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…
U.S. insurers hesitant to cover aducanumab
Health insurers in the U.S. are seeking more data from Biogen regarding its $56,000-per-year Alzheimer’s treatment Aduhelm (aducanumab) before agreeing to pay for the treatment, according to Bloomberg. None of the 25 large insurers that took part in a Bloomberg News survey found that the drug was “medically necessary.” Humana Inc. is, however, covering Aduhelm…
Small Pharma Inc. plans Phase 2b trial of DMT for depression
Small Pharma Inc. (TSXV:DMT) is prepping a Phase 2b clinical study to test the use of its lead candidate, SPL026, an N, N-dimethyltryptamine (DMT) in treating major depressive disorder (MDD). DMT is present in Ayahuasca, a South American psychedelic brew. The company has announced that it has had positive discussions with FDA regarding the planned…
EMA gives thumbs down to Biogen’s Alzheimer’s drug aducanumab
Biogen (NSDQ:BIIB) and Eisai Co., Ltd. (Tokyo, Japan) have announced that the European Medicines Agency (EMA) has given its marketing authorization application for Aduhelm (aducanumab) a “negative trend vote.” The Committee for Medicinal Products for Human Use (CHMP) with the EMA will likely adopt a formal opinion on the application during meetings scheduled for December…
Athira Pharma shares update on its ACT-AD and LIFT-AD studies of Alzheimer’s candidate ATH-1017
Athira Pharma (NSDQ:ATHA) announced that its lead development candidate, ATH-1017, had balanced baseline characteristics to date in two ongoing late-stage Alzheimer’s studies. Presenting the data at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference in Boston, the company’s chief medical officer Dr. Hans Moebius said that the baseline characteristics are consistent between the ACT-AD…
Athira Pharma CEO steps down in the wake of research misconduct allegations
Shares of Athira Pharma (NSDQ:ATHA) jumped 9.35% in mid-day trading after the company announced the resignation of embattled CEO Leen Kawas. Kawas will also give up her seat on the Bothell, Washington–based company’s board. Facing allegations that she doctored a series of images in research papers, Leen Kawas was placed on leave in June. Several…
Biogen misses on Q3 revenues, posts Street-beating EPS
Biogen (NSDQ:BIIB) shares ticked up today on third-quarter results that were mixed compared to the consensus forecast. The Cambridge, Massachusetts-based company posted profits of $329.2 million, or $2.22 per share, on sales of $2.2 billion for the three months ended Sept. 30, 2021, for a -53.1% bottom-line slide on a sales decline of -18%. Adjusted…
Aduhelm sales sputter in Q3
While sales of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) could increase if CMS decides to back the drug, few patients are currently receiving the therapy. Approved in June under FDA’s accelerated review pathway, the drug has generated $2 million in sales to date. Of that sum, $300,000 came from the third quarter. Analysts had expected the…
Roche’s amyloid-targeting gantenerumab wins breakthrough therapy designation for Azheimer’s
Roche (OTCQX: RHHBY) has announced that its investigational anti-amyloid beta antibody gantenerumab for Alzheimer’s disease received breakthrough therapy designation from FDA. The agency has granted the status to a range of investigational Alzheimer’s, including lecanemab from Eisai and Biogen and donanemab from Eli Lilly. Biogen’s aducanumab had also received the designation before FDA approved it in…
Voyager Therapeutics’ stock jumps 57% following Pfizer licensing deal
The gene therapy company Voyager Therapeutics, Inc. (NSDQ: VYGR) has reached an agreement with Pfizer (NYSE:PFE) to license novel capsids from its RNA-driven TRACER screening technology. A capsid refers to the protein shell of a virus protecting its genome. “We believe that our TRACER platform has the ability to produce not only enhanced blood-brain-barrier penetrant…
AbbVie’s migraine drug Qulipta wins FDA nod as a preventive migraine treatment
Qulipta (atogepant) from AbbVie (NYSE:ABBV) has become the first calcitonin gene-related peptide (CGRP) agonist to win FDA approval for the preventive treatment of migraine headaches. In recent years, the agency has approved two related drugs, Ubrelvy (ubrogepant) from AbbVie subsidiary Allergan (NYSE:ABBV) and Nurtec ODT (rimegepant sulfate) from Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN). Both…
Cassava Sciences reveals top-line results from Alzheimer’s trial interim analysis
Cassava Sciences (NSDQ:SAVA) announced that its experimental Alzheimer’s drug simufilam was associated with an improved cognition score at 12 months. Specifically, recipients of the drug showed a 3.2 point improvement on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) from baseline to month 12. Austin, Texas–based Cassava also announced that 68% of study participants demonstrated improved…
Why Impel NeuroPharma is targeting the migraine market
The analgesic dihydroergotamine (DHE) has perhaps the longest track record of any effective migraine medicine. Seattle-based Impel NeuroPharma (NSDQ:IMPL) aims to reestablish DHE as a cornerstone of acute migraine treatment following the FDA approval of Trudhesa, a DHE nasal spray. Trudhesa uses the company’s Precision Olfactory Delivery (POD) that delivers the drug to the vasculature…
European regulators offer positive opinion on Janssen’s schizophrenia treatment
Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion. The committee recommended using long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia. The recommendation…
Amylyx Pharmaceuticals preps NDA filing for ALS drug AMX0035
Cambridge, Massachusetts–based Amylyx Pharmaceuticals intends to submit a New Drug Application (NDA) to FDA for AMX0035 (sodium phenylbutyrate and taurursodiol) to treat amyotrophic lateral sclerosis (ALS), which is also known as Lou Gehrig’s disease. The company decided to file after a series of meetings with the FDA, including a pre-NDA meeting on July 15. AMX0035…
QurAlis selects development candidate for ALS
Privately-held biotech QurAlis plans to begin clinical development for the first-in-class molecule QRL-201 for amyotrophic lateral sclerosis (ALS) in the second half of 2022. QRL-201 is now the subject of IND-enabling studies. The drug candidate targets the restoration of STATHMIN-2 (STMN2) expression in ALS. STMN2 is a protein encoded by the STMN2 gene that is involved in…
Report: Congressional committees have questions over Biogen’s Alzheimer’s drug
The FDA’s relationship with Biogen is under scrutiny following the controversial approval granted to the company’s Aduhelm Alzheimer’s drug. According to a report from Endpoints News, the House Energy & Commerce and Oversight committee chairs issued a letter this week requesting that acting FDA Commissioner Dr. Janet Woodcock and the FDA provide very specific information by…