PharmAsia News from Elsevier Business Intelligence

Hanwha Biologics CEO Paul Coleman On Developing Biosimilars In Korea: An Interview With PharmAsia News (Part 2 of 2)

Fri, 17 May 2013 12:11:59 -0400

The former Biogen Idec exec sits down to talk about Hanwha’s biosimilars strategy and pipeline, and why its deal fell apart with Merck to develop a biosimilar of Enbrel.

GSK Price Cuts Fuel Growth In Emerging Markets

Fri, 17 May 2013 08:46:49 -0400

GlaxoSmithKline has been growing in emerging markets on the back of price cuts that drive volume and market access.

Australia Judge Rejects $527 Million Settlement Over Vioxx

Fri, 17 May 2013 02:17:58 -0400

An Australian court rejected a class-action settlement that would have had Merck pay 1,700 plaintiffs a maximum of less than $2,000 each for damages caused by its since-withdrawn Vioxx (rofecoxib) arthritis drug.

China FDA To Enhance Drug Quality, Innovation And Safety

Fri, 17 May 2013 02:09:40 -0400

China FDA Deputy Commissioner Yin Li says future pharma regulations will focus on quality, innovation, safety, integrity, and authenticity.

Zensun Licenses China Marketing Rights For Heart Drug To SciClone

Fri, 17 May 2013 02:05:34 -0400

Zensun Science & Technology and SciClone Pharmaceuticals have signed an agreement that would have the U.S. drug maker license to market Neucardin, the first of a new class of drugs for treating advanced chronic heart failure.

New EDL To Intensify Competition In China

Fri, 17 May 2013 02:05:17 -0400

The new national essential drug list will likely trigger industry consolidation, diverse strategies, and rigorous marketing.

25% Of Foshan Health Institutes In Guangdong Involved In Malpractice

Fri, 17 May 2013 01:57:34 -0400

Foshan City’s health bureau discovered that one-fourth of its 910 health institutes were involved in malpractice.

Becton Dickinson Enters China’s Low-end Market Via SinoPharm

Fri, 17 May 2013 01:51:00 -0400

U.S.-based medical technology company Becton Dickinson is entering the low-end market in China through partnerships with SinoPharm and aims at tripling sales.

China’s NDRC Considers EDL Drug Price Cuts

Fri, 17 May 2013 01:32:12 -0400

China’s National Development and Reform Commission is considering adjusting essential drug prices.

RuiYi Signs On New Partners To Develop Anti-IL6 mAb In China

t.sami@elsevier.com — Thu, 16 May 2013 22:07:58 -0400

The China-U.S. hybrid signs on Shanghai-based Genor Biopharma in a co-development deal and contract manufacturer CMC Biologics to develop a cell line for RYI-008 for global manufacturing.

Malaysia Drug Regulators See Harmonization As Long-term Plus For Domestic Industry

e.lane@elsevier.com — Thu, 16 May 2013 21:44:55 -0400

Malaysia’s National Pharmaceutical Control Board sees harmonization as opening doors for investment and local manufacturers to gain markets regionally and abroad.

Whistleblower Found Fraud Endemic At Ranbaxy For More Than Decade

Thu, 16 May 2013 19:07:19 -0400

The fraud activities recently acknowledged by Ranbaxy Laboratories apparently were deep-seated in the company's operations for more than a decade, according to an in-depth report featuring the whistleblower who exposed the activity.

TaiGen Expects First Cross-Strait Drug Approval In China Next Year

Thu, 16 May 2013 19:01:52 -0400

TaiGen Biotechnology said it anticipates the first China approval of a Taiwan drug under a pharmaceutical cooperation agreement between the two countries.

India Institutes New Pricing System For Essential Drugs

Thu, 16 May 2013 18:55:36 -0400

India's new system of controlling the prices of essential life-saving drugs sold in the country has taken effect, replacing the prices control system it had used since 1995.

Japan Health Ministry Orders Probe Of HPV Vaccine Side Effects

Thu, 16 May 2013 18:52:19 -0400

Japan health authorities have issued a caution to physicians to be alert for side effects of cervical-cancer vaccines after a citizens group complained of unusually high numbers of problems.

Korea Suspends Production Of 5 Janssen Products

p.chang@elsevier.com — Thu, 16 May 2013 15:08:03 -0400

Ending a two-week investigation into GMP deviations of J&J’s Korean unit, the Ministry of Food and Drug Safety orders a halt on manufacturing of five products.

Another Ranbaxy Mystery: What Happened To Valsartan?

v.dandekar@elsevier.com — Thu, 16 May 2013 14:35:52 -0400

Ranbaxy’s valsartan application may have been held back after FDA detected lapses at the company’s new manufacturing site in Mohali, India, according to sources, but the beleaguered company has a plan to move forward.

Novo Struggles In Japan, Sanofi Struggles With Distributors: Emerging Markets Earnings Roundup (Part 7)

b.yang@elsevier.com — Thu, 16 May 2013 13:29:45 -0400

Both Novo Nordisk and Sanofi had a bumpy start of the year in Asia and emerging markets. Novo saw insulin sales decline in Japan and Korea, while Sanofi grew only 6.5% in emerging markets, well below the company’s long-term guidance of double-digit growth.

Eisai Sales Down, Aricept And Pariet To Decrease Further

Thu, 16 May 2013 06:16:25 -0400

Eisai announced its Japan sales for the fiscal year ending in March were ¥307.8 billion, a 12% decrease from the previous year.

Astellas Japan Figures For Lipitor Down 30% Due To Generics

Thu, 16 May 2013 06:09:29 -0400

Astellas announced results for the financial year ending March 2013 with sales for top drug Lipitor (atorvastatin) down roughly 30% at ¥61 billion due to 10% price revisions and competition from generics.

Daiichi Sankyo’s Japan Sales Up 8% After Long-Term Prescription Bans Lifted

Thu, 16 May 2013 05:56:59 -0400

Daiichi Sankyo’s 2012 Japan sales were ¥442.5 billion, thanks to prescription limits were lifted for Alzheimer drug Memary (memantine) and PPI Nexium (esomeprazole).

Japan Government Decides On Draft Guidelines For New Influenza Pandemic

Thu, 16 May 2013 05:52:55 -0400

The Japanese government released draft guidelines in case of a new global influenza.

Most New Patients In Japan Take DPP-4 Inhibitor As First Choice

Thu, 16 May 2013 05:42:08 -0400

More than 50% of patients with type 2 diabetes in Japan are prescribed a DPP-4 inhibitor, according to a JMIRI survey on prescribed oral hypoglycemic agents.

U.S. Group Wants India Removed From Import-Preference List Over CL Use

Thu, 16 May 2013 04:32:45 -0400

A group is urging removal of India from the U.S. Generalized System of Preferences program of beneficial import treatment, citing regulations that harm competitors, including those in the pharmaceutical industry.

Cipla Medpro Stockholders Agree To $488 Million Buyout By India Creator

Thu, 16 May 2013 04:27:47 -0400

South Africa's Cipla Medpro has agreed to a $488 million acquisition from Cipla, the India firm that helped create it as a source for its drug supplies.

Amgen-Beta JV Significant For China Medical Industry, Execs Say

Wed, 15 May 2013 19:08:47 -0400

Amgen-Beta Pharma, the joint venture formed recently by Beta Pharma and Amgen is far more ambitious than its initial focus on getting Vectibix (panitumumab) for colon cancer on China's market, company officials said.

India CL Case Seen Increasing Global Pharma Pressure For IP Protection

Wed, 15 May 2013 19:01:44 -0400

With South Africa's recent expression of interest in following India's lead in enforcing compulsory licensing, Western pharmaceutical companies see a confirmation of their fear the idea will spread throughout emerging markets.

PT Indofarma, Europe Partner To Produce Albumin In Indonesia

Wed, 15 May 2013 18:50:57 -0400

Indonesia's state-owned PT Indofarma said it plans to have its own albumin drug for local consumption in 2014 to end the nation's reliance on imports and serve the nation's own increasing need.

As New Biosimilars Roll Out, Indian Biotech Group Raises Quality Concerns

v.dandekar@elsevier.com — Wed, 15 May 2013 13:57:21 -0400

Leading biotech group ABLE cautioned the government that India should not become a dumping ground for low-quality biosimilar products. The group pointed at several concerns related to Cipla’s latest launch of Enbrel copies.

Hanwha Biologics CEO Paul Coleman On Developing Biosimilars In Korea: An Interview With PharmAsia News (Part 1 of 2)

Wed, 15 May 2013 13:02:29 -0400

The former Biogen Idec exec sits down to talk about Hanwha’s biosimilars strategy and pipeline, and why its deal fell apart with Merck to develop a biosimilar of Enbrel.

PhRMA Pushes Cost Savings Of Novel Drugs In Japan, Just As New Prices Announced

d.poppy@elsevier.com — Wed, 15 May 2013 10:04:54 -0400

Celgene CEO Robert Hugin outlined cost effectiveness of new drugs and met with Japan’s prime minister in his first overseas trip as the new chairman of PhRMA.

Celltrion Sale Problems Said Due To Trust In Company, Sources Say

Wed, 15 May 2013 01:55:46 -0400

Celltrion founder Seo Jung-jin recently offered for sale his controlling stake in an effort to prevent stock market manipulation of his attempt to sell it, but that has not saved a dive in its perceived value.

Toyama Licenses Cempra's Solithromycin Antibiotic For Japan Market

Wed, 15 May 2013 01:52:45 -0400

Toyama Chemical has licensed Cempra's solithromycin antibiotic for treating pneumonia and expects to begin clinical trials in Japan with a goal of applying for marketing approval within the next five years.

Jiangxi To Cut Prices Of 37 Drugs

Tue, 14 May 2013 20:12:45 -0400

The Jiangsu Development and Reform Commission will slash the prices of 37 pharma products May 15.

China To Launch EDL Policies In May; Tender Requests Before 2014

Tue, 14 May 2013 20:05:56 -0400

Chinese authorities plan to launch relevant policies surrounding the national Essential Drug List from May to August.

Flu-Stricken Guangdong Lifts Tamiflu Use Restrictions In Hospitals

Tue, 14 May 2013 19:57:07 -0400

Guangdong’s health bureau released guidance for neuraminidase inhibitors such as Tamiflu for clinical use in health institutes as peak flu season picks up speed.

Hunan To Trial Publicizing Blacklisted Pharma Practitioners

Tue, 14 May 2013 19:53:09 -0400

Hunan FDA will publicize blacklisted pharma on its Website for two years under its recently launched drug safety guidelines, keeping a public archive.

China Exempts Eight Devices From Compulsory Certification

Tue, 14 May 2013 19:49:53 -0400

Eight medical devices can now be registered in China without undergoing mandatory production certification, according to Chinese authorities.

Nippon Chemiphar Launches Gout Drug In Thailand As Part Of Asia Push

Tue, 14 May 2013 19:20:28 -0400

Nippon Chemiphar said it has launched its Xitrin Tab (uralyt) gout drug in Thailand, its first stop in an effort to expand its presence in Southeast Asia.

Daiichi Sankyo To Send More Personnel To Improve Ranbaxy Quality

Tue, 14 May 2013 19:03:48 -0400

Daiichi Sankyo plans to pour more of its personnel into India to help beef up quality control at its Ranbaxy Laboratories unit and get two of its plants back exporting generic drugs to the U.S. sooner than the original 2017 date.

Biohit Oyj Targets East Asia-Prevalent Form Of Stomach Cancer

Tue, 14 May 2013 18:46:12 -0400

Finland drug maker Biohit Oyj is eyeing China's drug market for what CEO Semi Korpela says could be a good fit for its Acetium (l-cysteine) treatment for a genetic form of stomach cancer prevalent in Asia.

A Closer Look: Ranbaxy’s $500 Million Settlement Includes Criminal Penalties

s.sutter@elsevier.com — Tue, 14 May 2013 10:58:44 -0400

The generic drug maker’s Ranbaxy USA Inc. subsidiary pleads guilty to seven felony counts brought in connection with a longstanding government investigation into data integrity issues and manufacturing violations at two Indian sites, but while the settlement eliminates some worries for the firm, operations still face the weight of a FDA consent decree.

Astellas Said Among Early Bidders To Acquire Optimer

Tue, 14 May 2013 03:12:42 -0400

Astellas Pharma, along with AstraZeneca and Cubist, are said to be among potential acquirers of Optimer Pharmaceuticals, a U.S.-based innovator of antibiotics considering a sale.

India Biotech Group Questions Approval Of Cipla's First Biosimilar

Tue, 14 May 2013 02:26:34 -0400

India's Association of Biotechnolegy Led Enterprises questions government approval of Cipla's recently launched Etacept (etanercept) for rheumatism as its first biosimilar drug, suggesting it may not have followed guidelines.

Boehringer Ingelheim To Develop More Than 10 Biosimilars In Japan

Mon, 13 May 2013 23:58:33 -0400

Boehringer Ingelheim plans to develop more than 10 biosimilars and start clinical trials on three products this year, according to Biopharmaceuticals Chief Wolfram Carius.

SymBio And Eisai Start Japan Phase II Trials Of Treakisym For Chronic Lymphocytic Leukemia

Mon, 13 May 2013 23:49:07 -0400

SymBio Pharmaceuticals has started Phase II trials in Japan in collaboration with Eisai for Treakisym (bendamustine) for use in treatment of chronic lymphocytic leukemia.

Japan MHLW: Medical Dispensing Fees Down In December 2012, Generics Share Flat

Mon, 13 May 2013 23:42:19 -0400

Medical dispensing expenses in Japan in December 2012 were down 0.1% to ¥589.2 billion ($5.7 billion) from the corresponding period a year ago, according to a MHLW report.

Tanabe Mitsubishi Japan To File For Approval Of SGLT-2 Inhibitor Canagliflozin By Mid-2013

Mon, 13 May 2013 23:38:36 -0400

Tanabe Mitsubishi plans to file an application for approval of the SGLT-2 inhibitor canagliflozin in the first half of 2013.

Malaysia To Phase In Medical Device Registration Process To Avoid Backlash

e.lane@elsevier.com — Mon, 13 May 2013 23:38:09 -0400

Malaysia will ease into a new law requiring all medical devices be registered as the country ramps up oversight of its biomedical sector.

CFDA Unveils New Details Of Drug Safety Plan To Give Provinces More Power

b.yang@elsevier.com — Mon, 13 May 2013 23:35:20 -0400

In his first major speech since SFDA’s reorganization, newly appointed China FDA Deputy Commissioner Yin Li laid out the agency’s plans to delegate drug safety oversight to provincial regulators but place responsibility on manufacturers.