PERTH, Australia – Melbourne-based Starpharma Ltd. submitted a rolling submission of its Vivagel new drug application (NDA) to the FDA for preventing and treating recurrent bacterial vaginosis (rBV). With that submission, the biotech company joins a very limited club of Australian biotechs to bring their products all the way through to registration.

PERTH, Australia – Implementing drug and device regulatory reforms that were begun in 2017 will continue to be top priorities for Australia's Therapeutic Goods Administration, according to its newly published TGA Business Plan 2017-18.

ADELAIDE, Australia – Australian biopharmaceutical companies engaged in drug development shouldn't waste their time trying to build a flagship company in Australia, said Race Oncology Ltd. CEO Peter Molloy. Rather, they should focus on partnering with big pharma as early as possible, he told attendees of the Ausbiotech conference.

ADELAIDE, Australia – Australian biopharmaceutical companies engaged in drug development shouldn't waste their time trying to build a flagship company in Australia, said Race Oncology Ltd. CEO Peter Molloy. Rather, they should focus on partnering with big pharma as early as possible, he told the Ausbiotech conference.

PERTH, Australia – Novartis AG's recent tender offer to acquire radiopharmaceuticals specialist Advanced Accelerator Applications SA (AAA) for $3.9 billion could bode well for Aussie radiopharma company Telix Pharmaceuticals Ltd., which announced its IPO to raise A$50 million (US$38.4 million) on the Australian Securities Exchange.

PERTH, Australia – Companies in the regenerative medicine space have long been pushing the Therapeutic Goods Administration (TGA) to regulate autologous cell and tissue products in Australia, and they strongly support the agency's moves toward stronger regulation.

PERTH, Australia – Companies in the regenerative medicine space have long been pushing the Therapeutic Goods Administration (TGA) to regulate autologous cell and tissue products in Australia, and they strongly support the agency’s moves toward stronger regulation.