Bye CF­DA: Chi­na's drug reg­u­la­tor to take new shape in ma­jor gov­ern­ment re­struc­tur­ing

A sweep­ing gov­ern­ment re­or­ga­ni­za­tion has re­wo­ven the Chi­na Food and Drug Ad­min­is­tra­tion in­to the fab­ric of an over­ar­ch­ing mar­ket su­per­vi­sion ad­min­is­tra­tion, giv­ing birth to a drug reg­u­la­tor un­der its purview.

The changes mean that af­ter five years of di­rect­ly re­port­ing to the State Coun­cil, the CF­DA will no longer be a stand­alone agency. The new­ly cre­at­ed mar­ket su­per­vi­sion ad­min­is­tra­tion will have a broad man­date cov­er­ing an­ti-mo­nop­oly laws, price con­trol, con­sumer goods qual­i­ty and safe­ty, etc — and that in­cludes every­thing food-re­lat­ed. It will, how­ev­er, leave the mat­ters of drug ap­proval to a sub-ad­min­is­tra­tion ded­i­cat­ed to drug reg­u­la­tion.

Of note is the fact that the new drug reg­u­la­tor’s au­thor­i­ty on­ly ex­tends to the provin­cial lev­el, del­e­gat­ing post-ap­proval mar­ket­ing and sales mon­i­tor­ing to coun­ty and city mar­ket su­per­vi­sion de­part­ments.

Those de­part­ments al­ready ex­ist in a num­ber of lo­cal gov­ern­ments, which con­sol­i­dat­ed com­merce, qual­i­ty con­trol and food/drug de­part­ments in­to one big struc­ture in­stead of fol­low­ing the ex­am­ple of the State Coun­cil in 2013, which cre­at­ed the stand­alone food and drug ad­min­is­tra­tion.

Hu Yinglian

That helps avoid con­fu­sion about over­lap­ping au­thor­i­ties, while al­low­ing the pro­fes­sion­al work of drug eval­u­a­tion in pro­fes­sion­al hands, Chi­nese Acad­e­my of Gov­er­nance pro­fes­sor Hu Yinglian told lo­cal mag­a­zine Cai­jing.

The reshuf­fle plan, which is wide­ly ex­pect­ed to be for­mal­ly en­dorsed by the Na­tion­al Peo­ple’s Con­gress lat­er this week, is the lat­est in a se­ries of back and forth changes over the past two decades.

Start­ing out as a stand­alone drug ad­min­is­tra­tion in 1998, the agency added food to its name in 2003, went un­der the au­thor­i­ty of the Na­tion­al Health Com­mis­sion in 2008, on­ly to be­come its own en­ti­ty again in 2013 — un­til now.

Ex­act­ly what the new struc­ture would look like re­mains un­clear, but we do know one thing for sure: Pres­i­dent Xi Jin­ping would like­ly stay in pow­er for the rest of his life to over­see these changes, thanks to a con­sti­tu­tion­al amend­ment passed weeks ago.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:
I think that culture, to some extent, is as hard, in fact even harder, than doing the science.
GSK has had one of the most moribund R&D groups in Big Pharma for years. They proved over and over again that they were very slow to fail, while often sticking with programs with limited commercial upside in an effort to find something that worked. An earlier attempt to prod some changes with “biotech-like” research groups executive dedicated to its pipeline assets was a bust.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.