Topic:

Regulatory

Latest Headlines

Latest Headlines

TCM-based oncology candidate wins U.S. FDA nod for PhIII, Xinhua says

A traditional Chinese medicine (TCM)-based candidate, Kanglaite, won U.S. FDA approval for a multiregion Phase III trial in pancreatic cancer treatment that uses a derivative of the coix seed, the state-run Xinhua news agency reports.

India's Gujarat state drugmakers speed up biosimilar race

Drug companies in India's leading industrial state of Gujarat, the base of Prime Minister Narendra Modi, are stepping up efforts to crack the domestic market for biosimilars as well as abroad, Business Standard reports.

Australia's CSL's rIX-FP PhIII meets endpoint, firm buys Rapivab rights from BioCryst

Australia's CSL unveiled Phase III trial results for hemophilia B candidate rIX-FP that met the primary endpoint and separately noted it bought exclusive rights to commercialize flu treatment Rapivab from BioCryst Pharmaceuticals last week. The note highlighted the growing reach of the biopharma in a core blood products business and in vaccines following its purchase of a Novartis unit last year.

FDA warns that transdermal patch for ADHD can lead to permanent skin discoloration

The FDA warned that a transdermal patch used to treat ADHD in children and adolescents can lead to chemical leukoderma, or permanent skin discoloration, as a result of the skin's repeated exposure to specific chemical compounds.

Japan approves Bayer sales of Eylea for diabetes-related visual impairment

Japan's Pharmaceuticals and Medical Devices Agency approved Bayer's Eylea for the treatment of diabetes-related visual impairment, the company said in a release June 26.

Australia's Ley hits back at drug firms on access to new medicines, reimbursement policies

A growing tussle between industry and Australia's Liberal-led coalition over efforts to trim drug reimbursement costs widened this week as Health Minister Sussan Ley hit back at Medicines Australia over the approval times for newer treatments and related costs.

Pharmacies want more time to comply with track-and-trace rules

This year the FDA gave drugmakers, wholesalers and logistics companies an extra four months to get on board with new regulations requiring them to be able to track lots of prescription drug products all along the chain of custody. Now pharmacy groups are asking if they could catch a similar break.

TxCell halts drug production, a decision made with French regulator

TxCell, a French biotech working on T-cell treatments for chronic inflammatory and autoimmune diseases, named Stéphane Boissel as its new CEO in April. And one of the first issues Boissel gets to confront is regulatory concerns over a pilot manufacturing facility.

CRO M&A ticks up in India, fueling hopes of turnaround

Contract research in India has seen a boost that, along with other green shoots news, has lifted the tone for an industry that has run through a rough patch of regulator and civil society scrutiny over claims of poor management and allegations of a disregard for patient safety and informed consent.

Ascletis plans China, Taiwan PhIII trials on chronic hep C therapies

China-based Ascletis Pharmaceuticals has notched up a first with plans for Phase III trials of danoprevir (ASC08) and ASC16 (PPI-668) to treat chronic hepatitis C in China and Taiwan. If successful, the trials could represent a milestone that could reach an estimated patient population of 30 million to 40 million, the highest worldwide.