Opinion &amp; analysis

Poseida, Legend/Janssen Look To Snag Celgene/ Bluebird’s BCMA Crown

The BCMA CAR-T therapies gap between industry leaders Celgene and bluebird bio and their competition in the space is closing, according to data released at the December 2018 American Society of Hematology (ASH) meeting in San Diego.

December 4, 2018

Vanda Warning Letter From US FDA Leaves Firm “Puzzled”

A recent letter to Vanda from the US FDA regarding the firm’s listing of indications without corresponding safety information on the company’s website left Vanda’s CEO confounded as to the reasoning behind this action, even as the firm moved to take corrective action.

November 5, 2018

Patients’ Preferred Endpoints May Not Satisfy Regulatory Needs, US FDA Says

At a meeting of mitochondrial disease drug development, officials of US Food and Drug Administration said that just because a measure is relevant to the patient community does not mean it can capture meaningful change in a clinical trial. Pink Sheet looks at the implications to sponsors.

August 2, 2019

FDA’s Withdrawn Reg On Data Fraud Hangs Over Zolgensma Incident

Democratic senators push data-challenged gene therapy Zolgensma into the center of the drug pricing debate as they press acting commissioner Sharpless to bring the hammer down on Novartis, but also question the US FDA’s decision to withdraw its proposed rule about data falsification in clinical and nonclinical studies last year. Did the FDA do the right thing by abandoning a proposed rule that, as they state, is not needed to protect research subjects or ensure integrity of clinical trial data?

August 2, 2019

One Cancer Start-Up’s Resolve To Crack The Mystery Of Metastasis

Rgenix, founded by three brothers who are prominent physician researchers, sees itself at the forefront of cancer treatment. They are finding drugs that shut off metastasis rather than the more common goal of using the immune system to destroy cancer receptors.

September 24, 2019

Gottlieb’s Short Tenure Will Be Felt Long After He Leaves US FDA

Tap into Pink Sheet’s look back on Scott Gottlieb’s nearly two year tenure as Commissioner of the US FDA. Examine the legacy of his short-lived, yet productive stint, and look back on his list of accomplishments as leader of the agency.

March 6, 2019

Pfizer Price Increases Underscore Rebate Problem, HHS’ Hargan Says

At December’s FDA/CMS Summit in Washington, Health and Human Services Secretary Eric Hargan used Pfizer’s recent price hike of 41 of its products as evidence that higher drug costs are a direct result of the rebate system, a viewpoint touted by the Trump administration in their quest to lower drug prices.

December 12, 2018

J.P. Morgan Notebook Day 2: Biogen, GSK, Bluebird, Roche, Amgen, Biohaven, Lilly And FDA’s Gottlieb

Scrip reports from Day 2 of the 2019 J.P. Morgan Healthcare Conference, bringing you the highlights to come out of the San Francisco meeting. Read the most important news from Day 2, including the latest from Biogen, updates on GSK’s oncology efforts, deal developments for bluebird and Lilly, and more.

January 9, 2019

L’Oréal E-Commerce Growth Approaches 50%: ‘We Are Now Clearly A Digital-First Company’

Beauty products leader L’Oréal has enjoyed much success thanks to E-commerce, the Asian market and travel retail continue to fuel gains at L’Oréal, which just posted its strongest first half like for-like growth in more than a decade. Skin care remains a key driver as well, offsetting a global slowdown in makeup that has hit the firm’s US business hardest, with little improvement expected this year. Will all this be enough to make up for sluggish conditions in North America and the US in particular, where more than half of L’Oréal’s sales are in makeup? Read the article to find out what else the company is banking on.

August 2, 2019

FDA Determined To Update Cosmetics Regs After Claire’s Refuses To Recall Asbestos-Tainted Makeup

The battle over traces of asbestos found in cosmetics products at Claire’s, a jewelry and accessories retail chain that caters to girls and young women, serves to illustrate the limitations of the US FDA’s oversight of cosmetics matters. Find out more here.

March 7, 2019

UK Notified Body BSI Sets Out Clear Post-Brexit Paths As It Goes Dutch

Leading UK and EU notified body BSI expects the UK to remain a full member of the EU regulatory regime post-Brexit, but it has a contingency plan. Learn what this contingency plan means for device manufacturers. Gain insights into the implications of a non-negotiated Brexit, and find out if the other notified bodies have contingency plans.

May 25, 2018

EMA Set For More Staff Losses & Activity Cuts Next Year

The European Medicines Agency braces itself for a major reduction in staff and decrease in activities. The move is a reaction to Brexit and the agency’s move from London to the Netherlands. The cuts are the latest challenge presented by Brexit, as the EMA braces for an overall 30% loss of staff.

December 11, 2018

Game On For Akili’s Cognitive Control Tech

$100.00

A digital video game developed by Akili Interactive Labs for treating cognitive disorders has demonstrated in a pilot study its ability to improve cognitive control test scores of neurotypical children and children with sensory processing dysfunction (SPD).

February 5, 2018