Weekly Digest

Keytruda’s KEYNOTE-189 trial marked a watershed moment in the history of lung cancer drug development by showing a monster survival benefit. Now, Merck & Co. is giving a five-year look at the data that made the PD-1 inhibitor the standard of care in newly diagnosed patients.

Sarepta Therapeutics has broken free from an FDA hold—put in place this June—on its phase 2 Duchenne muscular dystrophy (DMD) clinical trial.

Boehringer Ingelheim gained an FDA approval to treat generalized pustular psoriasis, a rare and life-threatening skin condition that causes eruptions of painful blisters. Spevigo is an IL-36 receptor inhibitor, and marks the first dermatology go-ahead for the German firm.

Roche has paid out $250 million cash to acquire Good Therapeutics as part of a bid to bolster its immuno-oncology efforts with the Seattle biotech's preclinical PD-1-regulated IL-2 program.

For a long time, AstraZeneca’s Imfinzi has mainly been limited to stage III non-small cell lung cancer. Now, the PD-L1 inhibitor has snatched a first for the immuno-oncology class, with two other important expansions awaiting FDA verdicts.

The trouble seemingly never ends for Philips’ beleaguered Respironics division.

After a rough regulatory start to the year, India’s Aurobindo Pharma is charting plans for growth. The Hyderabad-based generics juggernaut will plow 3 billion Indian rupees (about $37.7 million) into an expansion of its subsidiary CuraTeQ Biologics, the company said Thursday.

A team of researchers from two French universities has found that the absence of gonadotropin-releasing hormone could be driving olfactory dysfunction and cognitive decline in people with Down syndrome. In a small, pilot study published in Science, the team also showed that restoring GnRH could improve cognitive performance.

As venture capital pours into budding biotechs, we're launching the Fierce Biotech Fundraising Tracker to keep tabs on all things financing.

Medical Affairs plays a critical role in generating insights to inform strategic decisions, but that role is changing. This paper explores why, and how MA teams can stay ahead of the curve.

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Don’t miss these critical considerations when evaluating your HCP interactions management program.

Explore the new cell therapy handbook from Thermo Fisher Scientific.

Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals.

Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays?

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?