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The Lead

Ranbaxy: Lessons and Opportunities

April 10, 2014 8:48 am | by Girish Malhotra, President, EPCOT International | Blogs | Comments

Will Sun’s latest acquisition change the global pharma landscape, or result in yet another problem-filled “me too” pharma company?                    

Oramed Granted Patent in Hong Kong for Oral Administration of Insulin

April 10, 2014 8:16 am | News | Comments

Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development...

Gilead Announces Results From Phase II Study of Sofosbuvir Among Hepatitis C Patients in Japan

April 3, 2014 8:22 am | News | Comments

Gilead Sciences has announced topline results from a Phase 3 clinical trial (Study GS-US-334-...

Actavis Opens Asia Pacific Regional Headquarters in Singapore

April 3, 2014 8:09 am | News | Comments

Actavis has announced the official opening of its new regional office in Singapore that will...

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Novartis Top Management Quits Over Involvement in Clinical Study

April 3, 2014 8:04 am | News | Comments

Novartis Pharma K.K. said Thursday its president Yoshiyasu Ninomiya and two other top executives have resigned to take responsibility for its employees' inappropriate involvement in a clinical study led by medical doctors.     

Actavis Acquires Silom Medical Company

April 1, 2014 8:56 am | News | Comments

Actavis today announced that it has acquired Silom Medical Company, a privately held generic pharmaceutical company focused on developing and marketing therapies in Thailand, for approximately $100 million in cash.      

XTANDI Capsules Approved in Japan for Prostate Cancer

March 25, 2014 7:20 am | News | Comments

Astellas Pharma Inc. has obtained marketing approval of their oral androgen receptor signaling inhibitor, XTANDI capsules 40mg  for the treatment of patients with castration-resistant prostate cancer in Japan.      

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Japan Approves Forxiga® for Type 2 Diabetes

March 24, 2014 9:00 am | News | Comments

AstraZeneca today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved FORXIGA® (dapagliflozin in 5 and 10 mg tablets), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, as a once-daily oral treatment for type 2 diabetes.

Will India Soon be Free from Polio?

March 24, 2014 8:54 am | Videos | Comments

A polio-free India is one of the biggest global public health achievements of recent times.                           

Samsca® Approved in Japan as World's First Drug Therapy for ADPKD, a Rare Kidney Disease

March 24, 2014 8:05 am | News | Comments

Otsuka Pharmaceutical Co. has become the first company in the world to obtain regulatory approval for a pharmacological treatment of autosomal dominant polycystic kidney disease (ADPKD).           

Applikon Biotechnology to Open New Facility in Guangzhou, China

March 13, 2014 11:20 am | News | Comments

Applikon Biotechnology will open a new production facility on Wednesday March 19th in Guangzhou, China. The opening ceremony will be combined with a scientific seminar “Innovations in bioreactor technology”.        

Clinipace Worldwide Acquires Choice Pharma - Expands into Asia

March 11, 2014 11:09 am | News | Comments

With the merger, the company extends its global footprint to include 20 operational offices in 15 countries, including new offices in Taiwan, China, Hong Kong, South Korea, Vietnam, Singapore, and Malaysia.       

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IPS Tech Tips Episode 2: Changes in Biopharmaceutical Design

March 11, 2014 10:53 am | Videos | Comments

Peter Hanson, IPS' Director of Process Architecture, Asia and EMEA talks about changes in biopharmaceutical design for facilities in these emerging markets including shifts in investments and the types of investments.        

WuXi PharmaTech and Pacific Biomarkers Announce Collaboration

March 11, 2014 8:12 am | News | Comments

In a new agreement, PBI will provide access to its extensive menu of validated biomarker assays to support WuXi's integrated clinical trial testing services. This includes bioanalysis and central laboratory services for pharmaceutical and biotech companies performing clinical drug development in China.

Almac Expands Asia Pacific Operations, Establishes Regional Operations Centre in Singapore

March 11, 2014 8:03 am | News | Comments

Almac has announced the expansion of its clinical services and technologies capabilities to include on-the-ground leadership as well as technical, project and operational resources in Asia. The company has established regional hubs in Singapore and Japan to better enable the industry’s growing need to conduct clinical trials in Asia and/or manage global trials from the region.

Eisai President and CEO to Retire

March 10, 2014 8:39 am | News | Comments

Eisai Inc. has announced the appointments of Yuji Matsue as chairman and chief executive officer and Shaji Procida as president and chief operating officer, effective April 1, 2014. Mr. Matsue and Ms. Procida succeed current President and CEO Lonnel Coats, who will be retiring from Eisai in June 2014 after 18 years.

Efforts to Combat Leprosy in India Hindered By Stigma

March 10, 2014 8:19 am | by NIRMALA GEORGE, Associated Press | News | Comments

The stigma of leprosy endures in India, even though the country has made great strides against the disease, which is neither highly contagious nor fatal. Now the number of new annual cases has risen slightly after years of steady decline, and medical experts say the enormous fear surrounding leprosy is hindering efforts to finally eliminate it.

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Outsourcing to the Emerging Markets

March 7, 2014 11:24 am | by Bikash Chatterjee, President and CTO, Pharmatech Associates | Articles | Comments

The movement toward transparency is global, touching almost every aspect of society. Whether the topic is NSA eavesdropping in the U.S. or banking practices in the European Union, transparency and accountability go hand in hand. The pharma industry is no different.

FDA to Boost India Staff Overseeing Drug Imports

February 21, 2014 3:33 pm | News | Comments

The head of the Food and Drug Administration says her agency will add more inspectors in India to better monitor drugs from the country's burgeoning pharmaceutical industry, even as her agency also seeks closer cooperation with Indian regulators.

Novartis Case Linked to Structural Problems Between Doctors, Industry

February 20, 2014 8:02 am | News | Comments

The manipulation of clinical research data for a blood pressure drug sold by Novartis Pharma K.K. has led a special squad of Tokyo prosecutors to search the Japanese unit of the Swiss drugmaker as well as the university that conducted the research.

Tokyo Prosecutors Raid Novartis Pharma Over Drug Ads

February 19, 2014 8:01 am | News | Comments

Tokyo prosecutors raided Novartis Pharma K.K. on Wednesday over its alleged use of exaggerated advertising for a blood pressure-lowering drug, following a criminal complaint filed by the health ministry last month.       

Merck and Samsung Bioepis to Develop and Commercialize Insulin Glargine Candidate for Diabetes

February 10, 2014 8:45 am | News | Comments

Merck and Samsung Bioepis Co., Ltd., announced today that they have expanded their collaboration with an agreement to develop, manufacture and commercialize MK-1293, an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes.

AbbVie Expands Manufacturing Presence with $320 Million Investment in Singapore

February 6, 2014 8:00 am | News | Comments

AbbVie has announcesd a US$320 million [approximately S$400 million] investment to establish operations in Singapore for small molecule and biologics active drug substance manufacturing.           

FDA Commissioner Hamburg to Travel to India

February 5, 2014 11:12 am | News | Comments

Today, the U.S. Food and Drug Administration announced that Commissioner Margaret A. Hamburg, M.D. will travel Feb. 10-18 to India to further strengthen cooperation between the FDA and its Indian regulatory counterparts.     

GlaxoSmithKline Profits Nearly Triple in Fourth Quarter

February 5, 2014 9:06 am | News | Comments

GlaxoSmithKline says fourth-quarter earnings nearly tripled and sales rose 5 percent, even as an ongoing investigation hurt business in China.                  

China Halts Poultry Trading After New H7N9 Cases

January 28, 2014 8:09 am | News | Comments

Authorities in eastern China announced a ban Tuesday on live poultry sales following a spike in the number of people infected with the H7N9 strain of bird flu, with the busy Chinese New Year travel period already under way.     

Actavis to Divest Actavis Foshan, China

January 27, 2014 9:01 am | News | Comments

Actavis plc has signed and completed an agreement for Zhejiang Chiral Medicine Chemicals Co., Ltd  to acquire Actavis' interest in Actavis (Foshan) Pharmaceuticals Co., Ltd., an Actavis subsidiary based in Foshan, China.    

US Halts Drug Imports from Ranbaxy Plant in India

January 24, 2014 8:13 am | News | Comments

U.S. health regulators said Thursday they are barring imported drugs from an overseas factory operated by Ranbaxy Laboratories, India's largest drugmaker, due to quality control violations.          

Bird Flu Spikes in China Ahead of Lunar New Year

January 22, 2014 8:11 am | by MARGIE MASON, AP Medical Writer | News | Comments

A spate of bird flu cases since the beginning of the year in China has experts watching closely as millions of people and poultry are on the move ahead of the Lunar New Year holiday, the world's largest annual human migration. China has reported more than 50 H7N9 infections in 2014 after the strain jumped from birds to people for the first time last year.

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