On­ly months af­ter Texas-based TFF Phar­ma­ceu­ti­cals net­ted a part­ner­ship with Catal­ent, the com­pa­ny is ex­pand­ing its R&D and man­u­fac­tur­ing op­er­a­tions in the cap­i­tal of the Lone Star State, through the lease of a new 3,500-square-foot fa­cil­i­ty.

The new space will be cen­tered on in­creas­ing TFF’s to­tal lab space. The ex­pan­sion adds a ded­i­cat­ed lab for the down­stream pro­cess­ing of prod­ucts cre­at­ed via its thin film freez­ing as the com­pa­ny is look­ing to in­crease its in-house re­search. The ad­di­tion­al lab space will al­low the com­pa­ny to house larg­er equip­ment to scale up its man­u­fac­tur­ing abil­i­ties and pro­duce sup­plies for pre­clin­i­cal stud­ies. TFF plans to take its new space on­line by Au­gust.

TFF al­so plans to ex­pand its prod­uct de­vel­op­ment team in Austin, which will be based at the new fa­cil­i­ty but did not dis­close the num­ber of hands it wants to bring on. The lease arrange­ment was al­so used to fi­nance the fa­cil­i­ty. TFF dis­closed in an email to End­points News that the ex­pan­sion was self-fund­ed, but no hard fig­ure was giv­en.

Ac­cord­ing to the com­pa­ny, the fa­cil­i­ty was pre­vi­ous­ly used as a health­care test­ing lab­o­ra­to­ry and the com­pa­ny has, over the past two to three months, made mod­i­fi­ca­tions to en­able prod­uct de­vel­op­ment and test­ing of their tech­nol­o­gy.

“The Austin fa­cil­i­ty will en­able us to in­crease test­ing ca­pac­i­ty so that we can run a larg­er num­ber of fea­si­bil­i­ty stud­ies, in­clud­ing a fo­cus on bi­o­log­ics where de­mand has con­tin­ued to grow. Ad­di­tion­al­ly, as many of our part­nered pro­grams move to clin­i­cal eval­u­a­tion, the abil­i­ty to scale-up man­u­fac­tur­ing in par­al­lel be­comes mis­sion crit­i­cal,” said John Koleng, TFF’s VP of prod­uct de­vel­op­ment and man­u­fac­tur­ing.

Koleng said in an email that TFF’s part­ner base has grown sig­nif­i­cant­ly in re­cent years and has seen an in­creased de­mand for the use of their tech­nol­o­gy, es­pe­cial­ly giv­en its ap­pli­ca­tions for hard-to-de­liv­er modal­i­ties such as bi­o­log­ics.

TFF has been on the move this year, as in March, it inked a col­lab­o­ra­tion with Catal­ent fo­cused on the gen­er­a­tion, test­ing and man­u­fac­ture of dry pow­der for­mu­la­tions. The com­pa­ny’s thin film freez­ing tech­nol­o­gy works on both small and large mol­e­cules. The process con­verts mol­e­cules in­to an in­haled dry pow­der, which de­liv­ers the drug di­rect­ly to the lungs.

The com­pa­ny cur­rent­ly has four as­sets in its pipeline, two of which are in Phase II tri­als. They al­so have a part­ner­ship to de­vel­op an in­tranasal vac­cine for in­fluen­za, Ebo­la, Mar­burg and al­phavirus­es.

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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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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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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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.

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:

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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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.”

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

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