While an adverse event reported in Intellia’s gene therapy trial was a “non-concern” for analysts, it follows a handful of patient deaths in other trials for the modality and sent the company’s stock tumbling in pre-market trading.
Looking for a biopharma job in New York? Check out the BioSpace list of seven companies hiring life sciences professionals like you.
Patritumab deruxtecan was unable to significantly improve overall survival in patients with locally advanced or metastatic non-small cell lung cancer with EGFR mutations.
iTeos expects to absorb nearly $25 million in one-time costs for severance and termination payments. The biotech had 173 full-time employees at the end of 2024.
In a letter to the Department of Commerce, Novo Nordisk argued that unsanctioned compounded semaglutide, mostly from China, constitutes a national security threat to the U.S.
The canceled contract comes as Moderna nears a critical FDA decision for its next-generation COVID-19 vaccine.
FEATURED STORIES
As it nears a crucial FDA action date for its transthyretin amyloid cardiomyopathy candidate, BridgeBio focuses on its late-stage pipeline.
No patients have received Casgevy, CRISPR Therapeutics and Vertex Pharmeceuticals’ recently approved sickle cell gene therapy. Experts weigh in on the path to profit for the treatment and the therapeutic class in general.
Healthcare players are pointing fingers amid regulatory crackdowns on pharmacy benefit managers, but proposed reforms wouldn’t address a dearth of competition in the larger market.
A recent study estimated that Wegovy’s label expansion beyond obesity could push Medicare spending to $145 billion annually, but analysts remain dubious of the estimate.
The next generation of Alzheimer’s therapeutics is moving away from amyloid plaques and tau tangles, offering multiple approaches to slow cognitive decline.
Bispecific antibodies and anti-TIGIT therapies both appear to be writing comeback stories as cancer experts head to Barcelona for the 2024 European Society for Medical Oncology Congress. Radioligand therapies and synthetic lethality assets are also attracting attention.
FROM BIOSPACE INSIGHTS
While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience that would make change possible.
LATEST PODCASTS
In this episode BioSpace’s Greg Slabodkin, Tyler Patchen and Lori Ellis discuss Zepbound, Wegovy, the weight loss race and the future of this drug class.
This week, in (our inaugural episode!) BioSpace’s Greg Slabodkin, Tyler Patchen and Lori Ellis discuss the good, the bad and the ugly of biopharma’s reported Q3 earnings. They also tackle what’s going on at Pfizer, ADCs, deals and more.
Job Trends
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced important advancements across its suzetrigine pain program, which has the potential to be the first new class of medicine for acute and neuropathic pain in more than two decades.
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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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On Thursday, Kyverna Therapeutics is debuting on the Nasdaq with an upsized initial public offering which the biotech will use to support its pipeline of anti-CD19 CAR T therapy candidates. -
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. -
The Swiss pharma’s dealmaking momentum continues in early 2024 with the acquisition of German biotech MorphoSys in an effort to strengthen its oncology portfolio. -
Metagenomi could potentially raise over $100 million if the underwriters exercise their option to purchase additional shares in full, assuming an initial public offering price of $16 per share. -
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.
WEIGHT LOSS
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The plethora of genes involved in obesity presents an intriguing opportunity for both gene silencing and ex vivo gene therapy approaches. -
Building on last year’s potential $7 billion partnership with Flagship Pioneering, Pfizer and Flagship-founded ProFound Therapeutics will work on discovering new obesity candidates. -
Seeking to target the lucrative obesity market, Merck is focusing its R&D efforts on next-generation GLP-1 therapies that offer additional benefits beyond weight loss, according to company executives. -
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.
POLICY
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In a high-profile showdown Tuesday with Sen. Bernie Sanders’ Senate health committee, Novo Nordisk CEO Lars Fruergaard Jørgensen will be asked to defend the drugs’ U.S. monthly list prices of $969 and $1,349, respectively. -
Regulators, policymakers and others can more effectively battle the disease by creating incentives to make mpox a more attractive investment opportunity. -
A lawsuit filed by the Pharmaceutical Research and Manufacturers of America, which claims the Inflation Reduction Act’s Medicare Drug Price Negotiation Program is unconstitutional, now goes back to a lower Texas court. -
While unlikely to pass this year, given the Democrats’ control over the White House and Senate, the proposed legislation might be a harbinger of the Republicans’ agenda next year for the Inflation Reduction Act should they win the November elections. -
In the battle over drug prices, one sector of the healthcare industry has risen above all the players as the boogeyman: pharmacy benefit managers. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the lens now focused on PBMs’ business practices.
Use these ways to immediately make the a new co-worker feel at ease.
There are a few lessons from the pandemic about the work which everyone should learn to be more productive. We have compiled the list of them. So let’s take a look.
Think about why you are the best candidate for the position and sell yourself. Here are a few ways to do that.
How do you find success (and not feeling like you’re drowning) when you have to onboard to a new job virtually? We have a few ideas.
Depending on your master’s program of interest and your personal qualifications, you might need to take months (or years) to develop into the type of candidate that is admitted.
If you are certain that attending graduate school is the right move for you, it’s time to look into the specifics of various programs.
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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Bristol Myers Squibb presented the positive Phase III results on its already approved Opdivo-Yervoy combo at ESMO over the weekend, while separately announcing that it was returning Immatics’ bispecific T cell engager. -
The result comes months after an FDA advisory committee flagged the risk of potential overtreatment with perioperative regimens.
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High response rates reported by GSK and iTeos at the 2024 European Society for Medical Oncology Congress offer a ray of light for anti-TIGIT therapies after a string of failures. -
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. -
Tecentriq Hybreza, which combines Roche’s Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology, is being touted as the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy.
NEUROSCIENCE
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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. -
Accurately diagnosing Alzheimer’s disease pathologies is becoming increasingly important, but the U.S. is facing imaging resource constraints. -
While Sage Therapeutics’ drug candidate showed a slight difference compared to placebo in a mid-stage Huntington’s disease trial, William Blair analysts in a Tuesday note to investors said they “remain cautious” on dalzanemdor and “do not view the small numerical changes as definitive.” -
Despite concerns raised in FDA briefing documents about Eli Lilly’s Alzheimer’s treatment, donanemab, the committee concluded that the benefits outweighed the risks. -
In advance of an advisory committee meeting on Monday, the FDA’s internal reviewers have raised issues regarding Eli Lilly’s Alzheimer’s disease candidate donanemab, flagging problems with its study design and safety outcomes.
CELL AND GENE THERAPY
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A one-time treatment for Parkinson’s disease could be a ‘market changer,’ experts told BioSpace, adding that cell therapies could limit the adverse effects seen with current drugs. -
From gene-corrected cell therapies to a new CAR-T, the cell and gene therapy space looks to expand its reach into the market. -
Cullinan Oncology, now renamed Cullinan Therapeutics, is riding the growing wave of interest in autoimmune disorders by refocusing its bispecific T cell-engager CLN-978 for systemic lupus erythematosus. -
Roche’s Genentech subsidiary is terminating for undisclosed reasons its 2021 contract with Adaptimmune for the development of allogeneic T-cell therapeutics. -
Investors were disappointed in data from a mid-stage study of Enlivex Therapeutics’ Allocetra cell therapy for the treatment of sepsis. The Israeli company is considering a follow-on trial in sepsis caused by urinary tract infection.
