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Good morning. A few month in the past, after I first began writing this article, I shared the devastating information that the famed rat gap right here in Chicago was being removed. However as summer season approaches, it seems there now could also be a brand new animal-shaped indentation for us all to obsess over — the Chicago cicada hole.
Now let’s get into the biotech information of the day.
The necessity-to-know this morning
- Biogen is buying Human Immunology Biosciences, a privately held developer of medicine for immune-related ailments, for $1.15 billion and as much as $650 million in further funds if sure milestones are met.
FDA not sure if Guardant’s take a look at can be utilized for first-line most cancers screening
From STAT’s Jonathan Wosen: The FDA is looking for steering on whether or not Guardant’s blood-based colon most cancers screening take a look at may very well be a first-line screening possibility or whether or not sufferers should first decline different accessible choices like colonoscopy or stool-based exams, in line with briefing documents the company launched forward of an advisory committee assembly this Thursday.
Guardant’s sequencing-based take a look at, often called Defend, detects chemical modifications to DNA which might be telltale indicators of colon most cancers. If the FDA finally decides that Defend should be used after sufferers decline different conventional screening choices, then that will restrict the take a look at’s use — and Guardant’s income prospects.
Guardant printed outcomes earlier this 12 months that confirmed Defend may catch colorectal most cancers at phases 2 or later, however was much less efficient at detecting stage 1 most cancers and superior adenomas, precursors to colon most cancers. This has raised issues concerning the take a look at’s usefulness in contrast with present screening strategies.
Our reporters might be tuning into the advisory assembly Thursday — keep tuned for our protection then.
AstraZeneca’s ‘new period of progress’
Yesterday, throughout AstraZeneca’s first investor day in a decade, CEO Pascal Soriot laid out the corporate’s bold objectives for the following few years: it goals to almost double its income to $80 billion by 2030, banking on the launch of 20 new medication and continued progress of its most cancers and uncommon illness therapies.
Soriot famous there might be headwinds, just like the lack of exclusivity on its blockbuster diabetes drug Farxiga and the Inflation Discount Act, however he stated he nonetheless sees a “new period of progress” as he confirmed off the corporate’s flashy new analysis hub in Cambridge, England. AstraZeneca is focusing particularly on next-generation chemotherapies known as antibody-drug conjugates.
Learn extra from STAT’s Drew Joseph on what else Soriot needed to say concerning the firm’s plans in weight problems and its curiosity in China.
Maryland takes first steps to cap drug prices
From STAT’s Rachel Cohrs: Again in 2019, Maryland was a pioneer when it created a prescription drug affordability board to assist in giving state officers extra instruments to manage prescription drug prices within the state. The board had some hiccups over the previous few years and its progress was overtaken by Colorado’s affordability board, however the Maryland program is lastly getting up and working.
The Maryland board this week voted to advance price evaluations for six out of the eight medication it thought-about, together with Novo Nordisk’s Ozempic, Eli Lilly’s Trulicity, Boehringer Ingelheim’s Jardiance, and AstraZeneca’s Farxiga, Bloomberg Law reports. The board hasn’t determined whether or not to place price caps on the medicines but.
Colorado’s board is already going through a lawsuit from a pharmaceutical firm it’s concentrating on, so related motion may comply with in Maryland if the state decides to pursue higher fee limits.
A shocking off-label advantage of anti-seizure medication
Although there are three FDA-approved medication for treating alcohol use dysfunction, a unique kind of treatment, one which’s regularly used off-label, may very well present higher profit to sufferers with alcohol-associated liver illness, a brand new examine discovered.
Taking a look at well being data, researchers in contrast acamprosate, offered beneath the model identify Campral to deal with alcohol dependence, towards gabapentinoids, a category of anti-seizure medication. They discovered {that a} smaller share of sufferers on gabapentinoids progressed to superior liver scarring.
Charges of alcohol-associated liver illness have surged, making it the main explanation for liver transplants within the U.S.
Learn extra from STAT’s Isa Cueto.
The difficult calculus behind making H5N1 vaccine
If the H5N1 chicken flu virus ever acquires the flexibility to transmit to and amongst folks, the world would want loads of vaccine. However when ought to drugmakers truly begin scaling up manufacturing of such a vaccine?
Some producers which have been engaged on vaccines for H5N1 viruses for years have already produced small batches which have undergone early human testing. And a few thousands and thousands of doses within the low double digits have even been stockpiled by the U.S. authorities.
Nevertheless it’s a unique story when excited about producing vaccine on the huge portions wanted to vaccinate the world. That’s a high-cost, high-risk endeavor.
Learn extra from STAT’s Helen’s Branswell on the questions surrounding this determination and the manufacturing constraints at play.
Extra reads
- CDC asks states and cities to maintain flu surveillance at peak ranges due to chicken flu risk, STAT
- Senators strike bipartisan tone on extra pharma patent reforms, Endpoints
- In pharma tax probe, Wyden places Pfizer in sizzling seat with CEO letter, Fierce Pharma
- Opinion: What scientific real-world information can ship, STAT