Industry news

01 August 2016

Will Liquid Biopsies Transform Oncology Clinical Trials?

Ed Miseta / Clinical Leader

Epic Sciences says it has developed a technology that CEO Murali Prahalad believes will transform oncology trials by identifying and characterizing circulating tumor cells. Those cells have been long recognized as a key part of cancer metastasis. Tumors shed these cells into the circulatory system where they then travel to different parts of the body and, under the right conditions, become the genesis of new tumors.

Pfizer planning yet another plant expansion

Eric Palmer / Fierce Pharma

In yet another expansion of its manufacturing operations, Pfizer ($PFE) plans to lay out nearly $150 million to build a sterile manufacturing facility and warehouse at its site near Kalamazoo, MI. It is the third manufacturing project the drug giant has unveiled in the last couple of months.

Another step forward: India releases updated biosimilar guidelines

T.V. Padma / BioWorld

Following feedback from industry, health policy experts and the public, India recently updated its draft guidelines for biosimilars, narrowing down the conditions for waivers of late-stage trials and expanding some testing criteria. "The revised guidelines have considered some stakeholder input, relative to the conduct of clinical trials and safety/efficacy studies," Ranjana Smatacek, former director general of the Organisation of Pharmaceutical producers of India (OPPI), told BioWorld Asia.

Old patients with HIV are the new group with unique needs

Anette Breindl / BioWorld

n the early days of the AIDS epidemic, the life expectancy for those diagnosed with HIV was two years from the time of diagnosis. In the era of antiretroviral therapy, Johnson & Johnson's chief scientific officer, Paul Stoffels, told the audience at the 2016 International AIDS Conference this week, "people can see their kids and their grandkids grow up, if therapy is done well."

Work begins on plan to prioritize U.K. life sciences post-Brexit

Nuala Moran / BiWorld

Work starts Monday on drawing up a life sciences transition program that the industry intends to present to government on Sept. 6 as a blueprint for negotiating the U.K.'s exit from the EU on favorable terms for the sector. The intention is to spend the next six weeks scoping the risks that need to be addressed and identifying opportunities to make the U.K. domestic landscape as strong and attractive as possible in the post-Brexit future.

New tools for assessing drug value haven’t caught on with payers — yet

Ed Silverman / STAT

As prices for prescription drugs keep rising, several organizations have developed different ways to assess the value of new medicines based on such attributes as cost, quality of life, and effectiveness. But a new survey finds that even as health plans continue to criticize drug prices, they have not yet embraced these new tools.

MIT researchers develop hydrogel patch to deliver cancer combo

Alyssa Huntley / FierceBiotech

Researchers at MIT have published a paper about an adhesive hydrogel patch that could be used in the treatment of colorectal tumors after surgery.

New medication shows promise against liver fibrosis in animal studies

U.S. National Institute od Health

A new drug developed by scientists at the National Institutes of Health limits the progression of liver fibrosis in mice, a hopeful advance against a condition for which there is no current treatment and that often leads to serious liver disease in people with chronic alcoholism and other common diseases.

Pharma trade group says price gougers are outliers, but then accepts two more

Ed Silverman / STAT

or months, the trade group representing big drug makers has argued that Valeant Pharmaceuticals and Turing Pharmaceuticals, which was once run by Martin Shkreli, were outliers for brazen pricing practices that outraged Americans.

U.S. public opinion on the future use of gene editing

Cary Funk, Brian Kennedy and Elizabeth Podrebarac Sciupac / Pew Research Center

The potential genetic modification of humans and its ramifications have long been debated, but a recent scientific breakthrough in gene editing – a technique known as CRISPR – has raised the urgency of this conversation. In March and April of 2015, two separate groups of scientists published essays urging the scientific community to impose limits on genomic engineering, and the National Academies of Sciences, working in cooperation with the United Kingdom’s Royal Society and the Chinese Academy of Sciences, convened an international summit to discuss the science and policy of human gene editing.