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Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

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

Asia Executives To Watch: Takeda China GM; Wuxi NextCODE; Sosei

Takeda hires former Pfizer China executive as its new China GM; Wuxi NextCODE appoints its second COO in six months; Sosei appoints two VPs.

Appointments China

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

Cipla Secures Ex-FDA Official As Compliance Head

Indian firms have been making extensive efforts to improve their compliance record, including getting on board top-notch global talent. Cipla, which recently appointed a new head of respiratory manufacturing, has tapped an ex-FDA investigator as its audit and compliance director.

Appointments Companies

AbClon Shines On Korean Debut Amid Robust Investor Interest

AbClon has made a strong debut on the Kosdaq market with investors backing the innovative antibody drug firm in a year where IPOs by South Korean novel drug developers have been generally scarce.

Commercial Financing

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
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Europe

Set Alert for Europe

Latest From Europe

Portugal: An Uptick In Life Science VC Funding

An international VC, Vesalius Biocapital, is to invest in start-up life sciences and biotech companies in the western European country that is developing an entrepreneurial ecosystem.

Portugal Financing

More Is Better? UK Crowdfunding Platform Selects First Firms

Capital Cell's effort might be the beginning of a viable alternative to VC funding for budding biotech companies.

Financing United Kingdom

EU Moves To RATIFY Novartis' Rydapt for AML

Rydapt represents the first major development in targeted acute myeloid leukaemia treatment in more than 25 years as Novartis plots its commercial launch in Europe.

Cancer Approvals

Ocrevus Delay As CHMP Continues Assessment?

The CHMP's assessment of Roche's novel multiple sclerosis therapy Ocrevus continues, making a year-end approval unlikely.

Companies Approvals

Santhera Shares Sink On Duchenne Setback in Europe

Hopes were high for an expanded approval of Raxone but the CHMP's negative opinion has left the Swiss company's stock battered and bruised.

Policy & Regulation Companies

Samsung Bioepis’s Biosimilar Trastuzumab First To Take On Roche’s Herceptin In EU

Samsung Bioepis’s Ontruzant is likely to be the first biosimilar to take on Roche’s Herceptin in the EU market after it was recommended for marketing authorization by the EMA’s CHMP on Sept 15.

Biosimilars Approvals
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United States

Set Alert for United States

Latest From United States

Pharma Executives Need Convincing About Value-Based Contracts

Pharma company executives have limited experience with value-based contracts, but those that have experience are happy with them, says a new PwC report.

Pricing Debate Pricing Strategies

Trelegy Approval Boosts GSK's US Respiratory Business But Pressure Remains

With the FDA approval of Trelegy Ellipta, GlaxoSmithKline will enjoy first-to-market status with a LABA/LAMA/ICS triple combination therapy to treat COPD in the US. However, it faces the challenge of convincing payers.

Approvals Respiratory

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

Mylan Calls Allergan Restasis Patent Deal A 'Desperate Tactic'

Allergan's potential Restasis generic rival wasted no time attacking the company in court documents over the controversial deal Allergan signed with a Native American tribe to thwart generic competition.

Intellectual Property Legal Issues

US Approval Of Vabomere Could Help Alleviate TMC's Financial Troubles

The antibiotic Vabomere demonstrated statistical superiority over Zosyn, and could be a more attractive option than existing treatments for complicated urinary tract infections.

Approvals Infectious Diseases

Lilly/Incyte's JAK Inhibitor Baricitinib Poised For FDA Approval After All

It's possible that potential risk for thromboembolic events flagged in rheumatoid arthritis studies could be managed in labeling.

Inflammation Drug Review
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