Sun.Nov 13, 2022

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US FDA grants approval for AstraZeneca’s lung cancer therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) and platinum-based chemotherapy to treat Stage IV (metastatic) non-small cell lung cancer (NSCLC) in adults. The approval was based on the findings from the randomised, multicentre, open-label, international Phase III POSEIDON trial.

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STAT+: Roche’s experimental Alzheimer’s treatment fails to slow cognitive decline across two clinical trials

STAT News

Roche reported negative results Monday from a pair of clinical trials investigating an antibody treatment for people with early-stage Alzheimer’s disease — another setback for the Swiss pharma giant’s decades-long effort to develop medicines against the memory-destroying disease. The drug, called gantenerumab, slowed the rate of cognitive and functional decline compared to a placebo by 8% and 6%, respectively, — not enough to meet the primary goal of the two studies o

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Study examines total knee replacement in patients under 21

Medical Xpress

A new study from researchers at Hospital for Special Surgery (HSS) has evaluated trends in the use of total knee arthroplasty (TKA) in patients under 21 in the United States. The study was reported at the American College of Rheumatology (ACR) Convergence 2022 meeting (abstract number 08780).

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Best Places to Work in Biopharma 2023 Report Reveals Most Sought-After Employers

BioSpace

BioSpace's 2023 “Best Places to Work,” highlights innovative companies with a positive workplace culture, flexibility and strong leadership.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Repeat COVID infections increase risk of health problems: study

Medical Xpress

People who have had COVID more than once are two or three times more likely to have a range of serious health problems than those who have only had it once, the first major study on the subject said Thursday.

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BrainStorm Vows to Push for Adcomm Meeting on NurOwn in ALS

BioSpace

During its third-quarter earnings call Monday, BrainStorm Cell Therapeutics emphasized its commitment to seek an advisory committee meeting for NurOwn in ALS.

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Ionis Partners with Metagenomi to Add DNA Editing to Its Toolbox

BioSpace

Ionis Pharmaceuticals inked a collaboration deal with Metagenomi with the goal of adding DNA editing to its RNA-targeted technologies focused on up to four genetic targets.

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New cancer therapy takes personalized medicine to a new level

Medical Xpress

Personalized care has been a buzzword in medicine for years, but new research on cancer treatment is taking it to a new level.

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Satsuma’s Headaches Mount as Migraine Candidate Flops in Phase III

BioSpace

Topline results from the Phase III SUMMIT trial showed Satsuma Pharmaceuticals’ migraine candidate STS101 did not meet its primary efficacy endpoint.

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Research uncovers how UV light triggers immune activation and disease flares in lupus

Medical Xpress

After sun exposure, people with systemic lupus erythematosus (SLE) frequently develop skin rashes, which often are accompanied by a flare of their overall disease. This connection between ultraviolet (UV) light and disease flares in lupus is well known, but the way in which UV exposure actually triggers the disease has been poorly understood.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Indivior Bets $145M on Opiant’s Opioid Overdose Recovery Candidate

BioSpace

Indivior PLC announced it will acquire Opiant Pharmaceuticals and its lead candidate OPNT003, an intranasal-delivered opioid overdose recovery product.

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New patent expiration for Sucampo Pharma drug AMITIZA

Drug Patent Watch

Annual Drug Patent Expirations for AMITIZA Amitiza is a drug marketed by Sucampo Pharma Llc and is included in one NDA. It is available from four suppliers. There are nine…. The post New patent expiration for Sucampo Pharma drug AMITIZA appeared first on DrugPatentWatch - Make Better Decisions.

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Are You Looking for a Long-Term Partnership for Your Next OEM Project? Trust Our Expertise

BioSpace

Discover how Eppendorf OEM worked with the market leader in laboratory automation to develop a win-win business model and 25-year partnership.

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Meet the 2022 STAT Wunderkinds

STAT News

Read their stories.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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MBX Biosciences Secures $115M to Advance Precision Endocrine Peptides

BioSpace

MBX Biosciences secured $115 million in Series B financing to advance its pipeline of Precision Endocrine Peptides for endocrine disorders.

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New tentative approval for Amneal Pharms drug saxagliptin

Drug Patent Watch

[![saxagliptin structure]([link] Saxagliptin is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this compound. There are…. The post New tentative approval for Amneal Pharms drug saxagliptin appeared first on DrugPatentWatch - Make Better Decisions.

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Biogen-Lilly Solidly in the Lead After Roche's Alzheimer's Drug Misses in Phase III

BioSpace

Roche announced its investigational antibody gantenerumab failed to meet the primary endpoints in GRADUATE I and II - two Phase III studies in Alzheimer's disease.

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New tentative approval for Teva Pharms drug eltrombopag

Drug Patent Watch

[![eltrombopag structure]([link] Eltrombopag is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are eight patents protecting this compound. There are four…. The post New tentative approval for Teva Pharms drug eltrombopag appeared first on DrugPatentWatch - Make Better Decisions.

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The New Age of Decentralized Clinical Trials

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.

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A Guide to Research and Development: Skills and Experience Needed for a Career in R&D

BioSpace

Find out everything you need to know about research and development, including the skills it requires and what you should do if you’re ready to make the transition into R&D.

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Drug Patent Expirations for the Week of November 13, 2022

Drug Patent Watch

OCALIVA (obeticholic acid) Intercept pharms inc Patent: 7,138,390 Expiration: Nov 16, 2022 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact…. The post Drug Patent Expirations for the Week of November 13, 2022 appeared first on DrugPatentWatch - Make Better Decisions.

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Positive Data Ushers Stoke's Pediatric Dravet Syndrome Candidate into Phase III

BioSpace

Stoke Therapeutics is gearing up for a pivotal trial of its lead program for a rare genetic epilepsy disease and announced positive results from its Phase I/IIa study in children with Dravet syndrome.

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Which pharmaceutical companies have the most drug patents in France?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in France. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in France? appeared first on DrugPatentWatch - Make Better Decisions.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Akeso's Ivonescimab (PD-1/VEGF Bispecific Antibody, AK112) Granted Breakthrough Therapy Designation for I-O Resistance NSCLC Patients in China Akeso, Biopharma announced that the Center for Drug Evaluation of the China National Medical Products Administration has granted Breakthrough Therapy Designation for Ivonescimab combined with docetaxel for the treatment of locally advanced or metastatic Non-Small-Cell Lung Carcinoma patients who failed to respond to prior PD-1 inhibitor combined with platinum-based doublet chemotherapy. Innovent Presents Clinical Data of Phase Ia Study for IBI351 (KRAS G12C Inhibitor) as Monotherapy for Solid Tumors at the 2022 Chinese Society of Clinical Oncology (CSCO) Annual Meeting Innovent Biologics, Inc. presented the updated results of IBI351 from a phase Ia clinical trial at the 2022 Chinese Society of Clinical Oncology Annual Meeting. SK Biopharmaceuticals Receives Korea Drug Development Fund Investment Grant to Develop Novel Oncology Candidate, SKL27969 SK Biopharmaceuticals

BioSpace

The FDA approved AstraZeneca’s Imfinzi in combination with Imjudo and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer.

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A Democratic Senate improves the outlook for Biden health and science priorities, including key nominees

STAT News

WASHINGTON — The outlook for the White House’s health and science priorities just got a whole lot brighter. With a Democratic Senate, as the Associated Press projected Saturday night, it will be much easier for President Biden to get nominees confirmed, including whomever he taps to lead the National Institutes of Health. Public health officials like National Institute of Allergy and Infectious Diseases Director Anthony Fauci will face less scrutiny, as Democrats will maintain powe