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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

The Melon family, as seen in Concussion Awareness Now's latest campaign

Ab­bott in­tro­duces the Mel­on fam­i­ly to raise con­cus­sion aware­ness

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.