Pharminent · Daily Brief

October 6, 2026
Regulatory & Approvals

FDA clears Lilly’s Jaypirca for first frontline indication

The FDA approved Lilly’s noncovalent BTK inhibitor Jaypirca for its first frontline indication.

Pharmaphorum →$LLY

FDA requests public input on ibogaine clinical trial design

The FDA issued a request for information describing approaches it is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public comment on them.

FDA →

Janssen wins preliminary injunction against Accord’s golimumab biosimilar

On September 30, 2026, the U.S. District Court for the District of Delaware granted Janssen Biotech and Janssen Sciences Ireland a preliminary injunction in Janssen Biotech, Inc. v. Accord BioPharma, Inc., enjoining Accord’s golimumab biosimilar.

Big Molecule Watch →
Clinical Data

Vaxcyte’s VAX-31 pneumococcal vaccine meets phase 3 primary endpoints

Vaxcyte reported that its pneumococcal vaccine VAX-31 met the primary endpoints of a phase 3 trial. Shares in the company rose on the data.

Pharmaphorum →

Boehringer’s survodutide cuts weight up to 13.1% in phase 3

Boehringer Ingelheim’s survodutide produced weight loss of up to 13.1% after 76 weeks in people with obesity or overweight and type 2 diabetes in the phase 3 SYNCHRONIZE-2 trial, which met its co-primary endpoints, with 79.3% of treated patients achieving at least 5% weight loss.

PharmaFile →

Regeneron reports longer-term C-POST survival data for Libtayo at ESMO

Regeneron presented late-breaking phase 3 C-POST data showing longer-term survival outcomes for adjuvant Libtayo (cemiplimab) in high-risk cutaneous squamous cell carcinoma after surgery and radiation, along with a final phase 2 analysis of neoadjuvant Libtayo.

Regeneron →$REGN
Deals & Partnerships

Shionogi to acquire IntraBio for $2B in rare disease deal

Shionogi agreed to acquire Texas-based IntraBio for $2 billion, gaining Aqneursa, a marketed treatment approved for two rare inherited neurological disorders.

BioPharma Dive →

GE HealthCare to acquire Sofie Biosciences for $945 million

GE HealthCare agreed to acquire Sofie Biosciences for $945 million, expanding its radiopharmaceutical capabilities for manufacturing and distributing time-sensitive drugs used in PET imaging.

BioPharma Dive →

Lilly expands Gate Bioscience collaboration in $870M deal

Lilly expanded its collaboration with Gate Bioscience in a deal valued at $870 million, covering the company’s molecular gate approach aimed at hard-to-drug proteins.

Pharmaceutical Technology →$LLY

CSL and Alentis enter $1.6 billion global partnership

CSL and Alentis Therapeutics have entered a global partnership valued at $1.6 billion.

PharmExec →

STADA and SBP Group form biosimilars manufacturing partnership

STADA and Sino Biopharmaceutical, through its subsidiary Chia Tai Tianqing Pharmaceutical Group, agreed to a partnership under which CTTQ will develop, manufacture and supply biosimilar candidates while STADA holds the marketing authorizations and exclusive sales and marketing rights.

Big Molecule Watch →
Business & Finance

Nobel Prize in Medicine awarded to optogenetics pioneers

The 2026 Nobel Prize in Physiology or Medicine was awarded jointly to optogenetics pioneers Karl Deisseroth, Peter Hegemann and Georg Nagel, whose work the award committee said “laid the foundation” for a new field of brain research.

Pharmaphorum →

AstraZeneca opens Massachusetts R&D center backed by $1B investment

AstraZeneca opened a new global strategic R&D facility in Massachusetts as part of an investment of more than $1 billion in the state.

Pharmaceutical Technology →$AZN

AstraZeneca’s CEO discusses Summit drug after $2B investment

AstraZeneca CEO Pascal Soriot told CNBC that the Summit Therapeutics drug in which AstraZeneca invested $2 billion could drive the next generation of cancer combinations, speaking from the company’s new $1 billion R&D facility in Kendall Square in Cambridge, Massachusetts.

CNBC →$AZN

ESTEVE CDMO adds $17.5M to Illinois site expansion

ESTEVE CDMO is investing a further $17.5 million to expand capacity and containment capabilities at its Morton Grove facility in Illinois, taking total announced investment at the site to $33 million and funding two new 500-gallon reactors and enhanced containment in early-stage development laboratories.

PharmaFile →

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