Five years af­ter Bris­tol My­ers Squibb’s Cel­gene filed a pe­ti­tion with the FDA as part of an at­tempt to de­lay the launch of gener­ic ver­sions of its block­buster chemo Abrax­ane, the agency has fi­nal­ly, and al­most com­plete­ly, re­ject­ed the pe­ti­tion.

Al­though Cel­gene in 2018 (pri­or to the Bris­tol My­ers’ ac­qui­si­tion) set­tled with Te­va’s Ac­tavis, al­low­ing at least one Abrax­ane gener­ic to en­ter the mar­ket on March 31, 2022, the com­pa­ny in 2015 sent over a pe­ti­tion to the FDA, seek­ing to add new re­quire­ments for any com­pa­nies look­ing to make copy­cats of its treat­ment for breast can­cer, NSCLC and pan­cre­at­ic can­cer, among oth­er can­cers.

For in­stance, Cel­gene re­quest­ed that, in ad­di­tion to the cur­rent in vit­ro char­ac­ter­i­za­tion tests rec­om­mend­ed in FDA’s pa­cli­tax­el draft guid­ance, the agency in­clude ad­di­tion­al in vit­ro tests and cer­tain func­tion­al at­tribute tests that Cel­gene said are nec­es­sary to en­sure prod­uct qual­i­ty and demon­strate same­ness. The pe­ti­tion al­so as­serts that clin­i­cal im­muno­log­i­cal as­says should be re­quired of any ap­pli­ca­tion ref­er­enc­ing Abrax­ane, which brought in more than $1.2 bil­lion for Bris­tol My­ers last year.

Cel­gene fur­ther called on the FDA to re­vise its pa­cli­tax­el draft guid­ance, but the agency, in its re­sponse from June 30, de­murred. His­tor­i­cal­ly, the agency has lament­ed the fact it must use con­sid­er­able time and ef­fort to re­spond to such pe­ti­tions, when the com­pa­nies is­su­ing them of­ten are on­ly do­ing so as part of a wider at­tempt to block com­pe­ti­tion for their lu­cra­tive prod­ucts.

“Even if the Agency adopt­ed the changes to its Pa­cli­tax­el draft guid­ance urged in the Pe­ti­tion, AN­DA ap­pli­cants would be free to use an al­ter­na­tive ap­proach that sat­is­fies re­quire­ments in ap­plic­a­ble statutes and reg­u­la­tions,” the agency said.

Ac­cord­ing to the pe­ti­tion, all three of the pro­posed gener­ic ver­sions of Abrax­ane test­ed in Cel­gene’s stud­ies — none of which have been ap­proved by FDA — are mar­ket­ed in In­dia. But FDA says the pe­ti­tion “does not in­clude any da­ta from which FDA could con­clude that Cel­gene’s re­sults are ap­plic­a­ble to any prod­uct ap­proved by FDA or sub­mit­ted to FDA for ap­proval in an AN­DA or a 505(b)(2) ap­pli­ca­tion.”

And based on the lim­it­ed da­ta re­port­ed in the pe­ti­tion, FDA says, all three for­eign-sourced pa­cli­tax­el prod­ucts like­ly would not be el­i­gi­ble for ap­proval un­der the FDA’s 505(j) path­way for gener­ics and fol­low-on drugs.

But FDA does agree with one re­quest­ed re­vi­sion to the pa­cli­tax­el draft guid­ance to clar­i­fy the de­f­i­n­i­tion of “free” and “bound” pa­cli­tax­el or al­bu­min. “Specif­i­cal­ly, ‘frac­tion of free and bound pa­cli­tax­el or al­bu­min in re­con­sti­tut­ed sus­pen­sion’ should be re­vised to ‘frac­tion of free (in so­lu­tion) and par­ti­cle-bound pa­cli­tax­el and al­bu­min in re­con­sti­tut­ed sus­pen­sion,'” FDA said.

The agency al­so said it does not agree with the in­clu­sion of Cel­gene’s re­quest­ed tech­niques to char­ac­ter­ize a nano­ma­te­r­i­al.

“Be­cause the field of nan­otech­nol­o­gy and meth­ods to char­ac­ter­ize nano­ma­te­ri­als are rapid­ly evolv­ing, as ex­plained in its guid­ances, FDA gen­er­al­ly rec­om­mends the crit­i­cal qual­i­ty at­trib­ut­es of the prod­uct to be mea­sured and not the an­a­lyt­i­cal meth­ods to mea­sure these at­trib­ut­es,” FDA said.

And the agency said it dis­agrees with re­quir­ing that pa­cli­tax­el for­mu­la­tions aim­ing to be bioe­quiv­a­lent to, or oth­er­wise re­ly­ing on FDA’s find­ings of safe­ty and ef­fec­tive­ness for Abrax­ane, must en­sure the tis­sue dis­tri­b­u­tion and re­sult­ing pa­cli­tax­el con­cen­tra­tions to the tu­mor and healthy tis­sues are bioe­quiv­a­lent to en­sure equiv­a­lent clin­i­cal out­comes.

“In ad­di­tion, we dis­agree with the Pe­ti­tion’s con­tention that clin­i­cal stud­ies must al­ways be per­formed to ad­e­quate­ly as­sess any im­muno­genic­i­ty con­cerns due to the pres­ence of al­bu­min,” FDA said.

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

Treg cells have been getting more and more attention recently among autoimmune specialists. There’s been Jeff Bluestone’s Sonoma, the $157 million launch of GentiBio this summer and Egle Therapeutics — which launched just last week — to name a few.

Now, there’s a new Treg player jumping in that wants to distinguish itself in the market: Mozart Therapeutics. Today, the biotech is emerging from stealth in its official debut with a $55 million Series A — with a bunch of A-list Big Pharma names on board a syndicate led by ARCH.