Af­ter a months-long halt on pro­duc­tion, Emer­gent is back up and run­ning in Bal­ti­more

It’s been a long time since Emer­gent BioSo­lu­tions has been able to pro­duce Covid-19 vac­cines at its Bal­ti­more Bayview plant, but the FDA has giv­en the com­pa­ny the go-ahead to re­sume pro­duc­tion, a com­pa­ny spokesman con­firmed Thurs­day morn­ing in an email to End­points News.

The news comes two months af­ter the com­pa­ny said it was near a deal to re­sume. In a House sub­com­mit­tee meet­ing in June, CEO Bob Kramer said that his com­pa­ny was pre­pared to re­sume man­u­fac­tur­ing im­me­di­ate­ly af­ter it re­ceived the go-ahead from the FDA.

“We are proud to be re­sum­ing pro­duc­tion of bulk Covid-19 vac­cine batch­es fol­low­ing ad­di­tion­al re­views and col­lab­o­ra­tion with FDA and our man­u­fac­tur­ing part­ners,” Kramer told the Wall Street Jour­nal in a state­ment late Wednes­day. “We are grate­ful for the op­por­tu­ni­ty to help bring this glob­al pan­dem­ic to an end.”

This means J&J pro­duc­tion will re­sume. The CD­MO was pre­vi­ous­ly re­spon­si­ble for mak­ing drug sub­stance for the As­traZeneca jab as well, but af­ter Pres­i­dent Joe Biden’s ad­min­is­tra­tion or­dered J&J to take over con­trol of the plant, As­traZeneca en­gaged in dis­cus­sions with New Jer­sey-based CD­MO Catal­ent to move its op­er­a­tions over to its Mary­land fa­cil­i­ty.

Ear­ly in the man­u­fac­tur­ing process, Emer­gent was forced to toss drug sub­stance used in As­traZeneca’s jab. In that meet­ing be­fore the House sub­com­mit­tee, Kramer blamed the mix­up on flawed in­struc­tions from the British drug­mak­er.

Lat­er on, a batch of drug sub­stance in­tend­ed for the As­traZeneca vac­cine came in close prox­im­i­ty with a J&J batch, con­t­a­m­i­nat­ing it as well. That mix­up wasn’t no­ticed un­til J&J qual­i­ty con­trol work­ers picked up on it at one of its sites.

Be­fore those screw ups, Emer­gent tout­ed its abil­i­ty to man­u­fac­ture more than 1 bil­lion dos­es a year. Kramer went on CN­BC’s “Mad Mon­ey” in March to say just that, when it inked a $480 mil­lion, two-year deal with the US gov­ern­ment.

“The Amer­i­can peo­ple should have high ex­pec­ta­tions of the part­ners its gov­ern­ment choos­es to help pre­pare them for dis­as­ter, and we have even high­er ex­pec­ta­tions of our­selves,” Emer­gent CEO Bob Kramer said in a press re­lease. “We have fall­en short of those lofty am­bi­tions over the past few months but re­sump­tion of man­u­fac­tur­ing is a key mile­stone and we are grate­ful for the op­por­tu­ni­ty to help bring this glob­al pan­dem­ic to an end. We’d like to thank our gov­ern­ment part­ners as well as John­son & John­son for their sup­port.”

As­traZeneca’s vac­cine has been ap­proved in sev­er­al coun­tries around the world, but not the US be­cause of a rare but se­ri­ous blood clot in the brain that has been re­port­ed in some who’ve re­ceived that vac­cine. De­mand for J&J’s sin­gle-dose jab has waned do­mes­ti­cal­ly, re­cent­ly, but it re­mains a vi­able op­tions for coun­tries over­sees that are lack­ing ad­e­quate dos­es, par­tic­u­lar­ly those try­ing to in­oc­u­late peo­ple in rur­al ar­eas. J&J’s sin­gle-dose for­mat makes it eas­i­er to ad­min­is­ter to those who can­not make mul­ti­ple trips in­to a pop­u­lat­ed area to a clin­ic or hos­pi­tal. The US pledged to do­nate dos­es of J&J’s shot else­where, in­clud­ing 1 mil­lion to Bo­livia.

There are still around 30 mil­lion dos­es that have been made that the FDA has yet to clear J&J to dis­trib­ute. An­oth­er batch of J&J’s vac­cine was re­leased three weeks ago, bring­ing the to­tal num­ber to 40 mil­lion, while rough­ly 75 mil­lion have been de­stroyed.

“Based up­on our cur­rent ob­ser­va­tions of the im­ple­ment­ed cor­rec­tive ac­tions, FDA does not ob­ject to the re­sump­tion of man­u­fac­tur­ing” at the Bal­ti­more plant,” a let­ter to the FDA, ob­tained by the WSJ, said.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.