As drug developers aggressively pursue gene therapies and their makers, the manufacturing end of the supply chain is also fortifying itself for the wave of therapies expected to hit the market in the coming years. Less than a month after Thermo Fisher unveiled a $1.7 billion deal to swallow Brammer Bio — a company that does contract viral vector manufacturing for cell and gene therapy developers — Catalent is planning to fork over $1.2 billion for private-equity backed Paragon Bioservices.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

CAR-T therapies were hailed as a breakthrough when Novartis received the first FDA approval for Kymriah back in 2017. Though highly effective at treating certain types of blood cancers, CAR-Ts are also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome.

With this in mind, Autolus Therapeutics is looking to take a crack at a safer CAR-T and presented Phase II cohort data for its AUTO3 program at virtual ESMO 2020. The data showed that, among the 35 patients in the cohort being treated for r/r diffuse large B cell lymphoma, there were no instances of Grade 3 or higher CRS. Eight individuals saw Grade 1 inflammation while another four patients reached Grade 2.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

After nailing down the top drug franchise in cystic fibrosis, Vertex $VRTX is turning to the mRNA aficionados at Moderna $MRNA to use gene editing tech for a generation 2.0 attempt to master the disease. This is their 3rd pact together in 4 years as they jointly set their sights on the patients who are toughest to treat.

Researchers at Moderna and Vertex will now work together to develop lipid nanoparticles and mRNA to deliver gene editing tools to cells in the lung to spur production of functional cystic fibrosis transmembrane conductance regulator (CFTR) protein.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN