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Roche Pushes Personalization With $2.4bn Foundation Buy-Out

By picking up the rest of Foundation Medicine, which is now valued at $5.3bn, the Swiss giant is expanding its leadership in cancer diagnostics, genomics and molecular information for personal medicine.

M & A Cancer Digital Health

£88m Series B For Syncona-backed Freeline To Advance Liver Gene Therapy Focus

Chairman says Freeline's series B financing gives it adequate funds for Phase I/II trials in hemophilia B and entry into Fabry disease.

Financing Blood & Coagulation Disorders Commercial

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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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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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 South Korea

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

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

Research & Development Explore this Topic

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Catalyst Biosciences Drops On Study Halt

The appearance of neutralizing antibodies to Catalyst's investigational subcutaneous Factor IX product sent the company's share price southwards.

Clinical Trials Drug Safety Research & Development

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

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

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
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