Industry news

EMA Relocation Countdown: Some Industry Viewpoints

Raman Sehgal / Pharmaceutical Executive

July 1, 2018 marked the start of the six-month countdown to the European Medicines Agency (EMA) relocation of its operations to Amsterdam. Worryingly, there remains little guidance or clarity from the EMA as to the implications of the move, and Brexit, on the pharma industry.

Patient- & Customer-Centric Commercialization: A Case Study

Wills Hughes-Wilson, Alan Raffensperger, Birgitte Volck / Pharmaceutical Executive

Patient-centricity and customer-centricity are high on the agenda of many pharmaceutical companies. Most state that they are patient- and customer-centric or have an aspiration to be so. But what does that look like in reality, and how does one create, build, and lead a patient- and customer-centric approach from an operational perspective? And is it merely a branding or “feel-good” exercise, or can this approach drive deeper benefits, both from a business perspective and in terms of employee engagement?

Could even more cancer patients benefit from PARP inhibitors?

Arlene Weintraub / FiercePharma

PARP inhibitors like AstraZeneca’s Lynparza and Tesaro’s Zejula have revolutionized the treatment of ovarian cancers with BRCA mutations and are starting to take off in breast cancer treatment too. But the way that these drugs work could make them applicable to many more cancer types, some oncology researchers believe.

Russian Researchers Create Software that Predicts Parkinson’s Symptoms

Remedium

A new software can predict with an accuracy of 96 percent the form of Parkinson’s disease and future symptoms that a patient may experience. The software was the result of a collaboration between researchers at Peter the Great St. Petersburg Polytechnic University (SPbPU), the Institute of Experimental Medicine, and ITMO University, in Russia.

Russian scientists developed a combined cancer drug

GMP News

Gene Surgery, a resident of SKOLKOVO, has conducted preclinical study of AntioncoRAN-M, an original cancer drug developed in Russia. Two genes, including the “killer” of cancer cell DNA and immunostimulator, are enclosed in a polymer shell, which acts as a drug delivery vehicle. Experts believe that such drugs are the future of oncology, as they have less harmful side effects than chemo- or radiotherapy.

Four more pharma manufacturers will receive loans to buy labeling equipment

GMP News

“The Expert Council of the Industrial Development Fund approved five loans for projects in the Samara, Kirov and Bryansk regions, as well as in the Krasnodar Krai. The total cost of their implementation will exceed 1.1 billion rubles, including more than 675 million rubles that are the loans from IDF,” said Roman Petrutsa, Director of IDF.

UK government launches AMR research competition

GMP News

The Department of Health and Social Care (UK) is announcing the launch of a £10 million (approximately €11,3 million) research competition to fund innovations to tackle antimicrobial resistance (AMR) in humans. AMR, which includes bacterial resistance to existing antibiotics, is on the rise and poses a significant threat to health across the world. Without a better understanding of how to tackle and prevent AMR, treatable infections could become life-threatening and the advancements made in modern medicine over recent decades are at risk of being reversed.

Pfizer announced strategic reorganization

GMP News

Pfizer announced it will organize the company into three businesses: a science-based Innovative Medicines business which will now include biosimilars and a new hospital business unit for anti-infectives and sterile injectables; an off-patent branded and generic Established Medicines business operating with substantial autonomy within Pfizer and a Consumer Healthcare business. These changes will be effective at the beginning of the company’s 2019 fiscal year.

EMA survey displayed gaps in pharma industry preparedness for Brexit

GMP News

A recent European Medicines Agency (EMA) survey shows that marketing authorisation holders for more than half (58%) of the 694 centrally authorised products (CAP) with an important step in their regulatory processes in the United Kingdom (UK), are on track with their regulatory planning to ensure that their marketing authorisation remains valid once the UK leaves the European Union (EU).

11 July 2018

Clearside Biomedical Appoints Carol Hoang as Vice President, Medical Affairs

Сlearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, today announced the appointment of  Carol Hoang , Pharm.D., MBA, to the position of Vice President, Medical Affairs.