R&D channel feed

Hal Barron, GlaxoSmithKline R&D chief (GSK via investor day livestream)

Glax­o­SmithK­line trum­pets a PhI­II win in one of Hal Bar­ron's hand­picked drugs, a day af­ter Fi­bro­Gen's face­plant. Will it mat­ter enough to crit­ics?

As GlaxoSmithKline CEO Emma Walmsley charts a new course ahead of the Big Pharma’s planned split while simultaneously under immense pressure from activist investors, the company is touting positive topline results from a late-stage program Friday morning. And it comes less than 24 hours after FibroGen and AstraZeneca ran into a slapdown at an FDA adcomm for a similar drug.

The data come from an experimental drug known as daprodustat, with GSK evaluating the candidate for anemia associated with chronic kidney disease. Daprodustat reached its primary endpoints in five Phase III trials across a variety of patient populations and dosing regimens, GSK announced, ahead of planned regulatory submissions expected in 2022.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

Giovanni Caforio, AP Images

Bris­tol My­ers Squibb takes an­oth­er late-stage loss for Op­di­vo-Yer­voy com­bo in head and neck can­cer

Bristol Myers Squibb has worked overtime to hunt down an edge for its PD-(L)1 blocker Opdivo over rival Keytruda from Merck, including taking a bold combo strategy with CTLA4 inhibitor Yervoy. But in head and neck cancer, the combo keeps dropping duds.

Opdivo plus Yervoy failed to show clinical benefit in extending the lives of first-line patients with recurrent or metastatic squamous cell carcinoma of the head and neck, according to topline results from the Phase III CHECKMATE-651 study revealed Friday.

Emma Walmsley, GlaxoSmithKline CEO (Mandel Ngan/AFP via Getty Images)

A cou­ple weeks af­ter ac­tivist at­tack, Glax­o­SmithK­line un­veils big plans to cre­ate a UK biotech hub

A couple weeks after activist investor Elliott began its long-awaited attack on CEO Emma Walmsley, GlaxoSmithKline has unveiled a plan to sell over a third of the land at its Stevenage, UK, site to create “one of Europe’s largest ‘clusters’ for biotechnology” and early-stage life sciences companies.

The pharma is putting 33 acres up for sale, which GSK says could be developed into about 100,000 square meters of floor space and create thousands of jobs. All it would take, the company says, is a private developer to invest a little more than $552 million (£400 million).

Alex­ion touts new PhI­II da­ta of Soliris suc­ces­sor as planned As­traZeneca takeover looms

A little less than a week before AstraZeneca’s takeover of Alexion is expected to be completed, the rare disease biotech  offered up a cut of data for its Soliris successor.

In a Phase III study for Ultomiris looking at adults with generalized myasthenia gravis, the drug met its primary endpoint of significantly improving scores on a patient-reported assessment compared to placebo after 26 weeks, Alexion announced Thursday afternoon. Alexion hopes the topline results represent what could be Ultomiris’ third approval, after it notched OKs for a rare blood disorder called PNH and an ultra-rare chronic disease that damages the kidneys.

CD­MO AM­RI re­brands and snags a pair of small­er com­pa­nies to aid its shift to be­come a glob­al brand name

The folks at contract manufacturer AMRI were looking to transform their business into a disruptor. They first started with a name change — AMRI is now Curia — and then locked down two acquisitions they hope will take the company into the future.

Curia this week acquired LakePharma, a biotech with headquarters in California’s Bay Area and locations in Massachusetts and Texas as well. The company and its employees will help with large and small molecules from drug discovery through fill-finish manufacturing. A day earlier, Curia announced the acquisition of Integrity Bio, a formulation and fill-finish company from Camarillo, CA.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

Geoff McDonough, CEO (Generation Bio)

Gen­er­a­tion Bio snaps up Boston area plant as it rolls out a man­u­fac­tur­ing process it thinks will be a game chang­er

Generation Bio is looking to move the field of gene therapy into the future, and thinks it has a manufacturing process in place that will allow enough scale for broad disease indications. Now, all it needs is a plant to put those large-scale ambitions into action.

Generation signed a lease on a new 104,000-square-foot facility in Waltham, MA, set to become operational in 2023. The facility will be available for preclinical and clinical development for its lead hemophilia A program.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos dis­ap­points again as 2 key read­outs fail to gen­er­ate much en­thu­si­asm for Gilead­'s fad­ing part­ner

The analysts still left trying to determine if Gilead’s once-big collaborator Galapagos has anything of value to offer in the pipeline were left either shaking their heads Wednesday evening or looking for some hard-to-find silver linings in the latest round of disappointing readouts.

Let’s start with GLPG3970, which Baird’s Brian Skorney has called Gilead’s next best hope of delivering some upbeat news that could offer some real value to investors.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

Tom Lynch (Rob Tannenbaum, Endpoints News)

Tom Lynch moves to re­struc­ture Fred Hutch as acad­e­mia, in­dus­try con­tin­ue to push cell ther­a­py in­to sol­id tu­mors

By the time former Bristol Myers Squibb CSO Tom Lynch stepped in to run the Fred Hutch Cancer Research Center last year, both the potential and limits of the institute’s preclinical research had become clear.

The institute’s researchers, including famed virologist Larry Corey, had helped make CAR-T therapies a reality, contributing basic science and co-founding Juno Therapeutics, the cell therapy startup Celgene bought out for $9 billion. But while cell therapies have now proven an effective — even sometimes curative — therapy across multiple blood cancers, the approach has been frustratingly difficult to apply to solid tumors.

Shankar Ramaswamy (L) and Fraser Wright

Bank­ing on shared ex­pe­ri­ences — and now a big in­vestor — with broth­er Vivek, Shankar Ra­maswamy stacks up a $100M mega-round

Shankar Ramaswamy learned a lot when he went to work for his older brother Vivek at Axovant. He also gained some important relationships. And they are both coming into play as he takes his newly-founded gene therapy company up to the next level of R&D.

Earlier today Kriya Therapeutics rather quietly came out with the news that it has raised an even $100 million for its B round, just a little over a year after he and his crew snagged their $80 million launch round.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

In mul­ti­ple myelo­ma show­down, J&J adds an­oth­er feath­er to Darza­lex's cap

Sanofi’s Sarclisa burst onto the multiple myeloma scene last year to challenge J&J’s CD38 heavyweight Darzalex. But J&J isn’t going down without a fight, and now it’s touting another approval for the hard-to-treat blood cancer — along with an easier route of administration that could save patients hours of their time.

The FDA has given Darzalex Faspro the thumbs-up as a second-line treatment for adults with multiple myeloma in combination with pomalidomide and dexamethasone (Pd), Janssen said Monday. The approval marks the sixth indication for Darzalex Faspro, which is co-formulated with Halozyme’s recombinant human hyaluronidase PH20, a type of enzyme that catalyzes the degradation of hyaluronic acid.