Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

De­moc­rats pe­ti­tion US patent of­fice to probe Mer­ck­'s new Keytru­da re­quests

De­moc­rats in both the House of Rep­re­sen­ta­tives and the Sen­ate are ask­ing the US Patent and Trade­mark Of­fice (PTO) to take a clos­er look at Mer­ck’s pend­ing patents for its megablock­buster can­cer drug Keytru­da.

Sen. Eliz­a­beth War­ren (D-MA)’s of­fice an­nounced Thurs­day that the sen­a­tor, along­side Sen­ate Health com­mit­tee chair Bernie Sanders (I-VT) and Reps. Katie Porter (D-CA) and Prami­la Jaya­pal (D-WA), wrote a let­ter to PTO di­rec­tor Kathi Vi­dal on Wednes­day — ask­ing Vi­dal to scru­ti­nize any new patent re­quests from Mer­ck for Keytru­da, which hauled in $20.9 bil­lion last year.

The law­mak­ers ac­cused the phar­ma gi­ant of us­ing the US patent sys­tem to pro­tect its mo­nop­oly on the drug, say­ing that Mer­ck’s at­tempts to patent a sub­cu­ta­neous for­mu­la­tion of Keytru­da is akin to “ex­tend­ing its mo­nop­oly pow­er over the drug” and seems to be an ex­am­ple of an­ti-com­pet­i­tive busi­ness prac­tices.

“What ac­tions will USP­TO take to en­sure that Mer­ck’s at­tempt to seek dozens of patents ‘does not un­nec­es­sar­i­ly de­lay get­ting gener­ic, biosim­i­lar and more af­ford­able ver­sions of those drugs in­to the hands of Amer­i­cans who need them?’” the politi­cians added, say­ing that the patent of­fice should re­ject any of Mer­ck’s patent re­quests “that do not clear­ly meet the agency’s stan­dards of nov­el­ty, util­i­ty, and non-ob­vi­ous­ness.”

A Mer­ck spokesper­son told End­points News in re­sponse to the let­ter that “Mer­ck is con­tin­u­ous­ly in­no­vat­ing to en­hance the ben­e­fits of Keytru­da in or­der to reach greater num­bers of pa­tients and to in­crease ef­fi­ca­cy and con­ve­nience of the treat­ment.”

The spokesper­son added, “When ap­pro­pri­ate, Mer­ck pro­tects this ad­di­tion­al in­no­va­tion through the fil­ing of patent ap­pli­ca­tions, par­tic­u­lar­ly when we view the in­no­va­tion as nov­el, use­ful and nonob­vi­ous.”

War­ren and Sanders have spo­ken out against the phar­ma­ceu­ti­cal in­dus­try be­fore.

More re­cent­ly, War­ren asked the Fed­er­al Trade Com­mis­sion to in­ves­ti­gate cer­tain phar­ma buy­out deals last month — no­tably Am­gen’s $28 bil­lion plan to take over Hori­zon Ther­a­peu­tics and In­di­v­ior’s pro­posed ac­qui­si­tion of Opi­ant for $145 mil­lion up­front. The sen­a­tor, in a let­ter to FTC chair Lina Khan and two of the com­mis­sion­ers, called the deals “ram­pant con­sol­i­da­tion in the phar­ma­ceu­ti­cal in­dus­try.”

Sanders, a long-time crit­ic of the phar­ma­ceu­ti­cal in­dus­try and new­ly-tapped chair­man of the Sen­ate Com­mit­tee on Health, Ed­u­ca­tion, La­bor and Pen­sions (HELP), has been proac­tive in his cri­tiques of in­dus­try. The sen­a­tor re­cent­ly con­demned re­port­ed plans from Covid vac­cine gi­ant Mod­er­na to price its vac­cine be­tween $110 and $130 per dose in the US, a 300% in­crease, and has plans to grill Mod­er­na CEO Stephane Ban­cel next month.

“The huge in­crease in price that you have pro­posed will have a sig­nif­i­cant­ly neg­a­tive im­pact on the bud­gets of Med­ic­aid, Medicare and oth­er gov­ern­ment pro­grams that will con­tin­ue cov­er­ing the vac­cine with­out cost-shar­ing for pa­tients,” Sanders wrote at the time.

Mod­er­na lat­er said peo­ple won’t need to pay out-of-pock­et for its Covid vac­cine, re­gard­less of in­sur­ance sta­tus.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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