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Allergan out but Takeda sticks to guns on Shire

Allergan performed an odd about-turn after initially declaring its interest in pursuing a deal for Shire, before reneging on that statement only a few hours later by suggesting it wouldn’t follow through on its interest.

It announced it would not make an offer, before concluding: “Allergan continues its ongoing process of evaluating a full range of potential strategic actions that will create value for shareholders, such as divestitures, combinations and acquisitions.”

Top Ten most popular articles on Pharmafile.com this week

It's the end of another week and there's really been one story that has dominated the headlines – Takeda’s potential takeover of Shire. It should come as no surprise that our most viewed story of the week relates to the purchase.

FDA advisory committee sets GW Pharma up for approval

After the FDA advisory committee unanimously recommended GW Pharma’s Epidiolex for approval, the chances of it not receiving the nod are now slim to none.

All the data released by GW Pharma had pointed towards a strong case for approval, with a number of Phase 3 trials having been conducted to prove the drug’s efficacy in treating Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS).

However, there has always remained one question mark – would the FDA approve a treatment that is derived from cannabis?

BenevolentAI financing round takes valuation to $2bn+

BenevolentAI, a London based drug discovery biotech, has revealed that a $115 million financing round now sees the company valued beyond $2 billion.

The biotech itself is focused on using AI technology to speed up the drug discovery process. BenevolentAI has been around since 2013 and has already initiated 20 drug development programmes, demonstrating how quickly the technology is able to identify targets.

Merck KGaA finds consumer health buyer in P&G for €3.4bn

Merck KGaA has successfully found a buyer for its healthcare unit, after Proctor & Gamble announced that it was prepared to part with €3.4 billion to gain the rights to a portfolio that includes Seven Seas and Bion3 supplements.

To push the deal through, it is assumed that Merck had to climb down slightly on its valuation of the business, which it had initially pegged at around €4 billion. However, now that the deal has gone through, the company will be able to focus on its pharmaceutical business and potentially use the extra cash to grow its pipeline.

EMA initiates divorce process from the UK’s MHRA

The first stage of separation for the EMA from the UK came with the decision to relocate its headquarters to Amsterdam, and now the second stage has taken place whereby the EMA has reassigned the MHRA’s role vetting medicines to other countries.

All of this has been brought about by Brexit; the surprise decision to go ahead with uncoupling the EMA’s medicine verification process from the MHRA immediately after the deadline for Brexit will have brought even more uncertainty for UK industry.

EpiPen shortage hits UK and Canada hard, but not US

Manufacturing issues at the single Pfizer plant that produces the EpiPen epinephrine injector has caused serious shortages in the UK and Canada, but the US remains unhurt by supply issues.

The situation has developed to the point where Canada is now in direct conversation with the FDA to determine whether it will be able to gain access to some of US’ supply of the medicine.

Potential issues with supply of the EpiPen were announced back in January but it had been suggested the problems would be resolved by March.

Sanofi CFO set to step down this year

After a busy start to the year, with a number of acquisitions and a few divestments, Sanofi’s Chief Financial Officer, Jérôme Contamine, is set to retire before the end of the year.

The news broke through Bloomberg, after a Sanofi spokesperson confirmed that Contamine will leave the company, though he will be involved in the process of finding his replacement and ensuring a smooth transition process.

All indications point to approval for cannabis-based therapy

GW Pharma are inching step by step towards a likely approval with the FDA, after it received a strong recommendation within a briefing document prior to the FDA advisory committee meeting.

GW Pharma’s is seeking indications for two conditions of childhood epilepsy, Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), for its treatment, Epidiolex. The epilepsy drug is derived from cannabidiol in a purified form and is delivered to patients as a syrup.

FDA flip-flops on Alkermes' drug application

Two weeks ago, it looked like the hopes for Alkermes’ ALKS 5461 receiving approval would rely on returning to the clinic to undergo the lengthy process of gathering more data on the drug, after it received a Refuse to File letter from the FDA.

Now, the agency has switched up its position, catching everyone off guard with its decision to accept for review Alkermes’ NDA for ALKS 5461.

As the FDA is not compelled to provide a reason for this about-face, the only information coming out of the decision is from Alkermes.

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