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Saturday, September 29, 2018

Celltrion unit to market 2 biosimilars


South Korean biopharmaceutical firm Celltrion Inc. said Friday that it has inked a deal with its affiliate to sell two biosimilars –Truxmia and Herzuma.
Under the deal, worth 151.4 billion won (US$136.4 million) and equivalent to 15.95 percent of the company`s annual sales, Celltrion will sell the biosimilars to Celltrion Healthcare, which handles Celltrion`s overseas business.
Truxima, which references Roche`s MabThera, also known as Rituxan, is used in the treatment of a number of diseases, including rheumatoid arthritis and non-Hodgkin`s lymphoma, a type of leukemia.
Herzuma, a drug based on Herceptin — originally developed by Swiss pharmaceutical giant Roche Holding — is a drug to treat breast cancer.

Verma puts Medicaid insurers on notice, says CMS will begin ‘targeted audits’


Centers for Medicare & Medicaid Services Administrator (CMS) Seema Verma issued a warning to Medicaid plan sponsors on Thursday, warning the agency would begin targeted financial audits.
The warning came as Verma vowed to bring more transparency to the Medicaid program and “ensuring that states put up their fair share of state matching funds.”
“Transparency must also extend to our health plan partners,” Verma said during remarks at the 2018 Medicaid Managed Care Summit. “This room understands well that nearly all newly eligible individuals in Medicaid are served through managed care organizations. I’m putting you on notice now: CMS will begin targeted audits to ensure that provider claims for actual health care spending matches what the health plans are reporting financially.”
Moments later, Verma praised plan sponsors for their role in delivering quality care to Medicaid beneficiaries.
“I have seen firsthand the value that you bring to your partnership with states, and the resources that you can often bring to bear to serve the needs of our enrollees on the front lines,” she said.
CMS did not respond to a request to clarify when the audits would begin.
Administrator Seema Verma
✔@SeemaCMS
@CMSGov will begin targeted audits to ensure that provider claims for actual health care spending matches what the health plans are reporting financially.” 
Verma also signaled that CMS is moving forward with Medicaid work requirements despite a court ruling that struck down the agency’s approval of Kentucky’s waiver. She said the agency has finalized a work requirements demonstration waiver which it plans to announce “very soon.”

Citing conservative writer Arthur Brooks, Verma argued that the work requirements were not intended to “just kick people off Medicaid” but “put beneficiaries in control with the right incentives to live healthier independent lives.”
“I have heard the criticisms and felt the resistance, but I reject the premise, and here is why: It is not compassionate to trap people on government programs or create greater dependency on public assistance as we expand programs like Medicaid,” she said. “True compassion is giving people the tools necessary for self-sufficiency.”

ACETO Corp (ACET) Reports Q4 Loss of $0.48/Share


ACETO Corp (NASDAQ: ACET) reported Q4 EPS of ($0.48), versus $0.27 reported last year. Revenue for the quarter came in at $168.9 million, versus $194.6 million reported last year.

Apellis Pharmaceuticals (APLS) PT Raised to $34 at Citi


https://www.streetinsider.com/Analyst+Comments/Apellis+Pharmaceuticals+%28AP

Antares ATRS PDUFA set for September 29


Antares Pharma, Inc. (NASDAQ: ATRS) announced that the FDA has accepted its resubmitted New Drug Application (NDA) for the Complete Response Letter (CRL) of XYOSTED (testosterone enanthate subcutaneous injection). The FDA considered this resubmission a class 2 response and has assigned a PDUFA date of September 29, 2018.

Diabetes Patients Turn To Black Market For Affordable Insulin


After years of rising insulin prices, a growing number of diabetics and their families are now facing some tough choices when it comes to paying for the drug.
Some are turning to the black market to buy illegal insulin.
“So many people are dying because they just can’t afford their insulin,” parent Doreen Rudolph said.
Rudolph says she’s doing everything she can to make sure that doesn’t happen to her 27-year-old daughter, Nicole, a Type-1 diabetic.
When her daughter was first diagnosed, Rudolph says a vile of insulin cost about $21.
“Then it went up to 31, 45, 200, and then $400 a vile,” the desperate parent explained.
Even with insurance, Nicole now pays $1,300 every three months out of pocket.
“You pay or you die,” Rudolph conceded.
A recent study from Yale found one in four patients are now putting themselves at risk by rationing their insulin to help off-set the cost.
CBS2 found others are turning to a growing black market where they buy the drug at a fraction of the price.
“$200 for two boxes,” CBS2’s John Dias said, while speaking with a black market insulin seller.
Dias easily found insulin for sale online. They were posted by people like one woman from New Jersey, who told him as a diabetic herself, she has extra to sell.
“On one level, it’s understandable that people would look for other ways to find less expensive insulin,” Dr. Robert Gabbay with the Joslin Diabetes Center said.
He added that the practice is not only illegal, it could have fatal consequences.
“Who knows if it’s insulin but even if you know it’s insulin the safety margin and dosage of insulin is pretty narrow.”
“It’s ridiculous that it’s becoming a black market item,” Rudolph added. “In other countries, you can get insulin for $11 and it’s the same companies that are selling it.”
In an interview with CBS News last year, a spokesperson for the trade group that represents U.S. pharmaceutical manufacturers said the problem is not with the rising cost of the drug so much as with patients’ increasing insurance deductibles.
“It’s very upsetting that our government is allowing this… Somebody should care about us, the citizens,” a tearful Rudolph said.
The Justice Department is now investigating these price hikes. The American Diabetes Association is also calling for Congress to hold hearings on affordable insulin access.