Business-in-Brief

Collaboration

• The US FDA, Europe-based EMA, and Japanese PMDA have all decided to go ahead with a unified stance for the clinical development of new antibiotics. The regulatory bodies came together in an effort to combat the growing issue of antibiotic resistance, and after two meetings they’ve decided to work in unison to update their guidance documents to reflect new recommendations. They’re next proposed meeting should take place in October 2017 when they’ll hopefully reveal a plan of action.
  http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/06/news_detail_002763.jsp&mid=WC0b01ac058004d5c1
• The parent company of data giant Google – Alphabet – has made a move to increase its presence in pharma by investing in a $300 million fund towards growing European biotech Medicxi. Novartis, The European Investment Fund (EIF), and Verily – formerly known as Google Life Sciences –  have helped raise the money for the drug developers who deal with phase II drugs and beyond.
  https://www.ft.com/content/a7d73bc0-5113-11e7-a1f2-db19572361bb

Recalls

• The over-the-counter emergency contraceptive drug levonorgestrel has undergone a recall due to a packaging mishap. Perrigo’s pill has been withdrawn because certain boxes of levonorgestrel failed to actually contain any of the medication. This news comes soon after Perrigo’s CEO John Hendrickson decided to retire after 13 months at the company.
  https://www.accessdata.fda.gov/scripts/ires/index.cfm#Product_155932
  
• After failing test results for dissolution, Teva Pharmaceutical’s paliperidone extended-release 3mg tablets have been voluntarily recalled. The drug – used in the treatment of schizophrenia and schizoaffective disorders – has undergone a consumer-level recall in coordination with the FDA, since the failed tests mean that less active drug could be absorbed in the patient.
  https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563358.htm

Regulation

• Pfizer’s drug palbociclib has been shown to increase progression-free survival of breast cancer for a median of 24.8 months when given in combination with letrozole (14.5-month median with only letrozole) (1). However, the UK’s National Institute for Health and Care Excellence (NICE) decided in February that the pharma giant needed further clinical data before the drug would be made available on the National Health Service (NHS). While the drug is in regulatory limbo, Pfizer has decided to make the drug free to patients – ordinarily worth £79,560 (~US$ 102,000) for a full course.
  http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30343-1/fulltext
  
• The FDA have requested that Endo Pharmaceuticals remove their drug Opana ER from the market because of the opioid crisis in the US – the first time the agency has made such a request. In a statement, FDA Commissioner Scott Gottlieb said, “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm

Research

• Merck Sharp & Dohme’s fast-tracked pembrolizumab (Keytruda) combats multiple cancers – skin, head and neck, urothelial bladder, non-small cell lung cancer, and more – that stem from the same genetic abnormality, resulting in it being the first FDA-approved cancer drug that treats tumors based on genetic information rather than cancer location.
  https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm558048.htm
  
• Researchers from the Ben-Gurion University of Negev are developing a new ALS drug, based on a previously FDA-approved drug – Roche’s rituximab – which is currently used to treat autoimmune diseases.
  http://in.bgu.ac.il/en/Pages/news/drug_als.aspx

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