Re­call re­port: Amino acid IV pulled af­ter hair, oth­er for­eign sub­stances found in batch

A Cal­i­for­nia in­fu­sion ther­a­py com­pa­ny is vol­un­tar­i­ly re­call­ing one lot of an amino acid in­jec­tion made by Pfiz­er spin­out com­pa­ny Hos­pi­ra af­ter re­ports of fibers, hair and oth­er par­ti­cles of for­eign ma­te­ri­als were found in the so­lu­tion.

ICU Med­ical re­called 2,112 units of Aminosyn II, 15%, af­ter it be­came aware of the is­sue while in­spect­ing sam­ples as part of a rou­tine process, the FDA said. The ad­min­is­tra­tion of a drug with par­tic­u­lates that do not be­long can cause side ef­fects rang­ing from in­flam­ma­tion at the point of in­jec­tion to blood clots. So far, ICU Med­ical hasn’t re­port­ed any side ef­fects or ill­ness­es stem­ming from the con­t­a­m­i­na­tion.

Aminosyn II is a food re­place­ment IV drip that is used in pa­tients who are un­able to con­sume food the typ­i­cal way. It can al­so be used to pre­serve pro­tein and re­duce the break­down of sug­ars, fat­ty acids and pro­teins in stress con­di­tions. Aminosyn II can al­so be used to pre­vent or re­verse ex­cret­ing more ni­tro­gen than is tak­en in when feed­ing tubes should not be used.

The lot has an ex­pi­ra­tion date of April 1, 2022, and was man­u­fac­tured by ICU Med­ical in No­vem­ber 2020. Hos­pi­tals and dis­trib­u­tors should stop the use of the drug and re­turn it to its place of pur­chase.

Any­one who be­lieves they are ex­pe­ri­enc­ing side ef­fects should con­tact their lo­cal doc­tor, as well as the FDA through its re­port­ing fea­ture on its web­site.

ICU Med­ical ac­quired the Hos­pi­ra In­fu­sion Sys­tems from Piz­er in Feb. 2017. The com­pa­ny man­u­fac­tures IV com­pound­ing sys­tems, as well as so­lu­tions, smart pumps and nee­dle-free con­nec­tors.

In May, one lot of Hos­pi­ra’s li­do­caine hy­drochlo­ride in­jec­tion was re­called af­ter its la­bel was switched with a lot of bupi­va­caine hy­drochlo­ride in­jec­tion. That is­sue was iden­ti­fied af­ter the FDA in­ves­ti­gat­ed a cus­tomer re­port, and marks the com­pa­ny’s sec­ond re­call in just four months.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

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Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

From left to right: Mark Springel, Kristina Wang, Lin Ao, Soufiane Aboulhouda

George Church, his stu­dents, and top VCs go na­tion­wide with a biotech train­ing camp

One night last fall, Floris Engelhardt sat down in her Boston apartment and logged onto a Zoom call, armed with a comic and a vague idea about starting a biotech.

Engelhardt was joining a student-run “match night.” A postdoc at MIT’s Bathe BioNanoLab, where researchers use DNA and RNA like Lego blocks for nanometer-sized structures, Engelhardt wanted to find real-world applications for her work. She sketched out — literally — a plan to use DNA origami, a decade-old technique for precisely folding DNA, to make therapies.

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Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

Tur­moil at CBER: Pe­ter Marks grabs con­trol of FDA's Of­fice of Vac­cines ahead of 2 key ca­reer leader de­par­tures

FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.