A recent physician survey found that 89% of neurologists in the U.S. have concerns about the efficacy of the controversial Alzheimer’s drug Aduhelm (aducanumab) from Biogen (Nasdaq:BIIB) and Eisai Co. (TYO:4523). Nearly as many — 87% — were concerned about the drug’s safety profile. The survey from the physician social media network Sermo (New York City) asked more than…
Athira Pharma to continue open-label Alzheimer’s extension studies
The biopharma Athira Pharma (Nasdaq: ATHA) has lengthened the current open-label extension (OLEX) study for its Phase 3 LIFT-AD and Phase 2 ACT-AD trials of fosgonimeton (ATH-1017, NDX-1017), hepatocyte growth factor receptor agonist, focused on mild-to-moderate Alzheimer’s disease. The Bothell, Washington–based company made the decision based on feedback from its independent data and safety monitoring…
Biogen CEO Michel Vounatsos to step aside as Aduhelm sales continue to sputter
With the blockbuster dreams of the Alzheimer’s drug Aduhelm (aducanumab) dashed for the foreseeable future, Biogen has announced that its CEO Michel Vounatsos will depart. Vounatsos began his tenure as CEO in 2017. Vounatsos’ plans to exit the company came out on the same day that Biogen reported Q1 adjusted earnings per share of $3.62,…
Why Janssen’s nipocalimab could represent a ‘pipeline in a pathway’
At the heart of Johnson & Johnson’s (NYSE:JNJ) $6.5 billion acquisition of Momenta Pharmaceuticals in 2020 is a portfolio of drug candidates for immune-mediated diseases. One of the promising compounds in the acquisition is nipocalimab, which Janssen sees as a potential “pipeline in a pathway.” Nipocalimab holds promise for an array of diseases, ranging from…
Biogen gives up seeking European approval for aducanumab
After winning FDA approval for the controversial Alzheimer’s drug Aduhelm (aducanumab) in June 2021, Biogen (Nasdaq:BIIB) has encountered a string of setbacks. Most recently, the company has decided to yank its applications for market approval after the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for Aduhelm in December 2021. At that…
Alzheimer’s group files FOIA request related to CMS decision on amyloid-targeting antibodies
UsAgainstAlzheimer’s, a nonprofit organization committed to stopping Alzheimer’s disease, is hoping to get more information related to CMS’s national coverage determination related to coverage for Aduhelm (aducanumab) from Biogen (Nasdaq:BIIB) and other monoclonal antibodies targeting amyloid to treat Alzheimer’s disease. The organization has filed a Freedom of Information Act (FOIA) request for information about the decision. UsAgainstAlzheimer’s…
Neuron23 names chief medical officer
The early-stage biotech Neuron23 has appointed Dr. Sam Jackson as its first chief medical officer. South San Francisco, California–based Neuron23 specializes in developing precision medicines for genetically-defined neurological and immunological diseases. Jackson is a board-certified emergency physician with fellowship training in medical toxicology. “I am thrilled to welcome Dr. Jackson to our growing Neuron23 leadership…
Eisai amends Aduhelm collaboration with Biogen
Aduhelm (aducanuamab) co-developer Eisai Co. (TYO:4523) has agreed to modify its economic partnership agreement with Biogen (Nasdaq:BIIB). Starting January 1, 2023, Eisai will receive a tiered royalty on net sales of the Alzheimer’s disease therapy Aduhelm (aducanumab) rather than share profits or losses of the drug. Eisai would receive between 2% and 8% of annual sales…
Biogen plays up spinal muscular atrophy pipeline
As Biogen Inc. (Nasdaq: BIIB) continues to struggle to capitalize on the Alzheimer’s drug Aduhelm (aducanumab), the company is highlighting new data from its Spinraza (nusinersen) and spinal muscular atrophy (SMA) research program. First approved in 2016, Spinraza is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated to treat spinal muscular atrophy (SMA). At the…
AbbVie and Gedeon Richter unveil neuropsychiatric alliance
AbbVie (NYSE:ABBV) and Gedeon Richter have formed a co-development and license agreement focused on novel dopamine receptor modulators with the potential to treat neuropsychiatric diseases. Lake Bluff, Illinois-headquartered AbbVie and Budapest, Hungary-based Gedeon Richter have already collaborated for 15 years in central nervous system projects, including the development of cariprazine (Vraylar/Reagila), which is now authorized to…
iQure Pharma says iQ-008 meets Rule of 5 for neuropathic pain
The biotech iQure Pharma Inc. has announced that the analgesic compound iQ-008 demonstrated efficacy in in vivo experiments. In particular, Wilmington, Delaware-based iQure announced that iQ-008 meets Lipinski’s rule of five criteria. Also known as Pfizer’s rule of five, the Rule of 5 (RO5) helps pharmaceutical companies determine whether a compound is druglike. Additionally, iQure…
AbbVie shares positive Phase 3 atogepant data to prevent chronic migraine
Gepants have gained ground in recent years as a migraine treatment following the FDA’s approval of Allergan’s Ubrelvy (ubrogepant) in 2019. Now, AbbVie (NYSE:ABBV) has announced that a Phase 3 study testing Qulipta (atogepant) met its primary endpoint of reducing mean monthly migraine days over placebo. FDA approved atogepant as a preventive treatment of episodic…
CODA Biotherapeutics appoints new chief scientific officer
South San Francisco, California–based biopharma CODA Biotherapeutics names Susan Catalano as chief scientific officer. Founded in 2014, CODA Biotherapeutics is working on a gene therapy-mediated chemogenetic platform for intractable neurological disorders. Catalano aims to help advance the company’s platform to find treatments for unmet neurological needs. “CODA’s combination of deep expertise in gene therapy and…
Scientists find new potential drug targets for neurodegenerative diseases
Researchers at Oregon State University (OSU) have discovered a new class of potential drug targets for diseases like Alzheimer’s, Parkinson’s and amyotrophic lateral sclerosis (ALS). The scientists are working to identify the best method to attack the targets — oxidized proteins. The most potent oxidant of the bunch is peroxynitrite, which is produced in conditions involving inflammation.…
QurAlis bolsters its executive team with three new leaders
Cambridge, Massachusetts–based biotech QurAlis Corp., has appointed Bryan Boggs as head of regulatory affairs. In addition, Christopher Gerry Lohan will join as head of clinical operations, and Guzide Adhikari will take on the role of head of global supply chain management. The company is focused on developing novel treatments for amyotrophic lateral sclerosis (ALS) and…
Biogen unveils FTC aducanumab probe
In its annual SEC report, Biogen reported that the Federal Trade Commission had sent the company a civil investigative demand related to the controversial Alzheimer’s drug aducanumab (Aduhelm). The company received a similar notice from the SEC. Lawmakers in the U.S. House of Representatives and the Office of Inspector General of HHS are also investigating…
Lily delays timeline for Alzheimer’s candidate donanemab amidst aducanumab chaos
Eli Lilly (NYSE:LLY) announced it planned to complete the application for donanemab, which received FDA’s Breakthrough Therapy designation as a potential Alzheimer’s treatment last summer. Lilly had initially planned on filing the application for donanemab in the first quarter of the year. LLY shares fell 2.40% to $244.81 after announcing the news. Medicare had announced…
Patient groups voice disapproval for CMS proposal to limit coverage of aducanumab
Biogen’s (NSDQ:BIIB) Alzheimer’s drug Aduhelm (aducanumab) continues to be a source of contention. Advocates cite the need for a new therapy for the memory-robbing disease while skeptics remain unconvinced about the benefit-risk profile of the drug. Most recently, Alzheimer’s disease advocates have criticized Medicare’s proposal to constrain coverage for the drug to clinical trial participants. The…
FDA places clinical hold on Denali Therapeutics’ IND for Alzheimer candidate DNL919
Denali Therapeutics (NASDAQ:DNLI) has announced that the FDA has placed a clinical hold on the Investigational New Drug (IND) application for DNL919. The large-molecule drug candidate targets TREM2 or triggering receptor expressed on myeloid cells 2. South San Francisco–based Denali said it received an email from FDA stating that the agency had placed the IND…
Medicare recommends covering aducanumab for clinical trial volunteers only
Demand for Biogen’s (NSDQ:BIIB) monoclonal antibody Aduhelm (aducanumab) has been weak, leading the company to cut the wholesale cost of the drug in half to $28,200 for patients of average weight. Now, Medicare officials reached a preliminary conclusion that federal coverage of the drug should be limited to clinical trial participants. The agency went further, stating that…
Japan appears to eye Alzheimer’s drug Aduhelm with skepticism
Japan could follow the lead of the European Medicines Agency, which recommended refusing the marketing authorization of the controversial drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (Tokyo). Japan’s First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council recommended further discussion of the application for the drug. The NDC also requested additional information as…
FDA expands indications of Caplyta to include bipolar depression
Intra-Cellular Therapies (NSDQ:ITCI) has announced that Caplyta (lumateperone) has become the only FDA-approved monotherapy for depressive episodes linked to bipolar I or II disorder (bipolar depression). The approval also covers its use as adjunctive therapy with lithium or valproate. Lumateperone was initially FDA approved in 2019 as an atypical antipsychotic for treating schizophrenia in adults.…
Biogen slashes Aduhelm cost in half
Biogen (NSDQ:BIIB) has announced that it is cutting the wholesale acquisition cost of the controversial Alzheimer’s drug Aduhelm (aducanumab) by roughly half. Starting January 1, 2022, the annual cost for a 100 mg/mL injection of the drug will be $28,200 for a patient who weighs 74 kg (163 pounds). In related news, the Committee for…
Could milk peptides treat central nervous system disorders?
Scientists found milk components that may treat central nervous system (CNS) conditions, including anxiety and depression. These are new generation compounds that showed promising results in preclinical studies, predicting the avoidance of side effects caused by anxiolytics and antidepressants found in pharmacies. Milk can indeed calm down many people — just think of the glasses…
Biogen’s eyeing layoffs as Aduhelm sales sputter: Report
As Biogen (NSDQ:BIIB) continues to struggle to market the controversial drug Aduhelm (aducanumab), the company is eyeing up to 1,000 layoffs, according to a report from STAT. Biogen did not immediately respond to a request for comment. Following FDA approval of the drug in June, BIIB shares soared to a record high. However, its stock has…