EMA pulls an opi­oid from the 1950s used to treat dry cough

The Eu­ro­pean Med­i­cines Agency said Fri­day that it’s pulling from all Eu­ro­pean mar­kets phol­co­dine-con­tain­ing med­i­cines, which are an opi­oid used in adults and chil­dren for the treat­ment of dry cough and in com­bo with oth­er drugs as a treat­ment for cold and flu.

The de­ci­sion to pull the med­i­cines comes as the EMA points to the re­sults from the re­cent ALPHO study, which show that use of phol­co­dine dur­ing the 12 months pre­ced­ing anes­the­sia is linked to a risk of an ana­phy­lac­tic re­ac­tion re­lat­ed to the neu­ro­mus­cu­lar block­ing agents (NM­BAs) used (with an ad­just­ed OR of 4.2, and a 95% con­fi­dence in­ter­val of 2.5 to 6.9).

“Health­care pro­fes­sion­als should con­sid­er ap­pro­pri­ate treat­ment al­ter­na­tives and ad­vise pa­tients to stop tak­ing phol­co­dine-con­tain­ing med­i­cines,” EMA said.

Com­pa­nies mar­ket­ing phol­codines had to con­duct the ALPHO study fol­low­ing a pre­vi­ous safe­ty re­view from 2011.

“As no ef­fec­tive mea­sures have been iden­ti­fied to min­imise this risk, phol­co­dine med­i­cines are be­ing with­drawn from the EU mar­ket,” EMA added Fri­day, telling pa­tients on phol­codines to con­tact their doc­tors or phar­ma­cists and they will pre­scribe an­oth­er drug.

A 2013 re­view of the ev­i­dence link­ing phol­co­dine ex­po­sure to NM­BA hy­per­sen­si­tiv­i­ty not­ed that when phol­co­dine was with­drawn from the Nor­we­gian mar­ket in March 2007, the coun­try saw a “fall in phol­co­dine and sux­am­etho­ni­um sen­si­ti­za­tion rates and al­so in the in­ci­dence of NM­BA ana­phy­lax­is.” But EMA said those stud­ies did not con­vinc­ing­ly es­tab­lish a causal link be­tween phol­co­dine use and ana­phy­lax­is from NM­BA use.

Used as a cough sup­pres­sant since the 1950s, phol­co­dine-con­tain­ing drugs are au­tho­rized in Bel­gium, Croa­t­ia, France, Ire­land, Lithua­nia, Lux­em­bourg and Slove­nia. Phol­co­dine is of­ten used in com­bo with oth­er drugs, made avail­able as syrups, oral so­lu­tions, and cap­sules un­der var­i­ous trade names and as gener­ics, in­clud­ing Dimetane, Bio­ca­lyp­tol and Bron­ca­lene.

“For pa­tients sched­uled to un­der­go gen­er­al anaes­the­sia with NM­BAs, health­care pro­fes­sion­als should check whether pa­tients have used phol­co­dine-con­tain­ing med­i­cines in the last 12 months and main­tain aware­ness about po­ten­tial pe­ri­anaes­thet­ic ana­phy­lac­tic re­ac­tion re­lat­ed to NM­BAs,” EMA said.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.