FDA re­jects Aca­ci­a's lead drug — again — due to the same man­u­fac­tur­ing is­sue

Aca­cia Phar­ma did well on the R&D front — by 2017, it had con­duct­ed four pos­i­tive piv­otal clin­i­cal tri­als for its lead drug, Barhem­sys. Lat­er that year, it sub­mit­ted an FDA ap­pli­ca­tion to mar­ket the drug for res­cue treat­ment of pa­tients who de­vel­op post­op­er­a­tive nau­sea & vom­it­ing (PONV), de­spite hav­ing been giv­en pri­or antiemet­ic pro­phy­lax­is — on­ly to re­ceive a re­jec­tion in Oc­to­ber 2018.

The US agency made its de­ci­sion based on a pre-ap­proval in­spec­tion of a fa­cil­i­ty run by the con­tract man­u­fac­tur­er of the drug’s main in­gre­di­ent — amisul­pride — and not on clin­i­cal or non-clin­i­cal da­ta in the ap­pli­ca­tion, as­sured Aca­cia in a press re­lease, adding that the FDA had asked for no ex­tra stud­ies or da­ta analy­ses re­lat­ed to the treat­ment.

With re­newed en­thu­si­asm lat­er that month, Aca­cia said its con­tract man­u­fac­tur­er had agreed to “in­sti­tute a cor­rec­tive and pre­ven­tive ac­tion plan that will rec­ti­fy the de­fi­cien­cy iden­ti­fied as quick­ly as pos­si­ble. We con­tin­ue to plan for a launch in the first half of 2019,” Aca­cia chief Ju­lian Gilbert said in a state­ment.

Ju­lian Gilbert

Aca­cia then re­sub­mit­ted its mar­ket­ing ap­pli­ca­tion in De­cem­ber, in­di­cat­ing that the FDA’s con­cerns out­lined in the com­plete re­sponse let­ter had been re­solved. But on Fri­day, the com­pa­ny re­ceived an­oth­er re­jec­tion, with the FDA flag­ging the same con­cerns.

“We are on track to com­plete the qual­i­fi­ca­tion of an al­ter­na­tive sup­pli­er of amisul­pride and plan to en­gage with FDA as soon as pos­si­ble to de­ter­mine the most rapid route to ob­tain­ing ap­proval,” Gilbert said in a state­ment on Fri­day.

Barhem­sys is de­signed to help the 30-40% of sur­gi­cal pa­tients who suf­fer from PONV de­spite pri­or pro­phy­lax­is, as well as for com­bi­na­tion pro­phy­lax­is in high-risk pa­tients.

Cam­bridge, UK-based Aca­cia Phar­ma, which al­so has US op­er­a­tions in In­di­anapo­lis, was found­ed in 2007. It has an­oth­er amisul­pride-based drug — APD403 — in mid-stage de­vel­op­ment for chemother­a­py in­duced nau­sea & vom­it­ing.

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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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.

Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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In a win for Re­gen­eron, No­var­tis' sy­ringe for AMD drug de­clared 'un­patentable'

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

'Tis the sea­son: GSK ad­dress­es win­ter virus surges with celebri­ty and in­flu­encer vac­cine aware­ness cam­paigns

GSK is rounding up the usual suspects this winter — flu, respiratory syncytial and even shingles viruses — for multiple marketing efforts all aimed at encouraging vaccinations.

Mom influencers take center stage in its “Flu is a Family Affair” campaign to reach family decision-makers or “chief health officers.” GSK is asking them in the digital campaign to take care of themselves, and take the family along, when they go to the pharmacy or doctor’s office for a flu vaccine.

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Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

FDA takes next step in Tor­rent Phar­ma­ceu­ti­cal­s' trou­bled In­dia plant saga, is­sues OAI

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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