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Clovis, CEO Mahaffy Settle SEC Investor Fraud Charges Over Rociletinib Efficacy Claims

Clovis, CEO Patrick Mahaffy and former CFO Erie Mast will pay more than $20m to settle charges by the SEC that the company misled investors on the efficacy of rociletinib. Clovis raised $298m in a public stock offering during the timeframe SEC says it misled investors.

Legal Issues Leadership Companies

ICON CEO: CROs Must Be Aware Of Threat Posed By Big Tech

ICON’s CEO Steve Cutler talks candidly about the impact of biotech funding, disruptive tech providers, and the constant pressure of running one of the industry’s largest CROs.

Clinical Trials Leadership Research and Development Strategies

Tildrakizumab Set For Europe Debut - Can It Make A Dent?

Almirall's Ilumetri, licensed from Sun Pharma, has been cleared by the European Commission, upping the competition quotient in the psoriasis market and pitting the product directly against Johnson & Johnson's Tremfya.

Europe Commercial Strategy
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Case Study: Broad Thinking Yields Big Results

There are numerous details when considering product packaging that require both creative thinking and feature prioritization. Rather than developing a standard solution for the current need, it’s imperative to think broadly and design options that are cost-effective, simplify operations and save time and/or resources.

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Commercial Explore this Topic

Set Alert for Commercial

Galera Raises $150m To Take Lead Drug From Phase III To NDA Submission

Galera garnered $70m in Series C venture capital and $80m through a royalty deal tied to GC4419 and a follow-up drug for the treatment of severe oral mucositis caused by radiation therapy with an initial focus on head and neck cancer patients.

Financing Business Strategies StartUps and SMEs

Novo Nordisk Cuts 400 Jobs In R&D Reshuffle As It Broadens Its Horizons

Novo, which is under pressure to diversify and signaled plans to cut jobs back in August, will lay off 400 people as it reallocates resources to more efficiently bring in novel products through both R&D and business development, continuing a deal-making spree that's already under way.

Business Strategies Research and Development Strategies Companies

Pfizer Eyes First-To-Market Opportunity In Alopecia

Inflammation and Immunology Chief Scientific Officer Michael Vincent talked to Scrip about the first positive Phase II data testing a JAK inhibitor for hair loss caused by alopecia areata, next steps for development and the broader I&I portfolio.

Immune Disorders Research & Development

Asia Deal Watch: BIOCAD, Shanghai Pharma Agree On Pair Of Russian/Chinese Joint Ventures

The JVs will develop and commercialize therapeutics for multiple cancer types and autoimmune disorders in China. Novocure partners its Tumor Treating Fields technology with Zai Lab, while Fate and ONO will collaborate on off-the-shelf CAR-T therapies.

Asia Pacific Deals

Boehringer Ingelheim Is Getting Bets In Early In IO Space

The head of the German family-owned firm's venture fund tells Scrip that investing very early in promising start-ups gives Boehringer Ingelheim "a little bit of a head start" on rival pharma companies in identifying technologies that could translate into therapies five years down the line .

Financing M & A

Assessing Artios: $83m Series B, Big-Name Investors, Nothing In The Clinic

Cambridge, UK-based Artios Pharma attracted several new investors for its over-subscribed series B round in August 2018, but the company is yet to enter the clinic with its DNA repair drug portfolio and has many hurdles ahead to validate its technology. Scrip speaks to investors from LSP and Arix about why preclinical-stage biotechs are getting more attention in 2018.

Companies Financing

Xelpros Approval Adds Spark To Sun’s Site Too?

Xelpros may not be seen as a huge money-spinner, but its approval by the US FDA signals Sun Pharma's expanding interest in the US ophthalmology space. The clearance also potentially indicates that recent compliance issues at the company’s Halol site may not be all-encompassing.
Commercial Strategy

Is Quarterly Dosing For Teva's Ajovy Enough To Differentiate It From Other CGRP Inhibitors?

The US FDA approved Teva's fremanezumab dosed monthly and quarterly versus Amgen's monthly Aimovig, and will launch at the same price. However, it's packaged as a pre-filled syringe instead of an autoinjector, has a higher rate of injection site reactions and it may launch alongside Lilly's Emgality.

Approvals Launches

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

AbbVie Deployed Nurses As 'Runners And Cappers' In Humira Kickback Scheme, Suit Alleges

California Insurance Commissioner claims AbbVie gave kickbacks for healthcare providers to prescribe Humira and had nurse 'ambassadors' insert themselves between patients and physicians.

Advertising, Marketing & Sales Legal Issues Immune Disorders

Fix Antibiotic Payment Models To Spur R&D Investment, US FDA’s Gottlieb Says

Citing need for more ‘pull’ incentives to overcome commercial hurdles, FDA commissioner says a subscription-based fee reimbursement system would provide a foundation for return on investment of new antimicrobials targeting multi-drug resistant pathogens.

Infectious Diseases Reimbursement

Timing Is Everything – Unfortunately For Acorda, Timing Couldn't Be Worse

Acorda can't seem to catch a break. The Federal Circuit slapped down the company's last ditch effort to uphold its Ampyra patents and three days later the FDA postponed a decision on Inbrija, widening the gap between the entry of Ampyra generics and the launch of Acorda's new drug.

Neurology Business Strategies

Shire Snags EU Okay For Von Willebrand Drug Veyvondi

Although noises are still being made in Japan concerning the benefits of Shire's merger with Takeda, the former is going about the business of getting marketing green lights with the latest being for its inherited bleeding disorder treatment Veyvondi in Europe.

Blood & Coagulation Disorders Approvals

Research & Development Explore this Topic

Set Alert for Research & Development

Phase III Data Put Zealand's Dasiglucagon On Track, But Behind Others, For Hypoglycemia Rescue

Zealand Pharma stresses fast onset of dasiglucagon, which it plans to file on its own but develop commercially through partnership.

Metabolic Disorders Clinical Trials Commercial

Spectrum To Test Poziotinib's Potential As First Line Treatment Of Exon 20 Mutant NSCLC

Spectrum is expanding a clinical trial with its novel, oral pan-HER inhibitor poziotinib into the first-line treatment of NSCLC with EGFR or HER2 exon 20 insertion mutations, which could provide a much-needed new option for these patients. The move also marks further positive development progress for the drug, which the US firm licensed in from Hanmi.

Clinical Trials Cancer

ASLAN, Sosei Pipeline Assets Hit By Development Delays

Two Asia-based companies disclose delays to important clinical pipeline assets, one in oncology driven by apparent ethnic differences in response to prior therapy and the other a CNS molecule hit by an unexpected toxicity finding in an animal study.

Asia Pacific China

Viking’s Liver Fat Reduction Data Portend A New Competitor In NASH

In a Phase II study, Viking’s VK2809, with the same mechanism as Madrigal’s MGL-3196, shows significant liver fat reduction in NAFLD patients, along with reduction in LDL cholesterol.

Clinical Trials Liver & Hepatic
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