Covid-19 man­u­fac­tur­ing roundup: WHO let­ter out­lines re­boot of IP shar­ing pro­gram; In­dia backs down on do­mes­ti­cal­ly-pro­duced vac­cine tri­al

While vac­cine short­ages have kept many coun­tries in the midst of the pan­dem­ic, the World Health Or­ga­ni­za­tion is re­boot­ing its IP shar­ing scheme.

The Cos­ta Ri­can pres­i­dent Al­vara­do Que­sa­da and Di­rec­tor Gen­er­al of the WHO Tedros Ad­hanom Ghe­brey­sus re­leased a let­ter Thurs­day call­ing for the re­vamp­ing of the Sol­i­dar­i­ty Call to Ac­tion plan that was out­lined a year ago.

“The sin­gle most im­por­tant pri­or­i­ty of the glob­al com­mu­ni­ty is to stop the COVID-19 pan­dem­ic in its tracks, to halt its rapid trans­mis­sion and re­verse the trend of con­se­quen­tial glob­al dis­tress,” the let­ter says. “We know that this goal is on­ly achiev­able when every­one, every­where can ac­cess the health tech­nolo­gies they need for COVID-19 de­tec­tion, pre­ven­tion, treat­ment and re­sponse.”

Last year, the Covid-19 tech­nol­o­gy ac­cess pool was launched, but failed to gain in­ter­est from the phar­ma­ceu­ti­cal in­dus­try or high­er-in­come coun­tries. The pro­gram re­lies on vol­un­tary pool­ing of IP and man­u­fac­tur­ing trade se­crets, some­thing that some coun­tries such as the US and Rus­sia have ex­pressed in­ter­est in with­out much phar­ma buy-in.

In­dia backs down on do­mes­ti­cal­ly pro­duced vac­cine tri­al

As In­dia fights a sec­ond wave of Covid-19 that has killed tens of thou­sands of peo­ple, its gov­ern­ment has de­cid­ed to for­go lo­cal tri­als of a vac­cine for the “well-es­tab­lished” jabs, Reuters re­ports.

Res­i­dents have been re­ceiv­ing As­traZeneca’s vac­cine, which has been man­u­fac­tured at the Serum In­sti­tute in Pune, Ma­ha­rash­tra. Some In­di­ans have re­ceived Co­v­ax­in, from Bharat Biotech, and re­cent­ly the coun­try rolled out Rus­sia’s Sput­nik V vac­cine. But the jabs are in short sup­ply.

The gov­ern­ment is in talks with Pfiz­er, J&J and Mod­er­na for the ear­li­est pos­si­ble im­ports of the vac­cines, Reuters re­ports, but an in­sis­tence on lo­cal tri­als led to de­layed dis­cus­sions with Pfiz­er.

None of the drug­mak­ers have sub­mit­ted ap­pli­ca­tions for reg­u­la­to­ry ap­proval, the gov­ern­ment has said. On­ly 3% of the coun­try’s pop­u­la­tion has been vac­ci­nat­ed. The num­ber of re­port­ed cas­es has dropped in the last 2 weeks, but deaths are still high: 3,487 peo­ple died from the virus Wednes­day alone.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Covid-19 roundup: White House re­veals vac­cine do­na­tion plan; EU opts in for an­oth­er 150 mil­lion dos­es from Mod­er­na

President Joe Biden’s administration on Monday revealed the distribution list for 55 million of the 80 million doses of Covid-19 vaccines America plans to donate to lower-income nations:

Roughly 14 million doses will head to Latin America and the Caribbean, for a list of countries that includes Brazil, Argentina, Dominican Republic, Panama and Costa Rica.
Another 16 million doses are headed to Asia to help the following countries: India, Nepal, Bangladesh, Pakistan, Sri Lanka, Afghanistan, Maldives, Bhutan, Philippines, Vietnam, Indonesia, Thailand, Malaysia, Laos, Papua New Guinea, Taiwan, Cambodia, and the Pacific Islands.

Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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Kimberly Smith, ViiV via Youtube

They went from dai­ly to once every two months. But how much longer act­ing can HIV meds be? Vi­iV en­lists Halozyme's tech to find out

It wasn’t easy navigating the manufacturing and controls issues that had led the FDA to reject ViiV Healthcare’s first pitch for the once-monthly HIV regimen cabotegravir and rilpivirine. But even as Kimberly Smith was knee-deep in sorting out those problems and putting together a new package that finally won the regulators over this January, her business development team kept looking for things that would take them to the next level.

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