'Re­call ready': FDA urges com­pa­nies to com­ply with drug re­call guid­ance

The FDA has fi­nal­ized guid­ance to help com­pa­nies quick­ly re­call prod­ucts and take the nec­es­sary steps be­fore a prod­uct reach­es the re­call stage, as part of work pull vi­ola­tive prod­ucts and keep them out of the hands of con­sumers.

Ini­ti­a­tion of Vol­un­tary Re­calls of­fers guid­ance for com­pa­nies to de­vel­op pro­ce­dures in­clud­ing train­ing, plan­ning and record-keep­ing to re­duce the time a dan­ger­ous prod­uct is on the mar­ket and lim­it the risk of ex­po­sure. The FDA can re­call con­trolled sub­stances, bi­o­log­i­cal prod­ucts, hu­man cells, tis­sues and cel­lu­lar and tis­sue-based prod­ucts, as well as med­ical de­vices and food.

The re­port al­so ex­plains how to keep records and prod­uct cod­ing. Since re­calls af­fect the en­tire sup­ply chain, the FDA says that a pro­ce­dure should be in place to quick­ly in­form every­one in line, from down­stream sup­pli­ers to whole­salers and ven­dors. The fi­nal guid­ance builds off of a draft from April 2019.

“Vol­un­tary re­calls con­tin­ue to be the fastest, most ef­fec­tive way for a com­pa­ny to cor­rect or re­move vi­ola­tive and po­ten­tial­ly harm­ful prod­ucts from the mar­ket to help keep con­sumers safe,” said Ju­dith McMeekin, the FDA’s as­so­ciate com­mis­sion­er of reg­u­la­to­ry af­fairs. “It is crit­i­cal that all com­pa­nies in the sup­ply chain are ‘re­call ready’ to en­sure ap­pro­pri­ate ac­tions are tak­en swift­ly across the dis­tri­b­u­tion chan­nels to best pro­tect pub­lic health and the in­tegri­ty of the sup­ply chain. We will con­tin­ue to work with com­pa­nies to im­prove their re­call pro­ce­dures and min­i­mize Amer­i­cans’ ex­po­sure to po­ten­tial­ly harm­ful prod­ucts.”

There have been 14 drugs re­called since the start of 2022 alone, ac­cord­ing to the FDA’s web­site. Most re­cent­ly, Braun Med­ical was forced to vol­un­tar­i­ly re­call five lots of its 0.9% Sodi­um Chlo­ride for In­jec­tion USP 250ML due to flu­id leak­age or low fill vol­ume. That re­call was an­nounced Thurs­day.

In 2021, there were 77 drugs re­called. Most no­tably was the in­dus­try’s is­sues with ND­MA con­t­a­m­i­na­tion, a known prob­a­ble hu­man car­cino­gen with can­cer-caus­ing po­ten­tial.

In Jan­u­ary, Viona Phar­ma­ceu­ti­cals re­called 33 lots of met­formin hy­drochlo­ride af­ter find­ing traces of ND­MA. But Pfiz­er bat­tled is­sues with the con­t­a­m­i­na­tion of its an­ti-smok­ing drug Chan­tix in June, Ju­ly, Au­gust and Sep­tem­ber for ND­MA. Lots were dis­trib­uted in the US, US Vir­gin Is­lands and Puer­to Ri­co from May 2019 to Sep­tem­ber 2021. In 2018, blood pres­sure drug val­sar­tan was pulled for the same rea­son. Last Jan­u­ary, Nos­trum Lab­o­ra­to­ries twice vol­un­tar­i­ly re­called its gener­ic met­formin. In No­vem­ber 2020, a batch of 500 mg tablets was re­called for the same rea­son.

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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.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Merck closes in on a potential $40 billion buyout of Seagen, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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