Target to $96 from $86
Thursday, September 9, 2021
AstraZeneca Says Imfinzi-Tremelimumab Combo Improves Lung Cancer Survival
AstraZeneca PLC said Thursday that the combination of its Imfinzi immunotherapy with tremelimumab antibodies improved survival in lung cancer patients.
The pharmaceutical company said Imfinzi and tremelimumab with chemotherapy improved overall survival by 23% in 1st-line Stage IV non-small cell lung cancer at a Phase 3 trial.
"Adding a short course of tremelimumab to Imfinzi for those patients already receiving chemotherapy, reduced the risk of cancer progressing or death by 28% compared to chemotherapy alone," said Susan Galbraith, AstraZeneca's executive vice president at Oncology R&D.
Biogen Giving Out Free Doses of Alzheimer’s Drug Aduhelm
Biogen is reportedly offering free doses of its Alzheimer’s drug, Aduhelm (aducanumab). According to a Reuters report, the company sent the medication to a Florida neurology clinic free of charge.
A neurologist at Florida’s First Choice Neurology, Jeffrey Gelblum, said, “We have been using the Biogen access program — it is almost like a sample program — to get patients started.”
The drug, which was approved by the U.S. Food and Drug Administration (FDA) on June 7, has been mired in controversy ever since. It was authorized against the recommendation of its own Peripheral and Central Nervous System Drugs Advisory Committee, which voted against recommending it in November 2020. Three members of the panel resigned in protest.
The FDA also utilized an Accelerated Approval pathway, which requires follow-up studies for continued approval, and based it on a surrogate endpoint, clearance of beta-amyloid, instead of relief of symptoms. The advisory committee had asked if the agency planned on using surrogate endpoints and was told the agency did not expect to do so.
In addition, the drug has a price tag of approximately $56,000 per patient per year. While it is nowhere near being the most expensive drug on the market, the number of Alzheimer’s patients in the U.S. exceeds 3 million. Although Biogen and the FDA have since modified the drug’s label to early-stage disease, it is still an expensive prescription for a large population of patients, most of which would be on Medicare.
The Centers for Medicare & Medicaid Services (CMS) is still reviewing their pricing strategy for the drug.
Drug companies often offer free medications via patient assistant programs, “however, we have never heard of that for an injectable, infused drug,” Steven Lucio, Vice President of Vizient Inc., which partners with about half of U.S. hospitals to buy drugs, told Reuters.
The uptake of Aduhelm has been slow. Many, including the Veterans Health Administration (VHA) argue that there isn’t enough evidence of clinical benefit to justify widespread use. In addition, several insurers, such as UnitedHealth Group Inc., which is the largest private insurer supplying Medicare Advantage to seniors, indicated they are waiting for more information from Medicare.
“Mainly because of the uncertainty around insurance coverage … most doctors and systems are in a holding pattern,” said Anton Porsteinsson, director of the University of Rochester Alzheimer’s Disease Care, Research and Education Program. Porsteinsson’s facility is only using the drug in the context of clinical trials.
A Morgan Stanley survey of 78 neurologists indicated about half were willing to prescribe Aduhelm, but almost two-thirds said the FDA should not have approved the drug. Only eight of the survey participants had recommended it, with six reporting Medicare claims had been paid as of early August.
In the case of Florida’s First Choice, it has treated more than 30 patients with the drug, but only the first doses of two of those patients have been charged to Medicare. The first and second doses for the other patients came from the Biogen free program. Gelblum also said Medicare had reimbursed the clinic for the infusion aspect of claims but not for the drug itself. He does expect that to occur, though, in the next few weeks.
The Medicare review is expected to have a proposed decision by the end of the year and a final decision three months after. At this time, coverage is decided at the local level by Medicare administrative contracts, which have 12 jurisdictions across the country.
https://www.biospace.com/article/biogen-giving-out-free-doses-of-alzheimer-s-drug-aduhelm/
Centessa: Positive Topline Data in Study of SerpinPC in Severe Hemophilia
~ 88% reduction in median Annualized Bleeding Rate (ABR) for all bleeds and 94% reduction in median ABR for spontaneous joint bleeds in highest dose tested ~
~ SerpinPC observed to be well-tolerated ~
~ Company has initiated planning for global registrational program ~
~ Conference call and webcast scheduled for today at 8:30 a.m. EDT ~
Centessa Pharmaceuticals plc (“Company”) (Nasdaq: CNTA), together with subsidiary ApcinteX Limited (“ApcinteX”), today announced positive topline results from the Phase 2a part of AP-0101, the six-month repeat dose portion of its ongoing first-in-human proof-of-concept study evaluating SerpinPC in severe hemophilia A and B patients.
AP-0101 is a Phase 1/2a proof-of-concept study evaluating SerpinPC, an inhibitor of activated protein C (“APC”), in 23 male subjects with either severe hemophilia A or B who were not on prophylaxis.1 The Phase 2a part of the study assessed the safety, tolerability and pharmacokinetics across three dose cohorts (0.3 mg/kg, 0.6 mg/kg and 1.2 mg/kg) of SerpinPC administered as a subcutaneous (SC) injection every 4 weeks over a 24-week period (6 total doses). Reduction in the annualized bleeding rates (ABRs) were exploratory outcomes. Although eligible, none of the patients in the study had inhibitors.
SerpinPC was well-tolerated. As previously disclosed, one subject with a history of a skin disorder discontinued treatment on SerpinPC due to an injection site reaction. No other SerpinPC-related adverse events have been recorded. There was no reported sustained elevation in D-dimer, a sensitive measure of excess thrombin generation, throughout the 24-week study. Two subjects had anti-drug antibodies and remained on treatment without apparent impact on ABRs.
Conference Call and Webcast
Centessa Pharmaceuticals will host a webcast and conference call today, September 9, 2021, at 8:30 a.m. EDT to discuss topline data from the proof-of-concept trial. To access the audio webcast with slides, please visit the "Events & Publications" page in the Investors & Media section of the Company's website at https://investors.centessa.com/events-presentations. The call can also be accessed by dialing (855) 493-3565 (domestic) or (929) 517-9002 (international) with conference ID 8459296. An archive of today's webcast will be available on the Company’s website.
https://finance.yahoo.com/news/centessa-pharmaceuticals-announces-positive-topline-113000369.html
Lilly Inks Another RNA Collab, This Time With ProQR
Eli Lilly And Co (NYSE: LLY) is doubling down on RNA research as it pens another pact with a quiet RNA editing player focused on neuroscience, ProQR Therapeutics N.V. (NASDAQ: PRQR).
In May, Lilly teamed up with MiNA Therapeutics to tap its small activating RNA (saRNA) technology platform for up to five targets.
ProQR will receive an upfront payment of $20 million and an equity investment of $30 million, with up to $1.25 billion as milestone payments for five targets using its RNA platform.
ProQR’s oligonucleotide platform, dubbed Axiomer, recruits “endogenous” enzymes in the cell, called ADARs, to attach to target RNA and induce adenosine to inosine base switch.
This approach can potentially reverse more than 20,000 G to A mutations known to cause human disease.
FDA declines Humanigen Emergency Use Authorization for Lenzilumab in Hospitalized COVID
FDA has committed to working with Humanigen in the development of lenzilumab and has invited Humanigen to submit additional data as it becomes available
NIH’s ACTIV-5/BET-B study is expected to provide further data that may support a new EUA request
Humanigen remains committed to completing regulatory processes underway seeking Marketing Authorization for lenzilumab to treat hospitalized COVID-19 patients in the U.K. and other territories
Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ announced today the U.S. FDA has declined its request for emergency use authorization of lenzilumab to treat newly hospitalized COVID-19 patients. In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19.
"We remain committed to bringing lenzilumab to patients hospitalized with COVID-19," said Cameron Durrant, MD, Chief Executive Officer, Humanigen. "We believe the ongoing ACTIV-5/BET-B trial, which has been advanced to enroll up to 500 patients, may provide additional safety and efficacy data sufficient to support our efforts to obtain an EUA to treat hospitalized COVID-19 patients."
https://finance.yahoo.com/news/fda-declined-humanigen-emergency-authorization-041600134.html
Walgreens Boots, VillageMD Open 18 Village Medical At Walgreens In Phoenix Area
Walgreens Boots Alliance (WBA) and VillageMD announced Wednesday the opening of 18 Village Medical at Walgreens locations in the Phoenix area with plans to open four additional locations by end of this year.
Through the Walgreens and VillageMD integrated care model, patients are able to receive comprehensive primary care alongside convenient and cost-effective pharmacy services.
In Arizona, chronic diseases such as heart disease, cancer, lung disease, stroke, diabetes and liver disease are responsible for seven out of 10 deaths among Arizonans each year.
Village Medical primary care physicians and Walgreens pharmacists work together to provide care for chronic conditions, as well as everyday illnesses and injuries.
Village Medical at Walgreens locations also provide access to COVID-19 testing and vaccinations through the Walgreens pharmacy, in addition to increased access to neighborhood primary care providers, via in-person or telehealth visits.
The 22 Village Medical at Walgreens locations in Arizona will create more than 800 jobs within the community. Village Medical will employ nearly 500 STEM (Science, Technology, Engineering, and Mathematics) well-compensated professionals.
Village Medical at Walgreens locations accept a wide range of health insurance options. Patients may access care and support through in-person, at-home and telehealth visits.
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