Tag Archives: TGA

Blackmores takes over top-notch pill facility

Blackmores has confirmed settlement on the acquisition of Catalent Australia’s “world class” manufacturing facility in the Melbourne suburb of Braeside. This represents the company’s expansion into soft-gel and tablet manufacturing, with the facility, Blackmores Braeside, licensed by Australia’s Therapeutic Goods Administration as well as international regulators to produce medicines. It …

Read More »

Pharmacists’ lead role in safety of medicines

Pharmacists have demonstrated their commitment to making medicines in Australia safe and fit for their intended purpose by taking a lead role in reporting medicine and vaccine side effects. The Therapeutic Goods Administration annual performance statistics report, released this week, showed 24,000 medicine and vaccine adverse reaction reports were made …

Read More »

Key reforms in TGA agenda for 2019-20

The Therapeutic Goods Administration has released its annual business plan update, revealing a focus on major regulatory reform and a continued international perspective for 2019-20. The updated plan sets out the organisation’s product regulation, regulatory reform, international engagement and regulatory compliance agenda along with an overview of key activities and …

Read More »

Downside of codeine upscheduling hailed

The TGA’s upscheduling of codeine has produced a welcome downside, with researchers describing “a massive and abrupt reduction in codeine poisonings”, and data revealing codeine sales have halved. This week, researchers from the University of Sydney published the first peer-reviewed research to examine the short-term implications of the February 2018 …

Read More »

Kisqali a cancer treatment option for younger women

Aromatase inhibitor (AI), Kisqali, a CDK4/6 inhibitor has received a specific indication from the Therapeutic Goods Administration (TGA) for use in pre-/peri-menopausal Australian women with advanced metastatic HR+/HER2-breast cancer. This is said to be supported by significant overall survival data from the study, MONALEESA-7. MONALEESA-7 has reportedly demonstrated Kisqali significantly …

Read More »

Pure caffeine sales ban

Following a report into the safety of caffeine powders and highly concentrated caffeine products, the Morrison government has banned the sale of pure and highly concentrated caffeine food products for personal consumption. The ban comes as a result of a report commissioned by Minister for Aged Care and Senior Australians …

Read More »

E-cigarettes linked to severe lung illness

A statement on e-cigarettes has been issued by Australia’s Chief Medical Officer, following multiple US deaths linked to vaping, and warnings by the US Centres for Disease Control regarding the use of e-cigarettes. The statement, issued jointly by the Chief Medical Officer and State and Territory Chief Health Officers, refers …

Read More »

Vaporisers pass the TGA smoke screen

The Therapeutic Goods Administration (TGA) has this week approved the registration of a range of medically approved vaporisers in Australia. The approval of the Storz & Bickel GmbH & Co. KG medical standard vaporisers has been welcomed by Spectrum Therapeutics Australia (Spectrum), the medical division of Canopy Growth Corporation Australia …

Read More »

Therapy for multiple myeloma patients TGA approved

Multiple Myeloma

A novel triplet therapy for newly diagnosed multiple myeloma (NDMM) patients is now Therapeutic Goods Administration (TGA) approved. Revlimid (lenalidomide), in combination with bortezomib and dexamethasone (RVd), is now indicated for the treatment of patients with previously untreated multiple myeloma. The medication is an immunomodulating agent that inhibits the proliferation …

Read More »

New e-learning modules for pharmacists

The Pharmaceutical Society of Australia (PSA) and the Pharmacy Guild of Australia (Guild), in partnership with the Therapeutic Goods Administration (TGA) have developed two new e-learning modules for pharmacists. The e-learning modules are said to be designed to help pharmacists increase their knowledge of the regulatory requirements applied to complementary …

Read More »