For­mer head of Chi­na's FDA boot­ed in wake of sear­ing vac­cine scan­dal as lead­ers im­pose 'se­vere pun­ish­men­t'

The for­mer head of Chi­na’s Drug Ad­min­is­tra­tion has been forced to re­sign in the af­ter­math of a vac­cine scan­dal that rocked the coun­try.

Bi Jingquan

Bi Jingquan — who presided over Chi­na’s drug reg­u­la­to­ry agency for three years be­fore a gov­ern­ment re­vamp put him in charge of a mar­ket su­per­vi­sion bu­reau — is step­ping down along­side two deputy provin­cial gov­er­nors and a may­or in Jilin, where the com­pa­ny at the heart of the scan­dal is based. Jiao Hong, the cur­rent head of the CDA, is be­ing asked to con­duct a “deep re­flec­tion.”

The news came di­rect­ly out of a Polit­buro Stand­ing Com­mit­tee meet­ing led by Pres­i­dent Xi Jin­ping, mark­ing ex­act­ly a month since the CDA re­vealed that Changchun Chang­sheng had fal­si­fied records re­gard­ing their ra­bies vac­cine, and that their GMP cer­tifi­cate has been re­voked.

A few days af­ter that an­nounce­ment on Ju­ly 15, Chang­sheng put out word that they had al­so been pun­ished for pro­duc­ing sub­stan­dard DTP vac­cines — a manda­to­ry shot for chil­dren that pre­vents diph­the­ria, tetanus and per­tus­sis (whoop­ing cough).

As pub­lic anger erupt­ed, it was fur­ther dis­cov­ered that Chang­sheng pro­duced and sold close to 500,000 of those prob­lem­at­ic dos­es, al­most dou­ble the orig­i­nal 250,000 in­ves­ti­ga­tors first found.

Con­cur­rent with the Polit­buro meet­ing, the State Coun­cil has or­dered a con­fis­ca­tion of all pro­ceeds that Chang­sheng has ob­tained through these il­le­gal ac­tiv­i­ties. And two weeks ago lo­cal po­lice filed to ar­rest 18 staffers in­volved, in­clud­ing chair­woman Gao Jun­fang.

The wide­ly re­port­ed scan­dal is a big slap in the face for a drug reg­u­la­tor that’s been brand­ing it­self as a bea­con of re­form, vow­ing to speed up do­mes­tic in­no­va­tion and fa­cil­i­tate en­try of nov­el for­eign drugs while re­main­ing strict on drug safe­ty.

That point is not lost on the Polit­buro:

[This case] has caused se­ri­ous ad­verse im­pact, both ex­pos­ing gaps in our mon­i­tor­ing sys­tem, and re­flect­ing sys­temic flaws in the pro­duc­tion and dis­tri­b­u­tion of vac­cines. We must learn our les­son, be vig­i­lant, clean up the chaos with se­vere pun­ish­ment, and ac­cel­er­ate im­prove­ment of a longterm mech­a­nism for vac­cine and drug reg­u­la­tion.

Se­vere pun­ish­ment, of course, is a fa­mil­iar tac­tic in Bei­jing. In 2007, in an ef­fort to demon­strate it’s se­ri­ous about drug safe­ty, the state ex­e­cut­ed for­mer drug chief Zheng Xi­aoyu on bribery charges.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

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KalVis­ta's di­a­bet­ic mac­u­lar ede­ma da­ta falls short — will Mer­ck walk away?

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.

UP­DAT­ED: Ob­sE­va makes case for best-in-class hor­mone sup­pres­sive ther­a­py in pos­i­tive uter­ine fi­broid study

About a month after the Swiss biotech disclosed a failed late-stage study in its IVF program, ObsEva on Monday unveiled positive pivotal data on its experimental treatment for heavy menstrual bleeding triggered by uterine fibroids.

ObsEva in-licensed the drug, linzagolix, from Japan’s Kissei Pharmaceutical in 2015. Two doses of the drug (100 mg and 200 mg) were tested against a placebo in the 535-patient Phase III study, dubbed PRIMROSE 2, in patients who were both on and off hormonal add-back therapy (ABT).

Ear­ly-stage can­cer biotech nails $85M C round; Flem­ming Orn­skov's Gal­der­ma scores 'break­through' sta­tus

→ Zentalis Pharmaceuticals just nabbed an $85 million round from a syndicate that includes Matrix Capital, Viking Global Investors, Redmile Group, Farallon Capital, Perceptive Advisors, Surveyor Capital and Eventide Asset Management. Their lead drug is ZN-c5, which is currently in Phase I/II trials. The biotech describes that drug as a “potential best-in-class oral Selective Estrogen Receptor Degrader for estrogen receptor-positive, HER2-negative (ER+/ HER2-) breast cancer.”