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12/13/2018

Zhejiang Huahai Pharmaceutical received a warning letter from the FDA for issues related to impurity control, change control and cross-contamination from one manufacturing line to another. These issues are connected to nitrosamine impurities found in valsartan-containing medications, which the company supplies to Mylan.

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Seeking Alpha
12/13/2018

A CDC report found the rate of fatal drug overdoses involving fentanyl increased by about 113% each year from 2013 to 2016, and the drug played a role in about 29% of all overdose deaths in 2016, making it the nation's deadliest drug. Following fentanyl in 2016 were heroin and cocaine, involved in 25% and nearly 18% of overdose deaths, respectively.

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fentanyl, CDC, cocaine, heroin
12/13/2018

Kaleo has announced the availability of Evzio, or naloxone, at a cost of $178 per carton, down from $4,100. The reduced price is available for first responders, government agencies, health departments and other qualified groups if bought directly from authorized distributors or Kaleo.

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Kaleo, naloxone, Evzio
12/13/2018

Mallinckrodt's abuse-deterrent reformulation of opioid painkiller Roxicodone has been rejected by the FDA, which said further assessment is needed for some parts of the application.

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Reuters
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Mallinckrodt, FDA
12/13/2018

AdvaMed has joined other groups in amicus briefs to back the American Clinical Laboratory Association's lawsuit over the new market-based Medicare rates for laboratory tests implemented under the Protecting Access to Medicare Act. The groups argue the definition of "applicable laboratory" used in HHS' PAMA implementation required less than 2,000 of 58,593 Medicare Part B reimbursed laboratories to report market-based pricing, and only 21 hospital labs found they were applicable labs under the definition.

12/13/2018

The FDA has tweaked a final guidance released last year on user fees and refunds for device biologics license applications and premarket approval applications to include information on device BLAs from a superseded guidance.

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Regulatory Focus
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FDA
12/13/2018

European regulators have granted UK-based PredictImmune a CE-IVD mark for its prognostic biomarker test, called PredictSURE IBD, which is designed for inflammatory bowel disease.

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FDAnews
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IBD, bowel disease, EU
12/13/2018

People who follow a vegan diet might need to take certain supplements or eat certain foods to maintain oral health, writes dentist Stephanie McGann. Inadequate vitamin B12 can lead to gum disease, too little calcium can weaken tooth enamel, and plaque can build up on the teeth of people who do not consume enough arginine, McGann writes.

12/13/2018

BioXcel Therapeutics' investigational new drug application for neuroscience candidate BXCL501 for acute treatment of agitation was accepted by the FDA for review. The company anticipates data from a first-in-human pharmacokinetic and safety study of the drug in healthy volunteers in the first half of next year.

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Seeking Alpha
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BioXcel Therapeutics
12/13/2018

Partners Celgene and Bluebird Bio said they have completed enrollment for their midstage study to evaluate their chimeric antigen receptor T-cell therapy candidate bb2121 as a treatment for patients with relapsed or refractory multiple myeloma. The trial will administer the CAR-T therapy to 140 patients from the US, Europe and Canada who have undergone a minimum of three previous myeloma therapies.

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Myeloma Research News
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multiple myeloma