Pharmacy groups praise Senate Finance Committee letter on DIR fees | Faulty pens prompt recall of Takeda's Natpara | Consumer advocates, unions alarmed by potential AbbVie-Allergan merger
September 13, 2019
Specialty Pharmacy SmartBrief
News for the specialty pharmacy industry
Leading News
Pharmacy groups praise Senate Finance Committee letter on DIR fees
The Senate Finance Committee sent a letter to HHS and CMS requesting reform of direct and indirect remuneration fees concerning pharmacies under the Medicare part D program. "This letter reflects the strong bipartisan recognition that pharmacy DIR fees must be stopped to prevent harm to patients and to the pharmacies that serve them," pharmacy groups said in a joint statement.
Drug Topics (9/13) 
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Specialty Pharmacy Update
Faulty pens prompt recall of Takeda's Natpara
Takeda issued an immediate recall for all lots of its Natpara parathyroid hormone in the US. The company said there is a potential danger of rubber fragments detaching into the pen cartridge during administration.
BioPharmaReporter (9/10) 
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Consumer advocates, unions alarmed by potential AbbVie-Allergan merger
Consumer advocacy groups and unions asked the Federal Trade Commission to block AbbVie's proposed $63 billion purchase of Allergan, and asked the FTC to go beyond considering product overlaps.
Reuters (9/12) 
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Legislation & Regulation
Mepolizumab gains FDA nod for pediatric severe eosinophilic asthma
An expanded indication for GlaxoSmithKline's Nucala, or mepolizumab, gained the FDA's approval as a treatment for pediatric patients with severe eosinophilic asthma between the ages of 6 to 11. The subcutaneous injection received FDA approval in 2015 as a supplementary maintenance therapy for patients with severe asthma aged 12 years or older.
Medscape (free registration) (9/12) 
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FDA approval granted to tenapanor for adult IBS with constipation
FDA approval granted to tenapanor for adult IBS with constipation
The FDA has approved Ardelyx's Ibsrela, or tenapanor, to treat adult irritable bowel syndrome with constipation, to be taken twice daily in 50-mg doses. Patients who have or are suspected of having mechanical gastrointestinal obstruction are not advised to take Ibsrela.
Medscape (free registration) (9/12) 
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Clinical & Research News
VBI Vaccines, GSK partner to test cancer vaccine for glioblastoma
VBI Vaccines has partnered with GlaxoSmithKline to assess it vaccine candidate VBI-1901 in a Phase I/IIa study in patients with recurrent glioblastoma. An additional arm will be added to evaluate VBI-1901 in combination with Glaxo's AS01B adjuvant, a component of its Shingrix shingles vaccine.
Seeking Alpha (9/11) 
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Small study looks at antibiotic use before immunotherapy
People with cancer who took broad-spectrum antibiotics in the month before receiving immunotherapy drugs had significantly shorter survival, regardless of cancer type, compared with those who weren't given antibiotics, UK researchers reported in JAMA Oncology. However, the study was small and no effect was seen among those given antibiotics during immunotherapy.
The Guardian (London) (9/12) 
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Trends & Technology
Experts: Cyberrisk will continue to threaten health care in 2020
Experts say ransomware, cryptojacking, device hacking, data theft, phishing and insider breaches will remain the primary cyberthreats in health care next year, and health care organizations should patch and update critical systems regularly, train employees and avoid common mistakes like using out-of-office autoreplies. Cybersecurity should be a priority at the board and executive levels, and organizations that cannot afford to hire experts full-time should form partnerships, says Fairwarning CEO Kurt Long.
CSO (free registration) (9/11) 
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Coalition publishes guidance for sharing cyberrisk info in health care
The Healthcare and Public Health Sector Coordinating Council recently issued guidance for sharing information on cyberthreats, risks and responses in the health care sector. The guidance is meant to help health care organizations understand the importance of cybersecurity information sharing, provide resources to start participating in threat sharing and help organizations establish an appropriate information management structure.
HIPAA Journal (9/12) 
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Ditch the dream and be a doer, not a dreamer.
Shonda Rhimes,
television producer, writer
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