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Featured Stories


An About Face As Biogen Says It Will File Aducanumab In Alzheimer’s

Biogen surprised investors with news that it will file aducanumab with the FDA based on data from more patients treated at the highest dose than in the interim futility analysis that led to termination of two Phase III studies in March.

Clinical Trials Research and Development Strategies Neurology

Novartis's Zolgensma Finds Commercial Legs In A First For Gene Therapy

Zolgensma generated $160m in the third quarter, a strong launch for the gene therapy's first full quarter on the market.

Sales & Earnings Launches Gene Therapy

An Early Surprise Win For BMS’s Opdivo/Yervoy In Lung Cancer

CheckMate-9LA testing nivolumab plus ipilimumab plus chemo was stopped early due to a survival win. The promise of another foothold in first-line lung cancer could buoy investors ahead of what could be disappointing Q3 sales.

Clinical Trials ImmunoOncology Cancer

Spotlight On APAC

'Buy China' In Procurement Schemes - Should You Worry?

A recent trade group report points to a rising and alarming "Buy China" trend in procurement rounds in the country. Although largely in medical device bidding, it may potentially affect the pharma sector, an analysis from the recent “4+7” centralized bidding scheme show.

China Commercial

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Novartis Adds To NASH Pipeline By Licensing Pliant’s Integrin Inhibitor

Deal for preclinical asset adds an anti-fibrotic mechanism to Novartis’ NASH program. Pliant produced preclinical data showing strong anti-fibrotic effect.

Deals Research and Development Strategies

Interview: Why Europe’s Biotech ‘Prime Time’ Is Now

The chairman of Sofinnova Partners told Scrip his newly launched biotech start-up fund aims to profit from Europe’s top science, relatively realistic asset prices, and geopolitical position between the US and China. 

 

Financing StartUps and SMEs

Vertex Trikafta Approved As First Triple Combo For Cystic Fibrosis With $311,503 Price Tag

The US FDA cleared the combination in just three months for patients with the most common genetic mutation. Company sets price above double regimen Symdeko, but in line with trailblazer Kalydeco.

Approvals Launches

Roche Notches Big IO Win With Tecentriq/Avastin Combo In First-Line HCC

Following quickly on a Bristol trial failure with Opdivo in first-line HCC, Roche’s PD-L1 inhibitor looks poised to be the first immunotherapy approved in the setting, with plans for US, EU and China filings.

Clinical Trials ImmunoOncology

Roche Expects Better Xofluza Sales After New Indication

Flu treatment is newly approved for patients at higher risk of flu complications, and Roche is studying other patient groups that could help expand its potential market.      
Approvals Advertising, Marketing & Sales

Tech Transfer Roundup: Trio Of Deals Bolster Spherix’s Cancer Strategy

The New York biotech announces option deals with two universities, asset license from CBM BioPharma. Bayer inks research collaborations with Japan’s RiKen and with a pair of Boston research hospitals.

Deals Research and Development Strategies
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AstraZeneca’s Farxiga Approval In Heart Failure A First For SGLT2 Inhibitors

Farxiga, with a new indication to prevent hospitalization for heart failure in type 2 diabetes patients, is the first drug among the SGLT2 class to gain this indication outside of diabetics with renal disease.

Approvals Cardiovascular

J&J's Spravato Set For EU Launches Soon

If the nasal spray is approved by the European Commission, seven months after getting the green light in the US, Spravato will offer the first new mechanism of action in 30 years to treat major depressive disorder.
Neurology Drug Review

Kiadis Crushed By EMA Rejection Of T-Cell Therapy

The Dutch company's dataset on its stem cell transplant adjunct ATIR101 is not enough to satisfy European regulators as the standard of care in post-transplant patients has changed since the original filing.
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Novartis’s Fevipiprant Hit By Phase III Asthma Failure

Novartis’s investigational oral therapy for asthma fell at the first Phase III hurdle but pivotal studies in severe disease will be key to prospects.

Respiratory Clinical Trials

Seattle Genetics Poised For Big Breast Cancer Launch On Positive Tucatinib Data

The company expects to file an NDA for tucatinib in the first quarter after a pivotal trial showed a significant improvement in PFS and OS for patients with advanced or metastatic HER2-positive breast cancer, including those with brain metastases.

Clinical Trials Research and Development Strategies

Pipeline Watch: Phase III Readouts For Bimekizumab, RHB-104

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.

 

 

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