Imlifidase, an IgG-destroying enzyme, could receive FDA approval in the second half of 2026 and hit peak sales of $306 million, according to William Blair.
Phase III data showed that Inluriyo improves progression-free survival versus standard endocrine therapy.
Companies that have broken ground on or are actively constructing manufacturing facilities in the U.S. are exempted from the tariffs, according to President Donald Trump’s social media post on Thursday.
Though details remain scant, the pending order is expected to be the latest effort in President Donald Trump’s campaign to bring drug prices down to the same level as economically similar countries.
The regulatory greenlight was backed by two Phase III trials that showed normalized growth hormone levels in patients with the rare pituitary condition. It’s the first approval for Crinetics Pharmaceuticals and something CEO Scott Struthers predicted “will transform people’s lives.”
Looking for a biopharma job in Pennsylvania? Check out the BioSpace list of six companies hiring life sciences professionals like you.
FEATURED STORIES
FDA Commissioner Marty Makary last week announced a directive that would limit industry participation in the agency’s advisory committees. But not only do company reps serve only as non-voting members, a 1997 law actually requires industry involvement.
Disruptive conditions are typical in non-Western markets. The U.S. industry, thrown into a period of significant change as the Trump administration overhauls HHS and considers implementing tariffs, could learn a thing or two by looking overseas.
Like they say about the weather in Iceland, if you don’t like an action taken by the new administration, wait five minutes; it’ll probably change. The markets, it seems, don’t react kindly to that kind of policymaking.
Analysts have had to throw out their assumptions for the biopharma industry’s recovery heading into the first quarter earnings period given the ongoing tariff drama.
Johnson & Johnson’s Joaquin Duato is no longer the highest paid CEO in pharma. Meanwhile, just two women make the top 10.
AI is enabling the development of a next generation of drugs that can more precisely target cancer cells while sparing healthy tissues.
LATEST PODCASTS
New revelations from the showdown between Novo Nordisk’s CEO and Bernie Sanders’ Senate health committee Tuesday; PhRMA’s legal victory in IRA case; the federal interest rate cut and anticipated approval for schizophrenia.
Infusions of Vertex and CRISPR Therapeutics’ Casgevy and bluebird bio’s Lyfgenia have begun; Moderna targets 10 approvals through 2027; more oral obesity drug data; the latest from ESMO and more.
In this episode, Lori and guests discuss practical approaches regarding artificial intelligence and investor and industry confidence in its current state.
Job Trends
AstraZeneca is pleased to announce that Truqap™ in combination with fulvestrant is now available in Canada for the treatment of adult female patients with hormone receptor -positive, human epidermal growth factor receptor 2 -negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1 or PTEN alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
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
-
BridgeBio’s Attruby wins approval for transthyretin amyloid cardiomyopathy while the FDA accepts Alnylam’s application for Amvuttra in the indication; Cassava’s controversial Alzheimer’s drug flunks Phase III; Amgen’s MariTide fails to impress investors, Donald Trump’s controversial nominations continue. -
With Elevidys expansion in hand, Sarepta commits up to $10 billion to develop short interfering RNA–based drugs to build out its pipeline. -
Novartis has disclosed roughly $19.4 billion in deals in the past five years. CEO Vas Narasimhan says there’s more to come. -
The deal has secured Novartis the chance to work with Ratio Therapeutics on a novel drug candidate that could fortify the Big Pharma against competition from would-be radiopharmaceutical rivals such as BMS and Lilly. -
The acquisition will give BioNTech full ownership of an investigational bispecific antibody targeting the PD-L1/VEGF-A pathways, a hot area in oncology that could potentially replace standard checkpoint inhibitors for cancer treatment.
WEIGHT LOSS
-
It’s been a rocky few months for BioAge Labs, which shuttered a Phase II trial of its lead candidate azelaprag Tuesday after the molecule caused liver-based side effects. -
Versant Ventures continues to invest in the increasingly competitive obesity space, this time launching Helicore with $65 million and a GIP-targeting asset intended to induce higher-quality weight loss. -
The GLP-1 IPO arena has been heating up for the past two years and Metsera’s ask is one the largest in recent history. -
Patients taking Novo Nordisk’s Wegovy plus Veru’s enobosarm saw 71% lower lean mass loss than those who were taking Wegovy alone but investors await more data. -
The readout comes on the heels of CagriSema’s disappointing Phase III performance, where it missed Novo’s projection of 25% weight reduction.
POLICY
-
While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety, access and liability. -
While the Trump administration has painted the jettisoning of staff and regulations as good for business, there are multiple reasons it’s unlikely to work out that way. -
At a sometimes-contentious U.S. Senate hearing, the Health and Human Services secretary was evasive on the rationale behind cuts being made to the department and his endorsement of the measles vaccine amid a rapidly growing outbreak. -
The third cycle of the drug price negotiations will involve drugs under Medicare Part B. New prices are set to take effect in 2028. -
The Most Favored Nation directive would allow drugmakers to directly sell their products to patients at a lower cost, cutting out what President Donald Trump called “the middlemen.”
Keep reading to take a look at some of the best pharma jobs for travelers. These jobs will allow you to see different parts of the world while working in an exciting and fast-paced industry.
Thinking about starting a career in biotech? We’ve put together a guide to help you decide where to go within the biotech field and what steps you should take to get there.
The search for a biopharma job can be daunting, but it doesn’t have to be. Here is a complete guide to the biopharma job hunt, from researching job openings to writing resumes and cover letters.
Even if you aren’t looking for a new role in biopharma, nurturing relationships will only benefit you in the long run. To help, here is a complete guide to networking in the life science industry.
To help alleviate some of the stress related to finding a new job, we’ve created a comprehensive guide detailing how to prepare for your biopharma job search.
Requesting disability accommodations is vital for your success in the workplace. You can find out everything about how to ask for accommodations in our guide.
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 partners are pushing to expand Enhertu’s list of indications beyond its standing uses in breast, lung and gastric cancers. -
Protagonist Therapeutics notches a milestone in its pact with Takeda for rusfertide. New data show that many patients with a chronic blood cancer taking the drug didn’t need to have their blood removed to bring down dangerously high hemocrit levels. -
More than a decade after Merck’s Keytruda and BMS’ Yervoy ushered in the immuno-oncology revolution, the space is at a crossroads, with experts highlighting novel targets, combinations and pre-emptive immunization as the next wave for IO. -
The company will push through with an accelerated approval application for odronextamab in follicular lymphoma, leaving diffuse large B cell lymphoma behind. -
In the Phase III SERENA-6 trial, camizestrant—in combination with CDK-inhibitors—beat out current standard-of-care treatments in terms of progression-free survival, according to AstraZeneca.
NEUROSCIENCE
-
Spravato’s monotherapy nod on Tuesday comes after a series of setbacks in the depression space. -
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a third-party provider while releasing Amylyx’s investigational ALS therapy from a previous pause. -
Computational research conducted by scientists from Washington University in St. Louis shows that GLP-1 agonists can have mental and cognitive health benefits but may also harm the kidneys and pancreas.
-
Biogen’s effort to buy Sage reveals its “desire to expand its pipeline at a discount,” according to analysts from BMO Capital Markets. -
As the year gets underway, analysts and biotech executives highlight cell therapy’s pivot from oncology to autoimmune diseases, a continued appetite for next-generation obesity drugs and an increased focus on neuromuscular, kidney and cardiovascular diseases.
CELL AND GENE THERAPY
-
In this short teaser, BioSpace’s Head of Insights Lori Ellis talks to CBER Director Peter Marks and Tom Whitehead, Co-Founder of the Emily Whitehead Foundation about anticipated discussions at the upcoming GenScript Biotech Forum. -
In a deal expected to close in Q1 2025, Roche will gain access to Poseida’s off-the-shelf CAR T candidates. -
By mid-2025, the biotech will split into two entities: a new, as-yet-unnamed innovative medicines specialist and a cell therapy company, the latter of which will inherit the Galapagos name. -
BioSpace presents 25 noteworthy biopharma startups in ’25; analysts forecast stronger M&A as the J.P. Morgan Healthcare Conference kicks off next week; GLP-1s continue to expand their reach as Novo, Lilly fight against compounders; and a look ahead to five key FDA decisions in Q1.
-
From ADCs and radiopharmaceuticals to cell and gene therapies, eager young startups are betting on advances in biopharma’s most competitive therapeutic spaces—and attracting dollars from Big Pharma.
