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Featured Stories


AZ's Dapagliflozin Impresses In Topline Phase III Heart Failure Study

AstraZeneca’s SGLT2 inhibitor has grabbed attention for its potential role in chronic heart failure patients, with or without type 2 diabetes, following initial results from the DAPA-HF study.

 

Clinical Trials Market Intelligence Companies

Amgen's US Biosimilar Launches Are Off To A Steady Start, With A Big Coverage Decision

United HealthCare agreed to cover Mvasi and Kanjinti in a preferred position. Amgen VP-oncology sales & marketing Susan Logan talked to Scrip about the company's first US biosimilar launches.

Biosimilars Launches Market Access

In Search Of Goodwill, Several Pharmas Commit To New Corporate ‘Statement Of Purpose’

The updated business principles may give pharma companies leverage, or at least talking points, as they continue to engage with the Trump administration on policies like the International Pricing Index and with US lawmakers on drug pricing legislation. J&J's Gorsky heads governing committee of multi-industry business group that revised its principles.

Pricing Debate Policy Leadership
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PRECISION MEDICINE RESEARCH: How Advanced Data Analytics Support The Journey From Clinic to Bedside

Precision medicine offers huge promise to patients and health systems. It can also substantially increase the efficiency of drug development by enabling more focused, data-rich clinical trials.

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Commercial Explore this Topic

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Nabriva Faces Skepticism After Years Of Preparing For Novel Antibiotic Xenleta's Launch

Lefamulin was approved in the US to treat community-acquired bacterial pneumonia, providing a needed IV and oral drug initially in the hospital setting, but new antibiotics have been a tough sell.

Infectious Diseases Approvals Launches

Juvenescence Raises $100M To Advance Anti-Aging Programs

The financing, which brings the total raised by Juvenescence to $165m, comes as longevity R&D programs supported by the company move towards human testing.

Financing StartUps and SMEs Regenerative Medicine

Bayer Says $7.6bn Farewell To Animal Health As It Sells Unit To Elanco

Bayer is relinquishing its Animal Health Unit to Elanco as the German major turns its focus more towards life sciences. The money received should help it pay down some Monsanto debt, but there are antitrust concerns.

Commercial Companies

Big Pharma Nibbles As Turkey’s Localization Policy Yields Limited Results

The Turkish Government’s carrot-and-stick “localization” policy has started to yield results with some multinational pharma companies including GSK and Sanofi disclosing joint production ventures with local companies, but these ventures have been limited by difficult economic conditions and worsening investment environment, and the fixed euro rate.

Turkey Manufacturing

Vanda Not Ready To Give Up On Jet Lag Indication For Hetlioz Despite CRL

Complete response letter follows July deficiencies letter that made approval seem highly unlikely. Vanda called the setback perplexing and said it plans to continue working to get jet lag disorder added to the Hetlioz label.

Commercial Life Cycle Management

US Is Land Of Opportunity For Zealand

The Danish group is beefing up its operations across the Atlantic as it prepares filings for dasiglucagon and glepaglutide.

Metabolic Disorders Strategy

AbbVie’s Post-Humira Strategy Continues Taking Shape With Rinvoq Approval

AbbVie now has both of its Humira successors approved in the US, following April’s Skyrizi approval for psoriasis. But Rinvoq faces stiff competition both within the JAK1 class and in rheumatoid arthritis generally.

Approvals Business Strategies

Glenmark On Course For Xolair Biosimilar Deal, US Capital Raise For Innovation

Glenmark appears close to sewing up a deal for its biosimilar version of Novartis/Genentech's Xolair amid the firm's ongoing focus on partnering out some key assets. It also expects to kick off plans to raise capital in the US for its innovation business in Q4 of fiscal 2019-20.

Commercial Strategy

Policy & Regulation Explore this Topic

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Sarepta Surprised By CRL For Exon 53-Skipping DMD Drug Golodirsen

The US FDA issued a complete response letter rejecting golodirsen based on risk of infection at intravenous infusion ports and preclinical renal toxicity.

Complete Response Letters Drug Safety Rare Diseases

Vanda Not Ready To Give Up On Jet Lag Indication For Hetlioz Despite CRL

Complete response letter follows July deficiencies letter that made approval seem highly unlikely. Vanda called the setback perplexing and said it plans to continue working to get jet lag disorder added to the Hetlioz label.

Commercial Life Cycle Management

Inrebic Approval Is A Boost For Myelofibrosis And Celgene's Buyer Bristol

Investors in Impact Biosciences, which sold the selective JAK2 inhibitor to Celgene for $1.1bn up front, could double their money with milestone fees based on fedratinib's approval.

Approvals Cancer

AbbVie’s Post-Humira Strategy Continues Taking Shape With Rinvoq Approval

AbbVie now has both of its Humira successors approved in the US, following April’s Skyrizi approval for psoriasis. But Rinvoq faces stiff competition both within the JAK1 class and in rheumatoid arthritis generally.

Approvals Business Strategies

Research & Development Explore this Topic

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Oxurion's Anti-PIGF Antibody Disappoints in Diabetic Macular Edema

The primary endpoint was missed in a Phase IIa study of Oxurion’s THR-317 in diabetic macular edema, but vision did improve in two patient subgroups.

 

Ophthalmic Clinical Trials Research & Development

AstraZeneca’s Imfinzi-Treme Checkpoint Inhibitor Combination Fails Again In NSCLC

The Phase III NEPTUNE lung cancer trial found the combination of Imfinzi and tremelimumab was no better than chemotherapy at extending overall survival. After repeat setbacks, AstraZeneca is now running out of opportunities to show its dual checkpoint blockade is effective in NSCLC.

Clinical Trials Companies

Pipeline Watch: Phase III Results With Osimertinib, Ripretinib And Evinacumab

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

Interview: Mereo All Set For Key Setrusumab Data

Although far from a one-product company, data in Q4 will be key to whether the brittle bone drug could become a blockbuster for the UK NASDAQ-listed biotech.

Strategy Orthopedics
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