Roche's new, sin­gle-dose flu drug gets the green light at a hard charg­ing FDA, break­ing in­to record-set­ting ter­ri­to­ry

Roche got the first new land­mark drug ap­proval we’ve seen in flu for 20 years — while set­ting a record on new drug ap­provals for the same pe­ri­od.

The agency gave a thumbs up to balox­avir mar­box­il for flu, which Roche proud­ly hailed as the first one-dose dose of a drug that can help deal with flu mis­ery. The phar­ma gi­ant now plans to roll it out as Xofluza, in plen­ty of time for the flu sea­son ahead.

San­dra Horn­ing

“If pa­tients see their doc­tors with­in 48 hours of symp­tom on­set, one dose of Xofluza can sig­nif­i­cant­ly re­duce the du­ra­tion of flu symp­toms,” says Genen­tech CMO San­dra Horn­ing.

Roche needs this one to counter the ar­rival of cheap Tam­i­flu gener­ics, but it may prove eas­i­er to get this ther­a­py through the reg­u­la­tors at FDA than it will be with pay­ers. While Roche’s drug hand­i­ly beat out place­bos, they weren’t so good against Tam­i­flu in the head-to-head. As the phar­ma gi­ant notes, their new drug and the old one reg­is­tered ex­act­ly the same in the du­ra­tion of symp­toms: 54 hours.

And while pa­tients may like some added con­ve­nience, don’t ex­pect pay­ers to pass up on deep dis­counts for gener­ics. They’ve proven far more in­ter­est­ed in cost than con­ve­nience. Yet Roche did have some good news for a sub­pop­u­la­tion, with their drug beat­ing Tam­i­flu in the in­fluen­za sub­type B cat­e­go­ry, with a me­di­an time to im­prove­ment of 74.6 hours com­pared to Tam­i­flu’s 101.6 hours (p<0.05). Their drug al­so re­duced “the time that the virus con­tin­ued to be re­leased from the body (vi­ral shed­ding; me­di­an time of 48.0 hours for balox­avir mar­box­il ver­sus 96.0 hours for both place­bo and os­eltamivir; p<0.0001).”

We still need a few more new OKs to get past the all-time drug ap­proval high at the FDA, but that would seem an easy task for an agency bent on ac­cel­er­at­ing OKs for drugs that can pass muster with reg­u­la­tors. 

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

Artist rendering of the Assembly Square site in Somerville, MA (BioMed Realty)

Bio­Med Re­al­ty snaps up in­no­va­tion cam­pus site with­in earshot of pricey and bustling Boston biotech hub

On the short list of the premier biotech hubs in the world, the Boston area has transformed into a home for innovation — and ridiculously high rent. Now, a real estate firm is seeking tenants for a major site in neighboring Somerville with more than enough elbow room.

Snapped up by BioMed Realty, the land — which consists of an existing 162,000 square-foot office building and a 7.5 acre site — will serve as an “innovation space” for a variety of research, technology and life science tenants, the real estate company said in a press release. Financial terms weren’t disclosed.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Union members strike in France, AP Images

Paul Hud­son faces down French unions in fight to re­struc­ture Sanofi

Sanofi CEO Paul Hudson is facing a familiar adversary in his efforts to cut up to 1,680 jobs from the French pharma giant: French unions.

Around 200 union members staged a one-day strike Tuesday at Sanofi’s main Covid-19 vaccine plant in Marcy-l’Étoile to protest the cuts, The Associated Press reported, with other members joining at other facilities across the country.

France’s finance minister Bruno Le Maire, meanwhile, went on French radio twice this week to talk about the company. On Monday, per Reuters, he told RTL that Sanofi would not close any plants or lay off any employees in the restructuring. But on Wednesday morning, he re-emerged on BFM and said he would like three things from the drugmaker, including confirmation that there will be no site closures and layoffs.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.