HGS Adopts Poison Pill to Hinder GSK Bid

May 18th, 2012

Human Genome Sciences LogoHuman Genome Sciences (HGS) on Thursday adopted a shareholder rights plan to confront GlaxoSmithKline’s hostile bid, and discharged the GSK’s $2.60 billion proposition as insufficient.

A week ago, GlaxoSmithKline (GSK) appealed directly to shareholders, after initially being rejected by HGS last month, with the $13-a-share proposition for GSK’s long-time partner and co-developer of the lupus drug Benlysta.

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Scottish Medicines Consortium Approves Pfizer’s Xiapex

May 16th, 2012

Pfizer LogoThe Scottish Medicines Consortium (SMC) has authorised the use of Pfizer’s Xiapex (collagenase clostridium histolyticum) on the NHS for patients with Dupuytren’s contracture, reversing their earlier decision to reject the drug.

Xiapex is the first medication available for the condition, which previously was only treatable with surgery, meaning that the SMC’s endorsement good news for patients who are entitled to receive it.

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Pixuvri Gains Conditional Approval from EU Commission

May 14th, 2012

Cell Therapeutics LogoCell Therapeutics has obtained conditional approval in Europe for their lymphoma drug, Pixuvri.

The European Commission has given the okay for Pixuvri (pixantrone) as monotherapy for the treatment of adults with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL), making it the first authorised treatment in this patient setting in the continent.  The decision covers the 27 EU member states, in addition to Liechtenstein, Iceland and Norway.

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GlaxoSmithKline Submit Hostile HGS Bid Worth $2.60 Billion

May 10th, 2012

GSK LogoGSK’s (GlaxoSmithKline’s) $2.60 billion bid to buy Human Genome Sciences (HGS) has taken a hostile direction, with GSK directly approaching shareholders with their previously-declined offer, instead of participating in HGS’ “strategic alternatives review”.

Last month, the board at Human Genome Sciences, which developed Benlysta (belimumab) with GSK, rejected GSK’s $13.00 per share offer, which signified an 81% premium to HGS’ stock price on April 18, the day prior to the bid being disclosed.  The bid was then rejected by the HGS board following consultation with financial and legal advisors and the board announced that they believed the bid “does not reflect the value inherent in HGS.”

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Janssen Submits XARELTO to US FDA

May 4th, 2012

Janssen LogoJanssen Research & Development announced earlier this week that they have submitted supplemental New Drug Applications (sNDAs) to the US FDA (Food and Drug Administration).

Janssen are pursuing approval from the FDA for the use of XARELTO (rivaroxaban), an oral anticoagulant, to treat patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention of recurrent venous thromboembolism (VTE).

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GSK and Yale Partner to Work on New Class of Drugs

May 2nd, 2012

GSK LogoUK drug maker GlaxoSmithKline (GSK) has partnered up with US Yale University under a collaboration that will concentrate on creating a possible new class of drugs.

Under the discovery agreement, GSK’s scientists will work alongside Yale researchers to build on Yale’s pioneering work with so-called proteolysis targeting chimeric molecules (PROTACs).

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Clinical Professionals Are Attending the ICR Conference

April 30th, 2012

ICR LogoClinical Professionals are attending the ICR Conference at the Grand Connaught Rooms, London.

This year’s conference will be the 33rd annual ICR conference.  The conference is titled Clinical Research sans Frontiéres and will take place from the 14th till the 15th May 2012.

Clinical Professionals will be exhibiting at stand 11.

The ICR Annual Conference & Exhibition is the flagship event in our calendar of professional networking events with hundreds of delegates attending, offering the opportunity to network with all levels of clinical research professionals, from Clinical Trial Administrators (CTAs) to Heads of Clinical Operations.

Schedule:
Monday 14th May: 9:30 – 16:30, followed by the ICR Team Challenge Quiz Semi Finals and a Networking Drinks Reception in the Exhibition Hall
Tuesday 15th May: 9:00 – 16:00

Clinical Professionals will also be exhibiting at the virtual careers fair for those of you unable to attend the conference.  The virtual careers fair will start on the 15th May at 7am, and finishing at 7pm on the 16th May.  Register for the virtual careers fair here

If you wish to book a meeting time, please contact either:
Simon at simon@clinicalprofessionals.eu or call +44 (0)207 822 1710; or
Lee at lee@clinicalprofessionals.co.uk or call +44 (0)118 959 4990

We look forward to seeing you!

The Clinical Professionals Team

ICR Programme

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US FDA Requests Additional Data on Takeda’s Alogliptin

April 26th, 2012

Takeda LogoTakeda Pharmaceuticals have suffered a key setback after US regulators rejected their type 2 diabetes therapy, alogliptin, and the fixed-dose combination of the medicine with Takeda’s Actos.

Actos lost patent protection in 2011, and generic versions of the drug are anticipated to hit the marketplace later this year.

The business received a second complete response letter from the US Food and Drug Administration (FDA) in response to the New Drug Applications for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor and the alogliptin/Actos (pioglitazone).

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Clinical Professionals To Attend ABPI Conference

April 24th, 2012

ABPI LogoClinical Professionals will be attending the ABPI Conference on Thursday, at the Lancaster, London.

The conference is called ‘can we afford innovation in medicine?’   Throughout the day innovation’s significance to the future of pharma will be examined in various keynote speeches, panel discussions and workshops.

The ABPI represents research-based biopharmaceutical companies of all sizes.  The conference is primarily focused on Health Economics, and offers the opportunity to network with all levels of professionals within the biopharmaceutical industry.

The conference runs from 10:30 till 5:25 and is followed by the ABPI Annual Dinner.

If you wish to book a meeting prior to the event, please contact either:

Matt Glisson on matthew@clinicalprofessionals.co.uk or +44(0)118 959 4990; or

Vicky Nyssen on vicky@clinicalprofessionals.co.uk or +44(0)118 959 4990

We look forward to seeing you!

The Clinical Professionals Team

ABPI Conference Agenda

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Mylan To Generate 500 New Jobs In Ireland

April 23rd, 2012

Mylan LogoLast week US generics company, Mylan, announced that they will be investing €76 million into expanding their operations in Ireland, in a move that will create 500 new pharmaceutical jobs.

By 2016, Mylan expect to have generated roughly 220 jobs in Galway, while 280 will be created at the company’s facilities in Dublin.  The business currently employs around 700 people across Ireland.

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