Re­call re­port: Chil­dren's au­to-im­mune dis­ease drug con­t­a­m­i­nat­ed with mold and yeast

A drug used to treat an au­to-im­mune dis­ease in chil­dren has been vol­un­tar­i­ly re­called by drug­mak­er Ja­cobus Phar­ma­ceu­ti­cal af­ter re­ports of the tablets be­ing con­t­a­m­i­nat­ed with yeast, mold and aer­o­bic bac­te­ria.

Three lots of Ruzur­gi 10 mg tablets, used to treat Lam­bert-Eaton myas­thenic syn­drome, have been re­called. The use of the drug in­creas­es the risk of se­ri­ous in­fec­tion, the FDA said.

Two of the three lots of ex­pi­ra­tion dates of March 2023, while a third has an ex­pi­ra­tion date of May 2023.  The lots have con­trol num­bers 18038, 18039 and 18079.

A Cana­di­an part­ner com­pa­ny per­form­ing test­ing on the drug in­formed Ja­cobus of the prob­lem in one lot, which led to an ex­pand­ed in­ves­ti­ga­tion that iden­ti­fied the oth­er two.

Any­one who be­lieves they might have side ef­fects from the prod­uct’s use should call the FDA, or com­plete an on­line re­port.

Pa­tients with Lam­bert-Eaton myas­thenic syn­drome suf­fer from their own im­mune sys­tem at­tack­ing their tis­sues, at the con­nec­tions be­tween nerve and mus­cles, which in­ter­feres with the abil­i­ty to send sig­nals to mus­cle cells. The dis­ease can cause weak­ness, and dif­fi­cul­ty walk­ing or tak­ing care of one­self, in ad­di­tion to dif­fi­cul­ty in talk­ing, swal­low­ing or chew­ing.

One lot of Azu­ri­ty’s drug for Clostrid­i­um dif­fi­cile-as­so­ci­at­ed di­ar­rhea, and en­te­ro­col­i­tis has al­so been re­called, the com­pa­ny an­nounced last week, for a mix up of the dilu­ent in­clud­ed in the kit.

Fir­vanq, Van­comycin 50 mg/mL has been re­called be­cause the kit con­tains a First Omepra­zole (FIRST-PPI) dilu­ent in­stead of a Fir­vanq dilu­ent bot­tle, the FDA said. The mix­up could be es­pe­cial­ly vul­ner­a­ble to el­der­ly and im­muno­com­pro­mised pa­tients.

“There is rea­son­able prob­a­bil­i­ty that the ad­min­is­tra­tion of in­ap­pro­pri­ate dos­es of oral van­comycin may lead to per­sis­tent di­ar­rhea as­so­ci­at­ed with de­hy­dra­tion and elec­trolyte ab­nor­mal­i­ties, re­cur­rence of Clostrid­i­um dif­fi­cile (C. dif­fi­cile) in­fec­tion, its pro­gres­sion to se­vere col­i­tis, colon per­fo­ra­tion re­quir­ing colec­to­my, and po­ten­tial­ly death,” the warn­ing said.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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House pass­es two bills on con­tin­u­ous man­u­fac­tur­ing, stock­pil­ing ahead of fu­ture pan­demics

The House of Representatives this week passed two bills to strengthen America’s national stockpile of medical supplies and to allow the FDA to designate colleges and universities as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing.

The stockpile bill, known as HR 3635, passed by a vote of 397-22. Introduced by Rep. Elissa Slotkin (D-MI) and 15 other cosponsors, the bill would improve America’s ability to respond to future pandemics, as well as handle the ongoing Covid-19 pandemic too.

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Martine Rothblatt (AP Photo/Jack Plunkett)

FDA re­jects Unit­ed's po­ten­tial PAH drug due to a man­u­fac­tur­ing is­sue

United Therapeutics said Monday that it received a complete response letter for its potential pulmonary arterial hypertension drug Tyvaso DPI, due to an issue with a third-party facility that performs drug substance testing. The company said it expects an approval will come by next summer.

The inspection issue appears to be the only problem the FDA took notice of, according to United. There were no issues with packaging, manufacturing or testing Tyvaso DPI at the MannKind Corporation facility, the company said.

Re­call re­port: Glass found in Mer­ck an­tibi­ot­ic threat­ens 22,000 vials

A Merck antibiotic has been recalled after reports of the presence of glass particulate matter, the company announced Tuesday.

One lot of Cubicin will be recalled, which includes about 22,000 vials of the 500mg dose of the intravenously administered drug.

The recall comes after a piece of glass was found in a vial, raising safety concerns.

“Our highest priorities are the health and safety of patients and the quality of our medicines and vaccines,” said Richard Haupt, the VP of vaccines & infectious diseases. “We sincerely regret any inconvenience caused by this recall.”