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News articles that impact bioprocessing

JULY 2020

Gapless X chromosome sequence

The work described by Green was detailed July 14 in Nature, in an article titled, “Telomere-to-telomere assembly of a complete human X chromosome.” According to this article’s authors, finishing the entire human genome is now within reach.

“[The first gapless assembly of a human chromosome] was enabled by high-coverage, ultra-long-read nanopore sequencing of the complete hydatidiform mole CHM13 genome, combined with complementary technologies for quality improvement and validation,” the article’s authors stated. “Focusing our efforts on the human X chromosome, we reconstructed the ~3.1 megabase centromeric satellite DNA array and closed all 29 remaining gaps in the current reference, including new sequences from the human pseudoautosomal regions and cancer-testis ampliconic gene families (CT-X and GAGE).”

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https://www.genengnews.com/news/gapless-x-chromosome-sequence-assembled

APRIL 2020

Due to the current viral pandemic, the BIO International Convention is transitioning to a new, virtual event format, BIO Digital, June 8-12

https://www.bio.org/events/bio-digital

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The Centers for Medicare & Medicaid Services (CMS) in the US has launched a new model to reduce co-pays for insulin products to US$35.

 

 

Costs for insulin products have historically been very high in the US. A single vial of rapid-acting insulin has cost upwards of US$250 and data from 2016 showed that the average out-of-pocket monthly cost for a diabetic in the US was US$360, compared to US$65 in the UK and just US$19 in Italy.

This is set to change as the US Food and Drugs Administration (FDA) has recently transitioned to a new regulatory pathway allowing biosimilars of insulin products to be developed

(Source : www.gabionline.net/Policies-Legislation/CMS-launches-insulin-co-pay-at-US-35?)

MARCH 2020 

Today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway. This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients. For the first time, a pathway will be open for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. The availability of safe and effective biosimilar and interchangeable versions of these treatments, including insulin, is expected to increase patient access, adding more choices and potentially reducing costs of these vital therapies.

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Full story at https://www.fda.gov/news-events/press-announcements/insulin-gains-new-pathway-increased-competition

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Insulin designated as a biologic in a landmark moment

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https://www.biopharma-reporter.com/Article/2020/03/24/Insulin-designated-as-biologic-by-FDA?utm_source=copyright&utm_medium=OnSite&utm_campaign=copyright

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On 23 March 2020, insulin products in the US transitioned to a new regulatory pathway which will allow biosimilars to be developed. The change should make insulin products more affordable for American citizens.

The change dates back to the 2009 Biologics Price Competition and Innovation Act (BPCI Act), which created a 10-year timeline for the transition of biologicals that were historically regulated under the Food, Drug and Cosmetic (FD&C) Act.

The BPCI Act created an abbreviated pathway under the Public Health Service Act (PHS Act) for biologicals shown to be biosimilar or interchangeable with an FDA-approved biological.

Under the Act, as of 23 March 2020, the subset of biologicals approved under the FD&C Act (which includes insulin) transition to being regulated as biologicals, allowing the abbreviated licensure pathway to be used.

It has previously been difficult to develop biosimilars of these drugs under FD&C Act due to ‘scientific challenges’ and ‘limitations on the scope of data that can be relied upon in a generic drug application’, says the US Food and Drug Administration (FDA). As a result, there has been limited competition in the market for these drugs and therefore higher prices.

Now, insulin and some other biologicals, e.g. human growth hormone, pancrelipase, chorionic gonadotropin, follitropin alfa and menotropins, will be open to competition from biosimilars, or interchangeable biologicals, which have been defined by FDA as a ‘biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable medications’.

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http://gabionline.net/Guidelines/FDA-opens-pathway-to-biosimilar-insulin-products?utm_source=GONL6&utm_campaign=f9c9b8a34d-GONL+V20D03-6&utm_medium=email&utm_term=0_bfb08b6fa4-f9c9b8a34d-%5BLIST_EMAIL_ID%5D&ct=t%28GONL+V20D03-6%29&mc_cid=f9c9b8a34d&mc_eid=%5BUNIQID%5D

FEBRUARY 2020 : The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), and to provide its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide.” Under that interpretation, the term protein would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. A chemically synthesized polypeptide would mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size. This proposed rule is intended to clarify the statutory framework under which such products are regulated.

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https://www.biopharma-reporter.com/Article/2020/02/25/FDA-alters-definition-of-biologic?

https://www.fda.gov/media/122985/download

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