Novartis buys rare disease gene therapy from Avrobio
Bio Pharma Dive
MAY 22, 2023
The pharma will pay nearly $90 million to acquire Avrobio’s treatment for cystinosis, an inherited condition caused by the toxic buildup of an amino acid.
Mon.May 22, 2023
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China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma
Pharmaceutical Technology
MAY 22, 2023
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SM17 is a humanised IgG4-k monoclonal antibody that targets IL-17RB to treat asthma, idiopathic pulmonary fibrosis (IPF), atopic dermatitis (AD) and other immunological disorders.
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Ironwood to buy rare disease drugmaker in billion-dollar deal
Bio Pharma Dive
MAY 22, 2023
The acquisition would give Ironwood a drug in late-stage testing for a condition known as short bowel syndrome, further building out the company’s gastrointestinal-focused research.
EMA validates Sobi’s marketing authorisation application for efanesoctocog alfa
Pharmaceutical Technology
MAY 22, 2023
The European Medicines Agency (EMA) has accepted and verified Sobi’s marketing authorisation application for a new factor VIII (FVIII), efanesoctocog alfa, to treat haemophilia A patients of all ages. The application is supported by results from the Phase III XTEND-1 trial in adults and adolescents and backed by the XTEND-Kids paediatric trial in patients aged under 12 years.
Racing to the finish line: help for reducing risks, ensuring security and driving faster speed-to-market
Bio Pharma Dive
MAY 22, 2023
When pharma manufacturers are racing to bring a new product to market, catastrophic printing errors and mislabeled materials can have a significant impact on timelines and budgets.
It’s Official: Artificial Sweeteners Don’t Work For Weight Loss, WHO Says
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 22, 2023
This week, the World Health Organization (WHO) advised that “non-sugar sweeteners should not be used as a means of achieving weight control or reducing the risk of noncommunicable diseases” such as diabetes and heart disease.
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FDA approves Krystal gene therapy for rare wound disorder
Bio Pharma Dive
MAY 22, 2023
Cleared to treat dystrophic epidermolysis bullosa, Vyjuvek is the sixth gene therapy for an inherited disease to gain clearance in the U.S.
Thermo Fisher Scientific opens sterile drug facility in Singapore
Pharmaceutical Technology
MAY 22, 2023
Thermo Fisher Scientific has expanded its sterile manufacturing and research capabilities in the Asia-Pacific region with the opening of a new sterile drug facility in Singapore. The new good manufacturing practices facility was established with support from the Singapore Economic Development Board. It comes with quick vaccine fill-finish capabilities and offers end-to-end pharmaceutical development and manufacturing services.
DoP floats tender to appoint consultant for valuation of BPCL
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 22, 2023
The Department of Pharmaceuticals (DoP) is initiating processes for valuation of the assets of Bengal Chemicals & Pharmaceuticals Ltd (BCPL) – a public sector undertaking which has shown resilience to overcome its financial troubles to turn around to profit – as part of the Central government’s divestment plans.
UK to provide up to £39m for AMR research
Pharmaceutical Technology
MAY 22, 2023
The UK government has announced that it will provide up to £39m in funding to conduct research for developing new treatments for antimicrobial resistance (AMR), which is also called ‘the silent killer’. The funding for the research programme will be provided under the government’s Global AMR Innovation Fund. Up to £24m will be provided over a period of four years to strengthen the UK’s collaboration with the global AMR research initiative, CARB-X.
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
How the digital front door benefits clinical trial patients, clinicians and sponsors
Bio Pharma Dive
MAY 22, 2023
A digital front door in clinical trials is a triple win that improves patient and clinician satisfaction, data quality and costs.
US FDA approves Krystal Biotech’s Vyjuvek for DEB
Pharmaceutical Technology
MAY 22, 2023
The US Food and Drug Administration (FDA) has granted approval for Krystal Biotech’s Vyjuvek (beremagene geperpavec-svdt) to treat dystrophic epidermolysis bullosa (DEB) in patients aged six months and above. Vyjuvek is a non-invasive, topical, re-dosable gene therapy that delivers functional human COL7A1 gene copies to offer wound healing. It is claimed to be both the first re-dosable gene therapy and the first and only FDA-approved treatment for both recessive and dominant types of DEB, a rare
May 22, 2023: EMBED Finds Racial and Ethnic Differences in Buprenorphine Initiation for Opioid Use Disorder
Rethinking Clinical Trials
MAY 22, 2023
In a secondary analysis from the EMBED pragmatic clinical trial, Black patients with opioid use disorder were less likely than White patients to be initiated on buprenorphine in the emergency department. The study’s findings were published recently in Academic Emergency Medicine. EMBED, an NIH Collaboratory Demonstration Project, was a cluster randomized trial across 21 emergency departments in 5 healthcare systems in the United States.
Ironwood Pharmaceuticals agrees to buy VectivBio for $1bn
Pharmaceutical Technology
MAY 22, 2023
Ironwood Pharmaceuticals has entered into a definitive agreement to buy Swiss biopharmaceutical company VectivBio in an all-cash deal valued at around $1bn. Ironwood will start a tender offer to purchase all outstanding ordinary VectivBio shares for $17.00 per share in cash. VectivBio is focused on the discovery, development and commercialisation of treatments for many rare conditions, including acute graft versus host disease and short bowel syndrome with intestinal failure (SBS-IF).
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
DrugChatter.com: AI Chat for Biopharmaceutical Drug Insights
Drug Patent Watch
MAY 22, 2023
Introducing DrugChatter.com: Empowering Access to Biopharmaceutical Drug Insights through AI Chat We are pleased to introduce DrugChatter.com, a groundbreaking platform that redefines the way professionals obtain concise, cited information on… The post DrugChatter.com: AI Chat for Biopharmaceutical Drug Insights appeared first on DrugPatentWatch - Make Better Decisions.
Biogen and Eisai seek UK’s marketing authorisation for lecanemab
Pharmaceutical Technology
MAY 22, 2023
Biogen and Eisai have submitted a marketing authorisation application (MAA) to the UK’s medicines and healthcare products regulatory agency (MHRA) for lecanemab to treat early Alzheimer’s disease (AD). Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody that will be used to treat mild cognitive impairment caused due to AD and mild AD dementia in people with the confirmed presence of amyloid pathology in the brain.
Vital patent for AlzeCure Alzheimer’s drug
Pharma Times
MAY 22, 2023
ACD856 is the leading candidate therapy on the company’s NeuroRestore platform
How to get the most out of your clinical trial search
Antidote
MAY 22, 2023
Participating in a clinical trial can be a worthwhile opportunity for any individual. Whether taking part as a healthy volunteer or enrolling in a study for a specific condition, being a medical research participant can provide the chance to be more involved in medical treatments, gain access to potential new therapies, and pave the way for medical breakthroughs to take place.
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.
How Pairwise Leverages CRISPR Technology for Leafy Greens
XTalks
MAY 22, 2023
Pairwise , a startup based in Durham, North Carolina, has launched its first CRISPR-developed product in the US: Conscious Greens. Touted as a mix of superfood leafy greens, the product claims to offer twice the nutrition of traditional romaine lettuce and comes with an appealing fresh flavor. This product is notable because the company claims it’s the first food product in the US that was developed using CRISPR technology.
Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis
Fierce Pharma
MAY 22, 2023
Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis zbecker Mon, 05/22/2023 - 14:43
Insmed unveils new research platforms and capabilities
BioPharma Reporter
MAY 22, 2023
US biopharma Insmed has announced progress across its early-stage research programs at the company's investor and analyst event, The Future of Rare at Insmed: Functional Genes, AI-Enhanced Proteins, Glowing Algae, and More.
Eisai makes lecanemab therapy application
Pharma Times
MAY 22, 2023
Treatment involves early Alzheimer’s disease and will be potentially used across Great Britain
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.
Pfizer, Moderna among many biopharma giants to post Q1 sales declines, as Novo Nordisk led growth charge
Fierce Pharma
MAY 22, 2023
Pfizer, Moderna among many biopharma giants to post Q1 sales declines, as Novo Nordisk led growth charge kdunleavy Mon, 05/22/2023 - 13:04
uBriGene targets North American growth with buy of Mustang Bio facility
BioPharma Reporter
MAY 22, 2023
uBriGene is expanding into the US market with the acquisition of a state-of-the-art GMP manufacturing facility from Mustang Bio.
Bayer's blockbuster hopeful Nubeqa, AstraZeneca's Forxiga pick up nods from England's NICE
Fierce Pharma
MAY 22, 2023
Bayer's blockbuster hopeful Nubeqa, AstraZeneca's Forxiga pick up nods from England's NICE zbecker Mon, 05/22/2023 - 10:44
FDA Approves First Nasal Nalmefene Spray for Opioid Overdose
BioSpace
MAY 22, 2023
FDA Approves First Nasal Nalmefene Spray for Opioid Overdose 5/23/2023
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.
With Dupixent leading the way, Sanofi’s taking on the 'big players' in respiratory diseases: exec
Fierce Pharma
MAY 22, 2023
With Dupixent leading the way, Sanofi’s taking on the 'big players' in respiratory diseases: exec kdunleavy Mon, 05/22/2023 - 07:33
UK missing out on being a 'life-sciences superpower' as participant numbers plummet due to lack of incentives
Outsourcing Pharma
MAY 22, 2023
The UK has the tools to become a life-sciences superpower but those thinking about taking part remain put off by the lack of financial motivation, a clinical trials start-up says.
ITX pharma virtual round table 2023
Pharma Business Blog
MAY 22, 2023
Dear all Thank you for your interest in our ITX pharma virtual round table. This event will be held online on Wednesday, 31 May 2023, from 15:00 to 16:00 CEST. After the success of our global ITX health industry convention last year, we will once again be discussing current developments, innovations and challenges that could have a major impact on the pharmaceutical, healthcare and life science industries from an indirect tax perspective.
WHO launches global network to detect and prevent infectious disease threats
The Pharma Data
MAY 22, 2023
WHO launches global network to detect and prevent infectious disease threats WHO and partners are launching a global network to help protect people from infectious disease threats through the power of pathogen genomics. The International Pathogen Surveillance Network (IPSN) will provide a platform to connect countries and regions, improving systems for collecting and analyzing samples, using these data to drive public health decision-making, and sharing that information more broadly.
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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