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Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

Korea Lowers Medical Cost For Rare Disease Patients, Eases Off-Label Use Rules

In an ongoing effort to improve access to drugs and provide more treatment options for rare disease patients, South Korea unveils new steps to lower their treatment costs and expand the scope of what are considered rare diseases.

South Korea Regulation

Novartis Diabetes Triple Drug Combination Deemed 'Irrational' In India

Novartis’s plans for triple drug diabetes combination which includes vildagliptin have been turned down in India at least for now, with an expert panel questioning the rationale of such therapy.
Review Pathway Metabolic Disorders

Opioid Indications Under TGA Scrutiny As Australia Tackles Growing Misuse

The Australian drug regulator is reviewing the indications, pack sizes and information documents for consumers of potent opioid products to see how misuse and overdoses can be prevented.
Australia Drug Safety

Gene Therapy INDs In China: Five Things To Consider

China is overtaking the US as the largest cell development market, with over 2,300 registered clinical trials. 

China Regenerative Medicine

Australia Publishes Plans For Global Regulatory Capacity Building

Australia has outlined its plans for building up regulatory capacity and work-sharing among medicines agencies at the regional and global level in the next financial year.

Australia Regulation

Dealing With Powerful ‘Vaders’ A Lingering Challenge For Japan’s AMED

Some three and a half years after its formation, Japan’s Agency for Medical R&D (AMED) is continuing its efforts to “de-Balkanize” academic research in the country, and to foster closer health research cooperation between government, academia and industry. While progress has been made, particularly in the genomics area, challenges still linger, its president concedes.

Japan Policy
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Europe

Set Alert for Europe

Latest From Europe

Brexit: Number Of Drugs At Risk Of Shortage Cut From 108 to 39

The European Medicines Agency plans to work directly with the marketing authorization holders of products that are still at risk of supply shortages to address the outstanding issues.

Brexit Regulation

EMA Targets Sponsors That Post Trial Results Too Late

Too many clinical trial sponsors are late in to reporting their study results on the publicly available EU Clinical Trials Register, and the European Medicines Agency is planning to chase up the laggards.

Clinical Trials Compliance

EU Approval Set For Three New Orphans And Lilly’s Emgality; Exondys Appeal Fails

The CHMP has upheld its previous negative opinion on Sarepta’s DMD treatment Exondys, but has given a raft of positive opinions on other novel products, including Lilly’s new migraine prophylactic Emgality, Spark Therapeutics’ gene therapy Luxturna for retinal dystrophy, and Vabomere, The Medicines Co/Rempex Pharmaceuticals’ new antibiotic for severe infections.

Europe Drug Review

English Court Queries EMA Primacy & Says Avastin Can Be Used In AMD

The English High Court has rejected attempts by Novartis and Roche to stop clinical commissioning groups from offering Avastin to wet AMD patients in a cost-containment move. In a development that has alarmed pharma firms, the court also questioned the exclusive role of the European Medicines Agency in marketing authorizations, saying that CCGs as well as the health technology assessment body, NICE, have competences in that area, and called on the UK regulator to review its guidance on off-label and unlicensed use.

Reimbursement Regulation

Not The End For Exondys In EU, Says Sarepta

Sarepta Therapeutics’ hopes of marketing its controversial Duchenne muscular dystrophy drug in the EU have again been dashed, but the company says it hopes to learn from EU regulators next year what it can do to get the drug to patients in Europe. Meanwhile, sales of the product are going well in the US.

Drug Review Approvals

GSK Invests In OTC Production, Prepares To Divest Horlicks Nutritional Business

Latest consumer health investment was $36m upgrade to a Canadian facility, which by mid-2019 will begin making Voltaren OTC topical gel products. GSK's next move in consumer health divestment is its pending sale of its Horlicks business.

Consumer M & A
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United States

Set Alert for United States

Latest From United States

To Lower Drug Prices, Look At Generic Industry Health Rather Than FDA, Woodcock Says

US FDA can encourage and increase competition, but cannot force generic companies to enter markets deemed unprofitable, CDER director says.
Pricing Debate Generic Drugs

Opioids Could Become Bioterror Weapons, US Fears; BARDA Funds Countermeasures

Opiant could get $4.6m to accelerate development of nasal nalmefene for treatment of opioid overdose.

Policy Research & Development

Pivotal Trials Are Cheaper For Unmet Needs And Orphan Drugs, JAMA Study Finds

Analysis of clinical trial costs for CDER’s 2015-2016 novel therapeutic approvals finds pivotal studies are most expensive when a new agent has a similar benefit to already marketed products with well-established clinical profiles. 
Clinical Trials Research and Development Strategies

Advertising Enforcement: US FDA Content To Let Competitors 'Duke It Out,' Woodcock Says

Office of Prescription Drug Promotion is focused on most egregious issues where human safety is at stake; CDER's Woodcock also says that First Amendment issues are affecting enforcement.
Advertising, Marketing & Sales FDA

Biosimilar Action Packages Low On US FDA Priority List For Redaction And Posting

Final review documents have been posted for only four of 12 biosimilars due to a backlog in applications considered the third priority level for redaction – a categorization that seems out of sync with the agency’s approach to labeling and its emphasis on promoting price competition.


Biosimilars Drug Review

US FDA’s Streamlined Drug Approval Packages Shine Less Light On Sponsor Interactions

CDER is no longer proactively posting mid- and late-cycle meeting minutes and certain correspondence with sponsors for new drug and biologic approvals; drugs center says it is focused on ensuring the most scientifically meaningful information is prioritized and posted in a timely manner, but some observers say the change raises transparency concerns.

Drug Review Approvals
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