Glenn Mattes, TFF Pharmaceuticals CEO

Texas biotech ex­pands R&D and man­u­fac­tur­ing ca­pa­bil­i­ties fol­low­ing Catal­ent part­ner­ship

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.

John Koleng

“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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate manufacturing operations from its South San Francisco headquarters location to other facilities or move the work to CDMOs, said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech has made changes in capabilities and invested more in technology, so it doesn’t need as many large-scale manufacturing facilities as it did in the past, she said.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)

No­var­tis pulls the plug on UK-based car­dio­vas­cu­lar study

Novartis is calling off a UK-based trial for Leqvio in the primary prevention of cardiovascular events in patients with high cholesterol, the company confirmed on Wednesday.

The Swiss pharma giant made the decision after “careful evaluation,” a spokesperson told Endpoints News via email. The trial, dubbed ORION-17, was planned in partnership with England’s National Health Service (NHS) and was part of the company’s strategy to establish Leqvio as a standard of care in cardiovascular disease management.

Drug short­age so­lu­tions brought be­fore Sen­ate Home­land Se­cu­ri­ty com­mit­tee

With more than 300 active drug shortages, the Senate Committee on Homeland Security and Governmental Affairs had its hands full on Wednesday with multiple experts testifying on drug shortages and possible solutions.

A picture of the shortage situation. presented by Erin Fox, an adjunct professor at the College of Pharmacy at the University of Utah, explained how some patients have died due to drug shortages, including with medication errors when substitutes were dosed incorrectly or when an emergency product was not available.

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FDA re­jects Ab­b­Vie's in­fu­sion ther­a­py for Parkin­son's, re­quests more in­fo on pump de­vice

The FDA rejected AbbVie’s 24-hour infusion therapy for Parkinson’s, saying it needs more information on a device used to administer the treatment before it can clear it.

The Chicago-area drugmaker said in a press release that the complete response letter from the agency didn’t include any requests for more efficacy or safety trials related to the drug, known as ABBV-951. The company said it aims to “resubmit the NDA as soon as possible.”

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Quince Ther­a­peu­tics faces takeover bid from share­hold­er Echo Lake Cap­i­tal

A bid to take over the biotech Quince Therapeutics has been put forward by one of its shareholders.

On Tuesday, Echo Lake Capital sent a letter to Quince’s board of directors putting forth a proposal to acquire all the biotech’s stock for $1.60 per share, which would value a takeover at around $58 million.

In the letter, Echo Lake said that it believes Quince’s stock is severely undervalued and that no drugs are being actively marketed or developed that require cash expenditures. It’s trading below the value of its assets, Echo Lake said.

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