| | | |   | Good morning, all. Damian here, informing you that yesterday marked the first time in 2022 that the XBI biotech index increased in value. It's still down about 20% for the year, but one assumes biotech investors will take good news wherever they can find it. | | | With positive new data, Sierra Oncology challenges a $2 billion blockbuster A cancer treatment from Sierra Oncology met all of its goals in a pivotal study, putting the small company in position to unseat a massively successful drug from partners Novartis and Incyte.
As STAT’s Adam Feuerstein reports, Sierra’s drug significantly reduced the symptoms of the blood cancer myelofibrosis, improving the rates of fatigue and pain while reversing the spleen enlargement that characterizes the disease. The drug also improved anemia, a hallmark of myelofibrosis, which differentiates it from Jakafi, the market-leading medicine that clears about $2 billion a year in revenue.
Sierra, which carries a market value of about $230 million, plans to file its treatment for FDA approval in the second quarter, setting the stage for a possible commercial launch in early 2023.
Read more. | As pricing pressure increased, Big Insulin spent more on lobbying Eli Lilly and Novo Nordisk, two of the world’s biggest manufacturers of insulin, boosted their lobbying budgets in 2021, coinciding with a congressional push to constrain the cost of medicine.
As STAT’s Rachel Cohrs reports, Lilly’s annual lobbying spend rose 29% last year, and Novo’s went up by 24%. Sanofi, the other heavyweight on the insulin market, spent roughly the same amount as it did in 2020.
It’s likely no coincidence that, in 2021, Democrats proposed policies that posed a greater threat to industry’s bottom line than any time in recent memory, with a particular focus on the cost of insulin. Those proposals stalled with last month’s unraveling of the legislative package containing the most ambitious parts of President Biden’s domestic agenda, and it remains to be seen whether Democrats mount another drug pricing offensive before this year’s midterm elections.
Read more. | A new era for neuroscience and oncology drug development: The biopharma driving R&D innovation Among the most incredible achievements of humankind over the last few decades are the indisputable advancements in medical science — remarkable treatments that contribute to longer, healthier lives worldwide. Yet, despite awe-inspiring innovations, millions of people live with complicated, difficult-to-treat conditions for which there remain limited or no treatment options. Alkermes is working to change this. Read the article here. | What does it take to get a cough medicine through the FDA? That’s the question facing Merck and its biotech rival after the agency's surprising rejection of a novel drug to quell chronic cough.
The news, disclosed yesterday, is that the FDA turned down Merck’s approval application for gefapixant, an oral drug, and requested “additional information related to measurement of efficacy.” It’s unclear what that means or how long it might take Merck to satisfy the agency’s questions. In two pivotal trials, Merck’s drug reduced coughing frequency by about 20% relative to placebo over 12 weeks, measured in coughs per hour.
It’s also unclear what this means for Bellus Health, a small biotech company at work on a competing therapy for chronic cough. In a Phase 2 trial, Bellus’ therapy led to a roughly 35% reduction in cough frequency and had fewer side effects than Merck’s pill. The FDA’s reluctance to approve gefapixant might mean there’s no clear threshold for novel cough medicines, which could cloud the future of Bellus’ drug. | Sanofi doesn’t want nosy neighbors doing espionage on its vaccine production In a rare pharmaceutical foray into urban planning, Sanofi is trying to stop the construction of a Toronto high-rise next door to its vaccine manufacturing plant, warning that it could have implications for Canada’s national security.
As STAT’s Ed Silverman reports, Sanofi’s argument boils down to this: The presence of new neighbors in tall towers could force the company to re-examine its facility’s security, and that process could delay the production of vaccines, and that delay would be bad for public health. The project’s developer contends that it has complied with all the relevant local laws and should be allowed to provide “much-needed apartment housing” in Toronto.
Beyond the espionage element, the dispute could be a test case for just how much influence global drugmakers wield. Sanofi has plans to expand the Toronto facility with $360 million in backing from the federal and Ontario provincial governments, adding about 900 jobs in the process. If the municipal government doesn’t side with Sanofi on the high-rise issue, the company could threaten to back out of the agreement.
Read more. | More reads - As Pfizer and BioNTech begin clinical trial of Omicron-based vaccine, timeline to authorization is unclear. STAT
Can open datasets help machine learning solve medical mysteries? STAT - Is it time to sell Biogen for parts after the Alzheimer’s drug debacle? Barron's
- It’s too early to tell whether CBD helps against Covid-19 — but researchers worry that won’t stop CBD makers. STAT
| Thanks for reading! Until tomorrow,  | | | |
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