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Roche Paying $390m Up Front For Fibrosis-Fighting Promedior

The deal, which includes up to $1bn for milestones, gives Roche Promedior’s PRM-151, a Phase III-ready asset for IPF that has also completed a Phase II study in myelofibrosis and could be effective in a broad range of fibrotic diseases.

Deals M & A Respiratory

NASH Companies Take The Stage At AASLD

NGM’s injectable might be best-suited as induction therapy for sicker NASH patients, Inventiva hopes its pan-PPAR agonist will outperform Genfit’s elafibranor, and Albireo thinks IBAT inhibition offers promise in NASH.

Research and Development Strategies Clinical Trials Liver & Hepatic

Double Delight For Novartis At The CHMP

Novartis has received two positive opinions in Europe, the most important being for Mayzent, its active secondary progressive multiple sclerosis drug which is key to the company's ambitions for growth in the neurology space.

Drug Review Europe Neurology

Spotlight On APAC

Embracing China 2.0: AZ, Merck KGaA Set Up Funds, J&J Steps Up Digital Push

AstraZeneca has pledged $1bn to a healthcare fund to support local innovation in China, joining big pharma peers J&J and Merck KGaA in fresh moves to embrace this market, where a new wave of digital technology transformation and fast-shifting trends now favor novel new therapies and the rise of local health start-ups

China Innovation


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Monroe Site Commercialization ‘Critical’ For Glenmark’s US Step-Up

Glenmark expects its first US manufacturing site to go commercial next year, accelerating growth in that market, while it sets right certain compliance blips back home. The Indian firm is also on course to divest certain non-core assets but notes that bringing in a minority partner for its API unit is not a priority.

Commercial Sales & Earnings

Women In High Places: Slow Progress In Pharma

With gender diversity only slowly increasing in biopharma c-suites, Scrip spoke to executives from five companies about the importance of change.

Leadership Strategy

Levorphanol Write-Down Dents Zydus in Q2 But Saroglitazar Expectations Build

As returns from levorphanol fall on the back of increased competition, Zydus Cadila writes down investment by $37.5m causing Q2 profits to slump 74%. Post successful Phase II trials in the US for NASH and NAFLD indications, its hopes are now pinned on saroglitazar magnesium.

Commercial Sales & Earnings

AZ, Omron Take China ‘Patient Journey’ Alliance Global

UK pharma giant’s head, International tells Scrip expanded alliance with diversified Japan group will develop solutions across the patient journey, while new China investments aim to tap into emerging innovation in this market.

China Research and Development Strategies

Sanofi Pasteur Head Loew On The Vaccine Unit's Future Growth Drivers

David Loew talked to Scrip about the next-generation meningococcal vaccine candidate MenQuadfi and a monoclonal antibody that may be the first RSV treatment for infants.

Vaccines Research & Development

Deal Watch: Allergan Keeps After Hair Loss With Exicure Deal

Allergan has tried to go after alopecia in the past; Exicure brings a new spherical nucleic acid (SNA) technology. In other recent deals, AstraZeneca sells Seroquel, Losec rights to Germany’s Cheplapharm.

Deals Business Strategies
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Policy & Regulation Explore this Topic

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Gene And Cell Therapies In Asia: Can China Deliver Despite Murky Regulations?

The first country ever to approve a gene therapy, China has been lagging in the area since due to a lack of clear regulatory pathways and insufficient financial incentives. Now a new crop of developers are aiming to revitalize ambitions and make the country a major power for promising novel treatments for rare neurodegenerative conditions, retinal dystrophy, HIV and cancer.

China Gene Therapy

Amarin Heads Into Vascepa Expansion Labeling Talks After Positive US FDA Panel Review

Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory committee members favored a broad claim for secondary and primary prevention reflecting the REDUCE-IT trial population, but some strongly opposed an indication that includes patients without established CV disease.

Advisory Committees Drug Review

Merck’s Ervebo Becomes World’s First Approved Ebola Vaccine

Merck Sharp & Dohme will begin manufacturing licensed doses of Ervebo in Germany and will continue to send investigational vaccine doses to Democratic Republic of Congo.

Vaccines Approvals
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ResTORbio Pins Hopes On Parkinson’s After Failed CSRI Study

Company terminates studies of its TORC1 blocker after it fails to prevent respiratory illness in elderly patients with clinically symptomatic respiratory illness (CSRI). ResTORbio is hoping the same drug will be effective in Parkinson’s disease.
Clinical Trials Research & Development

BioMarin’s Momentum Grows With Twin Blockbuster Plans

The frontrunner in hemophilia A gene therapy has been hit by data doubts, but this and achondroplasia drug could deliver in 2020.

Clinical Trials FDA

Sanofi Pasteur Head Loew On The Vaccine Unit's Future Growth Drivers

David Loew talked to Scrip about the next-generation meningococcal vaccine candidate MenQuadfi and a monoclonal antibody that may be the first RSV treatment for infants.

Vaccines Research & Development
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