FDA re­leas­es flur­ry of new, re­vised drug-spe­cif­ic guid­ance doc­u­ments

In an ef­fort to pro­vide sup­port for ab­bre­vi­at­ed new drug ap­pli­ca­tions, the FDA on Thurs­day is­sued a flur­ry of prod­uct-spe­cif­ic rec­om­men­da­tions, pro­vid­ing guid­ance for com­pa­nies look­ing to de­vel­op gener­ic ver­sions of a num­ber of pop­u­lar med­i­cines, in­clud­ing My­lan’s EpiPen (ep­i­neph­rine) al­ter­na­tive Adrenaclick, No­var­tis’ can­cer treat­ment Afin­i­tor (everolimus) and As­traZeneca’s can­cer treat­ment Lyn­parza (ola­parib).

In to­tal, new guid­ance was pub­lished for 32 drugs. On top of these new drafts, FDA re­leased 19 re­vised guid­ance doc­u­ments, in­clud­ing one for com­pa­nies look­ing to de­vel­op gener­ics of Eli Lil­ly’s erec­tile dys­func­tion drug Cialis, and oth­er glau­co­ma treat­ments and an­tibi­otics.

In ad­di­tion, FDA on Thurs­day re­leased Fed­er­al Reg­is­ter no­tices and draft guid­ance doc­u­ments on two oth­er prod­ucts that are unique.

In its prod­uct-spe­cif­ic guid­ance for tiotropi­um bro­mide in­hala­tion pow­der, the agency notes it ini­tial­ly ap­proved Boehringer In­gel­heim’s new drug ap­pli­ca­tion for the prod­uct, known as the Spiri­va Hand­i­haler, in 2004, though in 2012 Boehringer sub­mit­ted a cit­i­zen pe­ti­tion re­quest­ing that FDA adopt and ap­ply cer­tain re­quire­ments for gener­ic ver­sions of the bron­chodila­tor.

But FDA said Thurs­day that it will con­sid­er any com­ments on the draft guid­ance be­fore re­spond­ing to Boehringer’s cit­i­zen pe­ti­tion.

Sim­i­lar­ly, FDA in 2009 ap­proved Glax­o­SmithK­line’s treat­ments known as Serevent Diskus, Flovent HFA and Flovent Diskus 100, and the com­pa­ny sub­mit­ted a cit­i­zen pe­ti­tion re­quest­ing that FDA with­hold ap­proval of any AN­DA or 505(b)(2) ap­pli­ca­tion for gener­ic oral in­hala­tion prod­ucts con­tain­ing sal­me­terol xi­nafoate and/or flu­ti­ca­s­one pro­pi­onate un­less cer­tain con­di­tions were sat­is­fied, in­clud­ing some re­lat­ed to demon­strat­ing bioe­quiv­a­lence.

FDA again said it will con­sid­er any com­ments on the new draft guid­ance doc­u­ments be­fore re­spond­ing to GSK’s cit­i­zen pe­ti­tion.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.