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Commercial

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FDA Warning On Ocaliva Puts Intercept's NASH Opportunity In Jeopardy

FDA's warning about 19 deaths related to excessive, off-label dosing for Ocaliva in primary biliary cholangitis spurs fears doctors will curtail prescribing and, worse, that the larger upcoming NASH market opportunity may be affected.

Drug Safety Liver & Hepatic FDA

Keen Kevzara Pricing Will Be Sanofi’s Best Hope After Speedy NICE Nod

A three-month turnaround from approval in Europe for Sanofi’s rheumatoid arthritis drug to recommendation in England is pretty quick. The firm will need to maintain keen pricing in a competitive field.

Immune Disorders Reimbursement Health Technology Assessment
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Companies

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Latest From Companies

Allergan Urgently Seeks FDA Guidance To Unblock Vraylar sNDA Review

In its initial assessment of Allergan's sNDA for Vraylar, the FDA has found the application - for treating negative symptoms associated with schizophrenia – wanting, and thus says it doesn't merit a full review.

Approvals Companies

Roche Racks Up Another RoActemra Green Light To Boost Revenues

The Swiss giant's blockbuster is the first non-steroid therapy approved in Europe for giant cell arteritis and the first major advance in treatment for over 50 years.

Immune Disorders Policy & Regulation

VELOCITY Failure For Versartis's Lead Drug Sends Shares Into Tailspin

Versartis's long-acting growth hormone product missed Phase III non-inferiority endpoint, wiping more than 83% of the company's value.

Clinical Trials Companies

Genexine Edges Ahead In Pediatric GHD After Versartis Trial Failure

Versartis's failure in a Phase III study of somavaratan places Genexine's GX-H9 in a favorable position to become the best-in-class long-acting growth hormone for pediatric growth hormone deficiency.

Clinical Trials South Korea

Tyme Ticks On With Mid-Stage Development Of A Broad Cancer Therapy

The small biotech presented positive interim data from a Phase II trial testing its lead candidate SM-88 in prostate cancer at ESMO and is gearing up to initiate a trial in pancreatice cancer.

Cancer Companies

Zai Lab Soars On Nasdaq Debut

Shanghai-based drug developer Zai Lab shares jumped on its first day of public trading, reflecting the strong interest in drug development in China.

Financing China
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Deals

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Latest From Deals

Provention Builds On J&J Disease Interception Model

Founded earlier in 2017 with a plan of making quick "go/no-go" development decisions based on objective data, Provention taps into Johnson & Johnson for a pair of IBD candidates.

Deals Business Strategies

Parvus Seeks Autoimmune Answers Through Restoring Immune Tolerance

Emerging Company Profile: Partnered with Novartis on a nanoparticle candidate for type 1 diabetes, Parvus develops its proprietary Navacims to help the body’s immune system differ between a pathogen and itself.

StartUps and SMEs Business Strategies

Nuvelution Puts Business Model Into Action With Teva/Austedo Deal

Focused on drug development risk-sharing partnerships, Nuvelution signs its first partnership, with Teva, to conduct Phase III development of recently approved Austedo for pediatric Tourette syndrome.

Deals Research and Development Strategies

Sanofi Ready To Pull The Plug On Regeneron 'Life Support'

Global R&D President Elias Zerhouni said Sanofi has the knowledge and skills it needs to discover antibody drugs internally and it's time to end the perception that Regeneron is keeping Sanofi's R&D humming.

Deals Research & Development

Deal-Making Firm On Fosun’s Agenda As Overseas Revenues Spurt

With overseas revenues rising sharply in the first half of 2017, Fosun Pharma expects to build on its global investment strategy at a fast pace, striking more deals to acquire products and companies from developed markets.

BioPharmaceutical China

The Next Roivant Or Fortress? BridgeBio Raises $135m To Spin Out New Companies

BridgeBio's hub-and-spoke model is similar to the Roivant and Fortress strategies, but with a focus on drug candidates for genetic diseases in need of a bridge to future funding.

Financing Business Strategies
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Strategy

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Latest From Strategy

Refocused Novo Nordisk Says On 'Road To Recovery' After Traumatic 2016

Novo Nordisk's head of international operations says the company has learned from the past, taken corrective steps, and is now on the road to recovery.

Business Strategies Leadership

Diabetes-CV Disease Link Boosts EASD Buzz

Linkage between cardiovascular disease and type 2 diabetes was a top theme of discussion and data presented at this year's EASD meeting in Portugal's capital.

Metabolic Disorders Cardiovascular

Lupin Reviews R&D Thrust, Biosimilars Plan On Course

Lupin is reorienting its R&D priorities with a thrust on more definitive, near and mid-term opportunities while rationalizing its discovery program and trimming its headcount. The firm’s biosimilars program though remains on track with a filing anticipated in Europe and Japan this fiscal.

Commercial Strategy

Will Keytruda Price Differential Really Count In India?

Merck has launched Keytruda at an “India-specific” price but some experts say that the immuno-oncology therapy will likely still be beyond the reach of a majority of patients. Merck though also expects to offer a patient access program for those who can’t afford the therapy.

Commercial Strategy

Indian Generics Firms Must Shift Gears For Third Wave, Says Lupin MD

Indian firms must transition from “plain-vanilla” generics to more complex products, including biosimilars, if they want to continue growing. However, returns from the sector’s so-called Third Wave will be some time coming, warns Lupin’s managing director Nilesh Gupta.

Generic Drugs Business Strategies

Achillion Keeps Focus On Complement Factor D Inhibitors As J&J Exits HCV

J&J's decision to stop HCV development and end its partnership with Achillion has a ripple effect for the smaller biotech's strategy.

Business Strategies Companies
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Market Access

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Latest From Market Access

Pfizer Sets The Stage For A Biosimilar Showdown Over Exclusive Contracts

Pfizer filed a lawsuit against J&J over its efforts to block sales of Pfizer's biosimilar Inflectra through exclusive contracting for Remicade. The suit claims J&J coerced payers by vowing to withhold all Remicade rebates if any Inflectra is reimbursed. J&J says Pfizer has failed to show the value of Inflectra.

Biosimilars Legal Issues

Novartis Beats CAR-T Competitors To The Pricing Punch With Kymriah Approval

Novartis got a leg up on its competition Aug. 30 with an earlier-than-expected approval for Kymriah in pediatric ALL, ending the CAR-T pricing mystery with its $475,000 price tag, which the company is positioning as a relative bargain.

Approvals Pricing Strategies

Precision Medicine: Despite Gains, Optimum Use Far From Reached

Progress has been made in areas such as lung and breast cancer, but panelists at a recent conference noted there are many efficiencies yet to be realized in drug development and reimbursement.

Personalized Medicine Market Access
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Market Intelligence

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Latest From Market Intelligence

Snapshot Of The Opioid Crisis, An Infographic

The opioid market is expected to total $18.4bn by 2020 – but the growing crisis of opioid abuse plagues manufacturers, policy makers and public health. Scrip takes a look at the pipeline of abuse-deterrent formulations and physician opinions about what impact those will have.

Neurology Drug Safety

Bayer's Aliqopa Approval Gives PI3K Class A Second Chance in Follicular Lymphoma

Bayer's PI3 kinase inhibitor copanlisib now has accelerated approval in a common type of non-Hodgkin lymphoma, but the drug's competitive profile still awaits Phase III data.

Cancer Approvals

New Agents To Invade UC Market As Biosimilars Put Pressure On Stalwarts

The ulcerative colitis pipeline is bustling with novel drugs, with new modes of action, that are ready to take on the market leading biologic therapies and their biosimilar counterparts; five launches are anticipated from four different drug classes before 2022.

Market Intelligence Inflammation
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