Pro­duc­tion halt­ed at Ko­re­an phar­ma af­ter reg­u­la­tors find unau­tho­rized ad­di­tives in 13 drugs

Months af­ter the South Ko­re­an phar­ma Vivo­zon was or­dered to re­call and dis­card 13 drugs af­ter vi­o­lat­ing good man­u­fac­tur­ing prac­tice stan­dards, the Min­istry of Food and Drug Safe­ty has or­dered sus­pen­sions for a num­ber of drugs in­volved.

Any drugs that were found to have unau­tho­rized ad­di­tives have been sus­pend­ed for four months, the Ko­rea Bio­med­ical Re­view re­port­ed Fri­day. Tablet pro­duc­tion is sus­pend­ed for a month and 29 days, while cap­sule pro­duc­tion was sus­pend­ed for six weeks, and syrup pro­duc­tion for five.

Mean­while, Vivo­zon said that it has ei­ther with­drawn its per­mit for the drugs or trans­ferred them to a con­tract man­u­fac­tur­ing or­ga­ni­za­tion. Among the drugs in­volved are Dec­o­rafen, Re­bad­mi, Re­baratin, and Mu­copid. Eleven of the 13 will be made at an­oth­er site.

Vivo­zon was found to have made drugs with unau­tho­rized ad­di­tives and by­passed safe­ty test­ing in De­cem­ber 2021. Sam­sung Phar­ma and Binex have been hit with pun­ish­ments by Ko­re­an reg­u­la­tors for sim­i­lar rea­sons. The Ko­re­an reg­u­la­to­ry agen­cies said last year that it con­firmed that the phar­ma fab­ri­cat­ed doc­u­ments to cov­er up the use of unau­tho­rized ad­di­tives.

The com­pa­ny fell vic­tim to the ND­MA prob­lem that has plagued phar­ma man­u­fac­tur­ing for the past few years. Reg­u­la­tors re­called 150 mg cap­sules of Alza­tine back in March af­ter there were traces of the can­cer-caus­ing agent de­tect­ed. That fol­lowed the re­call of two more drugs in Jan­u­ary for the same rea­son.

A num­ber of phar­mas have been hit hard by traces of ni­trosamines found in their drugs. Pfiz­er re­called five lots of its blood pres­sure drug Ac­cupril just this week, as it has been forced to re­call sev­er­al drugs for the same rea­son. Viona Phar­ma­ceu­ti­cals, San­doz and Nos­trum Lab­o­ra­to­ries all re­called drugs this year for traces of can­cer-caus­ing agents.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

Nashville-based CD­MO nets a $65M Se­ries B to ex­pand fa­cil­i­ty and ca­pa­bil­i­ties

Another $65 million is music to the ears of the team at August Bioservices, a contract manufacturer in Nashville.

The company announced the Series B round last week, which will fund equipment in a new building expected to open in 2023, according to CEO Jenn Adams. It was led by Oak HC/FT, the same firm that led August’s Series A round in July 2020.

August Bioservices, a producer of materials such as prefilled syringes, IV bags and vials, was formed back in 2020 after the acquisition of PMI BioPharma Solutions, also based in Nashville. Adams said the goal was to build a business that could “address the scarcity of supply relative to sterile injectable manufacturing based in the US” and provide a broad range of manufacturing services.

Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to direct-to-consumer generic drugs, Mark Cuban has made another inroad in the ongoing battle over prescription drug prices. His cost-plus-15% generic drug company, frequently undercutting many competitors, now has its sights set on the employer healthcare market.

Cost Plus Drugs, which originally pledged to cut out PBMs, has now partnered with the PBM EmsanaRx, majority owned by the Purchaser Business Group on Health, to launch a supplemental drug discount program designed specifically for self-funded employers, the company announced Thursday.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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