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Analysis and opinion covers key topic areas such as:
Pink Sheet
By Brenda Sandburg 16 Jan 2020
An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.
Topic FDA Policy and regulation
Pink Sheet
By Ian Schofield 15 Jan 2020
Bluebird bio’s gene therapy Zynteglo, Akcea’s antisense drug Waylivra and BioMarin’s enzyme substitution therapy Palynziq were among the novel innovative medicines that were approved in Europe in 2019.
Pink Sheet
By Derrick Gingery 15 Jan 2020
The former US FDA principal deputy commissioner argues that accelerated approval, fast track and breakthrough designation standards may need updating, along with orphan and pediatric exclusivity requirements, to enhance the programs' efficacy.
Pink Sheet
By Sue Sutter 08 Jan 2020
Detection of nitrosamine impurities in some marketed drugs highlights need for standardized, consistent approach to systematically monitor risks of drugs throughout their lifecycles, CDER’s Janet Woodcock says. Safety monitoring overhaul is lagging behind new drug review modernization effort, but implementation is expected to begin in 2020.
Pink Sheet
By Michael Cipriano 08 Jan 2020
AstraZeneca's PARP inhibitor Lynparza becomes first US FDA-approved drug for pancreatic cancer based on progression-free survival endpoint, providing regulatory precedent for other sponsors to use that development approach; all other pancreatic cancer drugs had been approved based on an overall survival benefit.
Topic Cancer Clinical Trials
Pink Sheet
By Cathy Kelly 18 Dec 2019
Bill addresses ‘dead zone’ for pending applications for protein products transitioning to biologic status; generic and brand industries each win in different legislative provisions: inclusion of the CREATES Act, and a revised definition for ‘biologics’ that includes chemically synthesized polypeptides.
Pink Sheet
By Brenda Sandburg 06 Dec 2019
Rising Pharmaceuticals agrees to pay $3.1m, admits to conspiring to fix prices for hypertension drug, and enters into deferred prosecution agreement. Pfizer asks court to be removed from complaint by state AGs.
Pink Sheet
By Michael Cipriano 28 Nov 2019
From the approval of AZT to the generic drug scandal, Frank Young oversaw many seminal events at US FDA while commissioner from 1984 to 1989. After leaving the agency, he managed the approval of the NDA for Braeburn's opioid dependence drug Probuphine. Young passed away following a short bout with cancer.
Pink Sheet
By Francesca Bruce 20 Nov 2019
The Cancer Drugs Fund has improved access to oncology drugs, but if it is to remain fit for purpose it will need to evolve.
Topic Cancer
Pink Sheet
20 Nov 2019
Novartis finds itself facing possible criminal or civil action for admitted data manipulation on its application for Zolgensma, a gene therapy used to treat children with spinal muscular atrophy (SMA) – manipulation disclosed only after FDA approval. Pink Sheet was the first to report on the drug’s loss of EU accelerated assessment, nearly 3 weeks before the pharma giant admitted to submitting falsified data to FDA. Follow the scandal and anticipate its implications on the industry with Pink Sheet’s coverage and timeline.
Topic Cell and gene therapy FDA
Pink Sheet
By Sue Sutter 13 Nov 2019
REDUCE-IT enrolled a higher risk group than the broad population targeted by Amarin’s proposed indication statement, agency says; although reviewers conclude an interaction between the mineral oil placebo and statins cannot be excluded, any impact would have been small and unlikely to change overall treatment effect.
Topic Drug review FDA
Pink Sheet
By Mandy Jackson 08 Nov 2019
Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.
Topic Infectious diseases
Pink Sheet
By Nielsen Hobbs 05 Nov 2019
The US FDA has experienced an extended period with an acting commissioner. However, the agency continues to achieve its user fee dates, and hardly appears rudderless. Still, having a confirmed commissioner will give FDA more stability and power. But with application review looking to become more efficient and flexible, what could a new commissioner do to change the relationship between industry and FDA?
Topic FDA
Pink Sheet
By Michael Cipriano 05 Nov 2019
The Bone, Reproductive and Urologic Drugs Advisory Committee voted 14-1, with one abstention, in favor of approving Agile's transdermal contraceptive patch Twirla in a sharp divergence from the US FDA's negative evaluation of the drug, though it remains an open question of how the agency will ultimately come down.
Topic Drug review FDA
Pink Sheet
16 Oct 2019
When you look at newly approved drugs, the latest product reviews and the decisions made during the process, you can gain critical insights to inform your own strategic decisions. That’s what Pink Sheet delivers, and now you can try it for free.
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A well-respected and trusted industry source for the last 15 years, Generics Bulletin from Informa Pharma Intelligence provides in-depth news and analysis on issues that matter most to businesses across the generics, biosimilars and value-added medicines industries.
HBW Insight is a single source of regulatory, legislative, legal and commercial news and insight connecting the dots across 3 sectors, including over the counter medicines, vitamins and dietary supplements, and cosmetics, which have increasing points of intersection, helping you to anticipate global challenges, risks, and opportunities.
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