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Behind the Headlines, Episode 23: Patent Cliff Deals, Tariff Pressures, and the In Vivo Cell Therapy Bet
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Orlynvah is the first new, branded product for the treatment of uncomplicated UTIs to be introduced in the US in more than 25 years.

Webinar Date/Time: Tue, Sep 16, 2025 11:00 AM EDT

Ifinatamab deruxtecan shows promising trial results targeting B7-H3 in small cell lung cancer, offering a potential new option after chemotherapy failure.

Best Practices in Host Cell Impurity Analytics – Using Advanced Technologies and Methods to Monitor, Control and Quantify Host Cell Proteins
Webinar Date/Time: Thu, Sep 4, 2025 11:00 AM EDT

Bristol Myers Squibb and SystImmune’s iza-bren shows promising efficacy and safety in EGFR-mutant NSCLC after TKI and chemotherapy, backed by data from global and China-based trials.

The company was one of 17 to receive letters from the White House on July 31 detailing the steps each company must take to bring prescription drug prices down for Americans.

Type 1 diabetes is a lifelong condition that currently affects approximately 400,000 people in the UK.

Dan Williams, PhD, SynaptixBio CEO, discusses how rare disease drug development leverages genetic targeting and drives innovation and investment in pharmaceutical technology and precision medicine.

Strand advances targeted mRNA therapies, with Phase I STX-001 solid tumor data presented at the 2025 ASCO Annual Meeting.

The company is not developing an mRNA vaccine, but had been using one as the control in a 10,000-subject Phase IIb trial.

Surveyed by PharmTech Group, this collection of industry players offers their thoughts on HHS’ latest policy move.

The additional approval expands the label for Avtozma (tocilizumab-anoh) to now include the treatment of cytokine release syndrome, which aligns the therapy with all indications for which Actemra is approved in the US.

Biopharma’s future depends on seamless integration of technology, expertise, and strategy.

Webinar Date/Time: Wed, Aug 20, 2025 11:00 AM EDT

While no new mRNA-based projects will be eliminated, other uses of mRNA technology within HHS are not impacted by the announcement.

The new platform delivers CAR-T DNA and transposase directly in vivo, potentially lowering manufacturing complexity and expanding treatment access.

Under the licensing agreement, the proposed biosimilar candidate, PolyPB016, will be developed and manufactured by Polpharma Biologics and commercialized by Fresenius Kabi.

Phase III study findings emphasize donanemab-azbt's (brand name Kisunla) ability to slow the decline of patients exhibiting early symptomatic Alzheimer’s disease.

At AAIC 2025, Roche presented new data from its Alzheimer’s disease research efforts across its diagnostics and pharmaceutical portfolios.

The acquisition highlights growing investor interest in gamma delta T-cell therapies and reflects increased monetization of biotech licensing agreements.

The biological reagents provider is moving to a 5000-square-foot site in Cambridge Technopark to accommodate the company’s growth.

If action is not taken within 60 days, the White House said it would “deploy every tool in our arsenal” to improve drug pricing practices for American patients.

The licensing agreement between the two companies gives Pfizer the rights to develop, manufacture, and commercialize 3SBio’s bispecific antibody, SSGJ-707, which is in clinical trials for the treatment of a variety of cancers.


Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.
















