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Health Plan Disclosure Of ‘Negotiated’ And ‘Historical Net’ Drug Prices Required In HHS Rule

It’s not quite the rebate rule, but final reg aims for ‘a reduction in the use of rebates and other price concessions’ driven by the transparency requirement and broad definitions. PCMA warns that ‘mandating an increased level of disclosure for this information could result in higher prescription drug prices for consumers.’

Pharmacy Benefit Management Reimbursement Pricing Debate

Trump Or Biden, China Determined To Narrow Health Gap With US

Regardless of who wins, China seems to be looking beyond the 3 November US General Election, instead pouring in large resources to elevate its domestic health sector on a par with international standards, creating opportunities and profoundly impacting many areas from novel therapy development to investment decisions.

China Regenerative Medicine Reimbursement

Incoming EMA Chief Throws Weight Behind Antimicrobial Resistance Fight

Antimicrobial resistance, the lack of new antibiotics, and preserving the effectiveness of existing ones are high on the agenda for the soon-to-be new head of the European Medicines Agency, Emer Cooke.

Europe Safety Infectious Diseases

Spotlight On Coronavirus

COVID-19 Vaccines: FDA’s Broad Authority To Craft Narrow EUAs May Push Agency Out Of Its Comfort Zone

US FDA may not be comfortable using some of the powers the emergency use authorization statute provides to limit a product’s use; regulatory distinctions for EUAs go beyond the lower ‘may be effective‘ standard needed for an authorization versus an approval. EUAs come with a lot of other tools to micromanage use that aren’t available for most approvals. 

Coronavirus COVID-19 Vaccines

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COVID-19 Pipeline Tracker

Product candidates in development worldwide to address the 2019-nCoV pandemic, categorized by treatment and prevention. Subscription required.

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Performance Trackers

Keeping Track: Regeneron Ebola Antibody Cocktail Inmazeb Approved; Avenue Feels Pain From CRL; Scynexis Submits Oral Antifungal

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Approvals Drug Approval Standards Complete Response Letters

Global Pharma Guidance Tracker – September 2020

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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Policy & Regulation Explore this Topic

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Latest From Regulation

UK’s First Real-World Evidence Guideline Targets Randomized Trials

The UK Medicines and Healthcare products Regulatory Agency is developing a series of guidance documents on general points to consider when planning a trial to generate real-world evidence. The first document in this series focuses on prospective randomized trials.

Real-World Evidence Clinical Trials

MHRA Explains Entry Criteria for UK's New Innovative Medicines Pathway

A new licensing route is to be introduced by the UK MHRA next year for products that meet specific criteria, such as treating life threatening conditions or rare diseases and where there is a significant patient need. At a webinar this week, an MHRA medical assessor looked at the requirements that products will have to meet to enter the new pathway.

United Kingdom Review Pathway

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

UK Firms Face Thousands Of Variations To Update Safety Information

With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.

Brexit Safety

Coronavirus Notebook: MHRA Begins Rolling Review Of Moderna Vaccine, Sanofi/GSK Hook Up To COVAX

Russia seeks WHO endorsement of its Sputnik V vaccine, a UK BioIndustry Association taskforce identifies potential new antibody cocktails, and the European Centre for Disease Prevention and Control considers the best strategies for targeted vaccination programs.

Europe United Kingdom

US FDA’s Help May Get Charleston’s Hydexor Through Second Advisory Committee

After appealing FDA’s rejection, Charleston narrowly tailored the proposed indication for its emesis-reducing opioid to an in-patient population and crafted its own REMS to try and address advisors past safety concerns. Briefing documents indicate the FDA might have been learning towards approving the drug on the earlier review cycle, but the initial advisory committee vote shifted the agency’s thinking.

Advisory Committees Drug Safety

Latest From Policy

The Future Of Purdue: Will The ‘Public Benefit Corporation’ Model Take Off?

Purdue’s opioid settlement is making headlines for the size of the financial penalty. But the plan to re-imagine Purdue as a public benefit company could have far-reaching significance for the industry – if it ever gets off the ground.

Pricing Debate Legal Issues

Medicare’s Antibiotic Boost: Six Qualify For Add-On Payment

CMS final rule for hospital payment in 2021 includes enhanced payment for six novel antibiotics – including one that is not yet approved by FDA. New policies to encourage antibiotic innovation are clearly having an impact in the context of Medicare payments.

Medicare Infectious Diseases

Second-Guessing FDA? Sage Zulresso Denied Add-On Status In Medicare

Medicare’s doubts about trial design for Sage’s postpartum depression therapy suggests even ‘breakthrough’-designated products can struggle with the ‘substantial clinical improvement’ standard for NTAP status. Denial of enhanced payment for Zulresso ends a long winning streak by innovators.

Medicare Reimbursement

Clinical / R&D Explore this Topic

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Latest From Research & Development

Coronavirus Notebook: MHRA Begins Rolling Review Of Moderna Vaccine, Sanofi/GSK Hook Up To COVAX

Russia seeks WHO endorsement of its Sputnik V vaccine, a UK BioIndustry Association taskforce identifies potential new antibody cocktails, and the European Centre for Disease Prevention and Control considers the best strategies for targeted vaccination programs.

Europe United Kingdom

Where The COVID Vaccine Trials Stand: A Snapshot Of The Leaders And Rest Of The Field

With some studies about to finish and others on clinical hold, the coronavirus vaccine field approaches an inflection point as the US FDA prepares for its first advisory committee on the topic. Our charts and graphics offer a quick look at what stands where.

Clinical Trials Coronavirus COVID-19

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Lilly's US Bamlanivimab Contract Raises Difficult Allocation Considerations

The price of the antibody monotherapy for COVID-19 will be $1,250 per vial for wealthy countries. CEO David Ricks outlined the company's guidelines for pricing and distributing a limited supply.

Coronavirus COVID-19 Pricing Debate

Gilead’s Immunomedics Buy: Five Things To Worry About

Acquisition is based on the prospects for Immunomedics’ Trodelvy, but regulatory changes, manufacturing challenges, and research dynamics could upset even the best-laid plans.

Clinical Trials Commercial

Novavax Push For COVID-19 Vaccine Manufacturing Capacity Delays Flu Vaccine Application

As CEO Erck touts that its COVID vaccine has the 'best data,' Novavax prepares to enter Phase III trials and inks deal with Serum Institute to boost production even as its 'almost a perfect flu vaccine' remains on hold.

Vaccines Manufacturing

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA’s Final MOU On Interstate Compounding Now Awaits Signatures From States

US pharmacy group says that 10 to 12 states have indicated through an informal survey that they do not have the manpower or funding to implement the US FDA’s final MOU on inordinate compounding. They say what is at stake in these states is patient access to compounded medicines.

Manufacturing Quality

US Buy Of Lilly’s COVID-19 Therapy Now Turns On FDA's Manufacturing Quality Assessment

Under pressure to authorize use of Lilly’s bamlanivimab, the FDA must first weigh efficacy signals and GMP plant remediation progress.

Coronavirus COVID-19 Manufacturing

Access And Affordability Are Key, Says New EMA Head

Ensuring patients have access to approved medicines is a key priority for Emer Cooke, the soon-to-be new head of the European Medicines Agency. Cooke says she will probably be a very different type of “captain” of the “wonderful ship” that is the EMA.

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