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Successfully navigate the complex worlds of compliance, legislation, policy regulation, and industry developments with the expertise of our worldwide network of expert analysts and journalists.
Our team of global contributors helps you to anticipate challenges, minimize risks and maximize opportunities. Pink Sheet is the biopharma industry’s go-to source for business-critical insights and policy and regulatory intelligence.
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Pink Sheet gives you the power to go behind the regulatory and compliance headlines to understand the implications of worldwide industry developments on your business.
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With a network of journalists and analysts crisscrossing the globe, our industry experts and thought leaders track product progress from submission to approval. We also draw on the strength and expertise of the rest of the Pharma Intelligence family of analytical and market intelligence tools.
Analysis and opinion covers key topic areas such as:
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.
Pink Sheet
16 Oct 2019
Keep track of compliance, legislation, policy regulations, and industry developments with the expertise of our worldwide network of expert analysts and journalists on the ground in key global regions.
Pink Sheet
14 Oct 2019
With the opioid crisis in full swing in the US, government and regulatory agencies are announcing changes to guidance and legislation related to both new and existing drugs. Keep abreast of these critical changes with essential coverage from Pink Sheet.
Topic Drug approval FDA
Scrip, Pink Sheet, Generics Bulletin
30 Sep 2019
When it comes to M&A, Informa Pharma Insights has got it covered. Our readers benefit from exclusive executive interviews with industry leaders and expert analysts on business, pipeline and M&A strategy, broad and detailed coverage on implications of deal-making from antitrust to quality compliance, commercial and R&D infrastructure, regional repercussions and the impact on existing partners. 2019 has already been notable for major deals, from the closing of the $62bn Takeda/Shire acquisition to the agreed purchases of Celgene for $74bn by Bristol-Myers Squibb and of Allergan for $63bn by AbbVie, to Pfizer’s plan to merge its Upjohn generics business with Mylan.
Topic Business strategies
Citeline, Pink Sheet
26 Sep 2019
Rising costs, patient recruitment issues, shifting regulations, and more are making bringing new drugs to market more difficult than ever. Explore changes in clinical trial design being adopted in response to these challenges with reporting from Pink Sheet.
Pink Sheet
By Derrick Gingery 14 Aug 2019
Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.
Topic FDA Company analysis
Pink Sheet
By Neena Brizmohun 09 Aug 2019
The stakes are extremely high for companies called before EU or US regulators and scientific experts to answer queries about their new drug applications at the later stages of the review process. How they perform is critical. Consultant Kate Dion has a raft of helpful tips for companies facing this daunting situation. Neena Brizmohun reports.
Topic Drug approval
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12 Dec 2019
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12 Dec 2019
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11 Dec 2019
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11 Dec 2019
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11 Dec 2019
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11 Dec 2019
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11 Dec 2019
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10 Dec 2019
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10 Dec 2019
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10 Dec 2019
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10 Dec 2019
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09 Dec 2019
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09 Dec 2019
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09 Dec 2019
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09 Dec 2019
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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.
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