Blogs about Biotechnology, Pharmaceutical and Healthcare

11:25 EDT 22nd September 2017 | BioPortfolio

Read the latest opinions - blogs from pharmaceutical and life science industry experts.

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Friday 22nd September 2017

72K People Live on Maria-Ravaged Dominica. Its Hospital's ICU Was Destroyed.

Hurricane Maria left medical facilities on the Caribbean island of Dominica "worse than in a war zone," according to the country's leader.

Pfizer, Veritas, MGH Join Xconomy’s Healthcare + A.I. Conference on Nov. 2

Like a lot of fields, healthcare is riding the A.I. wave. We’re hearing about machine learning and other artificial intelligence techniques being applied to genomic analysis, drug discovery, imaging and diagnostics, patient-doctor interactions, and other clinical tasks. But there’s a lot of hype and challenges to go along with it. On November 2, Xconomy is […]

Technical Snapshots for These Biotech Stocks -- ImmunoCellular Therapeutics, Protalix ...

If you want a Stock Review on IMUC, PLX, SYN, or ABEO then come over to sign up for your free customized report. Read more...

Bio Roundup: RNAi’s Big Day, CAR-T For Kids, Drugs From Fungi & More

It’s been a year of biomedical milestones in the U.S., including the first approval of a CAR-T cellular immunotherapy, the first smartphone app to treat substance abuse, and the first approval of a cancer drug based on genetic signature instead of the tumor’s organ of origin. Add to the list the first successful Phase 3 […]

Apple Just Made QR Codes A Must Have For Your Strategy

QR codes just got interesting thanks to a stealth update from Apple. Here's how you can use QR codes to make your life easier...

Co-ordination, co-operation and reorganisation: the Fund’s national focus on health care in the 1970s

Aradigm: Hidden Binary Event Or Russian Roulette (With The FDA Spinning The Chamber)?

FDA approves bevacizumab biosimilar Mvasi

On 14 September 2017, the US Food and Drug Administration (FDA) approved its first biosimilar for the treatment of cancer.

Positive phase III results for Pfizer’s trastuzumab biosimilar

Pharma giant Pfizer announced on 10 September 2017 positive results from the pivotal phase III study of its candidate trastuzumab biosimilar. Pfizer says that ‘data from the REFLECTIONS B327-02 study demonstrates equivalence in objective response rate (ORR) for patients with HER2-positive metastatic breast cancer’.

Regulatory pathways for approval of biological products in Brazil

Up until 2002, Brazil had no specific guidance for biological products. In 2002 guidelines for biological products were published (RDC 80/2002), which had to be followed by both originator biologicals and ‘follow-on biological products’.

Comparable efficacy and safety observed in patients switched to biosimilar CT-P10

Rituximab is a monoclonal antibody that targets the CD20 protein that is primarily found on B lymphocytes. Through depletion of CD20-positive B cells in the peripheral blood and bone marrow, rituximab is effective for treating some haematological malignancies and immune-mediated diseases such as rheumatoid arthritis (RA). CT-P10 (Truxima) is a biosimilar of the rituximab reference product. It is t...

Second etanercept biosimilar approved in Canada

Sandoz, the generics division of Novartis, announced on 21 August 2017 that its etanercept biosimilar, Erelzi, is now available in Canada.

How a suicide taught this doctor a lesson

Saturday nights on my couch are usually late and peaceful. But my old friend, civil unrest, crept into my reprieve. Do I do one more “to-do task?” Or do I or continue my aimless net surfing? But it’s not exactly aimless now. I’d just stumbled across an online article: “When You are the Friend of […]

FDA forms working group to increase generics competition

US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb had announced the creation of a working group of senior staff focused on increasing generic drug competition.

3 Things In Biotech You Should Learn Today: September 22, 2017

Biosimilars applications under review by EMA – August 2017

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ...

Indivior to appeal US ruling on opioid addiction patent

UK-based addiction treatment manufacturer Indivior Plc have announced plans to appeal against a US court, which ruled that Indian generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) had not infringed patents on their opioid addiction treatment Suboxone.

Natera sélectionnée pour une étude sur l'ADN tumoral circulant dans le cadre du cancer de la ...

L'étude évaluera plus de 400 échantillons de plasma obtenus de manière prospective auprès de patients ayant subi un traitement contre le cancer de la vessie, et Read more...

Natera seleccionada para un estudio del ADN tumoral circulante en el cáncer de vejiga

El estudio evaluará más de 400 muestras de plasma recogidas de manera prospectiva de pacientes sometidos a tratamiento para el cáncer de vejiga, y cuya Read more...

Natera für Studie zu Zirkulierender Tumor-DNA bei Blasenkrebs ausgewählt

Die Studie wird über 400 prospektiv gewonnene Plasmaproben auswerten, die von Patienten stammen, die sich einer Blasenkrebsbehandlung unterzogen haben und deren Blut fortlaufend im Rahmen Read more...

Eleven Biotherapeutics Announces Completion of Vicinium Manufacturing for Ongoing Clinical ...

-- Topline Three-Month Data from Phase 3 Registration Trial Expected in Mid-2018 -- Read more...

Novocure Announces Data Presentations at the American Society for Radiation Oncology’s 2017 ...

Late-breaking oral presentation to focus on Optune five-year survival and health-related quality of life data Read more...

Gary Huber, DO, is Honored by the American Health Council for “Best in Medicine”

NEW YORK, Sept. 22, 2017 (GLOBE NEWSWIRE)

What Will Graham-Cassidy Do To Transplant Patients?

People with kidney or organ transplants are an overlooked group at grave risk under Graham-Cassidy.

Digital Health Market will Reach USD 536.6 Billion by 2025 - Transparency Market Research

Albany - NY, Sept. 22, 2017 (GLOBE NEWSWIRE)

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