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US Healthcare Bill's Failure Could Have Unpleasant Ripple Effects For Pharma

Having sat on the sidelines during the unsuccessful effort to repeal and replace Obamacare, the pharma industry may find the rest of its legislative agenda, from taxes to even user fee reauthorization, could become more difficult.

US Election 2016 Legislation Government Payers

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 Reimbursement

User Fees: Should US FDA Incur Penalties For Missed Deadlines?

Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.

Approvals FDA Regulation

Keeping Track: US FDA Clears Three Novel Agents Over Three Days – Bavencio, Symproic And Xadago

The latest drug development news and highlights from our US FDA Performance Tracker.

Performance Tracker Approvals Regulation

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

Policy & Regulation Explore this Topic

Set Alert for Policy & 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 Compliance

Latest From Regulation

Court Decision Means Longer Wait For Clarity On EMA’s Access To Documents Policy

The EU court’s dismissal of appeals filed by the European Medicines Agency in cases relating to its access to documents policy means stakeholders will have to wait even longer to get legal clarity on the policy. One lawyer believes that the case could result in a broader definition of what constitutes commercially confidential information.

Regulation Clinical Trials

US FDA First's RMAT Designation: Humacyte Got A 'Quick Response'

Humacyte's bioengineered blood vessel, Humacyl, demonstrated long-term potency in Phase II studies; the product, which will regulated as a biologic, can now benefit from increased interactions with FDA under the the Regenerative Medicine Advanced Therapy program.

Regenerative Medicine Biologics

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

Latest From Policy

Biopharma Asks US Supreme Court Not To Limit Patent Litigation Venue

Innovators say case before court could upend ANDA litigation by preventing consolidation of cases; Genentech sees potential impact on biosimilar suits.

Legal Issues Intellectual Property

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

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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

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Latest From Consumer

Alka-Seltzer Antacid Will 'Plop, Plop Fizz, Fizz' Without Aspirin

In advance of a US FDA advisory panel meeting on the safety of OTC monograph antacid/aspirin products, Bayer is removing aspirin from its pioneering Alka-Seltzer effervescent indigestion products. Bayer's Andre Schmidt talks about the safety advantages and consumer trends that helped spur the change.

Consumer Drug Safety

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

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