November 30, 2022

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.
Many thanks to all those who turned up at the EUBIO event in London this week — the whole team is now basking in the positive feedback we got and the photos are giving me FOMO. Endpoints is looking to bring these in-person gatherings to many more corners of the world. Stay tuned.
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With household names like Botox and cancer treatment Keytruda, it’s no surprise that the global injectable drugs market is expected to top $1.2 trillion between 2022 and 2030. With a projected 9% compound annual growth rate (CAGR) in that same period, the market is quickly expanding to provide desperately needed treatments in areas like oncology and orphan disease to psychiatric disorders and immunodeficiencies.
When it comes to the European Medicines Agency’s drug review committee, known as CHMP, any positive opinions it gives to a drug are all but certain to be approved across the EU. And the committee just doled out opinions to a batch of 10 drugs, including two with higher profiles.
The Committee for Medicinal Products for Human Use, aka CHMP, recommended seven brand-name drugs and three generic — for marketing authorization in the EU. And while the European Commission has to sign off before those drugs go to market, it’s rare that the commission bucks the committee’s choices.
Biohaven is looking for people living with obsessive compulsive disorder using TV, radio and digital ads to find patients for its ongoing obsessive compulsive disorder (OCD) trial.
Not unlike many pharma companies, Biohaven is seeking clinical trial participants for study — in its case, for an obsessive compulsive disorder drug candidate. However, unlike typical trial recruitment ads advising people to call this number or visit that website, the Biohaven campaign stars real OCD patients sharing their thoughts, worries and hopes.
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Making sure a pharma sponsor and the FDA are on the same page when it comes to a new drug development program, particularly around manufacturing, can be crucial to ensuring the drug gets a fair shake as the review process plays out.
One aspect of this dialogue is the agency may issue an information request (IR) via letter, email or fax — where FDA seeks a clarification to help its review.
But these IRs from CDER and CBER must be standardized, and adhere closely to what’s known as “Four-Part Harmony,” which is where reviewers are expected to communicate to sponsors: “(1) what was provided, (2) what is the issue or deficiency, (3) what is needed, and (4) why it is needed.”
The biopharma industry reputation is sliding again — and alarmingly fast. The pharmaceuticals, biotechnology and life sciences category fell almost 3 points (2.9) between the first and second quarter of 2022, according to corporate reputation monitor RepTrak.
While a two- or three-point drop may not seem significant, RepTrak points out that its historical data “warns us that a 1-point drop often results in a 4-5% drop in support.”
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After taking its Gilenya patent battle all the way to the Supreme Court last month, Novartis suffered yet another loss on Thursday — but it isn’t done fighting yet.
The Supreme Court has denied Novartis’ request to stay a lower court’s mandate invalidating a key Gilenya patent. The Swiss pharma giant says it stands to lose more than a quarter billion dollars in sales this year if generics for the blockbuster multiple sclerosis treatment are allowed to market.
Amgen estimates that biosimilars resulted in $3.2 billion in savings last quarter alone, according to its latest trend report. And though the last two years saw a decline in overall approvals, the number of programs in development — and the uptake of available biosimilars — is on the rise.
The team at Amgen took a deeper look at the US FDA’s 39 approved biosimilars — cheaper treatments that are just as safe and effective as their costly original biologics — and those still in development in its ninth annual trend report.
Last quarter’s biotech IPO raise was the lowest in five years, but the team at Prime Medicine thinks their “holy crap” gene editing technology can break the spell.
The Cambridge, MA-based company, founded by Harvard biologist and gene editing pioneer David Liu, penciled in a $151 million raise on Thursday, setting the terms for an 8.9 million-share offering at a range of $16 to $18. At the midpoint, the preclinical startup would be worth $1.7 billion.
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The nation’s largest lab provider is coming to your living room — with both its tests and a first-ever advertising campaign.
Quest Diagnostics’ lineup of 50+ tests, from sexually transmitted disease screenings to allergy and metabolic panels, lets people skip the line at doctors’ offices and get results at home. And now it’s launching its largest inaugural consumer marketing campaign in support.
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Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas
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