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Featured Stories


Longer Intervals OK With ViiV's Injectable Anti-HIV Regimen

Topline results from the Phase III ATLAS-2M study indicate that injections every two months of ViiV/Janssen’s two-drug anti-HIV regimen are non-inferior to a once-monthly injectable regimen.

 

Infectious Diseases Clinical Trials Research & Development

AstraZeneca Buys Priority Review Voucher With Two Big Filings On The Horizon

AstraZeneca paid $95m to Swedish Orphan Biovitrum for the voucher, which it could use to expedite the FDA review of roxadustat or trastuzumab deruxtecan.

Drug Review Launches Commercial

NICE Head Sir Andrew Dillon To Stand Down

Sir Andrew Dillon is leaving his role as CEO of England’s health technology assessment body after 20 years.

United Kingdom Health Technology Assessment Regulation
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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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Finance Watch: Chinook Debuts With $65m For Precision Kidney Disease Medicines

Private Company Edition: The start-up intends to take multiple drug candidates into the clinic by 2021. Also, Graybug Vision raises an $80m series B and Finch closes a $53m series C.

Financing Business Strategies StartUps and SMEs

Can Dr Reddy’s Carve Into Crowded Indian Avastin Biosimilar Market?

Dr Reddy’s debuts biosimilar bevacizumab in India but can the significant price differential for one strength of the product help it gnaw into a competitive market?

Commercial Strategy Biosimilars

Genexine, ToolGen Merger Collapses Amid Stock Drops, But Collaboration Still Planned

The planned merger between Genexine and ToolGen, which was poised to create a major Korean biotech entity, has collapsed amid recent generally weak investor sentiment over the sector. But the two sides will maintain their collaborations for new drug development going forward, with a focus on gene and cell therapies.

South Korea M & A

Oncorus Raises $79.5m To Take Its First Oncolytic Virus Into The Clinic

The company has two oncolytic virus platforms – a herpes simplex-based intratumoral injection and a synthetic virus-based intravenous technology for repeat systemic administration.

Financing StartUps and SMEs

Synlogic Pivots After First Clinical Failure

The synthetic biotics company is discontinuing development of SNYB1020, its first clinical-stage product, which failed to lower blood ammonia in cirrhosis patients.

Research and Development Strategies Clinical Trials

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

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

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Novo Nordisk's Ultra-Fast Acting Insulin Cleared For Pediatric Use In EU

A market opportunity has just opened up for Novo Nordisk’s ultra-fast acting mealtime insulin, Fiasp: its indications have just been extended to include younger EU patients who are aged more than one year.

 

Metabolic Disorders Approvals Commercial

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

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

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

Research & Development Explore this Topic

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Retrophin's Focus Shifts After Phase III PKAN Drug's Failure

Fosmetpantotenate missed all endpoints in a Phase III trial, so Retrophin will shelve the candidate for the rare disease PKAN. Now, the biotech turns focus to Phase III sparsentan in a pair of indications.

Clinical Trials Business Strategies Commercial

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

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

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
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