Ko­re­an reg­u­la­tors shut down Sam­sung Phar­ma man­u­fac­tur­ing af­ter find­ing ad­di­tives, false records

South Ko­rea’s health reg­u­la­tor has sus­pend­ed Sam­sung Phar­ma­ceu­ti­cal’s man­u­fac­tur­ing op­er­a­tions un­til mid-Feb­ru­ary af­ter the agency learned that a pro­duc­tion man­ag­er was tasked with re­spon­si­bil­i­ties of two dif­fer­ent plants. The rev­e­la­tion vi­o­lat­ed a law re­quir­ing each plant to be man­aged by one per­son.

Mon­day’s halt comes just months af­ter an in­spec­tion re­vealed a num­ber of vi­o­la­tions at one Sam­sung Phar­ma plant, in­clud­ing the use of ad­di­tives with­out per­mis­sion and false man­u­fac­tur­ing records, the Ko­rea Bio­med­ical Re­view re­port­ed.

Six drugs, in­clud­ing five of Sam­sung Phar­ma’s, have been sus­pend­ed from be­ing man­u­fac­tured. Geramin, Moarex, Com­bicin, and an Aprog­en Phar­ma­ceu­ti­cal drug Health­namine have all been halt­ed.

The com­pa­ny is in no way af­fil­i­at­ed with the South Ko­re­an elec­tron­ics gi­ant Sam­sung, or its sub­sidiary Sam­sung Bi­o­log­ics, a rep­re­sen­ta­tive for the com­pa­ny said.

In a state­ment on its web­site, Sam­sung Phar­ma at­trib­uted the er­ror to neg­li­gence, and care­less­ness in check­ing in on the man­ag­er’s work, and in­sist­ed that it was not a prob­lem with the qual­i­ty of prod­ucts shipped.

“Nev­er­the­less, (we are) deeply re­flect­ing on the in­con­ve­nience caused by not thor­ough­ly com­ply­ing with the stan­dards that we, as phar­ma­ceu­ti­cal man­u­fac­tur­ers, should abide by,” the state­ment said.

The three-month sus­pen­sion is the first step in a se­ries of po­ten­tial pun­ish­ments for com­pa­nies who vi­o­late the law that pre­vents the dou­ble-dip­ping of em­ploy­ees. The next is a six-month man­u­fac­tur­ing sus­pen­sion, and the third strike will see the agency re­voke a busi­ness­es li­cense, Ko­rea Bio­med­ical Re­view re­port­ed. The sus­pen­sion will start to­day and end on Feb. 14.

Ad­di­tion­al sanc­tions in­clude the halt of man­u­fac­tur­ing in­jec­tions for five weeks and a four-month sus­pen­sion of the five drugs un­der scruti­ny. In a pub­lic state­ment, the com­pa­ny an­nounced that the sus­pen­sion would cost the com­pa­ny 5.7 bil­lion won, or rough­ly $4.8 mil­lion.

In June, a tem­po­rary sus­pen­sion was or­dered af­ter vi­o­la­tions sur­faced, and the six drugs were forced to be re­called. Sam­sung Phar­ma il­le­gal­ly used ad­di­tives ar­bi­trar­i­ly and cre­at­ed false doc­u­ments to cov­er up the vi­o­la­tions. Reg­u­la­tors have al­so pun­ished com­pa­nies such as Vivo­zon and Binex for sim­i­lar vi­o­la­tions.

The news brought down the com­pa­ny’s stock in the South Ko­re­an mar­ket when it first broke in June. But shares fal­tered very lit­tle af­ter Mon­day’s news broke, still clos­ing high­er than the pre­vi­ous day.

In the state­ment, Sam­sung Phar­ma said that it would re­vis­it its found­ing phi­los­o­phy and fo­cus on its orig­i­nal du­ties as a phar­ma­ceu­ti­cal com­pa­ny.

“We will do our best to be­come a Sam­sung Phar­ma that can be trust­ed by share­hold­ers, cus­tomers, med­ical staff and pa­tients again by re­mov­ing the com­pla­cen­cy of the past,” it said.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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EMA is­sues warn­ing of IVF drug short­age due to man­u­fac­tur­ing is­sues

The European Medicines Agency recently noted the shortage of a drug that is used frequently in IVF procedures where women have ovarian stimulation (i.e. fertility treatment where the ovaries are stimulated to produce more eggs).

The drug, known as cetrotide, is now facing a shortage in Europe due to a potential manufacturing issue.

The EMA’s warning on Wednesday states that a technical issue at the main manufacturing site for cetrotide resulted in the closure of the site between December 2021 and March of this year. This led to reductions and delays in the supply of cetrotide.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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Faced with thou­sands of opi­oid law­suits, En­do says it will like­ly file for bank­rupt­cy 'im­mi­nent­ly'

Endo International will likely be the next pharma company to file for bankruptcy under a mountain of opioid lawsuits.

The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that “these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.”