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The FDA released guidelines Thursday in an attempt to clarify processes for assessing a drug candidate’s efficacy while examining several endpoints, simultaneously.
Shares of Immunic stock have plunged more than 70% in premarket trading after an early peek at its Phase Ib psoriasis drug candidate has so far failed to distinguish itself from placebo.
Johnson & Johnson will lay off 64 employees from its Manhattan-based pharmaceutical supplies business in the early part of 2023.
The proxy battle between Mereo BioPharma and Rubric Capital Management will come to a head on Nov. 18. Mereo issued a shareholder circular on Friday.
Kite Pharma entered into a global licensing deal with Refuge Biotechnologies to leverage the latter’s propriety gene expression plaform and develop potential blood cancer therapies.
A cover letter is an important part of any job application, but for those in the life sciences it is especially important. Find tips for writing a scientist cover letter as well as an outline and examples in our guide.
With the appointment of new CEOs, CMOs and CSOs, biopharma and life sciences organizations shuffled their leadership positions as Q3 comes to a close.
AbbVie is buying DJS Antibodies for $225 million in cash to gain access to the British company’s potential fibrotic diseases drug and antibody discovery program.
Erasca announced that it was expanding its existing partnership with Pfizer to assess its ERAS-007 in combination with the Big Pharma’s Ibrance.
Roche and Austria-based Hookipa Pharma tied up a licensing and research and development collaboration valued at more than $950 million focused on KRAS-mutated cancers.
After the Data Monitoring Committee reviewed the case based on protocol modifications implemented earlier this year, it was determined that enrollment in the trial and dosing may continue.
BMS’s blockbuster checkpoint inhibitor Opdivo hit the primary endpoint in the Phase III CheckMate -76K trial for a particularly intractable form of melanoma.
Kyverna Therapeutics filed its first IND application this week to test the efficacy and tolerability of KYV-101, a CAR-T therapy for lupus nephritis.
The FDA’s Obstetrics Reproductive and Urologic Drugs Advisory Committee voted nearly unanimously to withdraw the approval of Covis’ preterm birth drug Makena.
While worthy advances have recently been made in sickle cell disease, companies such as Graphite Bio, bluebird bio, Vertex Pharmaceuticals and Editas Medicine have loftier ambitions.
Massachusetts-based PIC Therapeutics has closed a $35 million Series A financing round centered around the advancement of its lead asset, a novel therapeutic for advanced metastatic breast cancer.
A Phase II trial studying PTC Therapeutics’ PTC518 in Huntington’s disease has been paused in the United States following a request from the FDA for additional data.
Jazz and Zymeworks entered into a $50 million licensing agreement over zanidatamab, Zymeworks’ bispecific antibody targeting HER2.
Advaxis and Ayala Pharmaceuticals entered a reverse merger deal to focus on two clinical-stage cancer therapies: AL102 for desmoid tumors and ADXS-504 for prostate cancer.
Backed by Pfizer, Merck KGaA and J&J, Nucleome Therapeutics secured £37.5 million (about $42.16 million) in an oversubscribed Series A financing round.