Mon.May 22, 2023

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Novartis buys rare disease gene therapy from Avrobio

Bio Pharma Dive

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.

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China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma

Pharmaceutical Technology

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

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.

Drugs 260
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EMA validates Sobi’s marketing authorisation application for efanesoctocog alfa

Pharmaceutical Technology

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.

Marketing 217
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Racing to the finish line: help for reducing risks, ensuring security and driving faster speed-to-market

Bio Pharma Dive

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.

Marketing 246
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It’s Official: Artificial Sweeteners Don’t Work For Weight Loss, WHO Says

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

More Trending

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Intercept suffers setback with negative AdCom decision for NASH therapy

Pharmaceutical Technology

Intercept Pharmaceuticals faced a setback after a US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) meeting on the prospective use of its drug Ocaliva in pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH) did not go in its favour. Twelve of the 16 AdCom members gave out a negative vote on whether the benefits of 25mg of Ocaliva outweigh the risks in NASH patients with Stage 2 or Stage 3 fibrosis based on available data.

Medicine 147
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DoP floats tender to appoint consultant for valuation of BPCL

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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Thermo Fisher Scientific opens sterile drug facility in Singapore

Pharmaceutical Technology

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.

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How the digital front door benefits clinical trial patients, clinicians and sponsors

Bio Pharma Dive

A digital front door in clinical trials is a triple win that improves patient and clinician satisfaction, data quality and costs.

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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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UK to provide up to £39m for AMR research

Pharmaceutical Technology

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.

Research 130
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May 22, 2023: EMBED Finds Racial and Ethnic Differences in Buprenorphine Initiation for Opioid Use Disorder

Rethinking Clinical Trials

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.

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US FDA approves Krystal Biotech’s Vyjuvek for DEB

Pharmaceutical Technology

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

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DrugChatter.com: AI Chat for Biopharmaceutical Drug Insights

Drug Patent Watch

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.

Drugs 105
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Ironwood Pharmaceuticals agrees to buy VectivBio for $1bn

Pharmaceutical Technology

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).

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Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis

Fierce Pharma

Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis zbecker Mon, 05/22/2023 - 14:43

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Biogen and Eisai seek UK’s marketing authorisation for lecanemab

Pharmaceutical Technology

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.

Marketing 130
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Pfizer, Moderna among many biopharma giants to post Q1 sales declines, as Novo Nordisk led growth charge

Fierce Pharma

Pfizer, Moderna among many biopharma giants to post Q1 sales declines, as Novo Nordisk led growth charge kdunleavy Mon, 05/22/2023 - 13:04

Sales 114
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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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Vital patent for AlzeCure Alzheimer’s drug

Pharma Times

ACD856 is the leading candidate therapy on the company’s NeuroRestore platform

Drugs 135
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How to get the most out of your clinical trial search

Antidote

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.

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How Pairwise Leverages CRISPR Technology for Leafy Greens

XTalks

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.

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Insmed unveils new research platforms and capabilities

BioPharma Reporter

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.

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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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Bayer's blockbuster hopeful Nubeqa, AstraZeneca's Forxiga pick up nods from England's NICE

Fierce Pharma

Bayer's blockbuster hopeful Nubeqa, AstraZeneca's Forxiga pick up nods from England's NICE zbecker Mon, 05/22/2023 - 10:44

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Eisai makes lecanemab therapy application

Pharma Times

Treatment involves early Alzheimer’s disease and will be potentially used across Great Britain

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SkinVive by Juvéderm: The New Dermal Filler Coming to the US

XTalks

Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness. SkinVive is FDA-approved for all Fitzpatrick skin types I to VI (lightest to darkest), addressing a range of skin quality concerns.

Filler 92
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With Dupixent leading the way, Sanofi’s taking on the 'big players' in respiratory diseases: exec

Fierce Pharma

With Dupixent leading the way, Sanofi’s taking on the 'big players' in respiratory diseases: exec kdunleavy Mon, 05/22/2023 - 07:33

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How Machine Learning Drives Clinical Trial Efficiency

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.

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uBriGene targets North American growth with buy of Mustang Bio facility

BioPharma Reporter

uBriGene is expanding into the US market with the acquisition of a state-of-the-art GMP manufacturing facility from Mustang Bio.

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FDA Approves First Nasal Nalmefene Spray for Opioid Overdose

BioSpace

FDA Approves First Nasal Nalmefene Spray for Opioid Overdose 5/23/2023

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UK missing out on being a 'life-sciences superpower' as participant numbers plummet due to lack of incentives

Outsourcing Pharma

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.

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Billy Dunn’s Prothena Board Position Reignites Ethical Debate

BioSpace

Billy Dunn’s Prothena Board Position Reignites Ethical Debate 5/23/2023

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.