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FTC And PBMs: Support For Investigation Building But Outcome May Ultimately Disappoint Critics
Federal Trade Commission’s ‘pro-competitive’ perspective could support conclusion that pharmacy benefit managers serve useful role in lowering drug costs, health policy expert suggests. FTC will get an earful about PBM practices, but ‘those complaints could be an indication that competition is working.’

PK Evaluation In Pregnancy: Can HIV Show A Way Forward?
US FDA workshop on efforts to advance pharmacokinetic data collection in pregnant women highlights the (slow-moving) antiretroviral experience, but COVID therapies show that regulatory receptiveness is a poor match for recruitment and liability concerns.

At Solicitor General’s Urging, Supreme Court May Take Up Patent Eligibility Dispute Riling Biopharma
Federal Circuit’s rulings on subject matter patent eligibility have fractured the court, the US government says in advising the high court to review American Axle v. Neapco to provide clarity. BIO, former PTO director Kappos and Sen. Tillis also urge Supreme Court to hear the case.
Spotlight On Coronavirus
EMA: First Adapted COVID-19 Vaccines Expected In September
As work continues on vaccines adapted to tackle variants of SARS-CoV-2, the EU regulator says the decision-making on such products should take place at a global level.
COVID-19 Vaccines: Spikevax Review Reflected Changing Realities Of Omicron In US
COVID-19 Vaccines In Five And Younger Could Get Earlier FDA Advisory Committee Review
Coronavirus Notebook: WHO Says Extra Vaccine Boosters Confer Some Limited Benefits, Emergex & Zosano Link Up On T Cell Vaccine Patch
US FDA To Train Investigators On mRNA Vaccine Manufacturing
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Pink Sheet Podcast
Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.
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Keeping Track: Lilly’s Mounjaro Enters Diabetes Market; Biogen/Eisai Lecanemab Leads Neuroscience News
CDER turned in its 13th novel approval of 2022 on Friday the 13th, and other drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
US FDA Performance Tracker

Global Pharma Guidance Tracker – April 2022
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.
European Performance Tracker
Policy & Regulation Explore this Topic
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Latest From Regulation
UK Prepares To Vaccinate Against Monkeypox
The UK Health Security Agency says it took a number of factors into account when deciding to use Bavarian Nordic’s smallpox vaccine Imvanex, including high European manufacturing standards, the US approval for monkeypox, and the lack of an alternative UK-licensed vaccine.
Global Pandemic Treaty: Working Draft To Be Discussed In July
The World Health Organization’s plan to have a global pandemic treaty in place by 2024 is drawing a lot of attention as work continues to produce a working draft by the middle of the year.
WHO Member States Agree To Strengthen Global Clinical Trial Ecosystem
World Health Assembly delegates have given the thumbs up to a resolution that draws on lessons learnt during the COVID-19 pandemic to improve global coordination on how clinical trials are designed, evaluated and reported.
EU Tracking CTR Impact On Clinical Trials Environment
The European medicines regulatory network has started publishing monthly metrics to offer insight into how the Clinical Trial Regulation is affecting the EU research space.
EU CHMP Opinions and MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Are Trial Sponsors Treading On Investigators’ Toes In Decentralized Trials?
The Danish regulator’s experience with reviewing and inspecting decentralized elements in clinical trials highlights concerns around the blurring of lines that divide the roles and responsibilities of sponsors and trial investigators.
Latest From Policy
MSD Removes ‘Key Barrier’ To English Funding For Keytruda In Triple-Negative Breast Cancer
MSD has agreed to restrict the use of its Keytruda combination therapy in a manner that means that Roche’s Tecentriq combination is no longer a direct comparator.
Inter-Agency User Fees? US FDA/ARPA-H Relationship Could Get Interesting
The Biden Administration’s signature health research agency ARPA-H is still in the formative stages. Authorizing legislation moving through Congress could set up a very interesting dynamic when it comes to working with the US FDA.
Ukraine War Could Spur Changes In The Clinical Trial Paradigm
Decentralized trials are way to help displaced Ukrainians remain in studies and could encourage greater participation from individuals in other countries, those overseeing sites in Ukraine say.
Clinical / R&D Explore this Topic
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Latest From Research & Development
Inter-Agency User Fees? US FDA/ARPA-H Relationship Could Get Interesting
The Biden Administration’s signature health research agency ARPA-H is still in the formative stages. Authorizing legislation moving through Congress could set up a very interesting dynamic when it comes to working with the US FDA.
House GOP Targets US FDA Applications With China-Only Data, Cites General Oversight Concerns
While industry concern with FDA’s policy shift on clinical data from China has focused on the disruption in business plans, Republican lawmakers appear to feel that the agency has not gone far enough and are seeking a GAO review of FDA’s entire bioresearch monitoring program.
US FDA and ARPA-H: Woodcock Has Questions
The FDA’s principal deputy commissioner wonders how the agency will work with ARPA-H to help get its projects to patients and the health care system given its other responsibilities.
Commercial Explore this Topic
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Latest From Commercial
Gene Therapy Development Should Involve Fewer Surprises, Says US FDA’s Marks
Regulators want to help smooth the process of bringing a gene therapy to market, hoping to iron out ‘surprises’ and even address reimbursement issues for the sake of patients.
Aduhelm Label Update Includes Seizure Risk And Recommends More MRIs
New safety information may help defense of CMS's coverage restrictions. FDA updated the prescribing information for Biogen’s Alzheimer's therapy after four cases of seizures were reported in a trial.
FTC’s Take On Two Pharma Mergers Shows Deals Can Clear Higher Hurdle
Pfizer’s acquisition of Arena without FTC intervention and Hikma’s acquisition of Custopharm with one product divestiture shows the commission is bound by anticompetitive facts of a deal. A more controversial merger may not get through, former FTC attorney says.
Manufacturing Explore this Topic
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Latest From Manufacturing
Surprise US FDA Facility Inspections Resume In India
Unannounced facility visits also were to start again in China, but FDA Commissioner Robert Califf said they have been delayed by the COVID-19 outbreak in the country.
US FDA Supply Chain Guidance Includes More Stakeholders, More Risks Than CARES Act
Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.
More Change With Less Hoopla To FDA Out-Of-Specification Investigations Policy
Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.
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