Pfiz­er’s Hos­pi­ra, plagued by qual­i­ty con­trol prob­lems at mul­ti­ple plants over the years, is once again find­ing it­self vol­un­tar­i­ly re­call­ing one lot of Propo­fol In­jectable Emul­sion, USP 100 mL avail­able for sin­gle pa­tient use in a glass flip-top vial.

The batch is be­ing pulled due to a vis­i­ble par­tic­u­late ob­served in a sin­gle vial dur­ing an an­nu­al ex­am­i­na­tion of re­tained sam­ples. The re­call is be­ing con­duct­ed with the FDA’s knowl­edge, with a re­call let­ter is­sued by the FDA on Wednes­day.

Ac­cord­ing to the FDA, any pa­tients that could re­ceive the im­pact­ed propo­fol are at risk of hav­ing life-threat­en­ing clin­i­cal ef­fects that in­clude the block­age of blood ves­sels such as de­creased blood flow to the brain, a heart at­tack, pul­monary em­bo­lus and/or. tis­sue necro­sis. Hy­per­sen­si­tiv­i­ty re­ac­tions and trans­mis­sion of in­fec­tious dis­eases can al­so oc­cur.

Hos­pi­ra, how­ev­er, has not re­ceived any re­ports of ad­verse events as­so­ci­at­ed with this is­sue so far. The FDA’s warn­ing notes that the vials were sent na­tion­wide to whole­salers, hos­pi­tals and the De­part­ment of De­fense in the US from June 10 through June 26 in 2020. The ex­pi­ra­tion date for the vials is May 1, 2023.

“Hos­pi­ra, Inc., places the ut­most em­pha­sis on pa­tient safe­ty and prod­uct qual­i­ty at every step in the man­u­fac­tur­ing and sup­ply chain process. Hos­pi­ra, Inc. has no­ti­fied di­rect con­signees by let­ter to arrange for the re­turn of any re­called prod­uct,” the FDA let­ter said.

The FDA is ad­vis­ing whole­salers and hos­pi­tals with any ex­ist­ing in­ven­to­ry of the lot to stop use and dis­tri­b­u­tion and quar­an­tine im­me­di­ate­ly. If any dos­es have been fur­ther dis­trib­uted the FDA is ad­vis­ing whole­salers to please no­ti­fy any ac­counts or ad­di­tion­al lo­ca­tions which may have re­ceived the re­called prod­uct.

The re­call is not Hos­pi­ra’s first go around. In 2021, two of their prod­ucts, Aminosyn II and ster­ile wa­ter in­jec­tion, were al­so re­called due to vis­i­ble par­tic­u­lates. A li­do­caine in­jec­tion from Hos­pi­ra was al­so re­called last year due to mis­la­bel­ing.

A not-so-funny thing happened to Novartis’ high-profile bid to take a PD-1 checkpoint out of China and get it approved in the US this year.

After paying BeiGene $650 million for US-plus ex-China commercialization rights for the drug — the latest in a long string of contenders to follow Keytruda and Opdivo — the FDA is deferring action on their application.

And there’s no new timeline on when the agency will make a decision.

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What a difference one really good Phase III readout and a couple of late-stage buyouts can make.

GSK CEO Emma Walmsley has been trying, hard, to build some excitement around the pipeline. And with the recent positive outcome for their RSV vaccine, she’s finally earning some market respect on that score. And with the big consumer split coming on Monday, with the birth of Haleon, you can expect plenty of buzz about the need for another M&A deal to position the company.

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With the FDA giving the thumbs up for more monkeypox vaccines to come from Bavarian Nordic’s manufacturing facility in Denmark, the US government is asking for a lot more as the CDC marks the total case count north of 1,400 people.

BARDA has asked the Danish vaccine manufacturer for 2.5 million more doses of their Jynneos vaccine, a non-replicating smallpox vaccine and the only FDA-approved vaccine against monkeypox and will be going to the strategic national stockpile, or SNS.

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As Philadelphia continues to garner the interest of companies like WuXi AppTec and SK, a Quebec-based CRO is also looking to expand manufacturing operations in the City of Brotherly Love on behalf of a client.

Altasciences, a drug formulation and manufacturing CRO, is constructing a manufacturing facility for California-based Alladapt Immunotherapeutics in the greater Philadelphia area. Alladapt is currently developing a precision therapeutic to address IgE-mediated food allergies.

Hello. Good morning. I’m Zachary Brennan, senior editor at Endpoints News. And thank you for joining us virtually at BIO for our panel on decentralized trials. Joining me today, we have Ronan Brown, Senior Vice President of IQVIA, Craig Lipset, founder of Clinical Innovation Partners, and Bari Kowal, senior vice president of Regeneron. I’m excited for today’s discussion and I’m sure you are too, but before we get into it, we have a brief word from Vice President Matt Blume with today’s sponsor, Catalent.

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Hello, and welcome to today’s Fireside Chat. I’m Zachary Brennan, senior editor at Endpoints News and with me today is Ian Thompson, senior vice president of Amgen.

Today we’ll be discussing the evolution of the US biosimilar space, which has seen not only a slow start when we compare to our European counterparts, but also long delays between when certain biosimilars win approval and when they actually launch in the US market. So, first off I wanted to start by welcoming Ian and I also wanted to hear his take on how he’s seen the momentum building around the biosimilar industry in recent years, and maybe why he thinks that is the case that has been building more in recent years.

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Sales of Pfizer’s Xalkori may be slipping as new drugs squeeze the oncology market, but the pharma giant hasn’t lost its appetite for new indications.

The FDA has come through with the most recent approval for the drug, giving Pfizer a green light to sell the therapy for treatment-resistant cases of inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors. Regulators cite a small but positive 21-patient study in pediatric and adult patients:

Applications are now open for Merck KGaA’s newest collaboration program focused on startups located in Asia.

The German pharma announced Thursday, sparing a few details, that it was launching a new program in Asia called Uptune, which “aims to generate collaboration opportunities with early-stage innovative companies.”

The plan, according to Merck KGaA, will support and give some financing to certain companies in the healthcare and life science space, plus electronics and smart manufacturing. It did emphasize it will look for companies with a focus on digital health and “innovative technologies/materials for semiconductor and display.”

French drug maker Sanofi has come under the scanner of the nonprofit National Advertising Division (NAD) after its arch-rival Johnson & Johnson complained about the company’s misleading advertising claims.

Sanofi has been asked to abandon claims that its over-the-counter drug Zantac 360° is the “#1 Doctor Recommended” for heartburn.

Zantac, a version of which was pulled from shelves in the US by GSK in 2019 due to impurities, is an H2 blocker that stops the secretion of gastric acid and is loaded with an active ingredient called famotidine. It is recommended for mild to moderate heartburn and indigestion.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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