Bris­tol-My­ers wins the fren­zied race to a first ap­proval for a PD-1/L1 check­point in Chi­na as reg­u­la­tors hus­tle up a quick OK

Bris­tol-My­ers’ $BMY Op­di­vo may be about to cede its top place in the PD-1/L1 world to Mer­ck, but in Chi­na to­day, they’re num­ber 1.

The Chi­na Drug Ad­min­is­tra­tion has ap­proved Op­di­vo for sec­ond line treat­ment of non-small cell lung can­cer, mark­ing the first of­fi­cial en­try of a check­point pi­o­neer in­to the boom­ing health­care mar­ket.

Bris­tol-My­ers, which has been fight­ing a los­ing war with Mer­ck for dom­i­nance in the NSCLC field in the US, wrapped their Phase III with a pre­dom­i­nant­ly Chi­nese group of pa­tients late last year, hus­tling the pos­i­tive re­sults to reg­u­la­tors as they looked to flank their ri­vals in Asia.

Chi­nese of­fi­cials re­spond­ed with a fast-paced ap­proval that took on­ly six months to achieve, high­light­ing a thor­ough reg­u­la­to­ry shake­up that has brought a host of top de­vel­op­ers in­to the mar­ket. Their an­nounce­ment in­clud­ed a note that the check­point ex­tend­ed over­all sur­vival by “around three months” in pa­tients with an ad­vanced case.

In a state­ment from the agency, au­thor­i­ties not­ed:

BMS ini­ti­at­ed and com­plet­ed clin­i­cal tri­als for Op­di­vo in ad­vanced NSCLC pa­tients whose can­cer pro­gressed af­ter plat­inum-based chemother­a­py, and used that to sub­mit their im­port­ed new drug ap­pli­ca­tion. The CDA ac­cel­er­at­ed the as­sess­ment us­ing the pri­or­i­ty re­view path­way, in­clud­ing tech­ni­cal eval­u­a­tion and au­dit­ing of clin­i­cal tri­al da­ta, and ap­proved reg­is­tra­tion on June 15, 2018.

Mer­ck, though, isn’t far be­hind. Bris­tol-My­ers’ big ri­val field for their ap­proval in Feb­ru­ary, which could leave them just a step be­hind Bris­tol-My­ers, if reg­u­la­tors con­tin­ue to act with a sense of ur­gency. Both for­eign and home grown bio­phar­mas see Chi­na as one of the big growth ar­eas, par­tic­u­lar­ly in on­col­o­gy, as As­traZeneca has helped high­light re­cent­ly with its own set of ris­ing num­bers.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Presage teams with Mer­ck on its Phase 0 test­ing; Kem­Pharm AD­HD drug wins ap­proval in chil­dren aged 6 and up

Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.

Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.

The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.