Product Development

Novartis downsizing internal efforts on CAR T in solid tumors

Novartis is pivoting away from internal development of CAR Ts in solid tumors, it said Thursday at its R&D day. The company is, however, pressing forward with the modality via partnerships, and plans to use...

U.S. biosimilars glass--half full or half empty?

Ten years after the U.S. created a pathway for biosimilars--and four and a half years after the first FDA approval--a few manufacturers have demonstrated that they can overcome the technical, regulatory and commercial barriers to...

Biogen Alzheimer’s data won’t sway believers or doubters either way

The upshot of Biogen’s aducanumab data is that the robustness of the compound’s efficacy remains in doubt. The CTAD presentation gave enough grist for believers to continue believing and skeptics to keep on doubting. Aducanumab...

New reimbursement models are coming to cancer diagnostics

A newly proposed payment model aims to increase reimbursement for cancer diagnostics by incentivizing companies to produce more clinical utility data. However, to drive widespread adoption, companies may also need to look to risk-sharing deals...

Sanofi adds in home-grown trispecific antibody technology to grow oncology franchise

Promising preclinical data from a trispecific mAb platform developed by Sanofi could provide a new growth platform for its cancer pipeline, as the pharma seeks to wean off its reliance on Regeneron. Sanofi (Euronext:SAN; NYSE:SNY)...

Major multinationals open, close, open R&D centers in China

After pulling back to reconsider their strategies, several pharmas are once again plunging into China’s life sciences innovation ecosystem, this time leaning more heavily on creation of innovation centers than R&D facilities. The changes reflect...

Navigating IP strategies in the world of digital therapeutics

For digital therapeutics, which straddle life sciences and tech, IP may be less important to creating value than the data they generate. As biopharma companies move into the world of digital therapeutics, they will need...

Hua Phase III diabetes data make good on glucokinase but disappoint investors

Hua’s announcement that glucokinase activator dorzagliatin met its endpoints in a Phase III diabetes study marks a watershed moment for a target whose disease-modifying potential was long stymied by the limitations of previous compounds. Yet...

Sickle cell disease poised for fresh infusion of hemoglobin-based endpoints

As new therapies designed to cut off sickle cell disease pathology at the root advance through the clinic, the field is moving beyond endpoints centered on pain crises to readouts based on hemoglobin. A single,...

Amgen to accelerate China strategy via BeiGene deal

Amgen is taking a hybrid approach to building out its China business that will allow it to accelerate its commercial plans in the country without biting off more than it can chew. Through the deal...

AZ replants R&D roots in China, goes all-in on innovation

In a big week for MNCs in China, AstraZeneca defined the latest move in its China strategy with an ‘all-in’ approach to innovation that goes full throttle by fostering R&D, AI and company formation. As...

Vertex’s triple therapy will reshape the landscape of cystic fibrosis trials

FDA approval of Vertex’s long-awaited triple therapy for cystic fibrosis is likely to seal the company’s dominance in the indication for years to come, with competitive threats barely touching the horizon. Moreover, uptake of the...

Novartis, Merck KGaA see opportunity in select pockets of MS patients

As companies continue to pile into the multiple sclerosis market with new therapies, Novartis and Merck KGaA are dissecting the landscape to define populations for their newly launched drugs. While the former is staking out...

Amgen deal gives BeiGene dry powder to grow its own pipeline

In its second major -- and potentially transformational -- deal with a U.S. company, BeiGene has entered a development and commercialization deal with Amgen that adds nearly two dozen compounds to the Chinese biotech’s marketed...

How a KRAS program transformed Mirati's story

With the first clinical data due on Mirati’s KRAS inhibitor next week, the market will get its first chance to justify -- or otherwise -- the large chunk of the company’s $3 billion valuation tied...