Social Media Ideas for Biologics License Application (Bla)

StockWatch: Positive Phase III Data Sells Investors on Intellia

The data was strong enough for Intellia to continue the rolling Biologics License Application (BLA) submission that it began in April. The company expects to complete the BLA filin...

The State of Biologics Testing Report 2026

This report is intended to inform discussion and decision making, not to prescribe solutions. Produced in collaboration with GEN, it reflects the collective voice of an industry ad...

<![CDATA[FDA Sends CRL to Cingulate for CTx-1301]]>

WuXi AppTec’s 1260H Listing Brings the BIOSECURE Act Back to Center Stage

By Steven J. Gonzalez —

Ipca inks licensing agreement with Bhami Research for biologics delivery platform access

Licencing agreement grants Ipca access to Bhami Research’s proprietary high-concentration subcutaneous biologics delivery platform for the development and commercialisation of mult...

<![CDATA[FDA Issues CRL to Elevar Therpaeutics for Combination of Rivoceranib and Camrelizumab ]]>

<![CDATA[Beyond JAK Inhibitors: Biologics Signal a New Era in Alopecia Areata]]>

Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance following the resignation of former commissioner Marty Mak...

A New Approach to Supporting Quality of Biologics

The United States Pharmacopeia (USP) is proposing a new approach for its work to support the quality and availability of selected biologic medicines. Building on decades of experie...

Major Biopharmaceutical Company Files First-in-Human Trial Supported by PAK BioSolutions GMP Purification System

A major biopharmaceutical company has filed a First-in-Human (FIH) clinical trial application with drug product manufactured using the PAK BioSolutions system. The milestone demons...

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Subcutaneous Formulation of Leqembi Iqlik]]>

Sanofi's subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector

- - • Sarclisa Escena administered via the CirCLIQ ® on-body injector (OBI) offers a treatment experience designed with patients and HCPs in mind - • The first anticancer tre...

What Data Says About Biologics-Related Ex Parte Challenges

An analysis of the 67 ex parte reexaminations used to challenge biologics patents over the last 13 years reveals that reexamination may emerge as an alternative to inter partes rev...