This week’s biotechnology news headlines include, Amgen drug appears “highly similar” to Humira says FDA staff, Novartis version of Enbrel is similar to Amgen’s FDA staff says, Amicus acquires biologic programs aimed to treat rare brain disorder, Pfizer and Merck launch late-stage ovarian cancer trial, FDA expands use of Pfizer’s Prevnar, Bio-Techne to acquire Advanced Cell Diagnostics, and Rocky Mountain Biologicals announces water for injection manufacturing facility.

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Headlines:

“Amgen drug appears ‘highly similar’ to Humira: FDA staff,” Reuters

“Amgen Inc’s version of AbbVie Inc’s Humira arthritis drug, the world’s top-selling medicine, appears similar in potency and safety to the original product, U.S. Food and Drug Administration staff members said on Friday.”

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“Novartis Version of Enbrel Is Similar to Amgen’s, FDA Staff Says,” Bloomberg

“Novartis AG’s biosimilar version of the arthritis drug Enbrel, which the Swiss company is seeking to sell in the U.S. market, is comparable to the original made by Amgen Inc., U.S. regulators said.”

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“Amicus Takes Aim at Rare Brain Disorder with MiaMed Acquisition,” Xconomy

“Rare disease drug developer Amicus Therapeutics has added a new prospect to its pipeline with the acquisition of a biologic program that the company hopes will eventually treat a genetic disorder whose seizures and neurological impairments have no approved treatment or cure.”

If you like this story, please see our blog titled “Gene Therapy Strengthened by Recent Successes”

“Pfizer, Merck launch late-stage ovarian cancer trial,” PharmaTimes

“Pfizer and Germany’s Merck have kicked off a large-scale, late-stage study assessing their immunotherapy avelumab in ovarian cancer. The companies will test the safety and efficacy of the drug in combination with, and/or as maintenance treatment to, platinum-based chemotherapy in patients with locally advanced or metastatic disease with previously untreated epithelial ovarian cancer.”

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“FDA expands use of Pfizer’s best-selling pneumonia vaccine,” Reuters

“Pfizer Inc said on Tuesday the U.S. Food and Drug Administration had expanded the use of its best-selling pneumonia vaccine, Prevnar, to adults aged 18 through 49.”

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“Bio-Techne to Acquire Advanced Cell Diagnostics for Up to $325M,” Genetic Engineering News

“Bio-Techne said it has agreed to acquire molecular pathology test developer Advanced Cell Diagnostics (ACD) for up to $325 million in a deal that expands the buyer’s offerings into genomics technology, as well as its presence within clinical labs.”

If you like this story, please see our blog titled “New Poster: Proving Clonality – A Documented Clonality Report for Regulatory Submission”

“Rocky Mountain Biologicals Announces Water for Injection (WFI) Manufacturing Facility in West Jordan, Utah,” Newswire

“RMBIO’s West Jordan, Utah facility specializes in the manufacture of USP high purity water, including water for injection (WFI) quality water, sterile water for irrigation (WIR) and purified water (PW). The multi-million dollar facility also includes manufacturing capabilities for saline, balanced salt solutions, custom process solutions and cell culture media.”

If you like this story, please see our blog titled “Cell Culture and Single Cell Passaging of Human Pluripotent Stem Cells Without the Need for ROCK Inhibitor”