Bay­er to cut in­ter­nal drug R&D work, ax­ing hun­dreds of re­searchers while look­ing to part­ners as it un­veils plan to slash 12,000 jobs

Bay­er is push­ing ahead with plans to re­struc­ture its drug R&D busi­ness and cut 900 re­search staffers as part of a broad plan to slash a to­tal of 12,000 em­ploy­ees in a world­wide re­vamp.

De­tails on the changes in R&D — some­thing that’s been ru­mored to be in the works for months — are slim, with no word about which projects are threat­ened. Their state­ment notes 900 jobs are be­ing cut in phar­ma R&D with an­oth­er 350 jobs slashed at a Ger­man fac­tor VI­II pro­duc­tion plant. The em­pha­sis now will shift in drug R&D, re­duc­ing in-house work while look­ing to ex­ter­nal part­ners to car­ry more of the load.

In their state­ment the Ger­man phar­ma com­pa­ny says that their R&D “mea­sures in­clude ac­cel­er­at­ed de­vel­op­ment of the in­no­va­tion mod­el and a re­struc­tur­ing of in­ter­nal R&D ac­tiv­i­ties. Re­sources freed up through the re­duc­tion of in­ter­nal ca­pac­i­ties are to be di­rect­ed to­ward strength­en­ing in­vest­ment in col­lab­o­ra­tive re­search mod­els and ex­ter­nal in­no­va­tions.”

Bay­er al­so plans to sell off con­sumer prod­ucts and ex­it the an­i­mal health busi­ness fol­low­ing its ac­qui­si­tion of Mon­san­to — which faces its own in­ter­nal cuts as a bliz­zard of law­suits be­siege the new own­ers.

With Roche shak­ing up the he­mo­phil­ia mar­ket with its new drug Hem­li­bra, Bay­er says that it will shut­ter “the fac­tor VI­II fa­cil­i­ty it has built in Wup­per­tal, Ger­many, and … fo­cus all re­com­bi­nant fac­tor VI­II pro­duc­tion in Berke­ley,” CA.

Ru­mors about a big shake­up in R&D have been cir­cu­lat­ing through much of 2018. Ger­many’s Wirtschaftswoche got it start­ed at the end of May, re­port­ing that the prospec­tive cuts could reach up to 1,000 in the re­or­ga­ni­za­tion. Reuters then re­port­ed that job cuts and out­sourc­ing were on the ta­ble as the Ger­man drug com­pa­ny looks to raise more cash to in-li­cense new ther­a­pies for its pipeline.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotechs that fit that general description.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Stephen Hahn, FDA commissioner (AP Images)

Stephen Hahn: FDA will make some changes amid Covid-19 per­ma­nent

The FDA will look to permanently implement some of the processes and policies adopted in its response to the Covid-19 pandemic, FDA commissioner Stephen Hahn said during a virtual briefing hosted by the Alliance for a Stronger FDA on Monday.

Hahn’s statements during the briefing closely mirrored statements he made in a pre-recorded video FDA uploaded to YouTube on Friday.

“As this pandemic has evolved, it was clear to all of us that some FDA processes needed to be adjusted to accommodate the urgency of the pandemic and I think the entire FDA team has now seen first-hand that we need to take a critical look at some of our processes and policies,” Hahn said.