The Pharm Exec staff

An international group of three scientists are the recipients of United States Pharmacopeial Convention’s 2014–2015 Global Fellowship Awards, aimed at advancing research involving quality standards for medicines.

The hemophilia treatment landscape is to undergo a radical shift away from established short-acting therapies, beginning with the launch of Biogen Idec’s long-acting rFVIII and rFIX products this year, according to research and consulting firm GlobalData.

Prescriptions to manage diabetes in primary care in the UK cost the NHS an average of £2.2 million ($3.7 m) every day in 2013-14, according to a report from the Health and Social Care Information Centre (HSCIC).

According to the Tufts Center for the Study of Drug Development R&D Management Report, more than half of all new drugs approved in the US between 2000 and 2011 were developed by companies that collaborated in one form or another with other entities.

The pharma, medical and biotech (PMB) sector, driven by the Novartis’s £8.6bn acquisition of GlaxoSmithKline’s oncology division, was the most active industry in UK M&A in H1 2014, with a 26.9% market share (£10.1bn), according to Mergermarket’s latest deal round-up.

The European Union’s decentralized procedure is to be used by international regulatory agencies as a model for facilitating generic-drug application assessments, as part of the International Generic Drug Regulations Pilot (IGDRP) project.

PharmaChk, a portable anticounterfeiting device, has received a $2 million transition-to-scale grant from Saving Lives at Birth: A Grand Challenge for Development.

Mexico’s pharmaceutical industry will be worth approximately US$22.5 billion by 2020, according to research and consulting firm GlobalData.

Medtech employment remained steady in last year with most medical device makers experiencing an increase in their workforce, according to a new jobs report published by EP Vantage.

With the recent approval of Jardiance in the US, Eli Lilly and partner Boehringer Ingelheim (BI) “have taken another step towards owning the most comprehensive diabetes portfolio in the industry”, according to research and consulting firm GlobalData.

Novartis reports that its KAE609 is the first antimalarial drug candidate with a novel mechanism of action to achieve positive clinical proof-of-concept in over 20 years.

FDA has announced it is taking steps to ensure that certain diagnostic tests are accurate, consistent and reliable.

The European Medicines Agency (EMA) has released the second module of a new overarching guideline on influenza vaccines for a six-month public consultation.

The Joint United Nations Programme on HIV/AIDS (UNAIDS) and the African Society for Laboratory Medicine (ASLM) have joined with a number of global partners to launch the Diagnostics Access Initiative.

A new report from Frost & Sullivan forecasts “robust demand” for HCV antivirals, with several strong competitors “maneuvering aggressively” to narrow the market gap by introducing a treatment that can outdo Gilead’s Sovaldi.

GSK announced that it has submitted a regulatory filing to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S.

The launch of several drugs with “extraordinary blockbuster potential” will more than triple the acute coronary syndrome (ACS) treatment market, from $12.3 billion in 2013 to $43.4 billion by 2023, according to research and consulting firm GlobalData.

Sanofi Pasteur, the vaccines division of Sanofi, reports that results of an efficacy study is a step closer to making dengue the next vaccine-preventable disease.

The steady decline of pharmaceutical sales representative access to physicians is spreading to previously rep-friendly specialties, says the ZS Associates spring 2014 AccessMonitorT report.

Today’s Financial Times (FT) reports that nearly $40bn was wiped from the biotech market’s value last week (a 6 per cent drop in the Nasdaq biotechnology index) following the Federal Reserve’s identification of biotech shares as a cause for concern.

Pharmaceutical online advertising has the highest viewability rates of any industry, according to a study by comScore, Inc.

The European Medicines Agency (EMA) has postponed formal adoption of the policy on publication of clinical trial data.

The vigorous return of M&A activity this year brings us back to the question: is more size and scalable efficiencies the best solution to the declining market power of pharmaceuticals in an endlessly restructuring healthcare system?

FDA issued a warning letter to GlaxoSmithKline Biologicals (GSK), North America on June 12, 2014 for deviations from cCGMP requirements found during an inspection from Mar. 31 to Apr. 9, 2014 of its influenza vaccine manufacturing facility in Quebec.

AbbVie’s recent $54 billion acquisition of Shire and subsequent relocation to Ireland will mean substantial tax savings for the US pharmaceutical giant, according to analysts at research and consulting firm GlobalData.

The pharma, medical and biotech industry is the leading sector for M&A activity this year, Mergermarket‘s Q2 M&A stats reveal.

Big Pharma employment dropped by 3 percent in the decade 2003–2013, allaying fears that industry consolidation and restructuring would lead to significantly reduced headcounts and payrolls, a report by EP Vantage reveals.

A new report from GlobalData states that the increase of biosimilars will have a negative impact on the biologics market after 2019.

The European Medicine Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines.

The future of GSK’s Tykerb (lapatinib) in the breast cancer market is unclear, after the combination of Tykerb and Herceptin in the large Phase III trial.