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Celltrion To Invest $33.6bn As It Lays Out Long-Term Ambitions

Celltrion unveils massive long-term investment plan to secure leadership in the global biopharma market, set up international sales distribution networks and support new bioventures and job creation, in the meantime contributing to Korea’s larger ambitions to develop as a worldwide drug industry hub.

South Korea Business Strategies Biosimilars

LifeArc CEO: UK Charity Is Cashing In Its Keytruda ‘Jackpot’ To Expand R&D Focus

The CEO of LifeArc tells Scrip why the UK-based medical research charity has decided to monetize a part of its royalty interest in Merck’s hugely successful cancer drug, Keytruda.

Deals Research & Development Cancer

What We Learned From Q1 Pharma Earnings Season

With US drug pricing pressures and generic and biosimilar competition weighing on big pharma, new launches and brisk business in China have been providing a silver lining. Scrip writers analyze the industry landscape in light of the first-quarter results.

Sales & Earnings Companies Commercial

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Embedding Time-Critical Scheduling in Drug Production

Manufacturing is the engine room of the pharmaceutical industry. Ultimately, a medicine has little value if it does not reach patients on schedule, in the required quantity and quality. Download this whitepaper which discusses time-critical scheduling in drug production.

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Reneo Reveals $50m Series A, Mitochondrial Disease Development Plans

The start-up run by ex-Lumena leadership is testing REN001 for rare genetic mitochondrial diseases with two Phase Ib trials under way and plans to start a third later this year.

Financing StartUps and SMEs Rare Diseases

Five Companies To Watch This ASCO

MacroGenics, Amgen, Celgene, Forty Seven and Iovance are all set to enjoy a good ASCO meeting with promising data for key products revealed in the abstract drop.

Cancer ASCO Clinical Trials

Syncona CEO On Why Its 10th Start-Up Focuses On T-Regulatory Cell Therapies

UK investment group Syncona Ltd has financed its tenth start-up, Quell Therapeutics, with the aim of developing engineered T regulatory (Treg) cell therapies.

Commercial Deals

Deal Watch: Ireland's Amryt Acquires Aegerion

European firms Amryt and Evotec have signed agreements to acquire two companies based across the Atlantic – Aegerion and Just Biotherapeutics, respectively. 

Deals M & A

Boehringer Doubles Down On Deafness With Rinri Backing

After making a move into hearing loss with an investment into Acousia Therapeutics, BI is backing a UK biotech which hopes to reverse neuropathic sensorineural hearing loss.

Ear, Nose & Throat StartUps and SMEs

Product Delays Dull Dr Reddy’s Despite Upbeat Management

Dr Reddy’s had a generally positive Q4 but a slow ramp in some products in the US and potential delays in anticipated launches there are among the challenges that appear to have jaded investor outlook. Management commentary, though, was optimistic, with around 30 launches lined up for the US, a China/India thrust and M&A staying an important cog for growth.

Sales & Earnings Commercial

Penalty For Daiichi As It Falls Short In Japan Flu Vaccine Project

Japanese firm fails to meet production capacity target under Japan national flu vaccine supply plan, triggering a financial penalty and the return of government grant money.

Japan Vaccines

Merck And The 'Strange Business' Of Antibiotics

Antibacterials have been part of Merck's mission for decades, despite the market challenges, and it's expecting two new approvals this year. Infectious disease VP Joan Butterton talks about tackling those challenges and incentives that may help the industry address antimicrobial resistance.

Infectious Diseases Research and Development Strategies

Policy & Regulation Explore this Topic

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Basilea-Pfizer’s Cresemba Heads For Indian Debut

Basilea’s Cresemba appears on course to a debut in India and partner Pfizer expects the novel antifungal to bolster its existing portfolio in the segment. Pricing of the product will be keenly watched.

Policy & Regulation India Launches

Pediatric Oncology Advances Could Prompt More FDA-Required Studies

Findings being presented at ASCO next month could signify major increase in targets relevant to pediatric oncology, meaning sponsors should prepare for more US FDA-required studies under the RACE for Children legislation.

Pediatrics Cancer

BIA Urges Biotechs To Flag Risks From UK R&D Tax Credit Reform

A UK government consultation on a new cap to R&D tax credits closes soon. The BIA is urging small companies to respond in an attempt to avert changes that could put small, virtual biotech firms out of business.

StartUps and SMEs Legislation

Joy For SMA Patients As NICE And Biogen Break Spinraza Deadlock

Between 600-1,200 people in England and Wales may be able to get Spinraza now that after 17 months of negotiations "appropriate flexibility" has led to an access agreement.

Health Technology Assessment Market Access

Research & Development Explore this Topic

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Ark Bio Of China Bets On Untapped Pediatric Antiviral Market Where Few Have Succeeded

Founded five years ago, Shanghai-based Ark Bio sees big potential in the less crowded pediatric antiviral treatment market. Now the start-up is in Phase II development for its lead asset ziresovir for respiratory syncytial virus (RSV) infection, which was licensed from Roche.

Research and Development Strategies Infectious Diseases China

BIO-Europe Spring 2019: InteRNA Sees MicroRNA Potential In Cancer Therapy

Roel Schaapveld is CEO of Dutch microRNA specialist InteRNA Technologies. He spoke to Mike Ward about the company’s therapeutic approach.

Platform Technologies StartUps and SMEs

Pipeline Watch: Phase III Readouts For Ivosidenib, Abrocitinib, Spartalizumab

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

MorphoSys Targets 2020 Tafasitamab Launch Following Good DLBCL Data

Morphosys says good L-MIND Phase II data back its plan to submit a US BLA to the US Food and Drug Administration by year-end, for a potential mid-2020 approval of tafasitamab.

Clinical Trials Companies