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Pfizer On Obamacare Rewind: No Short-Term Impact On Industry

Pfizer CEO Ian Read explains why industry has stayed on the sidelines during the current health reform debate and defends drug pricing practices during a speech to the National Press Club.

Policy Pricing Debate Market Access

Gottlieb's FDA: Specialized Groups Could Create Review Consistency, Speed

US FDA commissioner nominee might employ modular specialists to work with review divisions on issues related to gene therapies, molecularly-targeted drugs, adaptive clinical trial designs, or other complex issues.

Drug Review FDA Regulation

Denmark Leads New EU Task Force Exploring Use Of Big Data In Medicines Assessment

EU drug regulators have created a new task force to establish a roadmap and recommendations on how to use big data in the assessment of medicines.

Europe Regulation BioPharmaceutical

UK Not Planning To Add to Regulatory Burden for Life Science Industry Post-Brexit

The UK seemingly has no intention of imposing new regulatory requirements on life science companies after the country leaves the EU. That’s all well and good, but companies in the UK looking to continue doing business in the EU are worried they will face significant trade barriers post-Brexit. Everything will depend on the outcome of soon-to-start exit negotiations.

Europe United Kingdom Brexit

FDA Performance Tracker
For more on the FDA Performance Tracker, click here.

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

OTC Allergy Drug Use Increases: A Symptom With Multiple Causes

CHPA says growing use of allergy OTCs from 2009 through 2015 in the US is a sign of more consumers prioritizing self-care over using health care services, but allergy specialists say their patients often have to start with an OTC even when they have a prescription.

Prescription To Otc Switch Respiratory Reimbursement

Latest From Regulation

Black Triangle Scheme And Formal Inspections On the Cards In Australia

New pharmacovigilance-enhancing proposals from Australia’s Therapeutic Goods Administration signal the agency’s intention to become more proactive when it comes to monitoring drug sponsors.

Drug Safety Post Market Regulation & Studies

India Eases Approval Process For HIV, Hepatitis Combinations

India has outlined measures to fast track the regulatory process for certain combination products for HIV and hepatitis, and thereby facilitate early access to these treatments.

Review Pathway Infectious Diseases

FDA's NDA And BLA Approvals: Xadago, Bavencio, Symproic

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

Latest From Policy

Japan Price Reforms Will Be Pro-Innovation, Inclusive - Official

A Japanese official provides reassurances at BIO Asia that the government intends to abide by drug pricing policies that support innovation, although the research-based pharma industry remains concerned that sweeping reforms now under discussion may hamper R&D and investment in the country.

Japan Policy

Multi-Company Product Listing Agreements On The Rise In Canada

The pan-Canadian Pharmaceutical Alliance has negotiated product listing agreements with three hepatitis C drug makers in one of its first major negotiations with multiple manufacturers. The pCPA may want to negotiate more deals with several companies at once, particularly those with drugs in crowded markets.

Market Access Pricing Strategies

100% User Fees For US FDA? Trump Budget Revives Important Issue For Industry – But Not This Year

Trump Administration’s surprising call for increased user fees probably won’t have much impact on pending reauthorization process, but it does put on the table an important question for the biopharma industry to consider for the long term: should FDA be fully funded by user fees?

FDA Legislation

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Amgen Says Repatha Outcomes Trial Backs Up Its Pricing Math

Amgen walks through its price-setting model for PCSK9 inihibitor Repatha and says new outcomes data just presented at ACC provides more evidence that "prices that exist in the market are indeed value-based."

Health Technology Assessment Reimbursement

Will Physician Demand For Repatha Put Pressure On Payer Restrictions?

FOURIER outcomes data presented at the American College of Cardiology annual meeting fell short of expectations, but could increase physician demand for the PCSK9 inhibitor, making it harder for payers to say no.

Reimbursement Market Access

Zika Vaccines Might Be Approved By 2020

Nothing's even in Phase II yet, but sponsors and US government researchers remain optimistic.

Vaccines Research & Development

Commercial Explore this Topic

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Latest From Commercial

Pain Therapeutics Confident It Has US Approval Pathway Set For Remoxy ER

Biotech says it can complete two FDA-mandated studies by year-end and re-file the NDA rejected three times previously by the US agency. Pain Therapeutics also says it will not attempt to commercialize the abuse-deterrent opioid product without a partner.

Drug Approval Standards Complete Response Letters

With Promising Data, Janssen To Ready Vaccine For Next Ebola Outbreak

J&J says it will work with regulators to position its investigational Ebola Zaire vaccine for use in future outbreaks after publishing impressive Phase I prophylactic data in healthy volunteers.

Commercial Rare Diseases

US Denials Of HCV Treatment Coverage Rising, Regardless Of Payer Type

Trio Health data covering 15,000 patients over three years reveals that 29% of patients failed to start prescribed HCV treatment in 2016, up from 8% in 2104. The "non-starts" appear partially due to denials of coverage by payers and not even the sickest patients have been shielded.

Market Access Government Payers

Manufacturing Explore this Topic

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Latest From Manufacturing

Drug Compounder Acquitted Of Murder In Fungal Meningitis Outbreak Case

Jury convicts Barry Cadden on racketeering and mail fraud allegations for shipping contaminated methylprednisolone acetate for spinal injection, but clears NECC's head pharmacist on all 25 counts of second degree murder in seminal case that spurred legislation enabling major US FDA crackdown on injectable drug compounding sterility assurance practices.

Compliance Manufacturing

UK BioPharma Players Told 'Think Global, Act Local' For Post-Brexit World

The multi-faceted UK life sciences industry has been told to develop more connective tissue and encourage a more activist government industrial strategy to help it thrive after the country departs the European Union.

Brexit United Kingdom

EU Guidance Update Explains QP Declarations For GMP Compliance

Updated EU guidance has been issued on the qualified person (QP) declarations that companies need to provide in order to demonstrate compliance with good manufacturing practice requirements for active substances. The European QP Association believes the real worth of the updated guidance will depend on how tasks are assigned within individual companies.

Regulation Manufacturing

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

OTC Allergy Drugs: Not Just For Sniffles And Headaches, Sanofi Advises

The US office of Sanofi consumer division says 160 participants wore a wearable device for 30 days to track their sleep and activity. The 80 participants with allergies were less active and slept less.

Consumer Digital Health

Consumer Health Weekly Trademark Review March 14, 2017

OTC drug, personal care product and nutritional supplement trademark filings compiled from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

China India

Will Primatene Mist Inventory Ever Leave The Warehouse?

Amphastar has inventory for the emergency asthma product but is frustrated by the recent second complete response letter from US FDA seeking additional information. Human factors issued figured into CRLs for both Primatene Mist and intranasal naloxone.

Consumer Complete Response Letters