// Biotech and Pharma Therapeutics
Eisai and Biogen’s phase 3 Alzheimer’s win puts amyloid back in the driver’s seat, for now
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.
Aeon looks to phase 3 after Botox-like treatment hits midstage trial goals for rare muscle disorder
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.
A perfect storm: Europe’s generic industry weighs cuts to output amid energy crisis, pricing pressures and more
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.
Santen scores another FDA eye drop nod, this time in glaucoma and ocular hypertension
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.
MHRA raises concerns with switching between long-acting J&J, Novartis and Takeda drugs
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.
// 4th Industrial Revolution
A ‘disaster’, or a ‘clear path’ forward?: New FDA guidance on AI in medicine sparks strong reactions
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.
Hydrogel Injection Molding Offers Alternative to 3D Bioprinting
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.
New free software enables 3D image sharing in PACS
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.
7 innovative digital health offerings to treat diabetes
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.
DyAnsys’ neurostimulation device receives FDA clearance to treat post-cardiac surgery pain
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.
// Business & Markets
Novartis’ Sandoz sells Chinese finished drugs plant to CDMO Jiuzhou for $15.1M
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.
Ipsen doles out €52M to upgrade its Dublin manufacturing site, increase capacity
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.
Genentech pays $70M to access Arsenal’s armory of T-cell tools in quest for solid tumor 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.
GSK names Julie Brown, a 25-year AstraZeneca veteran, its first woman CFO
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.
Novartis wins on quantity, but Eli Lilly takes the cake on value of new launches: report
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.
// Legal & Regulatory
FDA slaps partial hold on Avidity’s lead program, docking dystrophy study over serious adverse event
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.
FDA advisory committee votes down Spectrum’s lung cancer hopeful in wake of efficacy concerns
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.
Eli Lilly hit with another age discrimination lawsuit—this time from a federal agency
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.
Biogen to pay $900M to settle lawsuit over MS drug outreach
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.
Nerviano Medical Sciences S.r.l. Announces Collaboration and Option to License Agreement with Merck
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.
// Research & Development
High blood pressure speeds up mental decline, but does not fully explain dementia disparities
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.
AstraZeneca dumps Ionis drug despite hit in phase 2 cholesterol trial
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.
In surprise result, Alzheimer’s drug from Eisai, Biogen shows benefit in large trial
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.
Researchers reveal SERCA2a as a molecular link between insulin resistance and early 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.
New Alzheimer’s drug slowed cognitive decline by 27%, study finds
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.
Russia plans to start use domestic reference materials in pharma sector
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.
Biden Medicare costs victory due mostly to Alzheimer’s drug change
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.
U.S. Senator Kaine discusses state of democracy, honors police officers who defended Capitol at Center for Politics event
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.
Biden Touts Medicare Premium Cut After Largest-Ever Increase
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.