Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)
The centerpiece of Novartis’s $9.7 billion buyout of the Medicines Company can finally go to market.
Branded Leqvio, the small interfering RNA therapy long known as inclisiran is the first and only FDA-approved treatment to reduce LDL-C, i.e. bad cholesterol, with just two maintenance doses a year after an initial dose and another one at three months.
Touting a ‘revolutionary approach,’ Novartis CEO Vas Narasimhan noted that the approval ‘creates new possibilities for how healthcare systems can impact cardiovascular disease, a defining public health challenge of our time.’ The label covers both atherosclerotic cardiovascular disease and heterozygous familial hypercholesterolemia.
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CALQUENCE is a registered trademark of the AstraZeneca group of companies.
At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.
Khurem Farooq, Gyroscope CEO
Christmas is coming early for Gyroscope.
In its latest gene therapy gambit, Novartis is paying $800 million upfront to acquire the Syncona-backed biotech, with another $700 million reserved for milestones.
Novartis has been diving deep into retinal disorders, and Gyroscope’s lead candidate adds a potential one-time treatment for geographic atrophy — a leading cause of blindness — to the pipeline.
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Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from the market.
‘An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval,’ they wrote to FDA, explaining how Aduhelm ‘did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression.’
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The FDA on Wednesday signed off on Pfizer’s Covid-19 pills, which are meant to help keep people out of the hospital.
The news comes at a crucial moment, as the Omicron variant has taken over Delta as the prominent strain in the US, and as monoclonal antibody infusions will likely be in very short supply as two of the three currently marketed are ineffective against Omicron.
Pfizer will see early supply constraints of their pills, which are made up of nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use, meaning doctors will have to be very careful on how they’re doled out. And if Merck’s pill is authorized soon too, there may be more options, although there’s also a drastic difference in efficacy between the two.
Christophe Weber (Miho Takahashi/The Yomiuri Shimbun via AP Images)
Takeda CEO Christophe Weber thought he had a win in the bag for TAK-721 — one of the experimental drugs spotlighted in the company’s $62 billion Shire acquisition — and went so far as to announce a brand name after snagging priority review last year. But months after missing its PDUFA date, the FDA’s now saying better luck next time.
Regulators handed TAK-721 a complete response letter for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus, Takeda revealed on Tuesday. While the pharma company didn’t share much information on the FDA’s reasoning behind the rejection, execs shared that the agency has recommended an additional clinical study ‘in order to help resolve FDA feedback.’
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Graphic: Alexander Lefterov for Endpoints News
Drug pricing reform has been a political football for years, with both Donald Trump and Joe Biden championing changes during their presidencies. Little has moved the needle on Capitol Hill, however, thanks in part to the drug industry’s powerful lobbyists.
In the most recent example, Democrats tried to allow Medicare to negotiate drug prices — an immediate non-starter for biopharma proponents. After months of negotiation, the measure fell apart in favor of provisions on a small subset of drugs that passed the House but marked a far cry from Biden’s promises and what many activists had hoped for. The bill, included as part of Biden’s broad social policy agenda, now appears dead after Democrats failed to secure 50 votes in the Senate.
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A little over a week after French regulators decided against authorizing Merck’s Covid-19 antiviral pill, the country has canceled its order, according to multiple reports.
A Merck spokesperson told Reuters that France’s planned purchase didn’t take place after the country’s health authority rejected the pill over growing concerns about efficacy and the impact of the Omicron variant. The country had pre-ordered enough doses to treat 50,000 patients.
Bob Baloh, Novartis Head of Neuroscience at NIBR (via Cedars-Sinai)
Even after agreeing to sell off $20 billion in shares back to Roche in November, Novartis got a bit more from its crosstown rival — successfully getting ahold of Roche’s head of neuro and rare disease R&D for themselves.
NIBR president Jay Bradner — a well-known name here at Endpoints — announced Bob Baloh’s appointment on Twitter. Baloh will be running NIBR’s neuroscience division.
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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)
In a surprise move, Biogen announced Monday that it will cut the price of its controversial Alzheimer’s drug Aduhelm in half, slashing the cost from $56,000 to $28,000.
The sudden discount marks a sudden turnaround for the big biotech as it struggles to turn around a drug whose stuck-in-the-mud sales and political ramifications have sent the company into turmoil and triggered the ousting of its longtime chief scientist. Biogen’s leadership had resisted calls since June to reduce the price of the drug.
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https://endpts.com/its-a-year-late-but-novartis-has-finally-steered-inclisiran-to-fda-approval-will-it-sell/
