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BioMarin receives FDA nod for its would-be blockbuster

BioMarin is confident that its newly approved treatment for phenylketonuria (PKU) is set to become a blockbuster and it’s priced the drug accordingly, at $488 per unit.

This might seem like a huge amount but when patients will eventually be using one or two units of pegvaliase per day, every day, that price starts to add up – meaning that cost per patient could end up between $170,000 and $340,000 each year.

Breast cancer screening scandal potentially involves even more women

The news broke at the start of the month that a number of women who should have been invited to breast cancer screening had not received their invitation due to an automated system error; at the time, it was suggested that it meant 450,000 women did not receive an invitation for a scan but further independent research suggests the number could be closer to over 502,000.

The researcher who made this discovery is Professor Peter Sasieni, of the Queen Mary University of London, after digging back into the publically available data.

Prothena guts workforce by more than half, after trial failure

Prothena Therapeutics has acted drastically by slashing staff numbers by more than half, after the failure of two pivotal trials for its lead candidate.

The company subsequently ditched NEOD001, when trials revealed that placebo treatment outperformed the drug candidate in the treatment of AL amyloidosis.

The reorganisation sees 63 positions cut away from the Dublin-based company, representing a shedding of 57% of the entire staff at the company.

John Crowley speaks on drug development and the FDA

Published on 24/05/18 at 09:31am

Pharmafocus spoke to John Crowley, CEO of Amicus Therapeutics, about his highly unusual career in the pharmaceutical and biotech industries.

Astellas begins major restructure, as 600 jobs slashed

Astellas, under the direction of new CEO, Kenji Yasukawa, has unveiled a major new restructure, ahead of a difficult looking year financially in 2019.

The new CEO, in place since 1 April, was given the task of turning around the business, after it reported slowing sales in 2017 and anticipates a major drop in profit during 2019.

If the first major announcement of the restructure are anything to go by, he may well be ruthless in his efforts to create a leaner business.

Report calls for tax rises to fund ailing NHS

A report published by the Institute for Fiscal Studies (IFS) has stressed that UK funding into the NHS needs to rise by 4% year on year for services to improve. It revealed for the service to even maintain current levels of care, spending would still need to increase by 3.3%.

Beyond the healthcare system, the report also identified an urgent need to put more money into social care funding and called for a 3.9% increase each year to meet the needs of an ageing population.

MSD’s Keytruda scores impressive first-line lung cancer data

MSD Keytruda has enjoyed the most success of the PD-1/L1 therapies in clinical trials recently and it’s rapidly cementing its position as the leader in the field with another set of stellar data, this time in metastatic squamous non-small cell lung cancer on a first-line basis.

Keytruda was used in conjunction with chemotherapy and managed to hit both its primary endpoints in overall survival and progression-free survival.

Vifor Fresenius snap up rights to Cara’s itch therapy

The joint partnership between Vifor Pharma and Fresenius Medical Care, Vifor Fresenius, has put down $50 in upfront cash and an equity investment of $20 million to gain the Ex-US, Japan and South Korea rights to Cara Therapeutics’ Korsuva.

Beyond the immediate $70 million investment, the deal is also back loaded with a potential $470 million in regulatory and commercial milestones.

World heading towards 25% of total population being obese

The latest global research paints a bleak picture of future global public health, predicting that almost a quarter of the entire global population will be obese by 2045, based on current trends.

With this rise in obesity, type 2 diabetes is also set to rise to 12% of all individuals having the condition.

At present, global obesity rates rest at 14% of the global population and 9% of individuals are living with type 2 diabetes.

Takeda begins to shore up finances with $280m divestment

Much has already been written about Takeda and its massive financial stretch to pull in the Shire acquisition, in the massive $62 billion deal.

It’s now beginning to trim down its business and looking to bring in some much needed cash to pay down the deal, with a divestment of its stake in Guangdong Techpool Bio-Pharma.

Takeda had acquired its stake in the business after its $14 billion takeover of Nycomed in 2010, which held a 51.34% majority stake in the company.

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