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Daiichi's Phase III Quizartinib Data Pave Way In Niche AML Market

Showing an overall survival improvement in the especially hard to treat FLT3-ITD mutated patients is a significant achievement in AML, analysts say.

Clinical Trials Research & Development Blood & Coagulation Disorders

Roche's Risdiplam Data Stir Up SMA Market

Positive results for the Swiss major's oral therapy suggests that Biogen and Ionis' monopoly of the lucrative spinal muscular atrophy market with Spinraza could soon be under considerable threat.

Rare Diseases Pediatrics Clinical Trials

Opdivo Approval Opens China I-O Doors But Pricing Key

China approves first immuno-oncology drug in the form of BMS’s Opdivo for lung cancer, opening up a new potentially huge market for the class, but much will depend on pricing and reimbursement policies.

China Cancer Approvals
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Innovation in the pharmaceutical industry has never been more exciting, and complicated. Disruptive technologies, such as artificial intelligence and digital health tools, and advanced therapeutic modalities including cell and gene therapies and antisense oligonucleotides demand that all health care stakeholders make efforts to move into the next generation of patient care and centricity.

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Commercial Explore this Topic

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Deal Watch: BridgeBio To Launch New Subsidiary Around Rare Disease Candidate Obtained From Alexion

Sanofi completes the transition of its infectious disease unit to Evotec. Perhaps not yet done with virology, Gilead licenses technology for HIV/hep B vaccines from Hookipa.

Deals Business Strategies Commercial

Scrip Asks... What Is The Future Of Biotech?

Scrip asked industry leaders during the BIO 2018 meeting to envision future changes to the rapidly evolving world of biotechnology, predicting what the next five years will bring. 

Innovation Business Strategies Personalized Medicine

Finance Watch: Investors Go Nuts For NASH As Madrigal Raises $300m, Galmed Skyrockets

Public Company Edition: Madrigal and Galmed shares more than doubled after reporting what were viewed as positive results in mid-stage NASH studies, with Madrigal going on to raise $300m on the back of the data. Not all is well for publicly traded firms, however, as Advaxis and Flex Pharma reveal layoffs.

Financing Business Strategies

Shionogi Deal Opens Asia To Sage’s Fast-Acting Antidepressant

Japan’s Shionogi has gained selected Asian rights to Sage’s promising fast-acting depression drug, in a deal worth up to $575m to the US company.

Japan Neurology

Lilly Stays Committed To Alzheimer's, Including Amyloid Hypothesis, Despite Many Failures

The failure of BACE inhibitor lanabecestat was the latest setback in Lilly's Alzheimer's pipeline, but the company has been working in this area with almost no success for decades, yet still feels a commitment to keep trying, Lilly Research Labs President Daniel Skovronsky tells Scrip.

Research and Development Strategies Neurology

Branded Advair Breathes Another Day; Mylan Says A CRL Is On The Way For A Generic

FDA alerted Mylan to expect a complete response letter related to its ANDA for generic Advair. The company said it still could receive an approval prior to the standard 90-day time period after responding to the letter, because the application has a priority designation.

Generic Drugs Respiratory

Big Pharma Voluntary List Price Reductions Doubtful, Sen. Warren Says

Companies responding to inquiries from Sens. Elizabeth Warren, D-Mass., and Tina Smith, D-Minn., did not indicate they are planning to reduce list prices, despite promises by President Trump, Warren told a June 12 hearing. 
Pricing Debate Pharmacy Benefit Management

Sun’s Halol Site Out Of Compliance Rut, Could Add Some SPARC Too

Sun's Halol manufacturing facility is over the compliance hump, receiving an EIR [Establishment Inspection Report] from the US FDA. The site, seen as core to India's top ranked firm's promising filings, including injectables, is also expected to lift the prospects of Sun's spin-off R&D arm, SPARC.

Manufacturing Compliance

Policy & Regulation Explore this Topic

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Dr. Reddy's Launches First Generic Suboxone Film; Indivior May Seek Injunction

Launch comes immediately after FDA approval of Dr. Reddy's and Mylan ANDAs while Indivior appeals district court ruling of non-infringement; Mylan settlement may delay its entry.

Generic Drugs Approvals BioPharmaceutical

Big Pharma Voluntary List Price Reductions Doubtful, Sen. Warren Says

Companies responding to inquiries from Sens. Elizabeth Warren, D-Mass., and Tina Smith, D-Minn., did not indicate they are planning to reduce list prices, despite promises by President Trump, Warren told a June 12 hearing. 
Pricing Debate Pharmacy Benefit Management

New EU Approval Further Boost For Tagrisso As Threats Recede

Tagrisso's march on the first-line EGFRm NSCLC market looks like it will be unimpeded by any near-term rivals following new data at ASCO as the EU becomes the latest market to approve it in the first-line setting.

Approvals Clinical Trials

Next-Generation Roche: How Data Analytics Will Keep It In The Lead In Oncology

Roche used its ASCO investor briefing to highlight its digital and personalized healthcare strategy, including examples of how it’s facilitating R&D and reimbursement – and how that should position it to be an oncology leader in the future. 

Digital Health ASCO

Research & Development Explore this Topic

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Bluebird 'Turns A Corner' With Lentiglobin Gene Therapy, Tests Remain

Updated results of studies of its Lentiglobin gene therapy using bluebird's new manufacturing process presented at the EHA meeting are encouraging but the real test will be in the longevity of its effects and the strength of its surrogate marker.

Clinical Trials Research & Development Blood & Coagulation Disorders

Samsung, Celltrion Aim For Biosimilar Confidence, Convenience With New Studies

South Korean biosimilars companies Samsung Bioepis and Celltrion presented new study results, designed to increase overall switching rates away from the branded originator therapies and address prescriber concerns as well as improve administration convenience, at the European League Against Rheumatology (EULAR 2018) held June 13-16 in Amsterdam, Netherlands.

Biosimilars Research & Development

HVIVO Seeks Big Pharma Partner For ‘Phase III-Ready’ Universal Flu Vaccine

Presenting Phase IIb data on FLU-v, specialized CRO hVIVO now hopes to secure a big pharma partner for Phase III studies and commercialization of the universal flu vaccine candidate. The product has been developed in a joint venture with SEEK.

Vaccines Clinical Trials

Teva's CGRP Inhibitor Fails In Chronic Cluster Headaches, Continues In Episodic

Unlike the migraine space, there is only one competitor for Teva's CGRP inhibitor in cluster headaches, but that opportunity narrowed with fremanezumab's failure in chronic cluster headaches, though a trial in episodic cluster headaches is ongoing.

Research and Development Strategies Neurology
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