BioSpace News Archive

Michael Andreini is president and chief executive officer of the Multiple Myeloma Research Foundation (MMRF).

FDA signage at its headquarters in Maryland

Manufacturing

FDA’s PreCheck Proposal a Welcome But Insufficient Step, Company Execs Say

While a new facility setup program aimed at encouraging onshoring received a positive reception at a recent meeting, industry representatives said the current rules on existing production plants are the main regulatory issues facing manufacturing teams.

October 14, 2025

·

4 min read

·

Nick Paul Taylor

Deerfield - Circa June 2019: Takeda Pharmaceutical Company. Takeda recently acquired Irish drugmaker Shire I

Artificial intelligence

Takeda Makes $1B+ AI Bet With Nabla to Build Out Early Pipeline

Nabla and Takeda first joined hands in 2022, to push “the boundaries of next-generation biologics discovery,” according to the startup’s CEO Surge Biswas.

October 14, 2025

·

2 min read

·

Tristan Manalac

Facade of Novo Nordisk's office in Fremont, California

Manufacturing

Violations at Novo’s Indiana Plant ‘Unacceptable,’ FDA Says

Slapped with the most severe post-inspection classification, the state of Novo Nordisk’s Indiana manufacturing site could pose a problem for clients, including Regeneron and Scholar Rock.

October 14, 2025

·

2 min read

·

Tristan Manalac

Ultralight plane from bottom with blue wave on black. Illustration background, banner with copy space

Earnings

Thanks to Pfizer, Drug Pricing Clouds Begin To Clear as Q3 Earnings Roll Out

J&J reports today, just two weeks after Pfizer secured certainty on tariffs and drug pricing. Analysts expect to hear about plans from the rest of the industry during third period earnings calls.

October 14, 2025

·

5 min read

·

Annalee Armstrong

Cancer of the brain as tumor growth diagnosis and symptoms of gliomas meningiomas astrocytomas and oligodendrogliomas as diagnosis of symptoms as a paper sculpture.

Alzheimer’s disease

Roche, Lilly Win First FDA Nod for Alzheimer’s Blood Test for Primary Care Use

Elecsys’ approval could help boost the uptake of currently approved Alzheimer’s disease therapies, including Biogen’s Eisai-partnered Leqembi, with CEO Chris Viehbacher recently noting that such biomarker-based tests could “remove some of the bottlenecks” in uptake.

October 14, 2025

·

2 min read

·

Tristan Manalac

Digital illustration of the White House, a road leading to it, and a stars and stripes pattern in the sky.

Earnings

No Trump Drug Pricing Plan for J&J—Yet

Reporting third quarter earnings on Tuesday, Johnson & Johnson CEO Joaquin Duato said the healthcare giant has not yet secured a drug pricing deal with the White House, but discussions are ongoing.

October 14, 2025

·

3 min read

·

Annalee Armstrong

Robotic claw clutching a money stock illustration

Series B

Kailera Banks Massive $600M Raise for Phase III Obesity Study

Kailera’s lead asset, KAI-9531, elicited an average weight loss of more than 17% in a Phase III study in China. The biotech expects to launch a global late-stage program for the drug this year.

October 14, 2025

·

2 min read

·

Tristan Manalac

Job Trends

Bonus Episode: Q3 2025 Job Market Update

In this bonus episode, BioSpace’s Vice President of Marketing ⁠Chantal Dresner⁠ and Careers Editor ⁠Angela Gabriel⁠ take a look at Q3 job market performance, layoffs and wider employment trends and policies impacting the biopharma workforce.

October 14, 2025

·

1 min read

·

Angela Gabriel

Press Releases

Oticara Announces Positive Phase 2 Results Demonstrating Durable Symptom Improvement with Novel Steroid Nasal Cream for Hard-to-Treat Post-Surgical Chronic Rhinosinusitis

October 14, 2025

·

4 min read