Roche picks up a speedy nod in Chi­na as reg­u­la­tors fol­low through on plans for a fast 48 new drug OKs

Chi­nese reg­u­la­to­ry au­thor­i­ties are fol­low­ing through with their plan to rush along a slate of new drug ap­provals. And Roche finds it­self near the front of the line formed to ben­e­fit from that new trend.

San­dra Horn­ing

Overnight Roche re­port­ed that the Chi­na Na­tion­al Drug Ad­min­is­tra­tion had fol­lowed up with a green light for Roche to start sell­ing Ale­cen­sa as a front­line ther­a­py for ad­vanced cas­es of ALK-pos­i­tive non-small cell lung can­cer. Roche her­ald­ed an OK that ar­rived just 8 and 9 months af­ter the EMA and FDA flagged the drug through for front­line use fol­low­ing new da­ta un­der­scor­ing its ef­fi­ca­cy in treat­ing pa­tients com­pared to a stan­dard of care.

Chi­na’s drug reg­u­la­tors have been hus­tling along their re­views, in­tent on get­ting a list of 48 pri­or­i­ty drugs in­to the mar­ket as swift­ly as pos­si­ble — elim­i­nat­ing bar­ri­ers that once took years to over­come in the boom­ing mar­ket.

The ap­proval to­day, not­ed Roche CMO San­dra Horn­ing, marks a “sig­nif­i­cant reg­u­la­to­ry shift, with the ap­proval re­ceived un­der un­prece­dent­ed time­lines.”

Roche has been speed­ing up the roll­out in front­line, ALK-pos­i­tive NSCLC af­ter a key late-stage study proved that it was sig­nif­i­cant­ly bet­ter than Pfiz­er’s lead­ing ef­fort with Xalko­ri. Ale­cen­sa al­so is pit­ted against No­var­tis’ Zyka­dia, though Pfiz­er has re­mained the one to beat in clin­i­cal tri­als. In the ALEX tri­al the Ale­cen­sa arm hit a me­di­an PFS of 25.7 months with Xalko­ri pa­tients reg­is­ter­ing on­ly 10.4 months.

Look for a slate of new drug ap­provals to hit in Chi­na as reg­u­la­tors con­tin­ue to make short work out of a long list of pri­or­i­ty meds. While far from per­fect, Chi­na’s drug mar­ket has been bustling as drug­mak­ers hunt down a mar­ket that will ri­val the US and Eu­rope. Can­cer drugs, which have been placed on reg­u­la­to­ry fast tracks in the US and Eu­rope, make up a fourth of the 48 meds that Chi­nese of­fi­cials have high­light­ed for VIP treat­ment.

One of those meds is Keytru­da, which was ap­proved in Chi­na last month based on Phase Ib melanoma da­ta. And more are com­ing.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The company calls it “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” the Boston Globe reported, quoting a spokesperson.

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Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

John Quisel, Disc Medicine CEO

Disc Med­i­cine goes pub­lic in re­verse merg­er with strug­gling Gem­i­ni Ther­a­peu­tics

After licensing a failed Roche schizophrenia drug last year, Disc Medicine is going public via a reverse merger with Gemini Therapeutics.

The combined company, while still named Disc Medicine, will trade under the stock symbol $IRON, in reference to Disc’s lineup of therapies for blood iron disorders. Alongside the merger, Disc has secured $53.5 million in another financing round, building on the $90 million Series B it raised in September.

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Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.