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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
22 Feb 2019
By partnering with the Pink Sheet. Pink Sheet is the world’s premier provider of compliance, legislation, policy regulation and industry developments for biopharma decision makers, arming subscribers with the critical information they rely on daily to implement their strategies.
Topic BioPharmaceutical
Pink Sheet
By Francesca Bruce 22 Feb 2019
Regulatory harmonization is gathering pace in Latin America, which is good news for pharmaceutical companies.
Topic Policy and regulation
Scrip, Pink Sheet
By Mary Jo Laffler 19 Feb 2019
The data and analysis for this webinar were drawn from Pink Sheet and Scrip, both part of the Informa Pharma Intelligence suite of intelligence solutions.
Pink Sheet
By Michael McCaughan 14 Feb 2019
Here is what to expect from – and some free advice for – seven industry executives as they prepare for a hearing on drug pricing in the Senate Finance Committee.
Topic Drug approval
Pink Sheet
By Brenda Sandburg 07 Feb 2019
'Number of different initiatives' coming in next several months to make drugs more affordable, including for PrEP prophylaxis, HHS Assistant Secretary for Health Giroir says. Multi-agency approach is key strategy.
Pink Sheet
By Brenda Sandburg 01 Feb 2019
Fallout from Supreme Court's Escobar decision and Department of Justice memos could impact types of healthcare fraud complaints in which the government intervenes.
Topic Drug approval Strategy
Pink Sheet
By Cathy Kelly 01 Feb 2019
Proposed US rule would establish two new safe harbors against anti-kickback enforcement, one covering price reductions at the point of sale and the other protecting flat service fees paid by manufacturers to pharmacy benefit managers. But rebates to "PBMs to buy formulary position" in Medicare/Medicaid would lose protection.
Pink Sheet
28 Jan 2019
FDA cosmetics operations likely shuttered with shutdown; Stomp leads Kemin's global marketing; Unilever delivers on fragrance transparency pledge; Lentein protein to Canada through CK Ingredients; and Deciem founder Truaxe dead at 40.
Topic US Shutdown FDA
Pink Sheet
By Sue Sutter 28 Jan 2019
Exhaustion of US FDA's PDUFA funds before partial federal government shutdown ends could lead sponsors or agency to assert that reviews for certain types of drugs should continue under an exception to the Anti-Deficiency Act, former FDA officials say.
Topic US Shutdown FDA
Pink Sheet
By Derrick Gingery 28 Jan 2019
Compounding carryover money runs out, crippling some activities although inspections will continue; countdown to the end of PDUFA fee balance continues.
Topic US Shutdown FDA
Pink Sheet
By Derrick Gingery 28 Jan 2019
More than 300 generic drug applications might be officially filed when the shutdown ends, substantially increasing stress on assessors and other Office of Generic Drugs staff.
Topic US Shutdown FDA
Pink Sheet
By Ferdous Al-Faruque 28 Jan 2019
As the partial US government shutdown enters its second month, the backlog of device pre-market applications is building. AdvaMed is proposing language that would allow FDA to accept and review new user-fee-funded submissions during government shutdowns.
Topic US Shutdown FDA
Pink Sheet
By Ian Schofield 23 Jan 2019
The BioIndustry Association wants the government to rule out a “no-deal” Brexit, saying it would be bad for patients and the life sciences sector.
Pink Sheet
By Michael Cipriano 16 Jan 2019
FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.
Topic FDA
Pink Sheet
By Ian Schofield 10 Jan 2019
New drug approvals in the EU were again dominated by oncology in 2018, although medicines for infectious diseases came a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some key new arrivals in the areas of multiple sclerosis, genetic disorders, metabolism and migraine.
Topic Drug approval Drug review
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19 Mar 2019
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19 Mar 2019
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19 Mar 2019
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19 Mar 2019
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19 Mar 2019
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19 Mar 2019
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19 Mar 2019
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19 Mar 2019
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18 Mar 2019
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18 Mar 2019
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18 Mar 2019
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18 Mar 2019
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18 Mar 2019
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18 Mar 2019
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18 Mar 2019
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