// Biotech and Pharma Therapeutics

Eisai and Biogen’s phase 3 Alzheimer’s win puts amyloid back in the driver’s seat, for now
September 28, 2022 / Biogen / Eisai / Alzheimer’s / Iecanemab – And rightfully so (should the raw data ultimately match the press release’s version). The two pharma partners found that lecanemab slowed disease progression among patients with mild Alzheimer’s by 27% compared to patients given a placebo, with effects starting at six months and continuing through the remainder of the study. Alzheimer’s progression is measured using a cognitive scale that assesses six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Naturally, the biggest industry winners are the two companies developing the drug. But because of the breadth of the race to treat Alzheimer’s, they aren’t the only ones feeling the wind at their backs. The results also provide the most significant piece of validation yet for the hypothesis that targeting amyloid plaque buildups in the brain can stave off Alzheimer’s symptoms, with Eisai’s CEO writing in the company’s release that the results “prove” the hypothesis. Read Full Article on Fierce Biotech >>
Aeon looks to phase 3 after Botox-like treatment hits midstage trial goals for rare muscle disorder
September 23, 2022 / Migraine / Botox / FDA / Clinical Data – The botulinum toxin family of treatments may be best known for aesthetic applications like Botox, but companies have applied them more widely. In Aeon Biopharma’s case, its candidate ABP-450 hit its main goals in a phase 2 trial for a rare neck muscle disorder, setting the company up to launch a late-phase study next year. ABP-450, or prabotulinumtoxinA, is approved and marketed for cosmetic indications by Evolus under the name Jeuveau, but Aeon wants to know if the treatment holds potential in medical indications. The latest phase 2 results are for CD, a painful and rare neurologic condition that triggers neck muscles to contract involuntarily, but Aeon is also exploring ABP-450 as a treatment for neurological and gastroenterology conditions, according to a Sept. 23 release. Read Full Article on Fierce Biotech >>
A perfect storm: Europe’s generic industry weighs cuts to output amid energy crisis, pricing pressures and more
September 28, 2022 / European Union / Generic Drugs / Teva Pharmaceutical / Sandoz – A confluence of public health emergencies, armed conflict and historic pricing pressures is taking a toll on Europe’s supply of cheaper, off-patent medicines. In particular, soaring gas and electricity costs are threatening to upend certain manufacturers’ operations lest the EU intervene, the companies warned. Aside from the economic pressures inherent to Europe’s generic drugs industry, the COVID-19 pandemic and the war in Ukraine have presented a slew of new problems for manufacturers in the form of “dramatically increased” inflation, soaring raw material and transportation costs, and record-high energy prices, Medicines for Europe wrote (PDF) Tuesday in an open letter to the EU’s energy and health ministers.Read Full Article on Fierce Pharma >>
Santen scores another FDA eye drop nod, this time in glaucoma and ocular hypertension
September 27, 2022 / Santen Pharmaceutical / Glaucoma / Ophthalmic –For the second time in 15 months, Japanese ophthalmology specialist Santen has earned an FDA approval for its eye drops. The U.S. regulator has signed off on Santen’s Omlonti to reduce elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Santen developed the drug, otherwise known as omidenepag isopropyl ophthalmic solution, along with another century-old Japanese firm, UBE Industries of Tokyo. Read Full Article on Fierce Pharma >>
MHRA raises concerns with switching between long-acting J&J, Novartis and Takeda drugs
September 27, 2022 / Johnson & Johnson / Novartis / Takeda / MHRA – The U.K. drug regulator has told healthcare professionals to exercise caution when considering switching between long-acting attention-deficit/hyperactivity disorder (ADHD) therapies from companies including Johnson & Johnson, Novartis and Takeda. Multiple companies sell long-acting formulations of methylphenidate in the U.K. Branded products such as J&J’s Concerta XL, Novartis’ Ritalin XL and Takeda’s Equasym XL compete with generics for a share of the market, giving physicians the option of switching patients between similar formulations of the same active ingredient. Read Full Article on Fierce Pharma >>

// 4th Industrial Revolution

A ‘disaster’, or a ‘clear path’ forward?: New FDA guidance on AI in medicine sparks strong reactions
September 28, 2022 / FDA / AI in Medicine – New guidance from the Food and Drug Administration is triggering strong reaction from researchers and regulatory experts, who see it as an attempt to significantly expand the oversight of software tools used to guide clinical decisions. But they are sharply divided on whether that’s a much-needed change, or a dramatic overreach by regulators. Read Full Article on Stat News >>
Hydrogel Injection Molding Offers Alternative to 3D Bioprinting
September 28, 2022 / 3D Bioprinting / Bioprocessing / Cell Therapy –Hydrogel injection molding is a viable alternative to three-dimensional bioprinting, offering efficiency, scalability and reproducibility for even complex 3D cell-laden geometries and high-throughput cell product manufacturing. Time savings is a huge benefit, Jessica D. Weaver, PhD, assistant professor, Arizona State University, tells GEN. “Current extrusion-based systems generated a single 3D geometry in about five to 20 minutes…with up to another five minutes needed for set-up. In contrast, injection molding with a single mold takes one minute or less for a comparable geometry.” A robotics system could do that even faster. “We predict injection molding could be at least 5–20 times faster than current bioprinting methods.” Full Article on Gen Eng News >>
New free software enables 3D image sharing in PACS
September 28, 2022 / San Diego / 3D Patient Models / Patient Care –With Digital Imaging and Communications in Medicine standardization software, or DICOM, doctors can use the standard picture-archiving communication system imaging to import and export patients’ 3D models. Previously, 3D imaging was accessible only with specialized software. Media2DICOM, developed at Rady allows image technicians to either convert videos of patients’ 3D models or the 3D datasets themselves into standardized DICOM files. The files are then embedded within patient medical records and accessible through the healthcare facility’s PACS, where other patient media, such as computerized tomography and magnetic resonance imaging scans, are also available. Read Full Article on Health Care IT News >>
7 innovative digital health offerings to treat diabetes
September 28, 2022 / Digital Health / Diabetes / Tech –Advances in treatments for diabetes never stop coming. Whether that be in the form of insulin pumps or continuous glucose monitors, we’ve seen plenty. Moving away from the physical device, innovations in the digital diabetes space continue to impress. Digital therapeutics, artificial intelligence- and cloud-based offerings and more comprise an intriguing list of technologies. Here are seven digital offerings aimed at treating diabetes that you might want to keep an eye on: Read Full Article on Drug Delivery Business News >>
DyAnsys’ neurostimulation device receives FDA clearance to treat post-cardiac surgery pain September 27, 2022 / Digital Health / FDA / Cardiac Surgery – California-based DyAnsys, a medical device company specializing in the autonomous nervous system, has announced that Primary Relief, its percutaneous electrical nerve stimulator (PENS) system, received approval by the FDA to treat postoperative pain following cardiac surgery. According to DyAnsys, the PENS system can be used for up to three days following cardiac surgery and in a clinical trial reduced pain scores compared to a placebo device –and lessened the need for analgesics postoperatively. The company also notes fentanyl use by the Primary Relief group in the postoperative period was one-third of the control group. Read Full Article on Mobi Health News >>
Vision benefits company XP Health raises $17.1M and more digital health fundings September 28, 2022 / XP Health / Digital Health – XP Health, a company developing a digital-first vision benefits platform, raised $17.1 million in a Series A funding round led by HC9 Ventures, Valor Capital Group and ManchesterStory. Additional investors include Core Innovation Capital, GSR Ventures, Canvas Ventures, Plug and Play, CameronVC, Ken Goulet, Kevin Hill, Jeff Epstein and Brett Rochkind. This recent funding round followed a $5.5 million raise in 2021. “This round of funding enables us to strengthen the platform’s functionality and provide a stellar consumer experience in the most affordable way to employers, insurance carriers and employees,” Antonio Moraes, cofounder and CEO of XP Health, said in a statement. Read Full Article on Mobi Health News >>

// Business & Markets

Novartis’ Sandoz sells Chinese finished drugs plant to CDMO Jiuzhou for $15.1M
September 28, 2022 / Sandoz / Novartis / Plant Sale / China – Even as Novartis works to separate Sandoz, the Swiss parent hasn’t stopped making deals for the outgoing generics subsidiary. Chinese CDMO Jiuzhou Pharmaceutical said it plans to buy a Sandoz finished drugs plant in Zhongshan in southern China for $15.1 million, according to a securities filing (PDF, Chinese) to the Shanghai Stock Exchange. Read Full Article on Fierce Pharma >>
Ipsen doles out €52M to upgrade its Dublin manufacturing site, increase capacity
September 27, 2022 / Ipsen / Ireland / API / Manufacturing Facilities – Aiming to boost its presence in Ireland, Ipsen has spent 52 million euros to upgrade its Dublin manufacturing site. The expanded site in Blanchardstown will allow Ipsen to boost its production of active pharmaceutical ingredients by 10% this year compared with 2021. The company plans to invest 15 million euros more in the site between 2023 and 2026 as part of its growth strategy for the Irish market. Read Full Article on Fierce Pharma >>
Genentech pays $70M to access Arsenal’s armory of T-cell tools in quest for solid tumor CAR-T
September 27, 2022 / Roche / Genentech / Arsenal Biosciences / CAR-T – Puma Biotechnology has gone looking for gems in Takeda’s castoffs, emerging from its rummaging with an aurora kinase A inhibitor that failed a phase 3 trial in 2015 but has since moved the needle in another study. The biotech landed a global license for $7 million upfront plus up to $287.3 million in milestones. Read Full Article on Fierce Biotech >>
GSK names Julie Brown, a 25-year AstraZeneca veteran, its first woman CFO
September 26, 2022 / GSK / Emma Walmsley / Iain Mackay / Haleon – Five years ago, GSK made headlines when it hired Emma Walmsley to become the first woman to run a major pharmaceutical company. Now the Big Pharma has brought in another woman to control the company’s finances. Julie Brown will be GSK’s next chief financial officer. Brown, currently the chief operating and financial officer at fashion and beauty brand Burberry Group, is set to replace Iain Mackay. Read Full Article on Fierce Pharma >>
Novartis wins on quantity, but Eli Lilly takes the cake on value of new launches: report September 26, 2022 / Novartis / Eli Lilly / Mounjaro / Drug Launch – New drugs are a staple of the pharmaceutical industry and a key strategy for drugmakers to deliver long-term growth. But, according to a new report by Evaluate Vantage, quantity doesn’t always trump quality. While Novartis leads the Big Pharma pack with the most launches over the past five years, Eli Lilly’s new drugs have the most value, Evaluate Vantage reports. Novartis’ 14 new approvals over that timeline rank “thoroughly middle table” in terms of value, according to Evaluate’s analysis. On the flip side, Eli Lilly’s Mounjaro has the highest value of any new launch at $27.5 billion. Read Full Article on Fierce Pharma >>
With Lilly’s Mounjaro set for stardom, an Alzheimer’s win would be ‘icing on the cake’: analysts
September 23, 2022 / Eli Lilly / Mounjaro / Navo Nordisk / Wegovy – With Eli Lilly’s latest Type 2 diabetes launch and obesity hopeful in the running to become “the biggest drug ever,” an approval for donanemab—the company’s experimental antibody effort against Alzheimer’s disease—would simply be “icing on the cake” for investors. That’s according to analysts at UBS, who think Lilly’s dual GIP and GLP-1 receptor agonist tirzepatide, which was recently cleared by the FDA in diabetes as Mounjaro, could clinch a staggering $25 billion in peak sales. So far, AbbVie’s immunology stalwart Humira is the most lucrative drug in biopharma history. Read Full Article on Fierce Pharma >>

// Legal & Regulatory

FDA slaps partial hold on Avidity’s lead program, docking dystrophy study over serious adverse event
September 27, 2022 / Avidity Biosciences / FDA / Clinical Hold / Rare diseases –MARINA and its open-label extension are assessing the safety and tolerability of single and multiple ascending doses of AOC 1001 in adults with myotonic dystrophy type 1 (DM1). The candidate features an siRNA conjugated to an anti-TfR1 antibody, a design intended to mediate mRNA degradation in muscle cells. The single-ascending dose part of the study passed without any serious adverse events. However, as Avidity has moved from giving a single 1-mg/kg dose to multiple, larger doses, it has seen a serious adverse event. The event occurred among one of the 18 patients who received the 4-mg/kg dose, the middle of the three doses being tested in the multiple ascending dose stage of the study. Read on Fierce Biotech >>
FDA advisory committee votes down Spectrum’s lung cancer hopeful in wake of efficacy concerns
September 23, 2022 / FDA Advisory Committee / Spectrum Pharmaceuticals / FDA / NSCLC –After an almost yearlong wait, Spectrum Pharmaceuticals has received a pretty clear hint about whether the FDA will approve its lung cancer drug. Unfortunately, it’s unlikely to be the answer the company wants.The FDA’s Oncologic Drugs Advisory Committee (ODAC) met Thursday to review Spectrum’s oral tyrosine kinase inhibitor Pozenveo, also called poziotinib, for patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the human epidermal growth factor receptor exon 20 insertion mutation. Read on Fierce Biotech >>
Eli Lilly hit with another age discrimination lawsuit—this time from a federal agency
September 27, 2022 / Eli Lilly / Discrimination / Equal Employment Opportunity Commission / Litigation –Age discrimination lawsuits have been cropping up around the industry in recent years, and Eli Lilly is no stranger to such claims. Now, the company is defending against age discrimination allegations from a federal agency. In a new lawsuit, the U.S. Equal Employment Opportunity Commission (EEOC) says the company snubbed older workers for sales representative positions from April 2017 to 2021. Read on Fierce Pharma >>
Biogen to pay $900M to settle lawsuit over MS drug outreach
September 27, 2022 / Biogen / Lawsuit / MS Drug Outreach / Whistleblower – Biogen has agreed to pay $900 million to settle a whistleblower lawsuit accusing it of paying doctors to encourage them to prescribe its multiple sclerosis drugs, the U.S Department of Justice announced Monday. Between 2009 and 2014, Biogen paid hundreds of physicians for consulting advice and speaker training as well as meals and travel to Biogen events — payments that were alleged to be illegal kickbacks. Read on Biopharma Drive >>
Nerviano Medical Sciences S.r.l. Announces Collaboration and Option to License Agreement with Merck
September 21, 2022 / Nerviano / License Agreement – NMS-293 is an orally available PARP1 inhibitor, designed to be more PARP1 selective and brain penetrant compared to first generation PARP inhibitors. With its expected lower hematological side effect profile, it has the expected features for potential use not only as single agent but also in combination with DNA-damage accumulating agents in a wide range of tumors. NMS-293 is currently in early clinical development for the treatment of patients with BRCA mutated tumors as single agent and with recurrent Glioblastoma (GBM), a brain tumor with very high medical need, in combination with temozolomide (TMZ). Read on BioSpace >>
Seagen’s Tukysa picks up FDA priority review after Merck buyout talks said to sputter
September 20, 2022 / Seagen / Tukysa / Herceptin / Metastatic Colorectal Cancer – Seagen’s Tukysa has snagged a priority review alongside Roche’s Herceptin for adults with previously treated HER2-positive colorectal cancer, the company said Monday. The speedy regulatory tag comes a little more than two months after Seagen unveiled full results on the Tukysa-Herceptin combo from its pivotal phase 2 Mountaineer trial at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer. Read on Fierce Pharma >>
Facing ‘imminent’ Gilenya generics and a $300M sales hit, Novartis takes patent fight to Supreme Court
September 20, 2022 / Novartis / Gilenya / Patent Litigation / US Supreme Court – Back in June, the appeals court overturned a prior decision in favor of the Swiss drug giant. In doing so, the court sided with Chinese generics maker HEC Pharma and found a patent on the multiple sclerosis drug is invalid, opening the prospect of early competition. Since Gilenya is Novartis’ third biggest drug by sales, the decision carries real commercial weight. If generics launch this year, Novartis expects a $300 million hit to its 2022 revenue guidance, the company said Wednesday. Novartis’ effort to petition the Supreme Court could take several months, the company said. Read on Fierce Pharma >>

// Research & Development

High blood pressure speeds up mental decline, but does not fully explain dementia disparities
September 28, 2022 / Dementia / High Blood Pressure – The researchers traced high blood pressure’s association with declining brain function over years, in data from six large studies that they pooled and analyzed. They show that blood pressure-related cognitive decline happens at the same pace in people of Hispanic heritage as in non-Hispanic white people. The team had set out to see if differences in long-term blood pressure control explained why Hispanic people face a 50% higher overall risk of dementia by the end of their life than non-Hispanic white people in the United States. Read Full Article on Medical Press >>
AstraZeneca dumps Ionis drug despite hit in phase 2 cholesterol trial
September 23, 2022 / AstraZeneca / Ionis Pharmaceuticals / Cholesterol Drug / Clinical Trial Data – Ionis designed the antisense therapy ION449 to reduce plasma levels of PCSK9 and, by extension, lower low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia. AstraZeneca, having licensed the asset in 2015, put the hypothesis to the test in the phase 2b SOLANO clinical trial. The study randomized 411 people to receive subcutaneous doses of ION449, also known as AZD8233, or placebo once a month. ION449 achieved a 62.3% reduction in LDL-C after 28 weeks compared to placebo, causing the study to hit its primary endpoint with a p-value of 0.001. However, the results fell short of AstraZeneca’s efficacy criteria. As such, the Big Pharma opted against moving the drug candidate into phase 3. Read Full Article on Fierce Biotech >>
In surprise result, Alzheimer’s drug from Eisai, Biogen shows benefit in large trial
September 27, 2022 / Alzheimer’s / Eisai / Lecanemab – An experimental Alzheimer’s disease drug developed by Eisai and Biogen succeeded in a large Phase 3 trial, raising its chances for regulatory approval and boosting a long-running hypothesis about how to treat the most common cause of dementia. Trial results showed treatment with the drug, called lecanemab, slowed clinical decline by 27% compared to a placebo over an 18-month period, the companies said in a Tuesday statement. Alzheimer’s symptoms were measured on a commonly used rating scale that assesses cognitive and functional performance. Read Full Article on Biopharma Dive >>
Researchers reveal SERCA2a as a molecular link between insulin resistance and early diabetic cardiomyopathy
September 28, 2022 / SERCA2a / Diabetic / Cardiomyopathy – Diabetic cardiomyopathy (DCM) is a progressive complication associated with type 2 diabetes (T2D), causing deterioration of cardiac function in diabetic patients, independent of coronary artery disease, and hypertension. It is possible for DCM to appear at the onset of diabetes, and can progress to heat failure. DCM is a complex disorder triggered by multiple factors, such as glucose and lipid toxicity, oxidative stress, and ionic disturbances. Previous studies have shown abnormalities in cardiomyocyte calcium ion homeostasis in DCM; however, the underlying mechanism of its occurrence as well as its role in the pathogenesis of DCM is not yet clear. Sarcoplasmic reticulum/endoplasmic reticulum ATPase 2a (SERCA2a) is a calcium pump for calcium ion recycling in the sarcoplasmic reticulum in cardiomyocytes. It transports calcium ions from the cytosol to the lumen of the sarcoplasmic Read Full Article on Medical Press >>
New Alzheimer’s drug slowed cognitive decline by 27%, study finds
September 28, 2022 / Alzheimer’s / New Drug / New Study – Similar to Aduhelm, Alzheimer’s drug lecanemab reduces abnormal clumps of beta amyloid, proteins that are typically a sign of Alzheimer’s disease. According to a press release, the study—called CLARITY-AD—enrolled 1,795 patients with mild cognitive impairment caused by Alzheimer’s disease, or early-stage Alzheimer’s. Roughly a quarter of the participants were Hispanic and African American. The patients were then tested using the Clinical Dementia Rating sum of boxes (CDR-SB), which measures six domains of cognitive decline with a score ranging from zero to 18, with a higher score meaning more severe cognitive decline. Read Full Article on Advisory Board >>

// Politics

Russia plans to start use domestic reference materials in pharma sector
September 28, 2022 / Russia / Pharma – The Russian Parliament (State Duma) has said it will consider establishing the priority of using domestic reference materials in the pharmaceutical industry. Currently local pharmaceutical manufacturers use such samples to control the quality of drug batches. Now most of the players continue to use the products of the US and European Pharmacopoeias, imported through third countries, however there is a possibility such a situation will change already… Read Full Article on The Pharma Letter >>
Biden Medicare costs victory due mostly to Alzheimer’s drug change
September 27, 2022 / Biden / Medicare / Alzheimers – U.S. President Joe Biden claimed victory on Tuesday for a drop in costs for tens of millions of Americans covered by the Medicare health program, though it is primarily due to a decision to severely limit coverage of an expensive, new Alzheimer’s drug. Biden highlighted a drop in premiums next year for the first time in over a decade for Medicare Part B, which among other things covers doctor and hospital visits as well as drugs they administer. He said the result will be a saving of more than $60 a year per beneficiary. “It’s going to be a godsend for many families,” Biden told healthcare advocates in a White House Rose Garden event. Read Full Article on Reuters >>
U.S. Senator Kaine discusses state of democracy, honors police officers who defended Capitol at Center for Politics event September 23, 2022 / US Senator Kaine / State of Democracy – The Center for Politics held a conference Friday to discuss the state of democracy five years after the events of Aug. 11 and 12, 2017 and one year after the insurrection at the U.S. Capitol. U.S. Sen. Tim Kaine (D-Va), shared his thoughts on faith and threats to democracy before honoring U.S. Capitol and D.C. Metropolitan police officers who received the first-ever Defender of Democracy awards. The first event, “Religion, Secularity and Public Life,” began at 11 a.m. in Old Cabell Hall and concluded the six-year Religion and Publics Project, which was funded by the Henry Luce Foundation. About 75 individuals attended the event. Read Full Article on The Cavalier Daily
Biden Touts Medicare Premium Cut After Largest-Ever Increase September 27, 2022 / Biden / Medicare / White House – President Joe Biden hailed a drop in premiums for the elderly and disabled on Medicare and lashed out at Republicans for opposing measures he said would also ease the burden on American families. Speaking at the White House on Tuesday, Biden said the premium cut shows his administration is reducing costs for health-care services, even though last year’s payments were inflated due to costs associated with a new Alzheimer’s drug. “For years, that fee has gone up — now for the first time in more than a decade it’s going to go down for millions of seniors and people with disabilities on Medicare,” Biden said. “That means more money in their pockets while still getting the care they need.” Read Full Article on Bloomberg Law >>