PharmAsia News Business Bulletin
This article was originally published in Scrip
A new regular roundup of commercial stories appearing in Scrip’s sister publication PharmAsia News, whose multilingual team of regional experts provides authoritative business intelligence focused on the Asian marketplace.
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US FDA Slams Dr. Reddy’s Over Fudged Tests
The US drug regulator, the FDA, has come down heavily on India’s Dr. Reddy's Laboratories over fudged test results and for failing to reveal the existence of a testing lab, in just one in a series of recent negative events to hit the major Indian generics company.
Sanofi Shines, Bayer Brighter, AZ Loses Leadership: China Roundup
Multinational pharmaceutical players in China are recovering in the aftermath of a drastic slowdown in the country, growing on average by 4% in the last quarter, although one leading company quadrupled that figure. PharmAsia News has combed through earnings reports to bring you the winners, laggards and most successful strategies among major global firms in China.
Two Global New Drugs, Viekirax Priced In Japan
The latest reimbursement price listing of drugs in Japan clears the way for the first launches worldwide of two new molecules for thrombocytopenia and diabetes, and also for the local launch of an important new hepatitis C therapy.
CHA Taking Stem Cell-Based Alzheimer’s Therapy Into Clinic
South Korea's CHA Biotech is set to begin the first clinical trial of a mesenchymal stem cell therapy for Alzheimer's disease, which the company plans to develop on a commercial scale by using proprietary technology that can store the cells for up to 24 months.
Zydus Set To Enter NASH Fray As US Trial Approved
Indian pharmaceutical company Zydus Cadila says the US Food and Drug Administration has endorsed its plans to conduct a Phase II clinical trial in the US of saroglitazar, its flagship novel drug to treat severe hypertriglyceridemia which can cause serious conditions like non-alcoholic steatohepatitis.
Eisai Exits Dermatology Through Roivant Deal
Eisai has followed in the footsteps of Japanese peer Astellas by divesting assets in the dermatology area, this time through a deal with Roivant for a clinical stage atopic dermatitis therapy that it sees as no longer fitting into its strategic priorities.
New Samsung Biosimilar Results Bode Well For Portfolio
With its first biosimilar product set to be launched by the end of this year, Samsung Bioepis has presented new long-term results from Phase III trials for several of its autoimmune disease biosimilars that show comparable safety and efficacy to the original products.
India Plans To Sell Generic Cancer, CV Drugs At Hefty Discounts
India has announced a pilot scheme to sell hundreds of generic cancer and cardiovascular drugs, as well as cardiac implants, at levels at least 50% below normal retail prices through government-run outlets, in a drive to make important medicines more affordable to its vast population.
Hanmi’s Roll Continues With ZAI China Cancer Deal
Hanmi is continuing to reap big dividends this year from its original R&D efforts. Following a major licensing out deal with Boehringer Ingelheim for a novel lung cancer therapy in July, the South Korean firm has now reached an additional licensing agreement for the therapy with ZAI Lab for China, Hong Kong and Macau, in a deal that will bolster the Chinese biopharma's growing oncology portfolio.
China Needs Newer Drugs To Control Diabetes Surge: IFPMA
A new report sheds light on the unusually low penetration of newer antidiabetic therapies in China, despite their additional therapeutic benefits, and the reasons behind the wider use of insulins and older oral glucose-lowering drugs. Poor monitoring and disease management may further worsen the situation in a country that already has the largest diabetic population in the world, it warns.
GeneOne Links With WRAIR For First MERS Vaccine Trial
South Korea's GeneOne Life continues to make progress in the development of the world's first DNA vaccine for Middle East Respiratory Syndrome (MERS). After filing an IND with the US FDA last month for a Phase I study, it has now signed an agreement with the Walter Reed Army Institute of Research to jointly proceed with the trial at the US institute.
Local Expertise Key To Tackling China Market: AusBiotech Meeting
Speakers from the legal, corporate and contract research sectors discussed the fast-moving changes that are impacting the legal and regulatory aspects of doing business in China at the recent AusBiotech conference in Melbourne, providing a broad range of advice for Australian and other pharma and biotech companies wanting to enter the rapidly expanding Chinese life sciences market.
OPINION: Impact Of The TPP On The Pharma Industry
The final text of the Trans-Pacific Partnership confirms beyond doubt the apprehensions expressed by civil society, academia and the generic industry about new barriers to access to medicines. The TPP has done away with several flexibilities provided under the TRIPS Agreement and the Doha Declaration on Public Health. Though the text mentions “nothing in this [IPR] Chapter limits a Party’s rights and obligations under Article 31 of the TRIPS Agreement,” the TPP Investment Chapter overrides these flexibilities, says D G Shah.
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