Sage lays off 55% of R&D workforce and refocuses pipeline
Pharmaceutical Technology
OCTOBER 17, 2024
Strategic restructuring will support the ongoing launch of the oral postpartum depression drug, Zurzuvae, and extend Sage’s cash runway.
Thu.Oct 17, 2024
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After rejections, AbbVie secures approval for Parkinson’s drug
Bio Pharma Dive
OCTOBER 17, 2024
Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.
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Glaukos eyes FDA approval for ocular therapy after Phase III win
Pharmaceutical Technology
OCTOBER 17, 2024
The company’s keratoconus medication, Epioxa, was effective in a Phase III trial, with plans to file for submission with the US Food and Drug Administration (FDA).
Sage to cut one-third of workforce, streamline drug pipeline
Bio Pharma Dive
OCTOBER 17, 2024
The restructuring, which follows clinical setbacks in Alzheimer’s, Parkinson’s and tremor, will also involve the departure of five senior executives.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
TikTok Says Cinnamon in Coffee Helps You Burn Fat. Here’s The Truth.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 17, 2024
(Strelciuc Dumitru/Getty Images) Cinnamon has been long used around the world in both sweet and savoury dishes and drinks. But a new TikTok trend claims adding a teaspoon of cinnamon to your daily coffee (and some cocoa to make it more palatable) for one week can help you burn fat.
Sanofi, expanding in radiopharma, strikes a joint venture deal
Bio Pharma Dive
OCTOBER 17, 2024
The French drugmaker will invest 300 million euros into a new entity that will develop lead isotope-based therapies for cancer under the Orano Med brand.
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October 17, 2024: GGC4H Pilot Finds Spanish-Language Intervention Feasible and Acceptable in Pediatric Primary Care
Rethinking Clinical Trials
OCTOBER 17, 2024
Dr. Margaret Kuklinski and Dr. Stacy Sterling In a pilot study for the GGC4H trial, researchers found that a virtual version of the Guiando Buenas Decisiones program delivered in the context of pediatric primary care was feasible, acceptable, and appealing to pediatricians and parents. The program is a Spanish-language version of the Guiding Good Choices intervention being implemented in the GGC4H trial.
Lexicon sells Viatris rights to cardio drug outside of the U.S. and Europe
Bio Pharma Dive
OCTOBER 17, 2024
The deal offers Lexicon a cash infusion of $25 million as the company tries to broaden use of the heart failure and diabetes medication.
High Court refuses interim injunction against Zydus’ breast cancer drug
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 17, 2024
In a setback to Swiss multinational pharma company F-Hoffmann-La Roche, the Delhi High Court has dismissed an application filed by the company seeking injunction against Zydus Lifesciences Ltd’s breast cancer drug Sigrima, a biosimilar of Pertuzumab.
Fresenius Kabi and Cellular Origins agree CGT manufacture automation
Pharmaceutical Technology
OCTOBER 17, 2024
Fresenius Kabi and Cellular Origins have announced a partnership to advance cell and gene therapy (CGT) by automating manufacturing.
3rd time's the charm: AbbVie scores FDA nod for continuous Parkinson's disease therapy Vyalev
Fierce Pharma
OCTOBER 17, 2024
AbbVie made history in 2015 with its Parkinson’s disease infusion pump therapy Duopa, kicking off a trend of delivery system innovation in the space as drugmakers sought to avoid the common pitfall | The 24-hour Parkinson's disease therapy crossed the FDA finish line after an initial manufacturing-related rejection last year and another snub in June.
Lexicon partners Viatris for global expansion of sotagliflozin
Pharmaceutical Technology
OCTOBER 17, 2024
Lexicon Pharmaceuticals has entered a licensing agreement with Viatris to commercialise sotagliflozin outside the US and Europe.
Novartis falls short in legal effort to undo FDA approval of MSN's Entresto generic
Fierce Pharma
OCTOBER 17, 2024
As a host of generics circle the gates, Novartis has lost another bid to waylay MSN Pharmaceuticals’ copycat of the Swiss pharma’s top-selling drug Entresto. | In a court decision filed in Washington, D.C., U.S. District Judge Dabney Friedrich rejected Novartis’ position that the FDA’s approval of MSN’s Entresto generic was unlawful. In issuing the decision, the judge upheld the green light that MSN won in July.
Bavarian Nordic’s mpox vaccine equally effective in teens as adults
Pharmaceutical Technology
OCTOBER 17, 2024
Bavarian Nordic’s MVA-BN vaccine showed equivalent antibody response and safety between teenagers and adults in an NIH study.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Disrupting Cancer Cells on the Go: Novocure’s Optune Lua Device for Portable NSCLC Therapy
XTalks
OCTOBER 17, 2024
The US Food and Drug Administration (FDA) has granted approval for Novocure’s Optune Lua device to be used in combination with existing treatments for metastatic non-small cell lung cancer (NSCLC). Designed for adults who have progressed after platinum-based chemotherapy, Optune Lua can be used alongside immune checkpoint inhibitors, such as programmed death receptor-1 (PD-1) and programmed death-ligand 1 (PD-L1) blockers, or the chemotherapy drug docetaxel.
First human skin atlas points way to healing without scars
pharmaphorum
OCTOBER 17, 2024
The first human skin atlas is helping researchers to understand how skin forms, the mechanisms behind disorders, and could usher in scarless healing
SPECTRALIS Flex Module Add-On Gets FDA Clearance, Aims to Improve Access to Ophthalmic Imaging
XTalks
OCTOBER 17, 2024
The US Food and Drug Administration (FDA) has granted clearance to imaging and healthcare IT company Heidelberg Engineering’s Flex Module, a multimodal, diagnostic imaging-only platform designed for imaging the posterior segment of pediatric and adult patients in a supine (face up) position. Being able to image macular and optic nerve pathologies in the supine position ensures that vulnerable individuals can receive timely and sight-saving diagnoses and treatments.
Investors and big pharma no longer avoiding techbio companies
BioPharma Reporter
OCTOBER 17, 2024
Investors and big pharma companies are waking up to the potential of techbio companies after years of avoidance, say experts at TechBio UK 2024, an event run by the BioIndustry Association (BIA).
Sage cuts a third of its workforce after R&D setbacks
pharmaphorum
OCTOBER 17, 2024
Sage has launched another round of layoffs as it deals with the fallout of dropping a key pipeline drug for Alzheimer's and Parkinson's
NIH study shows Bavarian Nordic's mpox shot elicits immune response in teens
Fierce Pharma
OCTOBER 17, 2024
With the clade 1 outbreak of mpox (formerly monkeypox) raging through the Congo and other countries in Central Africa, younger people have become markedly
NICE backs first targeted therapy for ALK+ lung cancer
pharmaphorum
OCTOBER 17, 2024
NICE backs NHS use of Roche's Alecensa as first adjuvant therapy for ALK+ NSCLC, and peri-operative use of MSD's Keytruda for all-comer NSCLC patients
The Promise of a Direct-to-Patient Model—Breaking Down What’s Really Needed for Better Patient Access
Drug Channels
OCTOBER 17, 2024
Today’s guest post comes from Greg Skalicky, President, EVERSANA and Faruk Abdullah, President, Professional Services & Chief Business Officer, EVERSANA Greg and Faruk walk through the marketplace pressures driving Direct-to-Patient commercialization models. They argue that a technology-enabled infrastructure, combined with clinical and reimbursement support specialists, can improve patients' access to new therapies, shorten the time to therapy, and enable better overall clinical outco
The New Age of Decentralized Clinical Trials
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Fierce Pharma Asia—Lilly's China expansions; Gilead's scrapped MASH deal; Leqembi's vial scrutiny
Fierce Pharma
OCTOBER 17, 2024
Eli Lilly is making a series of investments in China to support its manufacturing and R&D operations. Gilead Sciences has abandoned a liver disease collaboration with Yuhan. | Eli Lilly is making a series of investments in China. Gilead Sciences has abandoned a liver disease collaboration with Yuhan. A study suggests Leqembi's vial design could cost Medicare hundreds of millions of dollars in waste each year.
Regulatory considerations for biosimilar analytical similarity assessments
Drug Patent Watch
OCTOBER 17, 2024
Regulatory Considerations for Biosimilar Analytical Similarity Assessments Biosimilars, or follow-on biologics, are biopharmaceuticals that are highly similar to an already approved biological product.
Viatris makes good on CEO's dealmaking promise with $25M licensing pact for Lexicon's heart med Inpefa
Fierce Pharma
OCTOBER 17, 2024
After Viatris’ CEO earlier this year promised to be “opportunistic” about future business development moves, the company is making good on that pledge with a new licensing pact to bolster its cardi | Viatris is ponying up $25 million upfront to obtain the rights to sell Lexicon Pharmaceuticals’ SGLT1/SGLT2 heart med sotagliflozin, known commercially as Inpefa, in all global markets beyond the U.S. and Europe.
Australia joins EU in turning down Alzheimer's drug Leqembi
pharmaphorum
OCTOBER 17, 2024
Australia's Therapeutic Goods Administration (TGA) has said it won't approve Eisai and Biogen's Alzheimer's disease therapy Leqembi, saying its efficacy does not outweigh its risks.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Vivan renews five-year lease at UK biotech hub White City Place
Pharma Times
OCTOBER 17, 2024
The London hub is home to life sciences companies including Novartis, Engitix and invoX Pharma
Lundbeck acquires Longboard Pharmaceuticals in $2.6 billion deal
Outsourcing Pharma
OCTOBER 17, 2024
The acquisition will add a late-stage drug candidate with blockbuster potential to Lundbeckâs neuroscience pipeline.
New £4.5m initiative launched to address UK medicines manufacturing skills shortage
Pharma Times
OCTOBER 17, 2024
The two-year programme will use virtual reality technology to teach essential skills
Recent CTTI Publication Reviews Current Applications and Future Opportunities for Disease Progression Modeling
CTTI (Clinical Trials Transformation Initiative)
OCTOBER 17, 2024
A new CTTI publication , published in Clinical Pharmacology & Therapeutics , reviews current applications of disease progression modeling (DPM) and opportunities to advance the awareness and value of DPM in clinical trials. Use of modeling and simulation during drug development, otherwise known as model-informed drug development (MIDD), can help researchers make informed decisions when planning and executing clinical trials.
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
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