EU medical device and diagnostic regulatory overhaul: Key changes and their impact

On May 26th 2017, a new set of European Medical Device Regulations (“MDR”) and In Vitro Diagnostic Regulations (“IVDR”) entered into force. They represent a major overhaul and tightening of the previous directives and affect all companies marketing or developing devices and/or diagnostics under their name or trademark in the EU (termed ‘manufacturers’ in the regulations). The changes introduce a standardised regulatory framework for the EU that aims to be robust, transparent, and to overcome differences in interpretation and weaknesses brought to light in recent safety scandals.

Antibiotic Resistance, A Global Issue

The growing threat of bacterial resistance is a high priority global issue with 193 countries signing a landmark UN General Assembly declaration calling for coordinated effort in this area. Without urgent action today's routine infections could become killers and the face of medicine changed forever. At PharmaVentures we have reviewed how we have reached this current position and the ongoing roles of pharmaceutical and diagnostics companies.

Bugs as Drugs, Microbiome Dealmaking Poised to Take Off

With the growing understanding of numerous biologoical processes that are influenced by the 100 trillion microorganisms that make up the microbiome of an individual, there is an increasing number of Biotech and Pharma companies seeking to capitalize on this research to develop therapeutic, microbiome-based agents to treat disea

Infection Control, Secular Growth Drivers Power Investment and M&A

Infection control is a crucial part of healthcare service delivery. Patients undergoing surgery need to be protected from infection during and after procedures. Surgical instruments are required to be cleaned and sterilised for re-use. The hospital environment needs to be kept at good levels of hygiene to prevent hospital acquired infections (‘HAIs’).

Trends in the CMO Landscape

In the 3rd quarter issue of termsheet last year, we predicted a significant increase in pharmaceutical M&A deal values for 2015. In our latest white paper 'Trends in the CMO Landscape' we demonstrate the impact this increase in deal values has had on the Pharmaceutical industry and specifically in relation to CMOs and their future. We highlight the challenges facing the leading players and what strategies they are employing to address these in an increasingly competitive and fragmented sector. 

Stars in Our Eyes - Ophthalmology Drugs Report

The ophthalmology drug segment continues to shine brightly with a number of deals announced in November such as Genentech’s partnering with Novartis to split ex-US rights to Ophthotech’s eye drug, which could be worth more than $1 billion. Allergan, another of the major players in the market, recently acquired rights to Mimetogen’s tavilermide for $50 million upfront and more payments down the line.

Anti-Microbial Resistance and the search for New Antibiotics

The ‘antibiotic crisis’ is rarely out of the news these days, with headlines issuing dire warnings that the rise in resistance to anti-microbial drugs could result in a return to the medical dark ages. In order to tackle this problem, various initiatives have been proposed on both sides of the Atlantic, both to incentivise research into novel antibiotics and to change current prescribing behaviour in an attempt to limit the spread of resistance to existing antibiotic drugs.

An Accommodating Environment. Ophthalmology Device Transaction Activity 2010 to 2015

The ophthalmology device segment has experienced robust transaction activity with over 500 transactions taking place between January 2010 and the end of the first quarter in 2015.

In this white paper we look at the range of transaction activity by type, geography and stage, take a look at the sector market performance so far and discuss what we can expect in the future.

Are you Planning to Divest R&D or Manufacturing Facilities?

Leading CMOs are developing acquisition strategies based on reinforcing their customer base, expanding their geographic reach and broadening their capabilities. Similarly, customers are increasingly demanding simpler sourcing models that can deliver speed and reliability.

Divestment is often the most favoured strategy for surplus manufacturing or R&D assets. Our experience has taught us that delays in the divestment process can significantly erode value and  diminish attractiveness to buyers. Speed and control of the selling process is in a seller’s best interest as site operating costs usually make up a significant part of business operations. Every month of delay could add unnecessary thousands, if not millions to operating costs prior to a sale.

Immuno-Oncology, Revolution or Evolution?

Immuno-oncology is the latest and perhaps the most exciting development in cancer and immunotherapy. Here we look at why we can expect this to be a hot area for deal making in the immediate future.