Spec­trum Labs is­sues world­wide re­call of ep­i­neph­rine in­gre­di­ent

Three lots of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents used in the emer­gency med­i­cine ep­i­neph­rine are be­ing vol­un­tar­i­ly re­called by the man­u­fac­tur­er.

Spec­trum Lab­o­ra­to­ry Prod­ucts sent out a world­wide vol­un­tary re­call for the lots of ep­i­neph­rine USP, a bulk API pow­der used to man­u­fac­ture the pre­scrip­tion prod­uct. Ac­cord­ing to the FDA no­tice, the main com­plaints have found the prod­uct to be “dis­col­ored.”

Ep­i­neph­rine is pri­mar­i­ly used in life-threat­en­ing con­di­tions and treats a va­ri­ety of con­di­tions, in­clud­ing asth­ma, hy­per­sen­si­tiv­i­ty re­ac­tions, heart fail­ure, hy­per­ten­sion or shock, among oth­ers. Ac­cord­ing to the FDA, if the fin­ished prod­uct is man­u­fac­tured with dis­col­ored ma­te­r­i­al, it could re­sult in a less-ef­fec­tive prod­uct and may re­sult in death.

The pow­der it­self is pack­aged in “am­ber glass bot­tles” and is in a vac­u­um-sealed pouch. The af­fect­ed prod­uct can be iden­ti­fied by Spec­trum’s cat­a­log num­ber EP130 and was dis­trib­uted from its fa­cil­i­ties to cus­tomers in the US and Cana­da. The af­fect­ed lot num­bers are 1KG0865, 2KL0353 and 2KF0151.

In a state­ment emailed to End­points News, Tej Parikh, Spec­trum’s com­pli­ance man­ag­er, said that dis­col­oration may oc­cur when ex­posed to oxy­gen, but this does not nec­es­sar­i­ly mean that po­ten­cy is im­pact­ed.

“In this sit­u­a­tion, dis­col­oration was lim­it­ed to three lots of our Ep­i­neph­rine (L-Adren­a­line) USP prod­uct line. As a mat­ter of pre­cau­tion, Spec­trum Lab­o­ra­to­ry Prod­ucts has proac­tive­ly de­cid­ed to vol­un­tar­i­ly re­call these three lots. No oth­er lots of our Ep­i­neph­rine USP prod­uct line are af­fect­ed and we have not re­ceived any re­ports of ad­verse events re­lat­ed to this re­call,” Parikh said.

The FDA al­so not­ed that Spec­trum is no­ti­fy­ing dis­trib­u­tors and cus­tomers and is mak­ing the nec­es­sary arrange­ments for the re­turn of re­called prod­ucts. Con­sumers, phar­ma­cies and dis­trib­u­tors that have the cat­a­log num­ber EP130 should stop its use im­me­di­ate­ly.

An­oth­er one of the more re­cent re­calls oc­curred when Au­robindo Phar­ma USA is­sued a vol­un­tary re­call of two batch­es of the heart med­ica­tion Quinapril. That re­call was is­sued over a “ni­trosamine drug sub­stance-re­lat­ed im­pu­ri­ty” above the pro­posed lim­it.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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A new Genentech 'MS Visibility' campaign video features Black women living with or connected to MS talking about their experiences. (Genentech)

Roche’s Genen­tech de­buts next it­er­a­tion of MS cam­paign, high­lights ex­pe­ri­ences in Black com­mu­ni­ty

Roche’s Genentech is tackling diversity in multiple sclerosis again, this time with a focus on the Black community. Its “MS Visibility” effort, debuted in 2021, is now adding to the awareness campaign with new work that includes a set of videos featuring discussions among Black women and healthcare professionals.

“They’re incredibly inspiring Black women living with or connected to MS and they’re having just honest conversation about their experience and the unique barriers that their community faces,” said Jennifer Kim, head of neuroimmunology at Genentech marketing.

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