Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst re­cent­ly broad­er vac­cine man­u­fac­tur­ing ini­tia­tives from the EU and Eu­ro­pean com­pa­nies, the G7 sum­mit in the moun­tains of Bavaria has brought about some pos­i­tive news for clos­ing vac­cine and med­ical prod­uct man­u­fac­tur­ing gaps around the globe.

Ac­cord­ing to a state­ment from the White House, the G7 lead­ers have for­mal­ly launched the part­ner­ship for glob­al in­fra­struc­ture, PGII. The ef­fort will aim to mo­bi­lize hun­dreds of bil­lions of dol­lars to de­liv­er in­fra­struc­ture projects in sev­er­al sec­tors in­clud­ing the med­ical and phar­ma­ceu­ti­cal man­u­fac­tur­ing space.

The US will look to mo­bi­lize $200 bil­lion for PGII over the next five years through grants, fed­er­al fi­nanc­ing, and pri­vate sec­tor in­vest­ments. Along­side the oth­er G7 na­tions, a to­tal of $600 bil­lion will mo­bi­lized by 2027 for a wide range of glob­al in­fra­struc­ture in­vest­ments.

One of the ini­tial projects in­cludes the G7 mem­bers, the EU, mul­ti­lat­er­al or­ga­ni­za­tions and the US In­ter­na­tion­al De­vel­op­ment Fi­nance Cor­po­ra­tions (DFC) dis­burs­ing a $3.3 mil­lion tech­ni­cal as­sis­tance grant to In­sti­tut Pas­teur de Dakar (IPD) in Sene­gal.

The funds will be used to de­vel­op an in­dus­tri­al-scale flex­i­ble mul­ti-vac­cine man­u­fac­tur­ing fa­cil­i­ty. The fa­cil­i­ty will have the po­ten­tial to pro­duce mil­lions of dos­es of vac­cines for Covid-19 and oth­er dis­eases, with the po­ten­tial to use both vi­ral vec­tor and mR­NA tech­nolo­gies.

This comes at a time when Africa is be­com­ing more of a fo­cus for vac­cine man­u­fac­tur­ing.

On Thurs­day, BioN­Tech kicked off con­struc­tion work for an mR­NA man­u­fac­tur­ing fa­cil­i­ty in Ki­gali, Rwan­da. Ac­cord­ing to BioN­Tech, the fa­cil­i­ty — dubbed the African mod­u­lar mR­NA man­u­fac­tur­ing fa­cil­i­ty — has a tar­get for the first set of man­u­fac­tur­ing tools to be de­liv­ered to the site by the end of this year.

The Serum In­sti­tute, in May, al­so said it is con­sid­er­ing es­tab­lish­ing its first man­u­fac­tur­ing plant in Africa as part of a fur­ther step to­ward glob­al ex­pan­sion af­ter suc­cess­ful­ly mass pro­duc­ing and sell­ing hun­dreds of mil­lions of Covid-19 vac­cine dos­es out of its In­dia-based fa­cil­i­ties.

This al­so comes on the heels of the EU launch­ing a new ini­tia­tive for vac­cines and med­i­cines man­u­fac­tur­ing in Latin Amer­i­ca and the Caribbean to get drugs to the re­gion faster.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP)

FTC makes an ex­am­ple of GoodRx, bans dis­counter from shar­ing pri­vate health da­ta with ad­ver­tis­ers

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.