Af­ter ramp­ing up its vac­cine pro­duc­tion in South Africa, As­pen yet to re­ceive a sin­gle or­der

Stephen Saad

When As­pen Phar­ma­care made an agree­ment with J&J to make and sell its own gener­ic Covid-19 vac­cine much of the world re­joiced. As­pen CEO Stephen Saad said that it would help catch Africa up to speed with the rest of the world, and Pres­i­dent Joe Biden’s ad­min­is­tra­tion agreed and pledged $200 mil­lion to the plant in Gqe­ber­ha to ex­pand pro­duc­tion.

But now, de­spite be­ing the first fac­to­ry in Africa to make vac­cines for the con­ti­nent, the phar­ma has not re­ceived a sin­gle or­der, which could lead to the shut­ter­ing of the site, ac­cord­ing to a re­cent re­port from The New York Times.

A back­log in avail­able vac­cines has led to the slow dis­tri­b­u­tion in Africa. And health agen­cies now have no need for new dos­es un­til the old ones are ap­pro­pri­ate­ly ad­min­is­tered or ex­pired.

This may come as a sur­prise. Less than 20% of Africa is ful­ly vac­ci­nat­ed. That num­ber was ex­pect­ed to shrink when man­u­fac­tur­ing sites such as As­pen’s were up-and-run­ning. Saad said that his com­pa­ny would ramp up its Covid-19 vac­cine ca­pac­i­ty to 1.3 bil­lion dos­es a year by ear­ly 2024 and that the ex­pan­sion could gen­er­ate more than $542 mil­lion a year in ad­di­tion­al rev­enue.

Stavros Nico­laou

Mean­while, As­pen’s head of strate­gic trade de­vel­op­ment Stavros Nico­laou told the Times that As­pen will piv­ot to anes­thet­ic man­u­fac­tur­ing if there are still no or­ders from the phar­ma with­in the next six weeks. How­ev­er, not all 500 of the staffers will be suc­cess­ful in mak­ing the tran­si­tion, he said.

“CO­V­AX is still un­der con­tract with J&J and we would be very hap­py for any dos­es that we are still ex­pect­ing to be sup­plied by As­pen,” Gavi, the vac­cine al­liance said in a state­ment. “We have com­mu­ni­cat­ed this to J&J. How­ev­er, again this is sole­ly a de­ci­sion that rests with J&J.”

J&J’s in­tel­lec­tu­al prop­er­ty li­cense is good un­til the end of 2026 and in­cludes any new ver­sions of drug sub­stances as the threat of vari­ants looms. J&J’s vac­cine is ben­e­fi­cial in Africa, par­tic­u­lar­ly the rur­al parts, be­cause it is a sin­gle shot, mak­ing it eas­i­er for those who have to trav­el long dis­tances to be­come ful­ly in­oc­u­lat­ed.

It’s not the first bit of con­tro­ver­sy to come out of the plant. Re­ports came out in Au­gust that while the US poured mon­ey in­to the site in an ef­fort to pro­vide dos­es to the African con­ti­nent, the ma­jor­i­ty of dos­es made there were be­ing shipped over­seas to Eu­rope. That was hap­pen­ing at a time in which just 2% of Africans were vac­ci­nat­ed, and at least 800,000 had been shipped to Spain in June and Ju­ly.

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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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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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.

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.

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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.”

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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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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.

Bris­tol My­ers Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.