Wel­come to CPhI week: The drug man­u­fac­tur­ing in­dus­try's pre­mier con­fer­ence kicks off with the winds of change blow­ing

Wel­come to CPhI week!

Tues­day marked the open­ing of this year’s CPhI Glob­al con­fer­ence in Mi­lan, Italy, in what marks its re­turn to an on­site event for the first time since 2019.

In many ways, this year’s CPhI is dif­fer­ent for us here at End­points News. We aren’t on site — as we cer­tain­ly plan to be next year — so we can’t give you the in­side scoop you can ex­pect in the fu­ture. How­ev­er, our team has been close­ly fol­low­ing the biggest trends from the past year and are stay­ing abreast of what CPhI’s sta­ble of ex­perts are say­ing about the fu­ture of the in­dus­try.

First, man­ag­ing ed­i­tor Kyle Blanken­ship dives head­first in­to some of the biggest trends from the past 12 months in the man­u­fac­tur­ing in­dus­try — and a few things to ex­pect in the year ahead.

Then, in the first of a se­ries of trend pieces, man­u­fac­tur­ing re­porter Josh Sul­li­van looks at the growth of the CMO in­dus­try, which is poised to take its place among the big dogs in terms of man­u­fac­tur­ing ca­pac­i­ty in the com­ing years.

Josh then dives in­to the fu­ture of au­toma­tion in bio­phar­ma, the grow­ing role of con­tract man­u­fac­tur­ing in Chi­na, the sky-high con­fi­dence the in­dus­try has go­ing in­to 2022, and fi­nal­ly the lin­ger­ing ef­fects an in­spec­tion back­log could have on the in­dus­try writ large.

As al­ways, if you have any feed­back, we’d be hap­py to hear from you. En­joy CPhI, and if you’re in Mi­lan: Ciao!

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.

Michael Egholm, Standard BioTools president and CEO (IsoPlexis)

Eli Cas­din co-leads $250M in­fu­sion in­to mi­croflu­idics play­er that land­ed NIH fund­ing for Covid-19 test­ing

In about 17 months, Fluidigm has gone from working with sharks to Vikings.

The South San Francisco-based company, which landed NIH money in a Shark Tank-style program for Covid-19 testing, announced that it will take on an investment worth $250 million from Casdin Capital and Viking Global Investors. It will also rebrand, and call itself Standard BioTools. The investment will help the company focus on the highest growth areas of discovery and development and expand its CRO and CMO service providers. Right now, the company’s customer reach is limited to basic research, it said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

FDA's do­mes­tic in­spec­tion hold will con­tin­ue un­til Feb­ru­ary

Amid a backlog of inspections, the FDA has announced that it will extend its pause of domestic inspections not considered mission-critical due to the outbreak of the Omicron variant.

While the agency will continue both foreign and domestic inspections deemed mission-critical, others will be paused through at least Feb. 4, and restart as soon as possible after that.

Previously planned foreign inspections will carry on as long as they’re in a country that has been cleared, and are within the CDC’s Level 1 or Level 2 Covid-19 travel recommendation — otherwise, they’ll be rescheduled. The FDA hopes to return to a regular cadence for foreign inspections in April.