Bob Kramer, Emergent CEO

Emer­gent tossed near­ly 400M Covid-19 vac­cine dos­es in Bal­ti­more de­ba­cle, House re­port says

The ex­act num­ber of dos­es lost in the Emer­gent BioSo­lu­tions mishap at its Bal­ti­more plant has nev­er been ex­act­ly de­ter­mined. But a re­cent re­port from the US House se­lect sub­com­mit­tee on the coro­n­avirus cri­sis says that the com­pa­ny might have de­stroyed near­ly 400 mil­lion dos­es of Covid-19 vac­cines af­ter fail­ures to meet qual­i­ty stan­dards.

The re­port came to the de­ter­mi­na­tion via re­quests for in­ter­nal com­mu­ni­ca­tions be­tween Emer­gent ex­ec­u­tives, which the sub­com­mit­tee al­leges in­clud­ed ef­forts to hide ev­i­dence of con­t­a­m­i­na­tion in “an at­tempt to evade over­sight from gov­ern­ment reg­u­la­tors.”

“De­spite ma­jor red flags at its vac­cine man­u­fac­tur­ing fa­cil­i­ty, Emer­gent’s ex­ec­u­tives swept these prob­lems un­der the rug and con­tin­ued to rake in tax­pay­er dol­lars,” Rep. Car­olyn Mal­oney (D-NY) said in a state­ment. “Ul­ti­mate­ly, our re­port shows that Emer­gent’s man­u­fac­tur­ing fail­ures and de­cep­tive tac­tics led to the de­struc­tion of mil­lions of dos­es of des­per­ate­ly need­ed vac­cines. Emer­gent’s busi­ness prac­tices are sim­ply un­ac­cept­able, and I urge the fed­er­al gov­ern­ment to care­ful­ly con­sid­er fu­ture con­tracts in light of Emer­gent’s fail­ures.”

Orig­i­nal­ly, it was said that be­tween 75 mil­lion and 85 mil­lion dos­es of drug sub­stance was de­stroyed af­ter con­t­a­m­i­na­tion. The re­port finds that 400 mil­lion dos­es were de­stroyed be­tween April 2021 and Au­gust 2021. Emer­gent hid the ev­i­dence, the re­port al­leges, by re­mov­ing qual­i­ty-as­sur­ance hold tags from J&J batch­es that in­di­cat­ed that the con­tain­ers had qual­i­ty is­sues, in an ef­fort to avoid draw­ing at­ten­tion from FDA in­spec­tors. Emer­gent em­ploy­ees were wor­ried that the De­part­ment of Health and Hu­man Ser­vices was get­ting too in­volved in its op­er­a­tions af­ter the As­traZeneca-J&J mix­up.

The re­port al­so says that Emer­gent en­tered con­tracts with the two phar­mas de­spite its aware­ness that tech­ni­cal op­er­a­tions were not up to snuff for at least a few years.

“Our risk is high!” A note from a se­nior di­rec­tor of qual­i­ty said at one point. “We lack com­mer­cial GMP com­pli­ance ma­tu­ri­ty.”

The team at Emer­gent main­tains that there is noth­ing new in­clud­ed in the re­port, how­ev­er, and dis­putes the state­ment that 400 mil­lion dos­es of the vac­cine were de­ter­mined to me un­us­able, cit­ing the dif­fi­cul­ty that comes with es­ti­mat­ing the dosage equiv­a­lent of drug sub­stance that has not com­plet­ed the man­u­fac­tur­ing process.

“To equate these qual­i­ty con­trol ac­tions with a ‘dis­card­ed dose’ fig­ure dis­plays a lack of un­der­stand­ing re­gard­ing the bio­man­u­fac­tur­ing process,” the state­ment said.

The CD­MO main­tains that it nev­er know­ing­ly mis­led the FDA or any of the part­ners in­volved in the man­u­fac­tur­ing process. It al­so said that the first it heard of the sub­com­mit­tee’s re­port was through the me­dia.

“While it’s im­por­tant to an­a­lyze past de­ci­sions to in­form fu­ture plans – we must do so in the prop­er con­text and avoid the temp­ta­tion to Mon­day morn­ing quar­ter­back with the ben­e­fit of what we know to­day,” the state­ment says. “Emer­gent and our gov­ern­ment part­ners were at­tempt­ing to com­press in­to a few months the de­vel­op­ment and scale up of drug sub­stance man­u­fac­tur­ing process­es that nor­mal­ly take years. We were al­ways trans­par­ent with our pub­lic and pri­vate part­ners about our process and ca­pa­bil­i­ties and of­ten wel­comed BAR­DA, J&J and As­traZeneca per­son­nel on­site dai­ly.”

The re­port says the Pres­i­dent Don­ald Trump’s ad­min­is­tra­tion was aware of de­fi­cien­cies that the com­pa­ny had high­light­ed at the Bayview site when it was award­ed $628 mil­lion in fund­ing back in May 2020. As­traZeneca per­son­nel raised con­cerns to Emer­gent in Ju­ly of 2020, not­ing that the site wasn’t pre­pared for com­mer­cial man­u­fac­tur­ing, and in­ter­nal J&J com­mu­ni­ca­tions said that the phar­ma was un­clear if Emer­gent would be good-to-go come game time.

“I am stat­ing very loud­ly that this work is NON-CGMP com­pli­ant. And a di­rect reg­u­la­to­ry risk,” an out­side con­sul­tant told Emer­gent in No­vem­ber 2020.

The re­port al­so found that in­ex­pe­ri­enced staff and high turnover led to vac­cine con­t­a­m­i­na­tion, as the staff that was work­ing wasn’t trained prop­er­ly, and had lit­tle pre­vi­ous phar­ma ex­pe­ri­ence.

In Feb­ru­ary, Emer­gent an­nounced that its trou­bled Bayview plant would get a $100 mil­lion up­grade, as it start­ed mak­ing sched­uled up­grades ear­ly, and ex­pect­ed to be back in op­er­a­tion in Q2 2022. The work will al­low for “ad­di­tion­al non-pan­dem­ic work be­ing done in Bayview down the road,” CEO Bob Kramer said, and help sup­port the strength­en­ing of J&J’s sup­ply chain.

Right now, Emer­gent has a sup­ply agree­ment for San­doz’s gener­ic Nar­can, and plans to launch a live ty­phoid vac­cine and cholera vac­cine. It al­so has a sup­ply deal with the US gov­ern­ment for its an­thrax vac­cine, the drug that kicked off the com­pa­ny’s re­la­tion­ship with the gov­ern­ment years ago.

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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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.

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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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.