic Biosciences, BioSpace’s head of insights Lori Ellis discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment with Mike Garrett, CEO.
Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news.
Job Trends
Merz Therapeutics, a business of Frankfurt-based Merz Group, has entered into an Asset Purchase Agreement to acquire two commercial medicines from NASDAQ-listed Acorda Therapeutics.
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SPECIAL EDITIONS
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.
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.
DEALS
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Following in the footsteps of Novartis, J&J and Merck, GSK jumped into the J.P. Morgan dealmaking frenzy Tuesday, picking up respiratory and inflammation-focused Aiolos Bio. -
From the rising trend of royalty financing to other adaptive funding strategies, firms think outside the box in responding to unprecedented challenges. -
Harpoon has several antibodies in its pipeline that are engineered to redirect a patient’s T cells to recognize and kill cancer cells. -
The pharmaceutical giant will pay $28 a share to acquire Ambrx’s pipeline of ADCs, particularly its lead candidate for prostate cancer. -
The IPO window is starting to crack open this year, with Metagenomi and ArriVent making their offerings ahead of the J.P. Morgan Healthcare Conference.
WEIGHT LOSS
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Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, has proposed issuing a subpoena to Novo Nordisk President Doug Langa forcing him to testify regarding the company’s pricing for Wegovy and Ozempic. -
Seeking to carve out its own niche in the obesity space, Syntis Bio launched on Tuesday to develop an oral weight-loss treatment that mimics the effects of gastric bypass surgery. -
More patients are having to pay out-of-pocket for Eli Lilly’s weight-loss medication Zepbound than they did for type 2 diabetes drug Mounjaro, according to Lilly USA President Patrik Jonsson. -
Structure Therapeutics is offering over nine million shares on the heels of mid-stage data for its oral GLP-1 receptor agonist, which showed weight loss of 6.2% in overweight or obese patients. -
Novo Nordisk will face strong generic competition from at least 15 companies in China for its blockbuster GLP-1 receptor agonist products Wegovy and Ozempic, according to Reuters.
POLICY
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United States Pharmacopeia is recruiting expert volunteers from academia, industry, regulatory and healthcare to develop, revise and approve medicine, dietary supplement and food ingredient standards and solutions used in more than 150 countries to improve global public health. The volunteers will serve from 2025 to 2030. -
Massachusetts residents voted Tuesday against the Natural Psychedelic Substances Act, which would have seen some psychedelics, including psilocybin and dimethyltryptamine, legalized in the state. -
Senator Elizabeth Warren told the Federal Trade Commission that the acquisition of contract manufacturer Catalent could increase Novo’s dominance over the hot GLP-1 market, reducing competition and increasing prices. -
The U.S. Department of Justice alleged that Teva violated the Anti-Kickback Statute and the False Claims Act. The payment is in addition to the criminal penalty paid by Teva USA under its deferred prosecution agreement. -
WuXi AppTec looks to unload its Philadelphia manufacturing sites and WuXi Biologics slows its rapid expansion in the U.S. as the companies await the Senate’s review of the BIOSECURE Act that threatens to cut them off from U.S. biopharma.
If you’ve been furloughed, it’s normal to feel some apprehension, fear and/or doubt about your employment. These are four ways to stay productive if you’ve been furloughed.
Most job applicants don’t know about questions that they should ask at the end of an interview. Here are some not-so-common interview questions that you must remember to ask.
Once you do land your next job interview, you’ll want to address your layoff in the right way. Here’s how.
Finding common ground and making small talk are both skills that help you build that rapport with someone.
Of the resumes submitted to employers that use Applicant Tracking Systems (ATS), 75% are never seen by human eyes.
The global COVID-19 pandemic may not seem like the best time to accelerate your career, but some characteristics of this unusual time actually lend themselves to career-boosting activities. Whether you are still working from home or are back in your workplace, this article offers suggestions for pumping up your career.
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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Despite the disappointing late-stage results in non-small cell lung cancer, Jefferies analyst Stephen Barker contends the likelihood of FDA approval “remains high” for the experimental antibody-drug conjugate, though the regulator is now more likely to convene an advisory committee. -
Set to start in 2025, Relay Therapeutics is moving toward a pivotal study of experimental treatment RLY-2608 in heavily pretreated locally advanced or metastatic breast cancer. -
In advanced non-small cell lung cancer, Summit Therapeutics’ ivonescimab appears to be 49% more effective at reducing the risk of disease progression or death versus Merck’s Keytruda in a late-stage study. However, analysts contend the caveat is that the trial was conducted in an entirely Chinese patient population. -
Follow-up data from the MARIPOSA study show a favorable overall survival trend versus Tagrisso in EGFR-mutated advanced non-small cell lung cancer. The findings come just weeks after the Rybrevant-Lazcluze combination was approved for the first-line treatment. -
Using a computational biomarker, the companies say they can identify which patients would derive significant clinical benefit from their experimental antibody-drug conjugate. AstraZeneca and Roche are co-developing and commercializing a companion diagnostic for the biomarker.
NEUROSCIENCE
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Recent M&A activity indicates a potential resurgence in the appetites of larger companies for psychiatric drug development, but experts say the space may not offer a sufficient risk-reward proposition for R&D. -
Otsuka Pharmaceuticals announced Wednesday it is ending development of drug candidate AVP-786 after failing to improve agitation associated with dementia due to Alzheimer’s disease. -
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. -
Following a series of clinical failures, optimism builds for the first disease-modifying treatment. -
Disappointed with Phase I/II results for two Ionis-partnered programs, one for amyotrophic lateral sclerosis and another for Angelman syndrome, Biogen has opted to not proceed with their development.
CELL AND GENE THERAPY
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By votes of 11-0 and 8-3, respectively, an FDA advisory committee Friday deemed the risks of early death for both Johnson & Johnson’s Carvykti and Bristol Myers Squibb’s Abecma acceptable. -
Asgard Therapeutics, a Swedish gene therapy biotech, has closed a $32 million Series A round with help from prominent pharma players as it prepares for a 2026 IND. -
The FDA approved Bristol Myers Squibb’s Breyanzi for chronic lymphocytic leukemia and small lymphocytic leukemia prior to Friday’s adcomm for the company’s other CAR-T therapy, Abecma. -
With an advisory committee meeting slated for Friday, the regulator has posted briefing documents in which it has raised concerns about early deaths in patients treated with Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti. -
Allogene Therapeutics and Arbor Biotechnologies will use their allogeneic CAR T and next-generation gene-editing platforms to develop novel off-the-shelf CAR-T therapies for autoimmune diseases.
