Roche’s Genentech got a leg up in the packed anti-TIGIT race earlier this year when the FDA granted it the first breakthrough designation in the field based on some upbeat mid-stage data in non-small cell lung cancer. Now, looking to keep its lead, the pharma giant is offering a two-and-a-half-year look at the same patient group — but will two deaths crush its chances?
A combination of Genentech’s anti-TIGIT cancer tiragolumab plus PD-L1 inhibitor Tecentriq reduced patients’ risk of disease progression or death by 38% compared to those who received Tecentriq alone at a median follow-up of 2.5 years, the company said on Friday. In a pre-specified exploratory analysis of participants with high levels of PD-L1, the combo reduced the risk of disease worsening or death by 71% compared to the Tecentriq group.
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House Speaker Nancy Pelosi (Jacquelyn Martin/AP Images)
Back in January 2019, the late House Oversight Committee chair Elijah Cummings kicked off a nearly 3-year-long drug pricing investigation that culminated today in a major new report detailing how prices for vital drugs have risen substantially since their launch, while calling on the Senate to pass a bill that will allow Medicare to negotiate some prices.
The committee’s investigation focused on 12 of the most expensive drugs for Medicare, showing massive price spikes that have accumulated over the years and made some drugs, like insulin, entirely unaffordable for some, to the point where some diabetics have had to ration their life-saving insulin, and some have died.
Andreas and Thomas Strüngmann (via Agreus Group)
While the ultimate fate of Novartis’ big generics arm Sandoz may still be up in the air, there’s no doubt it’s in play as a potential buyout target.
Overnight, Reuters picked up on a report out of Germany that EQT and the billionaire Strüngmann brothers — enjoying a huge windfall from the overnight success of BioNTech’s mRNA Covid vaccine — are kicking the tires at Sandoz. And Novartis CEO Vas Narasimhan confirmed it.
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Xiayang Qiu, Regor Therapeutics CEO
Eli Lilly will license in Regor Therapeutics therapies for metabolic disorders, as a part of an agreement announced Friday that will give the Chinese biotech an upfront payment of up to $50 million, part of which is an equity investment.
In a vaguely worded release, Lilly said it has a license for certain Regor ‘intellectual property’ and will have an option to extend that license. In exchange, Lilly will oversee global clinical development and commercialization for any therapies, with the exception of China, Macau, Hong Kong and Taiwan. Regor, a Shanghai-based company, will reserve the rights to these regions.
Bristol Myers Squibb brought in more than $9 billion in sales from its anticoagulant Eliquis in 2020, and it continues to see growth with more than $8 billion in sales in the first nine months of 2021 (and another nearly $4.5 billion for Pfizer in 2021).
But in 2022, one of the largest PBMs in the US, CVS Caremark, has recently decided to no longer cover the megablockbuster, and instead will only offer coverage for warfarin and Janssen’s Xarelto.
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KEY POINTS
Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients. The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers. A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.
Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.
Please signup to continue — it’s fast and free. This article is sponsored by Catalent and produced by Endpoints Studio. Vlad Coric, Biohaven chariman and CEO
Days after reporting positive Phase III results for intranasal migraine med zavegepant, Biohaven chairman and CEO Vlad Coric is talking about marketing plans. It’s a month or more before Biohaven will file for FDA approval and likely a year before launch, but Coric is already thinking about messaging and commercialization.
His plan? A dual strategy to attract potential patients around speed to relief – zavegepant study results show the spray can provide relief in as fast as 15 minutes and a return to normal in 30 minutes – along with a secondary anti-nausea benefit in using an intranasal versus a pill.
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Stéphane Bancel, Moderna CEO (AP Images, Boston Herald)
Moderna says that it’s on its way to having an mRNA vaccine against not one, but two different seasonal viruses.
The biotech released the first early data from its flu program Friday morning, announcing that all doses of the shot significantly boosted antibodies in younger and older adults without ‘significant safety findings.’
A 500-person Phase II will confirm dose levels and compare it to an approved flu vaccine, the company said, and preparations for a large pivotal trial are underway. Moderna said it is also advancing new designs that can have potentially broader coverage of different flu strains than current shots.
A new healthcare SPAC is expected to price during Friday’s session, and it’s one that wants to take advantage of the industry’s buzziest sector.
The blank check company will make a $200 million debut on Nasdaq, coming to the public market on the backs of Stanley Capital fundraising. This SPAC is not only targeting life sciences, but life sciences companies with a specific focus on artificial intelligence. One need not look past the name as evidence — Healthcare AI Acquisition Corp.
Mathai Mammen, J&J EVP of pharmaceuticals, R&D (Rob Tannenbaum)
The new J&J has a fresh corporate face to show the public — several in fact.
As the healthcare conglomerate follows a now familiar pharma path in separating itself into an innovation-focused R&D-based group from its less appealing consumer side, it’s promoting some key individuals to the executive committee that steers the company.
Those fresh faces include Mathai Mammen, the global head of R&D who joins the inner circle as executive vice president of pharmaceuticals, R&D. External innovation chief Bill Hait becomes executive vice president, chief external innovation, medical safety and global public health officer. Jim Swanson, until today simply the chief information officer, adds the EVP part to his title in moving onto the committee. And Vanessa Broadhurst, company group chairman, global commercial strategy organization, has been appointed EVP, global corporate affairs.
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