PharmaFocus Today – Page 253 – media

European Commission orders Illumina to divest Grail

Dive Brief The European Commission on Thursday ordered Illumina to unwind its 2021 acquisition of liquid biopsy-maker Grail, establishing deadlines for the company to follow as well as potential penalties for non-compliance. The commission in September 2022 prohibited Illumina from buying Grail, maker of a blood-based early cancer detection test, over concerns that the merger would stifle innovation in the emerging market. Illumina and Grail completed the $8 billion deal anyway, in an alleged breach of EU merger control rules. Illumina, which is appealing the EC’s decision, said in a statement Thursday that it was reviewing the order. Dive Insight Illumina has been expecting the EC’s divestment instructions while maintaining that the commission does not have jurisdiction over the merger. The gene-sequencing industry leader is appealing the jurisdictional issue with the European Court of Justice. The company has said it will pursue parallel paths, working to divest Grail according to ...
- Source: drugdu
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- October 14, 2023
Mount Sinai researchers receive NIH grant to compare new treatment options for sickle cell disease

The Mount Sinai Health System has received a $12,180,625 grant from the National Heart, Lung and Blood Institute to compare new treatment options for sickle cell disease and determine which work best for specific patients. Jeffrey Glassberg, MD, Director of the Mount Sinai Sickle Cell Program, said, “Sickle cell traditionally has been a neglected disease, but it benefited from a flurry of innovation over the last decade and there are now three new medications approved for the disease.” “While this is welcome news, clinicians now have a new challenge. No studies have compared the drugs to each other or looked at their use in combination, so there’s very little information to help decide which of the new drugs are best for which patients.” The study, known as REAL (Registry Expansion Analyses to Learn) Answers, is a collaboration among 10 sickle cell centers across the United States that will implement a ...
- Source: drugdu
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- October 14, 2023
What to Expect

Ira Studin, PhD President Stellar Managed Care Consulting The old axiom, “The truth is somewhere in between” may be a useful lens to gauge how a new generation of obesity drugs will perform in the payer market. On one side is the school of thought suggesting that annual revenues will be in the multi-billions, with investment analysts’ tacitly assuming insurance will support demand. On the other side is the “PCSK9” school, referring to extreme barriers payers created to restrict Repatha and Praluent coverage as an alternative to statins. The discussion below will draw on conversations with payers and describe the likely payer market between these two sides. HEAVY DISCOUNT OR ELSE There is a through line from the cholesterol lowering drugs that put their stamp on the market starting in the 1990s and weight loss drugs today. Assuming Mounjaro follows Wegovy’s recently announced outcomes data, the parallel with statins centers ...
- Source: drugdu
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- October 14, 2023
Judge grants preliminary approval to Philips class action settlement

BY CHRIS NEWMARKER A federal judge in Pennsylvania has granted preliminary approval to an economic loss settlement involving lawsuits filed against Philips over its massive recall of CPAPs and other respiratory devices. U.S. District Court Judge Joy Flowers Conti’s order, filed yesterday, could just be the beginning of settling what has arguably been one of the medical device industry’s most serious recalls in recent decades. (Here is a full timeline of the Philips recall.) According to plaintiffs’ co-lead counsel, Philips has agreed to provide at least $479 million in compensation to device users who paid out of pocket to buy or rent the recalled devices, as well as payers who reimbursed users for the devices. Awards could range between $55.63 and $1,552.25 for each recalled device, plus a $100 award apiece for those who returned devices. “We are pleased that Judge Conti granted preliminary approval of the Philips economic loss ...
- Source: drugdu
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report

Antibodies and immunotherapies are all the rage in the lung cancer drug market, but older, small molecule drugs can still carve out a healthy niche-and AstraZeneca’s Tagrisso is set to be the leader in that market. That’s according to a new report out by analysts at GlobalData who see more than $7 billion in sales by 2029 for Tagrisso, a small molecule kinase inhibitor. It was first approved in 2015 for certain non-small cell lung cancer (NSCLC) patients with an EGFR mutation, later receiving a first-line green light in 2018 and an adjuvant approval in 2020. Tagrisso is AstraZeneca’s biggest-selling drug, making $5.44 billion in 2022, up 15% in 2021 and more than double its newer oncology drugs Imfinzi, an immunotherapy and PARP inhibitor Lynparza. “In the ever-evolving landscape of oncology, small-molecule drugs are carving a significant niche in lung cancer treatment,” said analysts at GlobalData. “Tagrisso is projected to ...
- Source: drugdu
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Incyte taps actor to help tell the stories of eczema patients, with focus on teen’s Opzelura experience

Incyte has activated star power for its latest Opzelura ad campaign, enlisting the actor and singer Mandy Moore to help share the stories of eczema patients. The campaign, Moments of Clarity, is an educational initiative focused on sharing details of the lives of people with atopic dermatitis, the most common form of eczema, and how they found relief from their symptoms. Moore, who has eczema but doesn’t use Incyte’s Opzelura, discussed her motivation for participating in the campaign in a video she shared with her 5.5 million followers on Instagram. “I’m well aware of the impact it can have on your daily life. Sometimes I feel particularly self-conscious about it, especially when I’m at work. Luckily, my day job allows for it to get somewhat covered up but … I don’t think it ever really feels good to show up for work when you’re not feeling your best. So I ...
- Source: drugdu
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After FDA snub, Lilly’s mirikizumab looks to regain momentum with phase 3 Crohn’s win

After the FDA passed on an approval for mirikizumab in ulcerative colitis earlier this year because of manufacturing shortfalls, the Eli Lilly drug is gaining new momentum with a win in a phase 3 Crohn’s disease study. The interleukin-23p19 antagonist achieved both primary endpoints and all of its major secondary endpoints in the VIVID-1 study, Lilly said in a Thursday release. The trial results will serve as the basis of regulatory submissions in the disease next year, the company added. In the study, Lilly’s drug helped 54.1% of participants achieve clinical remission at week 52, compared with 19.6% for those on placebo. However, the drug couldn’t prove superiority in the endoscopic response measure when pitted against Johnson & Johnson’s star immunosuppressant Stelara (ustekinumab). Still, mirikizumab’s results were “numerically higher” than its J&J counterpart, Lilly said. Lilly will pursue approval in Crohn’s in 2024, when it will submit a marketing application ...
- Source: drugdu
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- October 13, 2023
Haemonetics inks $253M OpSens buyout, adding cardiology guidewires to portfolio

Dive Brief Haemonetics has struck a deal to buy the interventional cardiology company OpSens for around $253 million. OpSens sells two pressure-sensing guidewires for use in percutaneous coronary intervention (PCI) and transcatheter aortic valve replacement (TAVR) procedures. The devices helped OpSens generate sales of C$34.2 million ($25.2 million) over the first nine months of its current fiscal year. Analysts at Needham told investors the takeover is consistent with the M&A strategy outlined by management and will give Haemonetics devices that complement its vascular closure products. Dive Insight Haemonetics created its vascular closure business early in 2021 by acquiring Cardiva Medical for $510 million. On a quarterly results conference call in May, an analyst said the subsequent growth has been “phenomenal.” Haemonetics voiced an appetite for more deals on its next quarterly call, when CFO James D’Arecca set out plans to accelerate growth through M&A. D’Arecca and the rest of the ...
- Source: drugdu
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Specific navigational errors may indicate early signs of Alzheimer’s disease

People with early Alzheimer’s disease have difficulty turning when walking, according to a new study using virtual reality led by UCL researchers. The study, published in Current Biology, used a computational model to further explore the intricacies of navigational errors previously observed in Alzheimer’s disease. Researchers, led by Professor Neil Burgess and colleagues in the Space and Memory group* at the UCL Institute of Cognitive Neuroscience, grouped participants into three categories: healthy younger participants (31 total), healthy elderly participants (36 total) and patients with mild cognitive impairment (43 total). They then asked them to complete a task while wearing virtual reality goggles, which allowed them to make real movements. In the trial, participants walked an outbound route guided by numbered cones, consisting of two straight legs connected by a turn. They then had to return to their starting position unguided. The task was performed under three different environmental conditions aimed ...
- Source: drugdu
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Roche’s Subcutaneous Ocrevus Rivals IV Formulation in Phase III MS Trial

By Kate Goodwin Pictured: Roche Building in Pleasanton/iStock, JHVEPhoto Roche’s Genentech claimed victory for the subcutaneous formulation of its multiple sclerosis blockbuster Ocrevus on Wednesday, with plans to submit Phase III data for regulatory approval. In the OCARINA II study, twice-yearly, 10-minute subcutaneous injections of Ocrevus were pitted against the currently approved IV formulation for multiple sclerosis (MS). The subcutaneous dosing proved as effective in patients with relapsing or primary progressive MS over a 24-week period as the IV version on pharmacokinetic, biomarker and MRI measures. Ocrevus works by targeting and removing a type of B cells that attack the myelin covering around the brain and spinal cord nerve cells. In the Phase III study, the subcutaneous injection provided rapid and sustained B-cell depletion similar to the IV infusion—97% and 98%, respectively, had levels of 5 cells/µL or less at two weeks, which was sustained over 24 weeks. Both formulations ...
- Source: drugdu
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