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Biogen’s Aduhelm headache returns as appeals court revives part of investor lawsuit

For more than a year, Biogen has been working to turn the page from its Aduhelm fiasco and focus on its newer Eisai-partnered Alzheimer’s disease medicine Leqembi. But a new ruling from the U.S. Court of Appeals for the First Circuit will make that effort a little tougher. After Biogen last year won the dismissal of an investor lawsuit surrounding disclosures into its Aduhelm research, the appeals court has reversed the ruling—in part—by focusing on one statement made by Biogen’s former chief medical officer Al Sandrock. Specifically, the appeals court flagged Sandrock’s statement from the company’s second-quarter earnings call in 2020. During the call, Sandrock stated that “[Y]ou really need to get to the higher dose,” adding, “I think our data are all consistent with that.” The court dubbed this the “all data” statement and painstakingly broke down the context behind the remark. To refresh readers’ memory, Biogen in March ...
- Source: drugdu
- 134
- October 14, 2023
Lilly’s Mirikizumab Shows Long-Term Remission in Phase III Crohn’s Trial

By Kate Goodwin Pictured: Eli Lilly world headquarters/iStock, jetcityimage A 52-week study finds Eli Lilly’s mirikizumab to be effective for long-term remission in over half of patients with Crohn’s disease. The company announced Thursday plans to submit a marketing application to the FDA for approval in 2024, followed by submissions to other global regulatory agencies. In the Phase III trial, moderately to severely active Crohn’s disease patients on mirikizumab demonstrated clinical remission as well as endoscopic response at the one-year mark. Over 54% of the patients in the treatment arm achieved clinical remission at week 52, versus 19.6% of those receiving placebo. The endoscopic response was seen in 38% of those on mirikizumab versus 9% on placebo. Safety was consistent with the known profile of the therapy with the frequency of serious adverse events greater in the placebo arm than the treated group, according to Lilly. The interleukin-23p19 antagonist demonstrated ...
- Source: drugdu
- 109
- October 14, 2023
Biogen Lays Off 113 Reata Employees Weeks After Completing $7B Acquisition

By Tristan Manalac Pictured: Biogen sign/The Boston Globe via Getty, John Tlumacki Biogen is laying off 113 employees from Reata Pharmaceuticals’ Plano, Texas site, according to a Worker Adjustment and Retraining Notification notice. The layoffs, set to take effect in late November, come just months after Reata was acquired by Biogen for $7.3 billion in July 2023. At the time, Biogen had just launched a sweeping cost-reduction program which involved terminating around 1,000 employees in an effort to save $1 billion in operating expenses by 2025. Late last month, Biogen completed the acquisition of Reata. In an emailed statement to Endpoints News, a Biogen spokesperson confirmed the job cuts which will mostly affect “roles where there are existing synergies at Biogen.” The positions include general and administrative services, as well as some development-focused jobs. “We are retaining those colleagues who have been essential to the launch of Skyclarys to ensure ...
- Source: drugdu
- 224
- October 14, 2023
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
- 185
- 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
- 161
- 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
- 184
- 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
- 161
- October 14, 2023
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
- 185
- October 14, 2023
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
- 158
- October 14, 2023
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
- 114
- October 13, 2023

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