Tedros Adhanom Ghebreyesus, WHO Director-General (Salvatore Di Nolfi/Keystone via AP)

Glob­al li­cense pro­gram to re­ceive Covid-19 sup­port from the NIH

A WHO pro­gram will see some sup­port from the Biden ad­min­is­tra­tion in the fight against Covid-19.

At the sec­ond Glob­al Covid-19 Sum­mit, the ad­min­is­tra­tion, through the NIH, has de­cid­ed to of­fi­cial­ly li­cense 11 Covid-19 re­search tools and ear­ly-stage vac­cine and di­ag­nos­tic can­di­dates. This will be done through the Med­i­cines Patent Pool (MPP), a UN-backed pro­gram, through WHO’s Tech­nol­o­gy Ac­cess Pool (C-TAP).

The li­cens­es will al­low man­u­fac­tur­ers from any­where in the world to work with the MPP and C-TAP to use these tech­nolo­gies for the po­ten­tial de­vel­op­ment of Covid-19 vac­cines, treat­ments and di­ag­nos­tics. This will serve to ben­e­fit peo­ple liv­ing in low- and mid­dle-in­come coun­tries.

In­clud­ed in the tech­nolo­gies li­censed is the SARS-CoV-2 sta­bi­lized spike pro­tein—a patent­ed in­ven­tion in­clud­ed in mul­ti­ple vac­cines.

The C-TAP aims to boost the glob­al sup­ply of vac­cines by fa­cil­i­tat­ing the shar­ing of in­tel­lec­tu­al prop­er­ty, knowl­edge, and da­ta with man­u­fac­tur­ers that can scale up pro­duc­tion. The NIH has al­ready grant­ed nonex­clu­sive li­cens­es to com­pa­nies for use of the SARS-CoV-2 sta­bi­lized spike pro­tein. How­ev­er, grant­i­ng fur­ther ac­cess through the C-TAP pro­gram will hope to en­able wider ac­cess.

Ac­cord­ing to the WHO, oth­er tools that are be­ing li­censed out in­clude the struc­ture-based de­sign of spike im­muno­gens, pseudo­typ­ing plas­mid, ACE2 dimer con­struct and a syn­thet­ic hu­man­ized lla­ma nanobody li­brary, among oth­er di­ag­nos­tic tools. The C-TAP pro­gram will al­so have ac­cess to sev­er­al vac­cine can­di­dates as well. The US will re­tain all of its ex­ist­ing rights on any li­censed tech­nolo­gies.

This move by HHS was ex­pect­ed to come, ac­cord­ing to a re­port from the Wash­ing­ton Post. Al­so, phar­ma gi­ants Pfiz­er and Mer­ck have es­tab­lished pri­or agree­ments with the Med­i­cines Patent Pool to ex­pand ac­cess to their Covid-19 an­tivi­ral pills.

“I wel­come the gen­er­ous con­tri­bu­tion NIH has made to C-TAP and its ex­am­ple of sol­i­dar­i­ty and shar­ing,” WHO di­rec­tor-gen­er­al Tedros Ad­hanom Ghe­breye­sus said. “Whether it’s to­day’s pan­dem­ic or to­mor­row’s health emer­gency, it’s through shar­ing and em­pow­er­ing low­er-in­come coun­tries to man­u­fac­ture their own health tools that we can en­sure a health­i­er fu­ture for every­one.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.