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Valeant

FDA rejects Valeant plaque psoriasis lotion over pharmacokinetic concerns

Beleaguered pharma firm Valeant has come up against another bump in the road as its plaque psoriasis lotion Duobrii (halobetasol propionate and tazarotene) was rejected for US approval by the FDA.

The decision could prove to be a significant setback for the firm, who had placed heavy expectations on the drug; Duobrii is one of seven products in Valeant’s pipeline which it predicts will break $1 billion in sales over the next five years. Valeant’s shares fell by 7.1% on the news of the rejection.

Top Ten most popular articles on Pharmafile.com this week

It’s been a week in which one of the largest pharmaceutical takeovers in history took place and yet it’s not the most talked about event of the week nor our biggest story of the week.

The reason? Well, when you have a perfect storm of a big pharma company, an under-the-table deal and President Trump all involved in a single story, it’s probably going to blow everything else out of the water.

Read our the week's ten most popular articles on Pharmafile.com now:

Valeant seeks clean slate with rebrand, new company name

In the latest attempt to reverse its ailing fortunes and distance itself from its polluted brand, Canadian pharma firm Valeant has announced that it is set to change its name, it has emerged.

Chairman and CEO Joseph Papa revealed that, as of July this year, the company will be known as Bausch Health Companies, a nod to its respected eye care subsidiary Bausch & Lomb, which it acquired in 2013.

Impax agrees to $35 million settlement over anticompetitive practices with Valeant generic

Impax Pharmaceuticals has acquiesced to paying a $35 million settlement in order to resolve part of an antitrust lawsuit it is facing related to allegations that it entered into an agreement to delay its own generic version of Valeant’s acne medication Solodyn from hitting the market.

Top Ten most popular articles on Pharmafile.com this week

Happy New Year from Pharmafile.com! We hope the first week of 2018 hasn't been too rough. To the surprise of no one, its business as usual in the pharma and life sciences industries - Pfizer has kicked the year off with a drug discovery agreement with Arvinas to the tune of £830 million, while Allergan looks to be following in the footsteps of Teva with the announcement of massive staff cuts in order to make cost savings.

Valeant and Pershing take $290m hit over insider trading

Valeant Pharmaceuticals will be hoping it can begin 2018 as a fresh start, after a turbulent few years, to say the least, with the settlement of a case claiming that it had been involved in alleged insider trading in 2014.

Valeant backs away from female libido pill

Image: Addyi/Sprout Pharmaceuticals

Only two years ago, Valeant was so keen to get involved with a pill reported to increase the female libido that it was prepared to pay $1 billion for the company that produced it – half of which was upfront. Now, it’s had cold feet on the deal and decided to sell the drug back to the company – taking a $1 billion hit for just 6% of future sales of the drug.

Valeant begins long comeback trail with FDA approval

Valeant has had precious little to be happy about over the last few years, it’s bounced from one piece of bad news to another; however, it has managed a rare piece of good news after the FDA finally gave the green light for its glaucoma drug, Vyzulta.

The approval comes after the drug had already received two rejections, though not for reasons regarding the drug’s efficacy. Twice the FDA raised concerns about the manufacturing facility in Tampa, Florida – in particular, citing the finding of metal particulates in samples.

Valeant focused on bringing new products to market, receives CRL

In its second quarter financial reports, Valeant strove to strike a positive note. It revealed that it had paid down $4.8 billion on its mountain of debt since the first quarter of 2016 and CEO, Joseph Papa, said that the company would focus on launching new products, instead of selling parts of the business, to further reduce this.

This message was marred slightly by the previous day’s news, which revealed that the aim of bringing new products to market had been missed on its eye drug that had been issued a second CRL on manufacturing issues.

Valeant takes huge loss on previous deal to pay down debts

It is an odd time for Valeant, where selling a part of its business for half of what it paid, only four years ago, represents a success. Valeant announced that it had sold Obagi Medical Products for $190 million, in cash, after having bought the dermatology business for $437 million in 2013.

This is how bad things have become for Valeant that a deal representing a loss has been spun as signs of progress for the company.

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