2023 in review: Cancer vaccines dose up on advances with tailored approaches
Pharmaceutical Technology
DECEMBER 22, 2023
As the number of patients with cancers continues to grow globally, research into personalised cancer vaccines is vital.
Fri.Dec 22, 2023
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Bristol Myers to acquire brain drug developer Karuna for $14B
Bio Pharma Dive
DECEMBER 22, 2023
The deal would hand Bristol Myers, which has newly made neuroscience a therapeutic focus, an experimental treatment for schizophrenia.
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Bausch Health gets grant for implantable corneal and intraocular mask with controllable opacity
Pharmaceutical Technology
DECEMBER 22, 2023
Improve Vision with Implantable Corneal and Intraocular Implants - Patent Granted to Bausch Health Companies Inc. Discover a method for clear visualization of the eye using a photochromic polymer mask and controlled external stimuli.
Sarepta tests FDA flexibility with bid to expand Duchenne gene therapy’s approval
Bio Pharma Dive
DECEMBER 22, 2023
The biotech is asking the agency to clear its treatment Elevidys in more patients with the disease, despite a confirmatory trial that missed its main goal.
Angelini files patent for method and apparatus for producing fluff-free absorbent cores
Pharmaceutical Technology
DECEMBER 22, 2023
Angelini Spa has filed a patent for a method and apparatus to produce fluff-free absorbent cores for sanitary articles. Discover how loose fibers and superabsorbent granular material are mixed and bound together to create an absorbent structure.
Ionis, Astrazeneca win FDA approval of competitor to Alnylam drug
Bio Pharma Dive
DECEMBER 22, 2023
The clearance of Wainua for transthyretin amyloidosis opens up a new front in a long-running commercial battle between Ionis and Alnylam.
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2024 forecast: M&A saw an uptick in 2023. Analysts expect the trend to continue
Fierce Pharma
DECEMBER 22, 2023
Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. | Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise.
China approves Takeda’s Livtencity for post-transplant CMV infection
Pharmaceutical Technology
DECEMBER 22, 2023
The China NMPA approved Takeda’s Livtencity to treat adults with post-HSCT or solid organ transplant cytomegalovirus infection/disease.
Patient perspectives: From public relations executive to chronic pain patient
Antidote
DECEMBER 22, 2023
Because Antidote’s key focus is connecting patients to clinical trials , hearing directly from individuals serves as a great reminder of why we do what we do. One patient we’ve had the pleasure of speaking with is Linda VandeVrede, a former high-tech PR executive who shared her story of chronic pain, clinical trials, and personal experience.
ImmunoScape and EDDC partner to develop TCR-based therapeutics
Pharmaceutical Technology
DECEMBER 22, 2023
ImmunoScape has signed a collaboration with EDDC to develop new T cell receptor (TCR)-based bispecific molecules for solid tumours.
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
J&J, Legend’s Carvykti slapped with FDA black-box warning over secondary cancer risk
Fierce Pharma
DECEMBER 22, 2023
As the FDA investigates a safety signal for approved CAR-T therapies, the agency has upgraded a warning about secondary cancers resulting from use of Johnson & Johnson and Legend Biotech’s Carv | As the FDA investigates a safety signal for approved CAR-T therapies, the agency has elevated a warning about secondary cancers resulting from use of Johnson & Johnson and Legend Biotech’s Carvykti.
Ono and EVQLV partner to develop new antibody drugs
Pharmaceutical Technology
DECEMBER 22, 2023
Ono has signed an agreement with EVQLV to utilise its AI-powered antibody design engine for the development of new antibody drugs.
iDose TR Is a New Injectable Glaucoma Treatment Approved by FDA
XTalks
DECEMBER 22, 2023
Glaukos Corporation, a leader in ophthalmic medical technology and pharmaceuticals with a focus on novel treatments for glaucoma, corneal disorders and retinal diseases, has secured US Food and Drug Administration (FDA) approval for iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog intended for one-time use per eye. This innovative therapy is aimed at decreasing intraocular pressure (IOP) in individuals with ocular hypertension (OHT) or open-angle glaucoma (OAG).
Trastuzumab imbotolimod by Bolt Biotherapeutics for Endometrial Cancer: Likelihood of Approval
Pharmaceutical Technology
DECEMBER 22, 2023
Trastuzumab imbotolimod is under clinical development by Bolt Biotherapeutics and currently in Phase II for Endometrial Cancer.
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
A look back at 2023: Smith + Nephew
pharmaphorum
DECEMBER 22, 2023
This year brought about a whole gambit of news and developments, of conferences and launches, all coming in thick and fast and excited about the pharmaceutical industry and healthcare system. Not least of these was Smith + Nephew’s opening of a new state-of-the-art surgical innovation and training centre in the heart of Munich, Germany, on 11th October.
Atamparib by Ribon Therapeutics for Breast Cancer: Likelihood of Approval
Pharmaceutical Technology
DECEMBER 22, 2023
Atamparib is under clinical development by Ribon Therapeutics and currently in Phase II for Breast Cancer.
More ‘Faux-zempic’ found, this time in ‘legitimate’ US supply chain, FDA warns
Fierce Pharma
DECEMBER 22, 2023
The FDA and Novo Nordisk are warning of c | The FDA and Novo Nordisk are warning of counterfeit versions of popular weight-loss treatment Ozempic that have been discovered in the “legitimate” United States supply chain.
Volrustomig by AstraZeneca for Cervical Cancer: Likelihood of Approval
Pharmaceutical Technology
DECEMBER 22, 2023
Volrustomig is under clinical development by AstraZeneca and currently in Phase III for Cervical Cancer.
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.
FDA approves Ionis, AZ’s Wainua for ATTR polyneuropathy
pharmaphorum
DECEMBER 22, 2023
AstraZeneca and Ionis get first approval for ATTR polyneuropathy drug Wainua (eplontersen), a rival to drugs from Alnylam and Pfizer
J&J seeks another FDA label for Rybrevant in NSCLC
Pharmaceutical Technology
DECEMBER 22, 2023
This signifies the third submission in four months from J&J for the Rybrevant development programme.
3 ways to make 2024 the year of the patient
pharmaphorum
DECEMBER 22, 2023
Discover three key strategies to make 2024 the year of the patient in healthcare. Learn how revolutionising trial design, embracing technology, and breaking down silos can improve patient care and outcomes.
Runimotamab by Genentech USA for Solid Tumor: Likelihood of Approval
Pharmaceutical Technology
DECEMBER 22, 2023
Runimotamab is under clinical development by Genentech USA and currently in Phase I for Solid Tumor.
Roles and Responsibilities of Specialized Clinical Supply Experts
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
AI and the human touch: Embracing a symbiotic future
pharmaphorum
DECEMBER 22, 2023
Discover how AI is transforming the healthcare industry by automating boring and mundane tasks, allowing healthcare professionals to focus on more interesting and important aspects of patient care.
Novartis gets grant for an apparatus for arresting longitudinal movement of a plunger
Pharmaceutical Technology
DECEMBER 22, 2023
Discover Novartis AG's recently granted patent for an innovative apparatus that prevents longitudinal movement of a syringe plunger. This apparatus, described in detail in Publication Number: US11771834B2, includes two members with stop surfaces to arrest the plunger's movement. Find out how this design ensures controlled and precise plunger movement, making it ideal for medical procedures like eye injections.
New patent expiration for Esperion Theraps drug NEXLIZET
Drug Patent Watch
DECEMBER 22, 2023
Annual Drug Patent Expirations for NEXLIZET Nexlizet is a drug marketed by Esperion Theraps Inc and is included in one NDA. It is available from one supplier. There are ten… The post New patent expiration for Esperion Theraps drug NEXLIZET appeared first on DrugPatentWatch - Make Better Decisions.
BioAtla gets grant for method of preparing conditionally active antibodies or antibody fragments
Pharmaceutical Technology
DECEMBER 22, 2023
Discover a groundbreaking method for preparing conditionally active antibodies. This recently granted patent covers evolving DNA to increase acidic amino acid residues, selecting mutants, and assessing activity under specific conditions. Explore the potential of this innovative approach.
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.
New patent for Ucb Inc drug FINTEPLA
Drug Patent Watch
DECEMBER 22, 2023
Annual Drug Patent Expirations for FINTEPLA Fintepla is a drug marketed by Ucb Inc and is included in one NDA. It is available from one supplier. There are twelve patents… The post New patent for Ucb Inc drug FINTEPLA appeared first on DrugPatentWatch - Make Better Decisions.
Hanmi Science gets grant for anti-pd-1/anti-her2 bispecific antibody with natural igg characteristics
Pharmaceutical Technology
DECEMBER 22, 2023
Discover a groundbreaking patent for a stable heterodimeric bispecific antibody that targets PD-1 and HER2 antigens. Learn about its unique amino acid sequences and potential therapeutic applications.
New patent for TEVA drug AUSTEDO XR
Drug Patent Watch
DECEMBER 22, 2023
Annual Drug Patent Expirations for AUSTEDO+XR Austedo Xr is a drug marketed by Teva and is included in one NDA. It is available from one supplier. There are nine patents… The post New patent for TEVA drug AUSTEDO XR appeared first on DrugPatentWatch - Make Better Decisions.
Jazz Pharmaceuticals gets grant for use of cbd for treating seizures in dravet syndrome
Pharmaceutical Technology
DECEMBER 22, 2023
Discover the groundbreaking patent granted to Jazz Pharmaceuticals for using CBD in treating treatment-resistant epilepsy. Learn about the specific dosage options and the significant reduction in seizure frequency. A must-read for researchers and medical professionals.
Accelerating Clinical Supply Through Integrated Drug Development
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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