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Cystic Fibrosis Drug Sales Should Soar; VX-661/Ivacaftor To Lead Way

Sales of key cystic fibrosis drugs will jump in western economies over the next decade, driven by strong uptake of high-cost CFTR modulator therapies and longer use as life expectancies improve, according to a new report by Datamonitor Healthcare.

Respiratory Market Intelligence Commercial

Speed Is Everything In CGRP Race As Amgen/Novartis Reveal Phase III Data

Amgen and Novartis revealed the first set of Phase III data for a CGRP inhibitor in the treatment of episodic migraine, potentially positioning the companies’ biologic erenumab at the head of the drug class.

Research and Development Strategies Neurology Commercial

GeNeuro’s Causal Approach To MS Treatment Gathers Momentum

GeNeuro is making good progress on its mid-stage clinical compound that is tackling a potential cause of multiple sclerosis. An early collaboration with Servier puts the Swiss biotech on a good footing if an ongoing Phase IIb trial – due to report interim data at the end of next year – is successful.

Neurology Clinical R and D BioPharmaceutical

Hanmi Does It Again - RAF Inhibitor Goes To Genentech In $910m Deal

After a series of blockbuster licensing deals last year, South Korea’s Hanmi has struck another major alliance, this time licensing out a novel oral RAF inhibitor that will strengthen biosimilar-threatened Genentech’s oncology portfolio.

Commercial Deals South Korea

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Commercial Explore this Topic

Cipla Sees Changed Profile; Wraps Up Europe Revamp

Cipla's management sees the firm's profile changing as it scales up its US business with new launches and a step-up in product filing intensity. The Indian company is also "largely done" with a restructuring in Europe that saw a significant cutback in personnel but is expected to make the European business profit-accretive.

Commercial Strategy India

1,000 Layoffs Expected At Novo Nordisk As US Pricing Pressures Bite

As a parting gift to Novo Nordisk staff, outgoing CEO Lars Rebien Sørensen has announced 1,000 job cuts at the company – around half in its home country of Denmark – in order to create a "sustainable balance between income and costs" in preparation for a challenging 2017.

Business Strategies Companies Commercial

Latest From Commercial

In-Licensed Drugs Bring More Growth Than In-House, Study Shows

Datamonitor Healthcare analysis finds that as companies across the biopharmaceutical industry rely increasingly on externally sourced assets, per-drug revenue bears out this strategy. Part one of a series on the review of the impact, and potential, of externalizing R&D.

Commercial Business Strategies

Deal Watch: Zymeworks Adds Daiichi To List Of Partners In I-O Cross Collaboration

Amgen gets into RNAi for cardiovascular indications with Arrowhead deal. Lilly and J&J out-license preclinical candidates, for epilepsy and cancer respectively, to smaller firms Cerecor and Tracon.

Deals M and A

Surprise Boehringer Decision Turns Hanmi Investors’ Hopes To Despair

Hanmi shares have gone on a wild roller coaster ride as bad news came after good. A day after it announced a huge licensing agreement with Genentech, the South Korean firm unveiled that Boehringer Ingelheim had decided to return rights to olmutinib, the EGFR inhibitor it licensed from Hanmi last July.

Commercial Companies

Allergan’s Oral Drugs Overlooked In CGRP Inhibitor Development Race

Allergan has two oral CGRP inhibitors – the only small molecules in the drug class in the clinic – but anti-CGRP biologics are likely to hit the market first. However, an effective oral product from a company that’s already marketing a migraine drug – Botox – could be an overlooked contender.

Commercial Research and Development Strategies

Maruho Broadens Derma Horizons Through Dual Licensing Deals

Derma specialist Maruho has taken steps to recharge its pipeline through deals with fellow Japanese firms for two novel assets.

Dermatology Deals

IPO Update: Novan, AC Immune End Summer Slowdown As Market Improves

Novan and AC Immune ended September with the first biopharma IPOs in 40 days as the performance of newly public companies’ stocks head into an upswing.

Commercial Financial Strategies

Policy & Regulation Explore this Topic

Brexit: Issues and Opportunities As UK Life Sciences Define A New Relationship In Europe

It's fair to say that the outcome of the June 23, 2016 referendum on the UK’s membership of the EU stunned not only the nation, whether you voted to leave or remain, but sent shockwaves through Europe and beyond. The UK’s pharmaceutical industry made no secret of its stance: it was all about remain – but it got a Brexit. Scrip’s Sukaina Virji gathered a group of pharma industry experts who had spent their summer working on making the best of the situation. Here’s an edited recount of their insightful discussion.

Brexit Commercial BioPharmaceutical

Amgen's Amjevita Approved As First Biosimilar To AbbVie's Humira

Company starts "a new chapter" with the first approval out of its biosimilar pipeline, which happens to be for the biggest drug in the world.

Approvals Biosimilars United States

Latest From Policy and Regulation

Multiple Myeloma Would Make Good Guinea Pig For Oncology Cost Control

With an array of high quality drugs and preference for stacked combo therapy in multiple myeloma, the disease is poised to become a testing ground for cost containment in oncology.

Market Access Cancer

What’s A Fair Price For A Biosimilar In Europe?

The views of biosimilar manufacturers and payers in Europe still vary widely as to what a “fair price” for a biosimilar should be, what discounts should be offered and when, and how to determine what is an appropriate return on investment, says a new report from Simon Kucher & Partners.

Biosimilars Europe

New Crohn’s Indication Puts Janssen’s Stelara On Equal Ground With Anti-TNFs

J&J’s Janssen Biotech subsidiary won FDA approval for the IL-12/IL-23 inhibitor Stelara to treat Crohn’s disease, giving it a second-line position alongside anti-TNF therapies for patients in need of new options.

Product Approvals Pricing Reimbursement

Jim O’Neill Is “Free For Global AMR Role” After Leaving UK Government

Having suddenly resigned from the UK Government Jim O’Neill says he’s now available to take on a global role, if asked, to promote concrete action on tackling antimicrobial resistance within promised timeframes.

United Kingdom Policy and Regulation

How Many Pricing Hearings Add Up To Action On Pricing Transparency?

Mylan’s discussion of how the drug supply chain absorbs pricing for EpiPen raised more questions than it answered during a House Oversight Committee hearing

Legislation Pricing Debate

Duchenne Surprise: Sarepta Prices Exondys 51 Below Expectations

It sparked at least one analyst to question how Sarepta came up with a price for FDA's first approved Duchenne muscular dystrophy treatment.

Approvals Drug Review

Clinical / R&D Explore this Topic

New Interim CAR-T Data Support Kite’s BLA Submission Plans

Kite Pharma Inc. executives reiterated plans on Sept. 26 to pursue US FDA approval this year for the chimeric antigen receptor T cell (CAR-T) therapy known as KTE-C19, keeping the company on track to seek accelerated approval for a form of advanced lymphoma before any of its competitors.

Clinical R and D Companies BioPharmaceutical

Array Rises As COLUMBUS Clears Phase III Melanoma Hurdle

Shares in Array Biopharma shot up by more than 80% on the release of top-line Phase III data from its COLUMBUS study of encorafenib and binimetinib, but more details are needed to gauge how the combination may fare against Novartis and Roche’s more established combos, and the newer IO therapies.

Cancer Clinical Trials Clinical R and D

Latest From Clinical R and D

Allergan’s Oral Drugs Overlooked In CGRP Inhibitor Development Race

Allergan has two oral CGRP inhibitors – the only small molecules in the drug class in the clinic – but anti-CGRP biologics are likely to hit the market first. However, an effective oral product from a company that’s already marketing a migraine drug – Botox – could be an overlooked contender.

Commercial Research and Development Strategies

Surprise Failure for Intra-Cellular Therapies’ Schizophrenia Drug Sends Shares Tumbling

The unexpected failure of a Phase III trial of Intra-Cellular Therapies’ lead product ITI-007 sent shares in the company down by more than 63%.

Clinical R and D Clinical Trials

GSK's Immunology Strategy Edges Closer To Delivering

GlaxoSmithKline is working to establish an immuno-inflammation portfolio and extend learnings to other therapy areas. Sirukumab could be GSK's first new product in I&I beyond Benlysta. Chief Immunology Officer Paul-Peter Tak outlined his strategy in an interview with Scrip.

Immune Disorders Business Strategies

Dravet Syndrome Indication Will Set GW Pharma Apart On US Epilepsy Market

GW Pharma is on track for 2017 filings for its marijuana-derived epilepsy therapy, Epidiolex (cannabidiol), following more positive data from the third Phase III study for the drug to be presented this year – however, Epidiolex's potential in Dravet syndrome will be its competitive edge to set GW apart from rivals.

Neurology Clinical Trials

INFOGRAPHIC: Heart Failure, A Growing Market

Heart failure is currently one of the most common reasons for hospitalization amongst people over 65 years of age. Causes of heart failure include atrial fibrillation, an erratic rhythm of the heart, and high blood pressure.

BioPharmaceutical Clinical R and D

GtreeBNT Aims To Validate Business Model Via Licensing Deals

2017 may be a milestone year for GtreeBNT as it progresses its late clinical stage pipeline in the US for various high-need indications including glioblastoma, the South Korean bioventure’s CEO assuring investors that he expects to see “good results” in the near future as it seeks licensing deals for its assets.

Clinical R and D Business Strategies