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Policy & Regulation

Insmed’s Amikacin Moves Closer To US Market In Refractory Lung Disease

FDA panel's recommendation that liposome inhalation suspension be labeled only for refractory nontuberculous mycobacterial lung disease and not first-line use aligns with analyst expectations; panel cites lack of clinical studies in treatment-naive patients and adverse event profile as reasons for limiting drug to patients with limited or no treatment options.


Infectious Diseases Respiratory Policy & Regulation

Express Scripts Rewards Low List-Priced Brands In 2019 Formulary, Retains Focus On Rebates

Mylan’s Symfi and Merck’s Zepatier gain preferred status on PBM's national preferred formulary for 2019. But more drugs are excluded from coverage – 242, up from 196 in 2018.

Pharmacy Benefit Management Pricing Strategies Private Payers
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Policy

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Latest From Policy

Who's Promised What: A Guide To Pharma Drug Pricing Pledges

Pharma companies have responded to mounting political pressure to lower drug prices by pledging to limit increases and even roll back the costs of certain drugs, but it's hard to keep track of who has promised what exactly. Here, Scrip provides a listing of pharma pricing pledges.

Companies Pricing Debate

Merck's New Pricing Pledge Shows Style Over Substance

A 60% price reduction on hepatitis C drug Zepatier sounds impressive, but the drug has been declining and the HCV space overall is shrinking. Another set of 10% reductions come on small-sellers that are now generic. 

Pricing Debate Pricing Strategies

Beyond Rebates: PhRMA Wants HHS To ‘De-Link’ Supply Chain Compensation From List Price

Focus should not be limited to rebates in Medicare Part D, manufacturers advise in comments on HHS drug pricing blueprint. Pharmacy benefit managers raise anti-trust issues with shift to upfront discounts.

Pricing Debate Pharmacy Benefit Management

Pfizer Agrees To Roll Back Prices On 40 Drugs, Yielding To Pressure From Trump

After a conversation with President Trump, CEO Ian Read agreed to cancel price increases on 40 drugs that took effect July 1, to give the administration time to work on its blueprint for improving the health care system.

Pricing Debate Pricing Strategies

India’s Cut-Price Generics Program Rebounds But Real Impact Still Limited

India's cut-price generic drugs scheme appears to have gathered some pace, covering over 700 medicines, offering sharp price differentials over brand name therapies and also garnering some private sector interest. But its on-ground impact in improving affordable access to medicines is still limited, some experts claim.

Policy Generic Drugs

Big Pharma Voluntary List Price Reductions Doubtful, Sen. Warren Says

Companies responding to inquiries from Sens. Elizabeth Warren, D-Mass., and Tina Smith, D-Minn., did not indicate they are planning to reduce list prices, despite promises by President Trump, Warren told a June 12 hearing. 
Pricing Debate Pharmacy Benefit Management
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Regulation

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Latest From Regulation

Regeneron's Extended Eylea Dosing Plan Suffers US FDA Delay

Competitors are moving forward on wet AMD products with longer dosing intervals, with Novartis close to filing with FDA.
FDA Regulation

Mehta Analysis: China, A Populist Pharma Power

With money pouring into biopharma in China, and regulatory reforms favoring market growth and R&D speed, western firms should watch their backs, warns Viren Mehta, founding partner of Mehta Partners LLC.

China Growth

FDA Commissioner’s Rx For US Biosimilars Market: Reform Contracting Practices And Payment Models

In unveiling the agency’s Biosimilar Action Plan, FDA's Gottlieb continued his pattern of provocative remarks by criticizing brand company practices and payment models that impede biosimilar competition and could ultimately undermine innovation. He also called for more action by the Federal Trade Commission and downplayed the impact interchangeability could have on biosimilar uptake. 


Biosimilars Biologics

Siga Ready For Next Phase, New Cash With Smallpox Drug Approval

Siga is entitled to a $41m “hold back” payment under its contract with the Biomedical Advanced Research and Development Authority and potentially a $50m payment related to the US FDA's extended shelf-life determination for stockpiled Tpoxx; company also picks up first priority review voucher awarded for a medical countermeasure, which it likely will monetize.


Approvals Animal Testing

Trump Tries To Shame A Defiant Pfizer On Drug Pricing

President Trump called out Pfizer’s recent price increases on Twitter July 9. Pfizer was one of only four companies that took a second round of price increases in 2018, according to analysts at Morgan Stanley. CEO Read has long defended the industry's pricing practices, even as public criticism of the high drug prices has grown. 

Pricing Debate Pricing Strategies

PTI’s Remoxy: Negative FDA Panel Review May Be The End Of Abuse-Deterrent Opioid's Road

Concerns that the extended-release oxycodone product poses the same potential for intravenous abuse as Endo’s withdrawn Opana ER drive FDA advisory committee recommendation against approval, laying the groundwork for a fourth complete response letter; FDA’s comparison of Remoxy to Opana during the meeting ‘borders on slanderous,’ PTI CEO Barbier tells Scrip, predicting sponsors will be dissuaded by the shifting regulatory goalposts for abuse-deterrent formulations.


Advisory Committees Drug Review
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