The Guardian - Pharmaceutical Industry

APRIL 25, 2023

Sign up for Guardian Australia’s free morning and afternoon email newsletters for your daily news roundup Continue reading. The opposition leader, Peter Dutton, has already lent support for the campaign, encouraging patients to ask pharmacists how “the proposed changes will impact you as a customer and them as a local small business”.

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The Guardian - Pharmaceutical Industry

MAY 16, 2023

Sign up for Guardian Australia’s free morning and afternoon email newsletters for your daily news roundup Continue reading. The government says allowing people to buy two months’ worth of medicine for the price of a one-month prescription will save patients up to $180 a year for each medicine.

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The Guardian - Pharmaceutical Industry

JULY 28, 2022

The authors of a study published in the journal JAMA Oncology on Friday said the lack of transparency should be concerning to Australia. Sign up to receive an email with the top stories from Guardian Australia every morning Continue reading.

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PharmaShots

MAY 26, 2023

Shots: Akebia will receive $10M up front, ~$100M in commercial milestones for rights to Vafseo in the EU & Australia along with royalty up to 30% of net sales. Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com

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The Guardian - Pharmaceutical Industry

SEPTEMBER 27, 2022

Sign up to receive an email with the top stories from Guardian Australia every morning Continue reading.

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PharmaShots

MAY 15, 2023

while (SKYLIGHT 4) demonstrated the long-term safety of fezolinetant Additionally, the MAA for fezolinetant is also under regulatory review in the EU, Switzerland, and Australia Ref: Astellas | Image: Astellas Related News:- Astellas Entered into a Definitive Agreement to Acquire Iveric Bio for ~$5.9B PharmaShots!

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PharmaShots

JUNE 28, 2023

Xigduo XR was approved in the US, Australia & other regions Ref: AstraZeneca | Image: AstraZeneca Related News:- AstraZeneca's Farxiga and Xigduo XR Receives FDA's Expanded Label Approval for Type 2 Diabetes (T2D) and Moderate Renal Impairment PharmaShots! For more information connect with us at connect@pharmashots.com

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PharmaShots

MAY 30, 2023

Nidlegy is being studied in the P-III trials for melanoma & non-melanoma skin cancers Ref: PR Newswire | Image: Sun Pharma Related News:- Sun Pharmaceutical’ Sezaby Receives the US FDA’s Approval for the Treatment of Neonatal Seizures PharmaShots! Your go-to media platform for customized news ranging for multiple indications.

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PharmaShots

JUNE 27, 2023

Shots: The P-IIb study evaluating amlitelimab, a fully human non-depleting mAb that binds to OX40-Ligand vs PBO in 390 adult patients across Australia, Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, Spain, Taiwan, the UK & the US The trial met its 1EPs & showed an improvement in avg. EASI score from baseline at 16wks.

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PharmaShots

JUNE 16, 2023

The study was conducted in the US, EU, Japan & Australia The study met its 1EPs & 2EPs i.e., improvement in OS & PFS, m-OS (7.4 Your go-to media platform for customized news ranging for multiple indications. vs 4.8mos.), m-PFS (3.7 vs 1.8mos.), DCR (56% vs 16%) while the median duration of follow-up was ~11mos.

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PharmaShots

JUNE 6, 2023

The sBLA of dostarlimab will be reviewed by health authorities in the US, Australia, Canada, Switzerland, Singapore & the UK under the Project Orbis Ref: GSK | Image: GSK Related News:- GSK Reports EMA’s Validation of MAA for Jemperli (dostarlimab) to Treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer PharmaShots!

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PharmaShots

MAY 26, 2023

The US FDA’s decision for NDA is expected on Nov 2023 The NDA was based on the P-III multi-regional clinical trial (FRESCO-2) evaluating fruquintinib + BSC vs PBO + BSC in 691 patients across the US, EU, Japan & Australia along with data from the P-III trial (FRESCO).

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PharmaShots

MAY 15, 2023

The company works closely with regulatory agencies to review the P-III data & the results will be submitted to a peer-reviewed scientific journal Ref: GSK | Image: GSK Related News:- GSK’s Arexvy Receives the US FDA’s Approval for the Prevention of Lower Respiratory Tract Disease in Individuals Aged ≥60 Years PharmaShots!

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PharmaShots

MAY 8, 2023

The therapy also received ODD in the US, EU, Russia, Switzerland, South Korea, Taiwan, Japan & Australia Ref: AstraZeneca | Image: AstraZeneca Related News:- AstraZeneca and MSD's Koselugo (selumetinib) Receive the EU's Approval for Neurofibromatosis Type 1 and Plexiform Neurofibromas PharmaShots!

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The People's Pharmacy

JUNE 15, 2023

The answer is AUSTRALIA! We often look to Australia for signs of the coming flu season. That’s because flu season is always six months ahead in Australia and New Zealand. The H3N2 type-A strain of influenza increased sharply in Australia (aka Oz) in early May and peaked there in mid-June. Guest what?

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Vaccines 76

PharmaShots

MAY 8, 2023

Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com

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PharmaShots

FEBRUARY 6, 2023

Shots: The companies collaborated to commercialize AVT23, a proposed biosimilar to Xolair (omalizumab) in the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand Alvotech will be responsible for the development and manufacture while Advanz Pharma will be responsible for the registration and commercialization.

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PharmaShots

JANUARY 31, 2023

The therapy was well tolerated with no major safety concerns Ref: GlobeNewswire | Image: Idorsia Related News:- Simcere Entered into an Exclusive License Agreement with Idorsia for Daridorexant in China when added to combination background antihypertensive therapy.

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PharmaShots

APRIL 24, 2023

The results were consistently comparing Syfovre-treated study eyes to the untreated fellow eyes Five regulatory agencies globally are currently reviewing the marketing applications; a decision in the EU is anticipated in early 2024 & decisions in Canada, Australia, Switzerland & the UK are anticipated in H1’24 Ref: GlobeNewswire | Image: (..)

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PharmaShots

FEBRUARY 3, 2023

The device is now approved as a treatment option for ventricular tachycardia (VT) in patients with non-ischemic cardiomyopathy The decision was based on the (LESS-VT) study in 600 adult patients who were randomized to either undergo treatment with a previously approved ablation device or the FlexAbility SE Ablation Catheter which showed that 80% of (..)

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PharmaShots

MARCH 27, 2023

The company also plans for regulatory approvals in the UK, Canada, Australia & Japan Ref: Pharming | Image: Pharming Related News:- Pharming’s MAA Application for Leniolisib Receives Approval by the EMA to Treat Activated Phosphoinositide 3-Kinase Delta Syndrome

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PharmaShots

JUNE 5, 2023

in EU, Japan, China, Australia & Latin America Alvogen will lead the US commercialization of NRX-101 & NRx will oversee the clinical development. a right of 1st negotiation for new indications of NRX-101 & new products containing D-cycloserine + antidepressant/antipsychotic Ref: Nrxpharma | Image: Alvogen PharmaShots!

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PharmaShots

MAY 8, 2023

Your go-to media platform for customized news ranging for multiple indications.

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pharmaphorum

DECEMBER 14, 2021

Shares in Vifor rose sharply this morning as news of the deal emerged, continuing strong gains since the start of the month when rumours of a deal started to drive the stock upwards. Since then, Australia opted to use Pfizer and BioNTech’s vaccine for the bulk of its immunisation requirements. billion last year.

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pharmaphorum

DECEMBER 22, 2022

The UK deal was also hailed by the Association of the British Pharmaceutical Industry (ABPI), which called it “fantastic news for British manufacturing and UK-based science and research [and] an important reminder that the life sciences industry has the potential to be a key growth driver for the UK economy.”

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European Pharmaceutical Review

JULY 11, 2023

This news follows the US Food and Drug Administration (FDA)’s approval of the anti-cancer treatment last month. The EC’s decision for Roche’s Columvi is indicated for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

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STAT

JULY 6, 2023

But while patient advocates are celebrating, critics see it as the unfortunate triumph of a flawed theory of the disease’s cause and predict the rollout of the drug will aggravate racial disparities in elder care , KFF Health News explains. Drugmakers are asking the U.S. nationals injured by acts of international terrorism.

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The FDA Law Blog

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. Respondents also asked FDA to align its standards to the emerging new guidances and ongoing global efforts to root out NDSRIs.

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pharmaphorum

FEBRUARY 24, 2022

The drug entered Phase 0 human trials in late November, an exploratory microdose trial of eight individuals in Australia. The new Phase 1 trial will be a double-blind placebo trial and will include 80 healthy volunteers divided into 10 cohorts. . The company raised a $225 million Series C round last summer led by Warburg Pincus.

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PharmaShots

MAY 24, 2023

including the United Kingdom, Australia, and Canada. including Europe, the UK, Australia, and Canada thus increasing its global recognition and acceptance as a highly beneficial treatment option. Revenue Analysis1 Trikafta/Kaftrio is developed and commercialized by Vertex Pharmaceuticals. independent.co.uk cysticfibrosis.ca

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Insurance Coverage FDA Hospitals Dosage 56

The Guardian - Pharmaceutical Industry

MAY 3, 2023

Sign up for Guardian Australia’s free morning and afternoon email newsletters for your daily news roundup Continue reading. The guild says while some medicines might be widely available in certain strengths, other dosages of the same medicines are scarce, affecting 133 medicines.

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Dosage 74

pharmaphorum

JULY 6, 2021

A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial.

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PharmaShots

FEBRUARY 2, 2023

Shots: The 1st patient has been dosed in the P-I/II trial evaluating AU-007 at 4 locations in Australia & 1 site in Huntersville, North Carolina The P-I trial consists of 3 dose escalation arms of AU-007 as monotx.

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The Guardian - Pharmaceutical Industry

FEBRUARY 9, 2023

It would be a mistake for Australia to narrow its health reform agenda to ignore access to new medicines The new year has brought with it an increased focus on Medicare reform to ensure it remains fit for purpose.

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The Guardian - Pharmaceutical Industry

APRIL 27, 2023

In the interests of reassuring the community, let’s address each of the alarm bells set off by the Pharmacy Guild Get our morning and afternoon news emails , free app or daily news podcast Will the sky fall in? Will pharmacists go broke?

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The Guardian - Pharmaceutical Industry

JUNE 8, 2023

Meanwhile, the Australian Medical Association has labelled the Pharmacy Guild’s opposition to the new rules a “sick joke”. Sign up for Guardian Australia’s free morning and afternoon email newsletters for your daily news roundup Continue reading.

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Labelling 51

The Guardian - Pharmaceutical Industry

AUGUST 10, 2023

Sign up for Guardian Australia’s free morning and afternoon email newsletters for your daily news roundup Continue reading. As part of ongoing medicine shortages caused by global supply problems since the Covid pandemic, children’s medicine has become a “hotspot” in the last couple of weeks.

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