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.

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”