Newsletter – Life Sciences Voice https://lifescivoice.com Life Sciences Voice | The leading resource for life sciences industry executives. Tue, 20 May 2025 22:45:56 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.1 https://lifescivoice.com/wp-content/uploads/2020/01/Life-Sciences-Voice-Favicon-favicon.ico Newsletter – Life Sciences Voice https://lifescivoice.com 32 32 Life Sciences Voice Top Five Newsletter https://lifescivoice.com/life-sciences-voice-top-five-newsletter-40/ Tue, 20 May 2025 22:36:59 +0000 https://lifescivoice.com/?p=10818 Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re looking at Eli Lilly’s $250 million investment in Purdue University, FDA’s decision to halt chikungunya vaccine in adults, the first-ever FDA-approved at-home cervical cancer screening kit, and more. Stay informed and inspired by the innovations driving life sciences forward!

Eli Lilly Expands Purdue Partnership with $250 Million Investment

Eli Lilly will invest up to $250 million through 2032 to expand its partnership with Purdue University. The collaboration focuses on AI-driven drug discovery, clinical trials, regulatory and manufacturing efficiency, and workforce development in Indiana’s life sciences sector. Purdue researchers will work on campus in West Lafayette and with Lilly scientists in Indianapolis and Lebanon. The partnership builds on previous agreements totaling over $100 million since 2017 and includes ongoing initiatives like the Lilly Scholars program and the Young Institute Pharmaceutical Manufacturing Consortium, which targets advancements in drug production technologies.

U.S. Recommends Suspension of Ixchiq Vaccine Use in Older Adults Amid Safety Review

The FDA and CDC have advised pausing the use of Valneva’s chikungunya vaccine, Ixchiq, in individuals aged 60 and older while investigations into serious adverse events (SAEs) continue. This follows similar actions by France and the European Medicines Agency, which cited 17 SAEs, including two deaths, in vaccine recipients aged 62 to 89. The CDC previously recommended caution for those 65 and older. Valneva, which has distributed over 40,000 doses globally, stated that most reported events involved older adults with pre-existing conditions and confirmed ongoing coordination with global health authorities.

FDA Approves First At-Home HPV Self-Collection Kit for Cervical Cancer Screening

The U.S. FDA has approved the Teal Wand, the first at-home prescription kit for HPV screening and cervical cancer risk assessment. Developed by Teal Health, the device uses a spongelike swab for self-collection without a speculum. Samples are mailed to a lab and tested using standard Pap smear methods. A study of over 600 participants found accuracy comparable to clinician-collected samples, with 94% preferring at-home screening. The device is for women aged 25 to 65 at average risk and will launch in California via Teal Health’s telehealth platform in June, with national expansion to follow.

Abeona Therapeutics Sells Priority Review Voucher for $155 Million After FDA Approval of Zevaskyn

Abeona Therapeutics sold a Priority Review Voucher (PRV) for $155 million shortly after receiving FDA approval for Zevaskyn, its gene therapy for recessive dystrophic epidermolysis bullosa (RDEB). The buyer was not disclosed. Zevaskyn, a one-time autologous cell-based therapy, is applied as a sheet to wounds to promote healing and reduce pain. Abeona plans a phased commercial launch in Q3 2025, initially treating 10 to 15 patients. Proceeds from the PRV sale are expected to fund operations for over two years. The transaction comes amid regulatory uncertainty and limited capital-raising options due to a depressed stock price.

Johnson & Johnson’s Gene Therapy for XLRP Falls Short in Phase 3 Trial

Johnson & Johnson’s gene therapy botaretigene sparoparvovec (bota-vec) did not meet its primary goal of improving vision-guided mobility in a phase 3 trial for X-linked retinitis pigmentosa (XLRP), a rare genetic eye disease. The LUMEOS study involved 95 participants, with 58 receiving a single injection of bota-vec. While secondary endpoints, such as patient-reported vision and letter chart assessments, showed improvement, the results lacked statistical significance. All treated participants experienced adverse events, with 53% linked to the therapy. Johnson & Johnson, which acquired full rights to bota-vec in a $415 million deal in December 2023, is evaluating its next steps.

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Life Sciences Voice Top Five Newsletter https://lifescivoice.com/life-sciences-voice-top-five-newsletter-39/ Tue, 29 Apr 2025 17:22:11 +0000 https://lifescivoice.com/?p=10725 Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re taking a look at Roche’s $50 billion injection into the US pharma production scene, Biolinq’s efforts in expanding and commercializing its glucose biosensor, FDA’s clearance for Click Therapeutics’ digital migraine prevention tool, and other top news! Stay informed and inspired by the innovations driving life sciences forward!

FDA Authorizes Click Therapeutics’ CT-132 for Migraine Prevention

The U.S. FDA authorized CT-132, a prescription digital therapeutic from Click Therapeutics, for the prevention of episodic migraines. Delivered via smartphone app, CT-132 showed reductions in monthly migraine days in a randomized, sham-controlled clinical trial and improved migraine-related quality of life. Approval came through the FDA’s de novo pathway, confirming its clinical validity. CT-132 addresses brain hypersensitivity by modifying behavioral responses to triggers and shows benefits even in patients using CGRP inhibitors. This marks Click’s first neurological and pain-focused approval. The company recently completed a Series C funding round led by Dassault Systèmes and its subsidiary, Medidata Solutions.

Orforglipron Matches Injectable GLP-1 Therapy in Phase 3 Diabetes Trial

Eli Lilly’s oral GLP-1 receptor agonist, orforglipron, met its primary efficacy endpoint in a 40-week Phase 3 trial, demonstrating A1C reductions of 1.3% to 1.6% compared to 0.1% for placebo. Weight loss ranged from 4.7% to 7.9%, with the highest dose group losing an average of 7.3 kg. Results were comparable to those seen with Novo Nordisk’s injectable semaglutide. Reported adverse events included diarrhea (up to 26%), nausea (18%), and indigestion (20%). This Phase 3 trial is part of a broader clinical program, with obesity trial results expected in late 2025 and regulatory submissions planned for obesity and Type 2 diabetes.

GSK’s Blenrep Gains U.K. Approval for New Multiple Myeloma Combinations

The U.K.’s MHRA approved GSK’s antibody-drug conjugate Blenrep (belantamab mafodotin) in combination with either bortezomib and dexamethasone or pomalidomide and dexamethasone for adults with relapsed or refractory multiple myeloma after at least one prior therapy. The approval is based on late-stage clinical trials showing improvements in progression-free and, in some cases, overall survival compared to standard care. Blenrep was previously withdrawn globally in 2022 after failing to outperform existing therapies as a monotherapy. Regulatory reviews for the new combinations are ongoing in 14 other countries, with GSK anticipating additional approvals later in 2025.

Roche Announces $50 Billion U.S. Investment Amid Trade Policy Shifts

Roche announced a $50 billion investment over five years to expand U.S. drug production facilities and build new ones focused on obesity medications, gene therapies, and glucose monitoring devices. The plan includes a gene therapy site in Pennsylvania, an AI research center in Massachusetts, and upgrades to facilities in Kentucky, Indiana, New Jersey, Oregon, Arizona, and California. This move comes as U.S. trade policies threaten global commerce, prompting Roche and peers like Johnson & Johnson and Eli Lilly to collectively pledge over $160 billion in U.S. manufacturing. Roche’s expansion also seeks to establish a drug export surplus.

 

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Life Sciences Voice Top Five Newsletter https://lifescivoice.com/life-sciences-voice-top-five-newsletter-38/ Tue, 22 Apr 2025 20:08:55 +0000 https://lifescivoice.com/?p=10645 Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re taking a look at how liver safety concerns have halted the development of Pfizer’s lead obesity asset, Merck’s deal with Cyprumed to leverage its oral peptide platform, the success of Lilly’s oral GLP-1 receptor in a phase 3 trial, and other top news! Stay informed and inspired by the innovations driving life sciences forward!

Pfizer Ends Development of Danuglipron Following Liver Safety Concerns

Pfizer has ceased development of its oral GLP-1 drug danuglipron due to a potential case of drug-induced liver injury observed during dose-optimization trials. The affected patient showed no symptoms, and the condition resolved after discontinuation. Despite liver enzyme levels being comparable to similar drugs, Pfizer opted to stop development after regulatory discussions. Danuglipron had shown high adverse event rates, including nausea (73%), vomiting (47%), and over 50% discontinuation across doses. Following a prior formulation setback, the drug was reintroduced as a once-daily pill but was now abandoned. Pfizer’s remaining obesity candidate is PF-07976016, currently in Phase II trials.

Merck Licenses Cyprumed’s Oral Peptide Delivery Platform in $493 Million Deal

Merck & Co. has entered a licensing agreement with Austria-based Cyprumed, potentially worth up to $493 million, to access Cyprumed’s oral peptide delivery platform for an undisclosed number of drug targets. The nonexclusive deal includes upfront and milestone-based payments tied to development, regulatory, and commercial progress. Merck may secure exclusive rights to specific targets later. The company will oversee all R&D and commercialization efforts. Cyprumed’s technology enhances peptide oral bioavailability using approved excipients. This agreement follows Merck’s earlier peptide-related deals, including with Unnatural Products and ongoing development of MK-0616 and efinopegdutide in its peptide pipeline.

Eli Lilly’s Orforglipron Shows Comparable Results to Semaglutide in Phase 3 Trial

Eli Lilly’s oral GLP-1 receptor agonist orforglipron met its primary efficacy endpoint in a Phase 3 trial, showing A1C reductions of 1.3% to 1.6% over 40 weeks in people with Type 2 diabetes, compared to 0.1% with placebo. Weight loss ranged from 4.7% to 7.9%, with the highest dose group averaging a 7.3 kg reduction. Reported adverse events included diarrhea (up to 26%), nausea (18%), and indigestion (20%). The results are part of a larger clinical program, with additional Type 2 diabetes and obesity trials ongoing. Lilly plans to seek approval for obesity in 2025 and Type 2 diabetes approval in 2026.

Vanda Sues FDA Over Restrictions on Off-Label Drug Promotion

Vanda Pharmaceuticals has filed a lawsuit against the U.S. FDA, alleging that the agency’s restrictions on off-label drug communication violate First Amendment rights. Filed on April 9 in the Southern District of Texas, the lawsuit centers on Vanda’s desire to share clinical data supporting the use of Hetlioz, approved for non-24-hour sleep-wake disorder and Smith-Magenis syndrome, for jet lag, an unapproved indication. Vanda argues that FDA policies deter the dissemination of accurate, non-promotional information. This legal action follows prior disputes, including the FDA’s rejections of Hetlioz for jet lag in 2019 and tradipitant for gastroparesis in 2024.

Johnson & Johnson MedTech Begins First Human Trial of Ottava Surgical Robot

Johnson & Johnson MedTech has completed the first clinical use of its Ottava surgical robot during a minimally invasive Roux-en-Y gastric bypass procedure at Memorial Hermann-Texas Medical Center. The system, which received FDA approval in fall 2023 to begin human trials, is intended for laparoscopic, open, and hybrid soft tissue surgeries. Initially slated for a 2022 debut, development was delayed by pandemic-related disruptions. Successful trial completion may lead to FDA de novo clearance for multiple upper abdominal procedures. Ottava integrates robotic arms with a movable patient table and is compatible only with instruments from J&J’s Ethicon division.

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Life Sciences Voice Top Five Newsletter https://lifescivoice.com/life-sciences-voice-top-five-newsletter-37/ Mon, 14 Apr 2025 23:57:13 +0000 https://lifescivoice.com/?p=10608 Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re taking a look at the consequences of Trump’s proposed tariffs on medical costs and supplies, the XBridge Program by BioMedX, meant to support medical initiatives in the U.S following cuts to the NIH, cuts made by OPM following Servier’s exit, and other top news! Stay informed and inspired by the innovations driving life sciences forward!

Proposed Tariffs on Pharmaceutical Imports Raise Supply and Cost Concerns

The U.S. may soon impose tariffs on pharmaceutical imports to boost domestic manufacturing, according to President Donald Trump. Though specific rates and timelines remain unclear, the plan has sparked concern among patient advocates and analysts, who warn it could worsen drug shortages and raise costs. Generic drugs, which make up 90% of U.S. prescriptions and often rely on foreign ingredients, are especially vulnerable. Experts argue that tariffs may disrupt already fragile supply chains and deter production. While some companies are investing in U.S. facilities, meaningful reshoring is a long-term process with limited short-term relief.

German Initiative Offers Interim Support for U.S. Researchers Facing NIH Funding Cuts

Amid ongoing funding instability and layoffs in U.S. research institutions—especially within federal health agencies—Germany’s BioMed X Institute has launched the XBridge Program to support scientists at risk of losing NIH funding. The program allows researchers to submit their NIH grant proposals, which are then shared with BioMed X’s network of pharmaceutical partners, including Roche and Sanofi. Interested companies may invite selected researchers to pitch their work. While not a replacement for federal grants, the initiative aims to maintain research continuity in human disease by linking scientists to private sector sponsors during periods of financial uncertainty.

Oncodesign Precision Medicine Faces Financial Strain After Servier Withdrawal

Oncodesign Precision Medicine (OPM) has cut executive salaries and laid off five employees following Servier’s exit from a Parkinson’s disease collaboration. Servier had co-sponsored a phase 1 trial of OPM-201 but withdrew before its results, disrupting OPM’s financial projections and halting an expected milestone payment. With only €5.1 million in cash at 2023’s end, OPM is reducing costs by focusing on priority programs like OPM-101 for metastatic melanoma. OPM is now seeking new partners for OPM-201 to continue advancing the program independently.

FDA Requests Additional Efficacy Data for Aldeyra’s Dry Eye Drug Reproxalap

The FDA has issued a second complete response letter to Aldeyra Therapeutics regarding its NDA for reproxalap, a RASP-modulating drug for dry eye disease (DED). While safety and manufacturing concerns were absent, the agency concluded that the updated data did not adequately demonstrate symptom relief, a key approval requirement. Despite prior trials—TRANQUILITY and the Dry Eye Chamber study—showing statistically significant improvements in redness and favorable trends in pain, the FDA is calling for an additional controlled study focused on symptom efficacy. Aldeyra, which reported consistent safety across 2,500 participants, plans to resubmit its application later this year.

Rallybio Halts RLYB212 Program Following Phase II Failure in FNAIT Study

Rallybio has terminated development of RLYB212, its monoclonal antibody for preventing fetal and neonatal alloimmune thrombocytopenia (FNAIT), after a Phase II study failed to meet pharmacokinetic and efficacy targets. The trial showed RLYB212 did not reach the minimum effective plasma concentration, and further dose adjustments were deemed unfeasible. Enrollment and screening have been discontinued, though patient safety monitoring will continue. The company will now focus on RLYB116, a C5 inhibitor in Phase I development for complement-mediated disorders. Other pipeline assets include REV102 for hypophosphatasia and RLYB332 for iron overload conditions, as Rallybio reallocates resources toward more promising programs.

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Life Sciences Voice Top Five Newsletter https://lifescivoice.com/life-sciences-voice-top-five-newsletter-36/ Tue, 18 Mar 2025 20:22:40 +0000 https://lifescivoice.com/?p=9848 Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re taking a look at Merck’s new production plant in North Carolina for Gardasil, Elance’s efforts to develop the next generation of obesity drugs, J&J’s suspension of its phase 3 depression program, and other top news! Stay informed and inspired by the innovations driving life sciences forward!

Merck Expands U.S. Manufacturing with New $1 Billion Facility in Durham

Merck has launched a new $1 billion, 225,000-square-foot bulk manufacturing facility at its Durham, North Carolina, complex. The facility, part of Merck’s 262-acre campus, will produce ingredients for Gardasil, the company’s HPV vaccine, as well as other vaccines for diseases like chickenpox and measles. The site, which employed over 1,000 workers last year, produced 70 million doses and plans to expand production. Equipped with advanced technology, including AI and digital twin modeling, the facility also manufactures TICE BCG for bladder cancer. The expansion aligns with Merck’s broader $12 billion U.S. investment in research and manufacturing infrastructure.

Harbour BioMed Launches Élancé Therapeutics for Innovation in Obesity Treatment 

China-based Harbour BioMed has introduced Élancé Therapeutics, a biotechnology company focused on developing bispecific antibodies aimed at promoting weight loss while preserving muscle mass. The company will leverage Harbour BioMed’s HCAb-based bispecific antibody technology alongside the Hu-mAtrIx AI platform from its subsidiary, Nona Biosciences. Currently, Élancé Therapeutics has multiple preclinical candidates that could complement existing GLP-1, GIP, and GCG receptor-targeting treatments. While Harbour BioMed has not disclosed financial details, the initiative aligns with broader industry efforts, including those by Roche and Altimmune, to develop obesity treatments that maintain muscle integrity.

Johnson & Johnson Halts Development of Aticaprant for Major Depressive Disorder

Johnson & Johnson has discontinued its phase 3 development of Aticaprant, an oral kappa opioid receptor antagonist, as an adjunctive treatment for major depressive disorder (MDD) due to insufficient efficacy. This follows the recent failure of Neumora’s Navacaprant in a similar phase 3 trial. Despite the setback, J&J has indicated it may explore alternative applications for Aticaprant. The company has shifted focus toward its $15 billion acquisition of Intra-Cellular Therapies, securing access to Caplyta, a phase 3-approved MDD treatment. The move aligns with J&J’s broader strategy to become a leader in neuroscience by 2030.

FDA Halts BioNTech’s Malaria Vaccine Trial

The U.S. Food and Drug Administration (FDA) has placed a hold on BioNTech’s phase 1/2a clinical trial for BNT165e, an RNA-based malaria vaccine candidate. The regulatory action, disclosed in a March 4 SEC filing, affects BioNTech’s investigational new drug (IND) application and its associated study. Prior to the FDA’s intervention, the company had voluntarily paused the trial. The study aimed to evaluate BNT165e’s efficacy in preventing Plasmodium falciparum malaria in healthy adults. BioNTech is working with the FDA to determine the next steps, as the future of its malaria vaccine program remains uncertain.

Pfizer and Arvinas’ Breast Cancer Drug Falls Short in Phase 3 Trial

Pfizer and Arvinas announced that their estrogen receptor degrader, vepdegestrant, did not meet the primary endpoint in its first phase 3 trial. The study compared vepdegestrant to AstraZeneca’s Faslodex in 624 patients with ER+/HER2- metastatic breast cancer. While the drug showed progression-free survival (PFS) benefits in patients with estrogen receptor 1 mutations, overall results were insufficient to reassure investors, causing Arvinas’ stock to drop 50%. The companies plan further analyses and a combination trial with Pfizer’s CDK4 inhibitor atirmociclib. Despite mixed outcomes, vepdegestrant remains a potential treatment option for a subset of breast cancer patients.

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Life Sciences Voice Top Five Newsletter https://lifescivoice.com/life-sciences-voice-top-five-newsletter-35/ Fri, 28 Feb 2025 23:18:01 +0000 https://lifescivoice.com/?p=9708 Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re taking a look at Eli Lilly’s move to counter compounded versions of its popular drug Zepbound in the market, the FDA’s approval of Romvimza for tenosynovial giant cell tumor, MeiraGTx’s gene therapy’s positive impact on vision restoration in children, and other top news! Stay informed and inspired by the innovations driving life sciences forward!
Eli Lilly Reduces Zepbound Prices and Introduces New Dosage Options
Eli Lilly has reduced the price of vials for its obesity drug, Zepbound, and expanded available dosage options. The 2.5-mg and 5-mg vials now cost $349 and $499 per month, respectively, while new 7.5-mg and 10-mg vials are priced at $599 and $699. A special pricing option allows patients to pay $499 for higher-dose refills if they adhere to a 45-day schedule. The move seeks to compete with compounded alternatives and rival medications like Novo Nordisk’s Wegovy. Regulatory changes may impact the availability of compounded versions, as the FDA recently removed Zepbound and Wegovy from its shortage list.
FDA Approves Romvimza for Rare Joint Tumor, Offering New Treatment Option
The FDA has approved Romvimza (vimseltinib) for treating tenosynovial giant cell tumor (TGCT) in patients for whom surgery is not viable. Developed by Ono Pharmaceuticals, Romvimza is a kinase inhibitor that targets the CSF1 receptor to limit tumor growth. Approval was based on Phase III MOTION study results, showing a 40% response rate at 25 weeks. Unlike competitor Turalio, Romvimza requires twice-weekly dosing and lacks a hepatotoxicity warning. Ono acquired the drug through its $2.4 billion purchase of Deciphera Pharmaceuticals and plans to launch it in the U.S. soon. TGCT can cause severe joint impairment if untreated.

MeiraGTx’s investigational gene therapy Restores Vision in Children with Severe Retinal Dystrophy
MeiraGTx’s investigational gene therapy for AIPL1-associated severe retinal dystrophy has led to significant vision improvements in 11 children born legally blind. A Lancet study on four treated children reported measurable gains in visual acuity within four weeks, while untreated eyes continued deteriorating to unmeasurable levels. Additional benefits included improved communication, education, and social interaction. One child developed cystoid macular edema, which partially resolved. The therapy, delivered via a single injection using an adeno-associated virus, is now under expedited regulatory review in the UK, with U.S. FDA discussions ongoing. Seven more children later received treatment in both eyes.
Roche Unveils Sequencing-by-Expansion for Faster, More Precise DNA Analysis
Roche has introduced sequencing-by-expansion (SBX), a patented genetic analysis technique that disassembles DNA and amplifies each base’s signal independently. SBX combines DNA synthesis with nanopore-based molecular reading, aiming to overcome the time constraints and signal discrimination challenges of traditional sequencing. The technology builds on Roche’s acquisitions of Stratos Genomics (2020) and Genia Technologies (2014). SBX stretches DNA up to 50 times its original length, enhancing readability before passing through nanopores for sequencing. While still in development, Roche plans to launch the technology next year, with potential applications in whole-genome, exome, and RNA sequencing.

FDA Approves Mirum’s Ctexli as First Treatment for Rare Genetic Disorder CTX
Mirum Pharmaceuticals secured FDA approval for Ctexli (chenodiol) as the first U.S.-approved treatment for cerebrotendinous xanthomatosis (CTX), a rare genetic disorder that disrupts fat metabolism. The approval follows Mirum’s $210 million acquisition of Travere Therapeutics’ bile acid portfolio in 2023. Clinical studies showed that 250 mg of Ctexli, taken thrice daily, effectively reduced toxic cholesterol metabolites. Due to potential liver toxicity, patients must undergo regular liver function tests. Though chenodiol was available off-label for over a decade, its full approval grants Mirum market exclusivity. Analysts estimate potential revenue between $150 million and $200 million annually.
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Life Sciences Voice Top Five Newsletter https://lifescivoice.com/life-sciences-voice-top-five-newsletter-34/ Wed, 19 Feb 2025 15:27:27 +0000 https://lifescivoice.com/?p=9677 Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re taking a look at Romvimza scoring FDA approval for treating Tenosynpvial Giant Cell Cancer, despite positive phase 3 results Bristol Myers having to cut off its allergy asset, Biogen securing $250 million in funding, and other top news! Stay informed and inspired by the innovations driving life sciences forward!

FDA Approves Romvimza for Rare Joint Tumor, Offering New Treatment Option

The FDA has approved Romvimza (vimseltinib) for treating tenosynovial giant cell tumor (TGCT) in patients unsuitable for surgery. Developed by Ono Pharmaceuticals, Romvimza is a kinase inhibitor targeting the CSF1 receptor to prevent tumor growth. Phase III MOTION study results showed a 40% response rate and significant improvements in mobility and pain. Unlike its competitor Turalio, Romvimza has a more convenient dosing schedule and lacks a hepatotoxicity warning. Ono acquired Romvimza through its $2.4 billion purchase of Deciphera Pharmaceuticals and plans to launch it in the U.S. soon to address this rare but debilitating condition.

Bristol Myers Squibb Cuts Drug Programs to Boost Cost Savings

Bristol Myers Squibb (BMS) has intensified its cost-reduction strategy, discontinuing plans to commercialize cendakimab despite positive phase 3 results and halting the development of a TYK2 inhibitor. CEO Chris Boerner increased the company’s savings target by $2 billion, prioritizing high-return investments. The firm opted to focus on Sotyktu over its TYK2 successor and is accelerating multiple myeloma research with an adjusted phase 3 trial for iberdomide. BMS remains committed to strategic investments, emphasizing programs with strong competitive advantages while withdrawing from less promising opportunities to streamline its pipeline.

Biogen Secures $250M for Lupus Drug, Eyes Billion-Dollar Market

Biogen has secured $250 million from Royalty Pharma to fund phase 3 trials of litifilimab, an anti-BDCA2 antibody for systemic and cutaneous lupus erythematosus (SLE/CLE). With few treatment options available, Biogen sees litifilimab as a major opportunity in an underserved market. The company opted for external funding to focus on other pipeline assets, including additional lupus treatments. Under CEO Christopher Viehbacher, Biogen has prioritized cost management, cutting R&D spending by 17% last year. If successful, litifilimab could contribute to Biogen’s projected $9-$14 billion peak sales, with regulatory submissions expected between 2027 and 2029.

Former Inizio Evoke Executives Launch Flex Marketing for Health Industry

A team of former Inizio Evoke executives has launched Flex Marketing, an independent agency specializing in pharmaceutical, biotech, medtech, and health tech marketing. Based in San Francisco, Flex offers market research, strategic planning, brand development, and data-driven analytics with a focus on adaptability. The agency is led by four partners: Gelling (client engagement), Amber Rogers (brand strategy), Jason Luis (omnichannel strategy), and Michelle Green (creative). With extensive industry experience, the team aims to provide tailored marketing solutions to global clients while maintaining independence and agility in a rapidly evolving healthcare landscape.

FDA Approves Penmenvy, First Meningococcal ABCWY Vaccine for Ages 10-25

The FDA has approved Penmenvy, a vaccine targeting meningococcal groups A, B, C, W, and Y, for individuals aged 10 to 25. Developed by GSK, Penmenvy combines elements from Bexsero and Menveo to enhance protection against invasive meningococcal disease. Approval was based on two phase 3 trials involving over 4,800 participants, demonstrating strong immune responses and safety. With meningococcal cases rising since 2021, the CDC’s Advisory Committee on Immunization Practices will soon vote on usage recommendations. Penmenvy’s approval marks a significant advancement in broad-spectrum meningococcal disease prevention.

 

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Life Sciences Voice Top Five Newsletter https://lifescivoice.com/life-sciences-voice-top-five-newsletter-33/ Wed, 22 Jan 2025 18:53:02 +0000 https://lifescivoice.com/?p=9591 Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re spotlighting Blueprint Medicines’ strategic pivot in cancer treatment, Regenxbio’s $810M gene therapy partnership, Sling Therapeutics’ progress in thyroid eye disease research, and other top stories shaping the field. Stay informed and inspired by the innovations driving life sciences forward!
Blueprint Medicines Refocuses Cancer Efforts, Axes CDK2 Program
Blueprint Medicines has announced the discontinuation of its CDK2 inhibitor program, including BLU-222, following a lack of success in securing big pharma partnerships. Despite promising early results, the company has chosen to redirect resources to its broader CDK-focused pipeline, aiming to develop best-in-class treatments for breast cancer and other solid tumors. This pivot aligns with Blueprint’s strategy of prioritizing high-potential assets, including its approved drug Ayvakit and preclinical CDK4 and CDK2 inhibitors.

Regenxbio Partners with Nippon Shinyaku in $810M Gene Therapy Deal
Regenxbio has teamed up with Nippon Shinyaku to advance gene therapies targeting mucopolysaccharidosis (MPS), a group of rare metabolic disorders. The partnership focuses on RGX-121 and RGX-111, promising candidates designed to address MPS II and MPS I by targeting the root genetic causes. Positive clinical trial outcomes and an accelerated FDA approval pathway highlight Regenxbio’s progress. With this alliance, the company strengthens its pipeline, which includes treatments for Duchenne muscular dystrophy and wet age-related macular degeneration.

Sling Therapeutics Challenges TED Treatment Landscape with Oral Linsitinib
Sling Therapeutics is advancing linsitinib, an oral treatment for thyroid eye disease (TED), into phase 3 trials after positive phase 2b/3 results. While its efficacy lags behind Amgen’s established therapy Tepezza, linsitinib’s convenient oral formulation and fewer side effects position it as a patient-friendly alternative. As the competitive TED treatment market evolves, Sling’s success will hinge on differentiating its approach and addressing unmet patient needs.

J&J Redefines NSCLC Treatment with Combination Therapy
Johnson & Johnson’s Rybrevant-Lazcluze combo has emerged as a new standard of care for EGFR-mutated non-small cell lung cancer (NSCLC), delivering a survival advantage over AstraZeneca’s Tagrisso in the phase 3 MARIPOSA trial. By targeting both EGFR and MET pathways, the therapy reduces treatment resistance and delays chemotherapy. With FDA approval secured and full trial results forthcoming, J&J positions itself as a formidable challenger in the NSCLC market.

Gilead Expands Inflammation Research with $1.7B Leo Pharma Partnership
Gilead Sciences is broadening its inflammation portfolio by partnering with Leo Pharma to develop therapies targeting the STAT6 pathway, integral to inflammatory conditions like eczema and asthma. The collaboration grants Gilead access to Leo’s oral STAT6 inhibitors, complementing its systemic therapy expertise. This marks another step in Gilead’s strategic evolution from infectious diseases to transformative treatments in oncology and inflammation.

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Life Sciences Voice Top Five Newsletter https://lifescivoice.com/life-sciences-voice-top-five-newsletter-32/ Tue, 15 Oct 2024 23:03:36 +0000 https://lifescivoice.com/?p=9056 Welcome to the latest edition of the Life Sciences Voice Top Five Newsletter, your source for the latest news in the life sciences industry! This week, we take a look at BMS gaining approval for its Schizophrenia drug, Immunae & AstraZeneca partnering up to use AI in their cancer treatment trials, AbbVie’s promising results for its Alzheimer therapy, and other top news!

Bristol Myers Squibb’s New Schizophrenia Drug Cobenfy Approved for FDA
Cobenfy by Bristol Myers Squibb has become the first new drug to be approved by the FDA for the treatment of schizophrenia in over 70 years. About 2.9 million adults are affected by schizophrenia in the U.S., and new hope for patients who cannot tolerate current treatments may soon be on the horizon with Cobenfy. Cobenfy fights the disorder using a different mechanism than current medications which block dopamine receptors directly. The company stated that it plans to introduce a program for patients to make the drug more affordable. The drug is heading to market by the end of October.

SunRISe-2 Study Discontinued by Johnson & Johnson
Johnson & Johnson halted its phase 3 SunRISe-2 trial of a drug-device combination of TAR-200 for delivering gemcitabine to the bladder, following an interim analysis finding the combination drug-device did not have efficacy over chemoradiation. The study included 550 patients with muscle-invasive bladder cancer (MIBC) but did not replicate the success observed in other bladder cancer trials using only non-muscle invasive bladder cancer (NMIBC). However, J&J still expects peak sales of more than $5 billion for its TARIS platform, with continued studies in NMIBC, and upcoming regulatory filings.

Genevant Partners with Repair Biotechnologies for Cholesterol Treatments
Repair Biotechnologies partnered with Genevant Sciences to harness Genevant’s lipid nanoparticle (LNP) technology for its cholesterol-degrading mRNA therapies against atherosclerosis. Combined with Repair, this gives them the ability to use LNPs to better deliver their treatments and degrade cholesterol buildups. Its agreement with Sanofi includes up to $107 million in milestone payments and further royalties for each product developed using the technology.

Immunai teams with AstraZeneca to pioneer cancer treatment trials using AI
AstraZeneca partnered with Immunai to improve aspects of cancer immunotherapy trials using AI-driven insights from its immune-cell atlas. The goal of this collaboration is to optimize patient selection, dosing, and biomarker identification in clinical trials with the potential to speed up new cancer treatments for patients. Based on research from MIT, Harvard, and Stanford, Immunai’s technology will be critical to studying the immune system’s role in disease progression. Immunai’s partnership with both companies comes in response to Immunai’s successful funding rounds and positions the two to break new boundaries in AI for drug discovery and cancer treatment innovation.

Results From AbbVie’s Tavapadon in Parkinson’s Treatment Are Promising
AbbVie has released positive results for the company’s oral dopamine receptor agonist, Tavapadon, for treating Parkinson’s disease. Two dosages of Tavapadon (5 mg and 15 mg) were significantly superior to placebo in reducing disease burden as measured by the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS UPDRS) at Week 26 in the TEMPO-1 trial. In addition to meeting primary and secondary endpoints, the drug also increased patients’ mobility. The side effects noted in the trial were of a mild to moderate nature.

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Life Sciences Voice Top Five Newsletter https://lifescivoice.com/life-sciences-voice-top-five-newsletter-31/ Sun, 01 Sep 2024 21:57:34 +0000 https://lifescivoice.com/?p=8810 Welcome to the latest edition of the Life Sciences Voice Top Five Newsletter, your source for the latest news in the life sciences industry! This week, we take a look at Eli Lilly’s anti-obesity drug seeing success in a weight loss study, Singapore’s Health Sciences Authority approving Bavarian Nordic’s mpox vaccine, FDA rejecting an MDMA based PTSD therapy, and other top news!

McKesson Invests $2.5B for the improvement of Oncology services.

McKesson Corporation has pledged $2. 5 billion to buy a 70% stake in Core Ventures, a joint venture formed with Florida Cancer Specialists & Research Institute (FCS). This strategic move will help to strengthen substantially McKesson’s position and share in the oncology market through the integration of the FCS’s network of more than 60 locations and 2,500 oncology professionals into the U. S. Oncology Network. McKesson intends to use this acquisition to advance the administration of cancer care in the country with emphasis on the methods of treatment and patients’ outcomes.

New Eli Lilly’s weight-shedding pill cuts diabetes risk

Eli Lilly’s newest anti-obesity drug, tirzepatide, has demonstrated the capability to lower type 2 diabetes risks in overweight and obese people. A large observational study with thousands of people showed not only that the drug helped participants shed pounds but also that it enhanced their blood sugar regulation and thus reduced the risk of developing diabetes. The drug acts on the GLP-1 receptor which is involved in the regulation of blood glucose levels and appetite.

Siemens Healthineers to Strengthen Its Diagnostic Portfolio Through a Deal with Novartis

Siemens Healthineers is planning to acquire Novartis’ European radiodiagnostic production network which is expected to enable it to expand its portfolio in the PET imaging segment. This $233M acquisition will also expand manufacturing capacity and knowledge to Siemens in the production of radiopharmaceuticals, used in diagnostic imaging of diseases like cancer. Integrated with Novartis facilities and experience the company expects to improve its product portfolio and gain a new market in Europe increasing its share in the medical imaging and diagnostics industry.

Singapore’s Health Sciences Authority Approves Bavarian Nordic’s Mpox Vaccine

Bavarian Nordic has received approval from Singapore’s Health Sciences Authority (HSA) for its mpox (monkeypox) vaccine, JYNNEOS, for individuals 18 and older. This vaccine, which also gives protection against smallpox, is the first of its kind to be approved in Singapore – a sign of the increasing global consciousness for effective vaccines in the fight against new emerging diseases. The approval comes as Bavarian Nordic works to increase the availability of JYNNEOS in other countries, which has already been authorized for use in several countries, including the United States of America and Canada.

FDA Rejects Lykos’ PTSD Therapy Drug That Contains MDMA

The U. S. Food and Drug Administration has turned down Lykos Therapeutics’ new MDMA-based PTSD treatment. MDMA is the psychoactive component of ecstasy. While there has been increasing concern about the efficacy of psychedelics for treatments, the FDA stated that there were issues with the safety and effectiveness of the treatment as it is. Lykos’ approach was based on new studies that showed that MDMA could help some patients overcome the traumatic experiences which had failed to respond to conventional treatments.

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