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Featured Stories


AstraZeneca Q1: Tagrisso Beats Expectations And Drives Oncology Performance

Tagrisso shines for AstraZeneca in the first quarter and the company is on track for approval of a fifth new cancer drug, in line with 2014 promises made by CEO Pascal Soriot when the company rejected takeover offers from Pfizer.

Sales & Earnings Cancer Business Strategies

FDA Flags Lower Efficacy For Merck's Keytruda, Roche's Tecentriq In Frontline Bladder Cancer Trials

In patients with previously untreated metastatic bladder cancer with low PD-L1 expression, PD-1 drugs alone don't work as well as chemo.

ImmunoOncology Approvals Clinical Trials

More Alzheimer's Pain As J&J Pulls Plug On BACE Inhibitor

J&J's Janssen unit is ending development of atabecestat after serious elevations of liver enzymes were seen in some patients who received the drug, increasing doubts about the BACE inhibitor mechanism as an appropriate target.

Clinical Trials Safety Neurology
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Addressing the Data Challenges of Pharmacovigilance

Thought Leadership from Oracle Health Sciences

Oracle Health Sciences

As pharmacovigilance adopts next-generation technology by leveraging artificial intelligence (AI) and the cloud, new possibilities are opening up for knowledge generation from the data collected and processed.

In a recent study commissioned by Oracle Health Sciences and conducted by Informa Pharma Intelligence, PV experts responded to the data challenges of pharmacovigilance. Read this whitepaper which explores the survey results and looks into three important developments around drug safety data, their analysis and how the industry is preparing for them.

Survey results include:

  • Artificial intelligence in adverse event processing.
  • Cloud solutions for pharmacovigilance.
  • Regulatory requirements for reporting.
View Survey Results

 

Commercial Explore this Topic

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Will Glenmark-Celon’s ‘Substitutable’ Seretide Deliver In Europe?

Glenmark-Celon’s generic Seretide Accuhaler dry powder inhaler (DPI) has hit the Danish market but whether it can build momentum around its regulatory clearance for substitution remains to be seen.

Respiratory Generic Drugs Commercial

Celsius Searches Single Cell Genomic Data For New Drug Targets

The company closed a $65m Series A round to interrogate single cells involved in diseases and identify genes responsible for their malfunction, providing new targets for precision medicines to treat autoimmune diseases and cancer.

Financing StartUps and SMEs Personalized Medicine

Takeda Looks To The New As It Braces For Velcade Generics

Takeda is facing major revenue challenges from US generics to its big seller Velcade, but is looking to successor and other new products to more than plug the gap.

United States Commercial

Piramal Critical Care Docks For China Push

Peter DeYoung, CEO of Piramal Critical Care, tells Scrip about his plans to take the group’s inhalation anesthesia portfolio to China and talks of the greater “competitive intensity” in the US amid quicker ANDA approvals by the FDA. Timelines around the potential US launch of the inhaled anesthetic agent, desflurane, however, appear hazy.
Commercial Strategy

Fortis Suitor Hikes Offer For Indian Hospital Chain After Board Accepts Rival Bid

The takeover battle for India’s Fortis Healthcare has accelerated, with Manipal Healthcare, backed by US investment management firm TPG Capital, raising its offer for the troubled hospital chain against the backdrop of a messy dispute over the bidding process. Malaysian suitor IHH Healthcare has also since extended its offer validity period.

India Commercial

Scrip Asks...What Is The Current Trend For Open Innovation In Asia?

Open Innovation and global partnering are becoming one of the most frequent themes of bio conferences in South Korea and elsewhere. Scrip talked to global experts at the recent Bio Korea 2018 meeting about their views on the current climate and trends for open innovation in Asia, as well as some challenges and benefits in pursuing open innovation approaches with Asian companies.

Commercial Innovation

Amgen's Aimovig Aims To Capture As Many Migraine Patients As Possible With $6,900 Price

Amgen and Novartis won the first US FDA approval for a CGRP inhibitor in the prevention of migraine headaches. The companies aim to quickly capture a big share of what they estimate to be an 8m-patient market in the US with a $6,900 per year price tag.

Approvals Launches

Pharming Turns A Profit After Reclaiming Ruconest

Pharming Group, a company that has been on the drug development scene since the ‘80s, has recorded a quarterly net profit for the first time – two years earlier than previously forecast.

Sales & Earnings Business Strategies

Policy & Regulation Explore this Topic

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Pharma Backs UK Parliament Report As 'No Deal Brexit' Fears Grow

The pharmaceutical sector has given its backing to a report from MPs which warns that a no-deal Brexit will have a hugely damaging effect on the industry in the country, turning it into "a second-tier state for new and innovative medicines."

Brexit Market Access Europe

Mehta Analysis: Trump Pricing Tempest In A Teapot Is An Opportunity For Biopharma Leaders

President Trump's much anticipated pronouncements on drug pricing reform leave a lot to be clarified. Biopharma companies and their leaders should grasp the opportunity to lead from the front and propose tangible and transformative actions that deliver benefits for all stakeholders, writes Viren Mehta, founding partner of Mehta Partners LLC.

Pricing Debate Strategy

How Drug Promotion Might Change Under Trump's Rx Pricing Plan

DTC disclosure requirements are shiny but probably not substantive; copay navigator might be weightier.

United States Pricing Debate

'Immediate' Steps To Lower Drug Prices: The HHS Action Plan

Many of US drug pricing blueprint's proposals could be accomplished administratively, but will still be shaped by stakeholder feedback.

Pricing Debate Medicare

Research & Development Explore this Topic

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Pipeline Watch: Phase III Progress With Burosumab, Duvelisib And Galcanezumab

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals Research & Development

Syndax Sees Subgroup Efficacy For Entinostat Plus Keytruda In NSCLC

The company says a subgroup of lung cancer patients with high pre-treatment monocyte levels showed promising response and PFS rates in study pairing Syndax’s selective HDAC inhibitor with Merck’s Keytruda. Mature data will inform future Phase III melanoma plans.

Research & Development ImmunoOncology

Immuno-Oncology: What To Watch At ASCO 2018

Cancer immunotherapy is once again set to dominate the upcoming American Society of Clinical Oncology annual meeting, with a continuing showdown for PD-1 inhibitors in lung cancer, a CAR-T battle, and disappointments for new IO classes.

ImmunoOncology Clinical Trials

Other ASCO 2018 Highlights – It’s Not All IO

The ASCO annual meeting will stage an upset in the EGFR field in lung cancer, and competition in breast cancer within the CDK4/6 and PI3 kinase inhibitor classes will get tighter. Loxo could once again steal the show with a tissue-agnostic drug, this time targeting RET. 

Clinical Trials Cancer
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