Bio Pharma Dive
JULY 28, 2023
The British pharma is deepening its investment in genetic medicine through a deal for a group of Pfizer’s gene therapy delivery tools, while the New York giant cuts back.
Pharmaceutical Technology
JULY 28, 2023
NS Pharma’s candidate would be the first to target Duchenne Muscular Dystrophy (DMD) patients amenable to exon 44 skipping therapy.
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Bio Pharma Dive
JULY 28, 2023
The deal is a major bet by Biogen and its new CEO Chris Viehbacher, who’s reorganized R&D, cut costs and laid off staff since becoming company head last year.
Pharmaceutical Technology
JULY 28, 2023
Senator Bernie Sanders has proposed price caps on drugs developed with federal funds, following a political career battling against high drug prices.
Bio Pharma Dive
JULY 28, 2023
The company will lay off 87% of its workforce and halt further research, including for a gene editing therapy to treat the rare disease PKU.
Pharmaceutical Technology
JULY 28, 2023
Bristol Myers Squibb has reported revenues of $11.2bn in the second quarter of 2023, versus $11.8bn in Q2 2022, indicating a drop of 6%.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 28, 2023
InSilicoTrials has entered a partnership with Axoltis Pharma for the advancement of therapeutic solutions for neurological disorders.
Drug Patent Watch
JULY 28, 2023
Annual Drug Patent Expirations for SYMBICORT Symbicort is a drug marketed by Astrazeneca and is included in one NDA. It is available from three suppliers. There are eleven patents protecting… The post New patent expiration for Astrazeneca drug SYMBICORT appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
JULY 28, 2023
Carmell Therapeutics has entered a definitive agreement and plan of merger with the regenerative medicine company Axolotl Biologix.
Drug Patent Watch
JULY 28, 2023
A review article in the Journal of Pharmaceutical Sciences analyzes the trends in drug repurposing through the 505(b)(2) pathway, as approved by the USFDA from 2010 to 2020. The study… The post Review of 505(b)(2) Drug Products Approved by USFDA from 2010 to 2020: A Focus on Intellectual Property and Regulatory Considerations appeared first on DrugPatentWatch - Make Better Decisions.
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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
Pharmaceutical Technology
JULY 28, 2023
Gilead Sciences has received approval from EC for Trodelvy, for pre-treated HR-positive, HER2-negative metastatic breast cancer.
Drug Discovery World
JULY 28, 2023
A report by University of Queensland (UQ) researchers has warned a global crisis of antibiotic resistance is inevitable, despite promising developments in new antibiotics. The Centre for Superbug Solutions at UQ’s Institute for Molecular Bioscience has monitored the clinical pipeline for more than a decade, with its latest snapshot showing 62 new antibiotics in development.
Pharmaceutical Technology
JULY 28, 2023
As several economies deal with inflation, there has been a reduction in deals involving contract manufacturing organisations.
Fierce Pharma
JULY 28, 2023
On Monday during a quarterly earnings call, when Biogen CEO Chris Viehbacher was asked about the company’s potential to execute M&A, he randomly offered “we’ve got, I think, about $7.3 billion | Biogen has revealed a proposal to acquire Reata Pharmaceuticals for $7.3 billion. The Texas-based rare disease specialist brings newly approved Skyclarys, the first treatment for the neurologic disorder Friedreich’s ataxia with peak sales potential of $1.5 billion.
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Pharma Times
JULY 28, 2023
Mage Biologics aims to progress a novel, orally administered monoclonal antibody - News - PharmaTimes
Fierce Pharma
JULY 28, 2023
Is AstraZeneca planning to peel off its China business? By CEO Pascal Soriot’s response to that question, it may only a contingency plan. | Is AstraZeneca planning to peel off its China business? By CEO Pascal Soriot’s response to that question, it may only be a contingency plan.
Pharma Times
JULY 28, 2023
The vital second batch represents a critical step on the candidate’s pathway to regulatory approval - News - PharmaTimes
Fierce Pharma
JULY 28, 2023
Teva’s CEO Richard Francis is adding to his constellation of new executives with a fresh business development hire from BeiGene. | Teva has enlisted BeiGene's Angus Grant, Ph.D, as its EVP of business development, the Israeli-American generics giant announced Friday. It was during Grant's tenure as chief business executive that BeiGene signed the high-profile PD-1 and TIGIT pacts with Novartis.
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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.
Pharmaceutical Commerce
JULY 28, 2023
CDMO’s Turku addition will span over 69,000 square feet and support the production of ATMPs.
Fierce Pharma
JULY 28, 2023
Even as Aubagio generics chip away at Sanofi’s sales in the U.S.—and soon, in Europe, too—the company is relying on a trio of new medicines to bring home at least €5 billion in peak sales in the co | As Aubagio generics chip away at Sanofi’s sales in the U.S.—and soon, in Europe, too—the company is relying on a trio of new medicines to bring home at least €5 billion in peak sales in the coming years.
Pharmaceutical Commerce
JULY 28, 2023
The pharma and biotech exec will begin his role on Aug. 1.
pharmaphorum
JULY 28, 2023
1000Farmacie Secures $25 Million in Series A Funding Nicole.
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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.
Drug Patent Watch
JULY 28, 2023
Annual Drug Patent Expirations for PYRUKYND Pyrukynd is a drug marketed by Agios Pharms Inc and is included in one NDA. It is available from one supplier. There are seven… The post New patent for Agios Pharms drug PYRUKYND appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
JULY 28, 2023
After cutbacks, Biogen adds new drug with $7.3bn Reata buy Phil.
Drug Patent Watch
JULY 28, 2023
Obeticholic acid is the generic ingredient in one branded drug marketed by Intercept Pharms Inc and is included in one NDA. There are ten patents protecting this compound. Drug patent… The post New tentative approval for Optimus Pharma drug obeticholic acid appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
JULY 28, 2023
News round-up for 24-28 July by DDW Digital Content Editor Diana Spencer. To coincide with the publication of the DDW eBook ‘ Antibody discovery: Breakthroughs accelerating therapeutic antibodies ’, our news highlights this week all focus on antibodies, particularly the recommendation by the EU’s CHMP for two bispecific antibodies that treat multiple myeloma and lymphoma.
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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.
XTalks
JULY 28, 2023
Wild Planet Foods, a sustainable seafood company based in McKinleyville, California, is expanding its product range with the introduction of five new seafood products now available at Whole Foods Market stores across the US. The new product lineup from Wild Planet includes Skipjack Solid Light Wild Tuna in Pure Olive Oil, Wild Smoked Pink Salmon in Extra Virgin Olive Oil, Wild Smoked Mackerel Filets in Extra Virgin Olive Oil, Wild Pink Salmon 3-Pack and Wild Tuna Quinoa Salad Ready-To-Eat Meal.
pharmaphorum
JULY 28, 2023
BMS feels the pain of Revlimid erosion, cutting forecasts Phil.
Pharmaceutical Commerce
JULY 28, 2023
Pandemic preparedness and curbing PBMs among the pending legislation that will have to wait until after summer recess.
pharmaphorum
JULY 28, 2023
Collaborative perseverance to bring change to medicine access Mike.
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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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