$REGN wins FDA approval for its gene therapy to treat a very rare genetic form of hearing loss. The company is giving away the therapy for free. OTOF-related hearing loss affects approx. 50 newborns per year, so really rare, but... are there any concerns from other gene therapy makers about a precedent being set whereby an otherwise expensive treatment is given away for free?
Who knew $REGN was developing an anti-GPRC5D T-cell engager? https://t.co/jyL1PAS0y5 $JNJ $PFE $BMY
Important new FDA reporting from @LizzyLaw_ @statnews FDA voucher program has become vehicle for political interference in drug review decisions, staffers say A new program intended to fast-track drug reviews at the Food and Drug Administration is quickly becoming a way for the White House and top political officials at the agency to exert control over which medicines make their way fastest to patients in the United States. -- Makary clears all voucher selections with the White House, inserting politics into FDA decision making. -- The White House is using the vouchers as bargaining chips in drug-pricing negotiations. -- Some vouchers awarded despite concerns of FDA staff, including $REGN gene therapy for type of deafness. -- Focus on voucher products means FDA staff has less time/resources to spend on reviews of other products. -- Vinay Prasad exerting greater control and inflluence over voucher reviews. -- $LLY demanded faster review of oral obesity drug. FDA complied, raising similar "FDA captured by industry" concerns that arose with Biogen and Aduhelm. Read the full story. Link below.
If you enjoyed #ASH25 you can catch up on all @ApexOnco coverage, including previews, here -> https://t.co/XIQrEeKMwY $TERN $JNJ $LLY $CGEM $ONC $NRIX $PFE $REGN $KURA
Kymera $KYMR drug positioned to rival Sanofi and Regeneron’s Dupixent succeeds in early-stage eczema trial https://t.co/W3m3dtydJR via @JonathanWosen $SNY $REGN
How the first nine drug companies won priority review vouchers from Marty Makary’s FDA https://t.co/6r3UlcN8Wn via @LizzyLaw_ $DISC $RVMD $REGN $ACHV
Also on the voucher list: $REGN DB-OTO gene therapy for deafness.
FDA declares Novo Nordisk $NVO (Catalent) plant, key to drug manufacturing for some biotechs, out of compliance. Impacting $SRRK and $REGN today. https://t.co/LLlei1xM7X via @elaineywchen
CRLs for $REGN Eylea & odronextamab, & $SRRK apitegromab, so it must be time for a party! https://t.co/S78cFYGFkh
FDA appears not to have published these recent CRLs (or have I missed them??): Linvoseltamab $REGN Datroway $AZN $DSNKY Talzenna $PFE Columvi $RHHBY
Quite a few (redacted) oncology CRLs released then: $REGN odronextamab x3 SC Rybrevant $JNJ $REPL $ATRA Patri-dxd $MRK $DSNKY Camrelizumab + rivoceranib x2
U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds Plant, once owned by $CTLT and now owned by Novo Nordisk $NVO, is widely used by pharma industry, including $REGN and $SRRK via @pharmalot and @elaineywchen https://t.co/bUv77rZlIv
$ALNY surpassed $REGN in market value today. https://t.co/hckkdLHErO
As if $REGN TCE division needed any more bad news, $GMAB Epcore FL-1 just read out positively, about 3 years ahead of schedule as far as I can tell.
$REGN regulatory update: Expects Eylea HD pre-filled syringe and RVO approval delays (August PDUFAs) due to FDA general site inspection issues at Catalent's Indiana manufacturing plant. That facility recently acquired by $NVO Odronextamab rejected (PDUFA was July 30) also due to Catalent facility.
$REGN third CRL for odronextamab! https://t.co/1CspjVXeCI
So any word from $REGN? Odronextamab Pdufa date (now only for follicular) was yesterday.
@BiotechObserver Patient deaths, manufacturing cockups, 2 CRLs, one indication dropped. Right... $REGN
$REGN Lynozyfic approved (8 days before Pdufa date)... odronextamab next?
#ESMOGI25 $REGN $GSK $RHHBY $COGT $REPL
