PTC to lay off more staff following drug setback in Europe
Bio Pharma Dive
SEPTEMBER 29, 2023
The biotech is expanding cuts it announced a few months ago after the EMA decided against renewing a conditional clearance for its drug Translarna.
Fri.Sep 29, 2023
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Karuna Therapeutics files for FDA approval for schizophrenia treatment
Pharmaceutical Technology
SEPTEMBER 29, 2023
Karuna Therapeutics has announced the submission of a NDA to the FDA for KarXT (xanomeline-trospium) for the treatment of schizophrenia.
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Structure boosted by early data for experimental obesity drug
Bio Pharma Dive
SEPTEMBER 29, 2023
Shares in the biotech surged on Phase 1 trial results for an oral GLP-1 drug Structure is developing, reflecting investor enthusiasm for the weight loss medicines.
AI is a pillar of tomorrow’s healthcare system, but limitations remain
Pharmaceutical Technology
SEPTEMBER 29, 2023
At the industry crossroads of healthcare and pharmaceuticals at the Life Sciences Baltics 2023 conference, all signs pointed towards an AI-based future.
Adlai Nortye IPO gives old Novartis cancer drug new life
Bio Pharma Dive
SEPTEMBER 29, 2023
The biotech is using the proceeds to bankroll Phase 3 testing of a drug the Swiss pharma studied widely before selling it off for cheap a few years ago.
Can reforms restore faith in India’s pharma industry after cough syrup scandals?
Pharmaceutical Technology
SEPTEMBER 29, 2023
India is known as the 'pharmacy of the world', producing a substantial quantity of generic drugs globally. However, its lax regulatory oversight has resulted in persistent drug recalls and scandals that have stained the country’s manufacturing reputation.
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Cambridge biotech Thymmune wins $37m NIH grant for thymic cell therapies
Pharmaceutical Technology
SEPTEMBER 29, 2023
The stem cell startup aims to bolster immune systems of patients born without a thymus or with poor thymic function by restoring T cell development.
Austrian State Secretary to speak at FlyPharma Europe 2023
Pharma Times
SEPTEMBER 29, 2023
FlyPharma Europe is an event for the pharma logistics industry, connecting professionals from across the globe - News - PharmaTimes
Leading providers of washing, disinfection and sterilisation equipment and services
Pharmaceutical Technology
SEPTEMBER 29, 2023
Pharmaceutical Technology has listed some of the leading providers of washing, disinfection and sterilisation in the pharmaceutical industry.
NHS medicines access in jeopardy says ABPI
Pharma Times
SEPTEMBER 29, 2023
Review raises concerns about approach taken by the DHSC regarding changes to Statutory Scheme - News - PharmaTimes
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
ModeX wins $168m BARDA contract to develop viral antibody therapies
Pharmaceutical Technology
SEPTEMBER 29, 2023
BARDA in the US has awarded a $168m Project NextGen grant to ModeX Therapeutics to develop anti-viral therapies.
Vitamin D Overdose Among Emerging Risks Identified by EFSA
XTalks
SEPTEMBER 29, 2023
The European Food Safety Authority (EFSA) recently released a technical report that shed light on eight emerging food safety risks, including vitamin D overdose. The report was a culmination of collaborations involving the Emerging Risks Exchange Network (EREN), the Stakeholder Discussion Group on Emerging Risks, EFSA’s diverse scientific bodies and its numerous working groups.
HitGen and SGC enter drug discovery partnership
Pharmaceutical Technology
SEPTEMBER 29, 2023
HitGen and the Structural Genomics Consortium entered a collaboration to discover drugs based on a DNA-encoded library (DEL).
In label expansion bid, AbbVie and Roche's Venclexta falls short in multiple myeloma subset
Fierce Pharma
SEPTEMBER 29, 2023
After establishing Venclexta as a treatment for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML), AbbVie and Roche were hoping to demonstrate the med's promise in a subset of mul | Despite the trial missing its primary endpoint of progression-free survival, the companies will soon discuss the "potential favorable trends" with health authorities.
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
Regeneron’s bispecific lymphoma antibody odronextamab wins FDA priority review
Pharmaceutical Technology
SEPTEMBER 29, 2023
The FDA has set 31 March 2024 as the PDUFA action date for reviewing odronextamab as third-line therapy for FL and DLBCL.
Proposed chemical ban would cause EU drug manufacturing to 'grind to a halt,' trade group warns
Fierce Pharma
SEPTEMBER 29, 2023
A proposed restriction on the use of fluorinated substances in Europe would have an “irredeemable impact” on the continent’s life sciences sector, the European Federation of Pharmaceutical Industri | A proposed restriction on the use of fluorinated substances in Europe would have an “irredeemable impact” on the continent’s life sciences sector, the European Federation of Pharmaceutical Industries and Associations (EFPIA) warns.
Fabre-Kramer gains FDA approval for major depressive disorder therapy
Pharmaceutical Technology
SEPTEMBER 29, 2023
Fabre-Kramer has obtained approval from the US FDA for Exxua to treat major depressive disorder (MDD) in adult patients.
Hutchmed cancer drug set to enter Japanese market through Takeda
Outsourcing Pharma
SEPTEMBER 29, 2023
Chinese biopharmaceutical company, Hutchmed Limited, has announced today (Friday September 29) that it has taken a step towards bringing a colon and rectum cancer drug to a third market.
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.
Amicus receives FDA approval for Pompe disease therapy
Pharmaceutical Technology
SEPTEMBER 29, 2023
Amicus Therapeutics has received approval from the US FDA for the two-component therapy to treat Pompe disease.
More Than a Feeling: Five Key Challenges When Walking Away From Commercial/340B Duplicate Payments
Drug Channels
SEPTEMBER 29, 2023
Today’s guest post comes from Micah Litow, Chief Operating Officer at Kalderos. According to Kalderos, at least 5% of commercial rebates are paid for prescriptions that also have discounts under the 340B Drug Pricing Program. Micah outlines why it's more than a feeling that manufacturers struggle to walk away from these duplicate payments. But as he explains, reliable data is crucial to avoid hearing that old song that PBMs play.
Deka Biosciences secures $20m to advance product pipeline
Pharmaceutical Technology
SEPTEMBER 29, 2023
Deka Biosciences has secured funding of $20m in a Series B2 financing round to advance the product pipeline.
Teva continues its transformation, hiring Christine Fox to take over US business
Fierce Pharma
SEPTEMBER 29, 2023
Teva CEO Richard Francis has continued his transformation of the company, bringing on Christine Fox as the new head of its U.S. commercial business.
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.
All About the Journey
Pharmaceutical Commerce
SEPTEMBER 29, 2023
A reflection on my time with Pharma Commerce thus far, and a plan of action for moving the brand forward.
The future of cancer care: Fast-tracking sustainability, access, and innovation in the Middle East
pharmaphorum
SEPTEMBER 29, 2023
The future of cancer care: Fast-tracking sustainability, access, and innovation in the Middle East Mike.
Enhancing Omnichannel Marketing with AI
Intouch Solutions
SEPTEMBER 29, 2023
Just as leading pharmaceutical companies progressively excel in implementing omnichannel marketing, the landscape is on the brink of a second phase of disruption from the availability of large language model generative AI applications. AI offers an enticing vision where we can create, execute and enhance omnichannel campaigns with accelerated time-to-market, campaign optimization, elevated levels of personalization and customer engagement.
Prescription for success: How creativity is the secret ingredient in pharma marketing
pharmaphorum
SEPTEMBER 29, 2023
Prescription for success: How creativity is the secret ingredient in pharma marketing Mike.
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.
Study finds new therapeutic targets for neurodegenerative disease
Drug Discovery World
SEPTEMBER 29, 2023
AI-driven drug discovery company Insilico Medicine and the University of Cambridge have discovered an approach to identify therapeutic targets for human diseases associated with protein phase separation (PPS). In this study, the researchers combined Insilico’s artificial intelligence (AI)-driven target identification engine PandaOmics with the FuzDrop method for predicting protein separation to identify PPS-prone disease-associated proteins.
New patent for Cmp Dev drug LIQREV
Drug Patent Watch
SEPTEMBER 29, 2023
Annual Drug Patent Expirations for LIQREV Liqrev is a drug marketed by Cmp Dev Llc and is included in one NDA. It is available from one supplier. There are two… The post New patent for Cmp Dev drug LIQREV appeared first on DrugPatentWatch - Make Better Decisions.
Top Pharma Ad Spenders in August 2023, AbbVie Splurges to Take Top Spots
XTalks
SEPTEMBER 29, 2023
AbbVie packed the punches with its ad spending in August, claiming the top three spots on iSpot.tv’s top pharma ad spenders for the month. The top two spots were taken by the company’s immunology meds Skyrizi and Rinvoq, followed by its bipolar and major depressive disorder drug Vraylar. Skyrizi maintained its number one position from July while Rinvoq slipped down one spot.
New patent for Avadel Cns drug LUMRYZ
Drug Patent Watch
SEPTEMBER 29, 2023
Annual Drug Patent Expirations for LUMRYZ Lumryz is a drug marketed by Avadel Cns and is included in one NDA. It is available from one supplier. There are thirteen patents… The post New patent for Avadel Cns drug LUMRYZ appeared first on DrugPatentWatch - Make Better Decisions.
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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