Regulatory

Australia implements opioid reforms to deal with 150 hospitalizations per day

January 7, 2020

PERTH, Australia – Australia’s Therapeutic Goods Administration is putting in place a number of opioid reforms to clamp down on the use of opioids to deal with increasing deaths and hospitalizations from the use of those drugs.

Regulatory front for Jan. 7, 2020

January 7, 2020

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The latest global regulatory news, changes and updates affecting biopharma.

Regulatory front for Dec. 31, 2019

December 31, 2019

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The latest global regulatory news, changes and updates affecting biopharma.

China approves Beigene’s PD-1, tislelizumab, as companies look to differentiate

December 31, 2019

By Elise Mak

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BEIJING – Chinese regulators granted the marketing nod to Beijing-based Beigene Ltd.‘s PD-1 antibody, tislelizumab, for treating patients with classical Hodgkin lymphoma (cHL) who have received at least two prior therapies. To be sold under the Chinese trade name Baize’an, tislelizumab is Beigene’s first drug to win approval in China, following an FDA approval for its BTK inhibitor, Brukinsa (zanubrutinib), last month. “We are preparing the commercialization of tislelizumab, and we will start supplying the drug soon,” Beigene’s media relations officer, Min Xiao, told BioWorld Asia.

FDA grants accelerated approval for Padcev to treat urothelial cancer

December 24, 2019

By Lee Landenberger

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A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer.

A sleigh full of approvals

FDA brings good tidings, with new drugs for breast cancer, insomnia, schizophrenia and migraine

December 24, 2019

By Michael Fitzhugh

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Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency.

Qilu scores first Avastin biosimilar approval in China, set to drive down prices

December 17, 2019

By Elise Mak

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BEIJING – Jinan, China-based Qilu Pharmaceutical Co. Ltd. has won the first approval for a China-developed biosimilar to Avastin (bevacizumab, Roche Holding AG). Its biosimilar QL-1101, to be sold under the trade name Ankada, has been approved to treat advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer.

Regulatory front for Dec. 10, 2019

December 10, 2019

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The latest global regulatory news, changes and updates affecting biopharma in Asia-Pacific.

Celltrion’s Remsima SC wins marketing approval in EU

December 3, 2019

By Jihyun Kim

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HONG KONG – Celltrion Healthcare Co. Ltd., a South Korean biopharmaceutical corporation, won European Union (EU) marketing approval for Remsima SC for the treatment of rheumatoid arthritis (RA), as a subcutaneous version of Celltrion’s infliximab biosimilar, CT-P13.

China updates reimbursement drug list, further encourages innovation at home

December 3, 2019

By Elise Mak

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BEIJING – China has updated its national reimbursement drug list (NRDL) to include innovative drugs that it has recently approved, including homegrown cancer drugs and foreign imports. Industry experts said they believe it is a move to drive biotech innovation at home.