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China gives more time to generic-drug makers; Cancer therapy developer plans IPO


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China gives more time to generic-drug makers; Cancer therapy developer plans IPO

Top news

* China's National Medical Products Administration lifted the Dec. 31 deadline imposed on drugmakers of generic medicines listed on the country's 2012 national essential drugs list to conduct bioequivalence tests for their products. Only 90 out of 289 of these drugs have completed the test, which aims to prove that generics are as good as the originals, as of the end of November.

* Harpoon Therapeutics Inc. — a portfolio company of Arix Bioscience PLC — is planning an IPO of its common shares to raise up to $86.3 million. The South San Francisco-based biotechnology company has applied to list its shares on the Nasdaq Global Select Market under the symbol HARP, and plans to use the money to advance its lead product candidate HPN424 for the treatment of castration-resistant prostate cancer, or CRPC, that has spread to other parts.

* Xanthic Biopharma Inc., doing business as Green Growth Brands Ltd., plans to make an offer to buy Canadian cannabis company Aphria Inc. at a valuation of about C$2.8 billion. Under the proposed offer, Toronto-based Green Growth would give Aphria shareholders 1.5714 of Green Growth common shares for each Aphria share that it does not already own.

In response, Aphria said it has set up an independent committee of directors to consider Green Growth's proposal and any formal offer. Irwin Simon, Aphria's newly appointed independent chair, said the offer "significantly undervalues the company," and is "quite risky" as Green Growth would still have to raise funds for the proposed acquisition, given the suggested price.

Drug and product pipeline

* AstraZeneca PLC's application to release cancer drug Imfinzi in China was accepted by regulators Dec. 26, according to the country's Center for Drug Evaluation. Imfinzi, also known as durvalumab, is an immuno-oncology checkpoint inhibitor that works by blocking the PD-L1 arm on tumor cells from linking up with a partner arm called PD-1 on the surface of immune cells, allowing the immune system to target the tumor.

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* The U.S. Food and Drug Administration approved Horizon Pharma PLC's medicine Ravicti to treat infants younger than two months old with a urea cycle disorder. The approval was based on positive data from a study that showed that children younger than two months who were treated with the drug maintained stable ammonia levels compared to when they had not begun the therapy.

* Foundation Medicine Inc. received approval from the Japanese Ministry of Health, Labour and Welfare for its diagnostic test to detect genetic mutations in any solid tumor type. Chugai Pharmaceutical Co. Ltd., a member of Roche Holding AG group that holds marketing authorization of FoundationOne CDx in Japan, filed for the approval in March.

Operational activity

* Biofrontera AG said the recently issued court order in its ongoing litigation with a Sun Pharmaceutical Industries Ltd. unit does not stop the company from marketing and selling its products to all current and potential customers. DUSA Pharmaceuticals Inc., a unit of Sun Pharmaceutical, had asked the U.S. District Court of Massachusetts in November for a preliminary injunction order against Biofrontera but the request was largely rejected by the court, Biofrontera said.

* Opko Health Inc. said the company, as well as its chairman and CEO Phillip Frost, agreed to pay an aggregate of about $5.6 million to settle fraud charges brought by the U.S. Securities and Exchange Commission. The securities regulator had charged 10 individuals, including biotech billionaire Frost, and several associated companies for allegedly facilitating market manipulation schemes.

Other features

* The Wall Street Journal highlighted the medical costs burdening patients in the U.S. due to the country's broken healthcare pricing system. Out-of-network charges, which come from healthcare service providers that are not part of an insurer's network, contribute greatly to the soaring costs of patients in the U.S. who are hospitalized or receiving treatment, the report noted.

The day ahead

Early morning futures indicators pointed to a higher opening for the U.S. market.

In Asia, the Hang Seng increased 0.10% to 25,504.20, while the Nikkei 225 declined 0.31% to 20,014.77.

In Europe, around midday, the FTSE 100 was up 1.80% to 6,703.46, and the Euronext 100 was up 1.69% to 906.87.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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