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Featured Stories


Takeda-Shire In India: Sleeping Giant?

Will Takeda take a less measured approach in India, where Shire brings it a significant on-market portfolio? Scrip outlines the current shape of things in the promising but complex emerging market as the two companies head towards combining forces globally.

Commercial M & A India

AstraZeneca’s Lokelma Approved In US With Label Benefits Over Veltassa

After delays caused by two complete response letters, AstraZeneca’s Lokelma has been approved in the US with label benefits over its major competitor, Vifor Pharma’s Veltessa.

Approvals Policy & Regulation Research and Development Strategies

Nabriva On Pace For Lefamulin NDA; Stock Tumbles Despite Trial Success

With a pair of Phase III trials demonstrating lefamulin’s non-inferiority to moxifloxacin in CABP, Nabriva plans to file an NDA later this year. But Nabriva’s share price fell during the day, perhaps due to safety concerns about the first-in-class antibiotic.
Research & Development Infectious Diseases Business Strategies
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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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Finance Watch: Early-Stage Firms Gain Deal-Making Insight As Golumbeski Joins VC Ranks

Private Company Edition: Celgene's former top deal-maker George Golumbeski is now a life science business consultant and venture partner at ARCH. Also, a VC investment surge portends another big year for biopharma, including $85m for Ansun and $66m for FogPharma.

Financing StartUps and SMEs Leadership

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

Dova’s Doptelet Gets First-To-Market Edge In Thrombocytopenia, Ahead Of Shionogi

Dova CEO Alex Sapir very confident of oral thrombopoietin receptor antagonist’s chances of taking market share from current standard of care, platelet transfusions, citing safety and convenience advantages.

Approvals Commercial

Pfizer's Three-Pronged Oncology Strategy Includes Expanding Ibrance, Xtandi, Developing Blockbuster Combos

Xtandi use in early prostate cancer, lorlatinib as second-line treatment for non-small cell lung cancer and dacomitinib for first-line NSCLC have upcoming user fee dates.

Research and Development Strategies Cancer

Diurnal Adrenal Franchise Takes Shape With Alkindi Launch

With the launch in Germany of Alkindi, Diurnal has kickstarted its plan of offering therapies that treat patients with cortisol deficiency diseases from birth right the way through to old age and the market is potentially a very lucrative one.

Metabolic Disorders Launches

Tomorrow’s CRO Steps Into The Real World

Last year, 187 deals took place in the pharma services realm, each one molding the acquisitive company into a slightly different shape to reflect the current needs of the pharmaceutical industry. One imperative continued to drive more large deals than all others: data.

Research and Development Strategies Deals

China JV Exit To Give Takeda More Focus, Cash

Takeda is selling its majority share in China biopharma joint venture Techpool to focus on its key growth areas in this market and raise cash ahead of the Shire acquisition, in a move that will also boost its former partner’s presence in manufacturing and critical care.

China Business Strategies

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

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

Missing In Action: China’s Best Shot In Ebola Vaccine Race

As the Congo grapples with the latest outbreak of Ebola, China has approved its first domestically developed vaccine in record time, hailing it a national innovation champion. But as the World Health Organization starts vaccinations in Africa, can China make the cut and compete with global players including Merck & Co?

China Vaccines

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

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

Research & Development Explore this Topic

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Hemlibra Hits The Heights In HAVEN Hemophilia Trials

Full results from the HAVEN 3 and 4 trials suggest that Roche’s hemophilia drug Hemlibra will indeed take a dominant market position in patients with or without factor VIII inhibitors although that make take some time as current therapy is already very effective and is supported by decades of safety experience.

Blood & Coagulation Disorders Clinical Trials Drug Safety

Dova’s Doptelet Gets First-To-Market Edge In Thrombocytopenia, Ahead Of Shionogi

Dova CEO Alex Sapir very confident of oral thrombopoietin receptor antagonist’s chances of taking market share from current standard of care, platelet transfusions, citing safety and convenience advantages.

Approvals Commercial

Pfizer's Three-Pronged Oncology Strategy Includes Expanding Ibrance, Xtandi, Developing Blockbuster Combos

Xtandi use in early prostate cancer, lorlatinib as second-line treatment for non-small cell lung cancer and dacomitinib for first-line NSCLC have upcoming user fee dates.

Research and Development Strategies Cancer

Phase III Beckons For A Short-Course Seasonal Allergic Rhinitis Jab

A marketing approval for a seasonal allergic rhinitis vaccine from Allergy Therapeutics has moved nearer with positive top-line Phase II results that define the dose to be used in a Phase III study.

Clinical Trials Ear, Nose & Throat
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