Oscars of science, drug shortage reporting requirements, and a new gene therapy... What’s new for pharma in business?
Maryam Mahdi |
Shire’s Los Angeles Building 8 facility has been named the overall winner of the ISPE Facility of the Year Awards. The company also won in the “Facility Integration” category. The project involved construction of a 120,000 square foot purification facility, which needed to be integrated into an 11.6-acre campus with eight other buildings and space constraints on all sides.
The Oscars of Science Awards took place in early November, with a number of prizes being awarded in life sciences, including for Joanne Chory (Salk Institute for Biological Studies and Howard Hughes Medical Institute), Don W. Cleveland (Ludwig Institute for Cancer Research at University of California, San Diego), Kazutoshi Mori (Kyoto University), Kim Nasmyth (University of Oxford), and Peter Walter (University of California, San Francisco).
For his impressive business acumen and leadership, Nik Kotecha OBE, Chief Executive of Morningside Pharmaceuticals, was named the Innovation Entrepreneur of the Year at the annual Great British Entrepreneur Awards. The company specializes in the manufacture and supply of generics and was the first to launch a generic version of the contraceptive pill in the UK.
EpiPen shortages are affecting many countries, including the UK, which has subsequently authorized 300 μg pens to be used beyond their expiration dates, as well as lowering the weight threshold for use of the higher dose EpiPen to 25 kg. The shortages have been attributed to manufacturing issues at a Pfizer plant, which makes the pens for Mylan.
Mandatory reporting requirements for sponsors will come into effect in Australia on January 1, 2019. Shortages of critical medicines will need to be reported to Australia’s Therapeutic Goods Administration (TGA) within two working days, and non-critical shortages within 10 working days. TGA will also have greater powers to penalize sponsors who deliberately fail to comply.
In response to ongoing drug shortages in the US, a group of healthcare organizations has issued a series of recommendations. Released in November, the 19 recommendations made by the healthcare coalition (consisting of The American Hospital Association, American Society of Anaesthesiologists, the American Society of Clinical Oncology, American Society of Health-System Pharmacists, and the Institute for Safe Medication Practices) suggest ways in which the problem could be resolved through regulatory, legislative and marketplace changes.
Luxturna, a gene therapy product used for the treatment of a rare retinal dystrophies caused by RPE65 mutations, has received EMA approval. This comes almost a year after the product had been approved for use by the FDA. The therapy, produced by Novartis, can be used to treat both adults and children.
The FDA has cleared Vitrakvi (larotrectinib) for use. The “tissue agnostic” treatment doesn’t target the specific location a tumor originated from; rather it treats cancers based on common biomarkers. This is only the second time a drug of this kind has been approved by the US regulator.
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