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.

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.

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.

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.

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.

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.