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Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

JT Gains World-First Topical JAK Inhibitor Approval

Latest new drug approvals in Japan include the first anywhere for a topical JAK inhibitor and also a marketing clearance for a new contender in the large prostate cancer space.
Japan Approvals

Kissei Discussing Rovatirelin Path After Mixed Phase III Results

Japanese firm in discussions with regulator as high-need novel therapy for spinocerebellar degeneration misses endpoint but shows promise in pooled analysis.

Japan Clinical Trials

Decade In Review: C-Suite Shifts At Family-Owned Indian Firms

Scrip traces some of the prominent changes in the corner office at front-line, family-owned Indian firms Cipla and Dr Reddy’s in the decade gone by.

India Commercial

Amgen To Buy Out Japan JV With Astellas

Full, planned acquisition of Tokyo-based operation will give US biotech giant a firmer foothold in key market and new platform for Otezla growth.

Japan Deals

HanAll Advancing Novel Dry Eye Contender Despite Mixed Top-Line

HanAll and Daewoong remain upbeat on dry eye candidate HL036 and are gearing up for a second Phase III US study despite the first missing its primary endpoint in just-released top-line results.

Ophthalmic Clinical Trials

Health Sector On High Alert As Wuhan Coronavirus Spreads

The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, the Chinese government maintains that the situation is “preventable and controllable.”

China Policy & Regulation
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Europe

Set Alert for Europe

Latest From Europe

After Real-World Data Row, AZ Looks To NHS England For Tagrisso Deal

Tagrisso has become AstraZeneca’s oncology flagship product, but cannot secure frontline use in England.
Commercial United Kingdom

Bayer's Efforts To Pioneer Tumor-Agnostic Market In Europe Held Back

Bayer’s drive to lead a new market opportunity in Europe for histology-independent cancer agents like Vitrakvi has been set back by interim decisions from the UK’s NICE and Germany’s IQWiG, but there is a now a clear pathway to follow.

 

Cancer Health Technology Assessment

NICE Draft Guidance: Rejects Keytruda In Head & Neck Cancer, Xospata In AML

A series of decisions on anticancer drugs from the UK’s NICE will act as a reminder to drug developers excited by potential breakthroughs that health technology assessment has become an exacting filter for new medicines to pass through.


 

Cancer Market Access

Novartis Inks World-First Pact With NHS England For Inclisiran

The innovative collaboration should accelerate access to the first-in-class cholesterol lowering drug acquired with The Medicines Company buy.

United Kingdom Deals

NICE Rejects Akcea’s High-Cost Waylivra

Initial knock-back from NICE means Akcea will need to improve commercial offer.

United Kingdom Market Access

Innate Pursues Anti-Leukemic In EU

Innate Pharma pursues refractory hairy cell leukemia opportunity with first-in-class CD22-directed immunotoxin, moxetumomab pasudotox-tdfk.

 

Cancer Business Strategies
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United States

Set Alert for United States

Latest From United States

HanAll Advancing Novel Dry Eye Contender Despite Mixed Top-Line

HanAll and Daewoong remain upbeat on dry eye candidate HL036 and are gearing up for a second Phase III US study despite the first missing its primary endpoint in just-released top-line results.

Ophthalmic Clinical Trials

Express Scripts Could Negotiate Drug Rebates For 100m Lives With Prime Therapeutics Deal

Manufacturers will face the “biggest PBM ever” in price negotiations for pharmacy benefit drugs as a result of the collaboration between the two pharmacy benefit managers.

Pharmacy Benefit Management Reimbursement

Lilly Adds Two More Humalog Authorized Generics As Insurance Deductibles Reset

With rebate reform efforts stalled, insulin manufacturer broadens efforts to lower prices through authorized generics, but PBMs may still like the big rebates they can get on the original brands.

Pricing Debate Generic Drugs

Lynparza Gets US OK For Pancreatic Cancer

The leading PARP inhibitor gets a new tumor type added to its label after a narrow ODAC vote in favor less than a fortnight ago.

Approvals United States

Sub Q Entyvio Hits Speed Bump After US Complete Response

Questions from FDA may delay progress to US approval of Takeda's more convenient formulation of blockbuster Entyvio.
United States Complete Response Letters

Astellas, Seattle Genetics Break Ground With US ADC Approval

Co-developers gain nod for novel antibody-drug conjugate that provides new option for patients with advanced form of bladder cancer.

Cancer United States
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