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FEATURED STORIES
Bookmark
* 09 Sep 2024
* NEWS
EMA PROBE PROMPTS NEW SAFETY MEASURES FOR DECADES-OLD DRUG METAMIZOLE
By Neena Brizmohun
The European Medicines Agency’s safety committee has concluded that the benefits
of medicines containing metamizole continue to outweigh the risks but that new
measures are needed to minimize the serious outcomes of agranulocytosis.
Europe Drug Safety Post Market Regulation & Studies
Bookmark
* 06 Sep 2024
* ANALYSIS
THEY’RE BACK! US FDA PANELS RETURN TO NORMAL AND THE SCHEDULE FILLS UP FAST
By Michael McCaughan
The US FDA is returning to the pre-COVID in-person advisory committee format and
the agency suddenly has a flood of meetings lined up for the fall.
Advisory Committees Drug Review Review Pathway
Bookmark
* 06 Sep 2024
* ANALYSIS
*
CLINICAL TRIALS IN CHINA: AS US LAWMAKERS CONSIDER CRACKDOWN, HERE ARE THE
IMPLICATIONS
By Sarah Karlin-Smith
If the US Congress continues to target trials at Chinese military hospitals, the
impact could be relatively small, while a broader focus could upend
multinational development programs.
Clinical Trials China Regulation
ARTIFICIAL INTELLIGENCE: HOW REGULATORS SEE IT
* 29 Aug 2024
* ANALYSIS
*
ARTIFICIAL INTELLIGENCE: CDER’S NEW COUNCIL TAKES CHARGE OF OVERSIGHT,
COORDINATION
By Sue Sutter
The Artificial Intelligence Council takes over work that three different
entities in the US FDA’s drugs center had been performing. The new, centralized
entity will develop and promote consistency in AI-related activities and advance
innovative uses.
Artificial Intelligence FDA
AI IN DRUG DEVELOPMENT: REGULATORY CLARITY NEEDED ON INSPECTIONS, HUMAN ROLE
REGULATORS WANT REDUCED ANIMAL TESTING – COULD AI BE THE ANSWER?
NAVIGATING THE LEGAL RISKS OF USING AI TO OPTIMIZE THE PHARMA SUPPLY CHAIN
PINK SHEET PODCAST: NEW US FDA DEVELOPMENTS IN AI REGULATION
Read all of the Pink Sheet's artificial intelligence coverage...
LATEST NEWS
GLOBAL PHARMA GUIDANCE TRACKER – AUGUST 2024 56 MIN AGO
EMA PROBE PROMPTS NEW SAFETY MEASURES FOR DECADES-OLD DRUG METAMIZOLE 2 HOURS
AGO
RECENT AND UPCOMING FDA ADVISORY COMMITTEE MEETINGS 6 SEP 2024
GLENMARK SHELLS OUT ANOTHER $25M TO RESOLVE CIVIL PRICE-FIXING CHARGES 6 SEP
2024
THEY’RE BACK! US FDA PANELS RETURN TO NORMAL AND THE SCHEDULE FILLS UP FAST 6
SEP 2024
CLINICAL TRIALS IN CHINA: AS US LAWMAKERS CONSIDER CRACKDOWN, HERE ARE THE
IMPLICATIONS 6 SEP 2024
PINK SHEET PODCAST: RARE PEDIATRIC DISEASE PRV DEADLINE, POTENTIAL MAKENA
COMPOUNDING BAN 6 SEP 2024
NEW EU APPROVALS 6 SEP 2024
DRC GETS FIRST MPOX VACCINE SHIPMENT & ISSUES EUA AHEAD OF WHO LISTING 6 SEP
2024
EU REGULATORS SHOULD USE AI ONLY WHEN ‘SAFE AND RESPONSIBLE,’ SAYS EMA 6 SEP
2024
US MEDICARE TO OFFER GUIDANCE ON REAL WORLD EVIDENCE TO SUPPORT COVERAGE 5 SEP
2024
OBESITY DRUGS WILL GET BROAD COMMERCIAL COVERAGE IN 2025 DESPITE COST CONCERNS,
SURVEY SAYS 5 SEP 2024
FLAWED BUT APPROVABLE? CRAFTING INDICATION POSSIBLE FOCUS OF ITERUM’S ANTIBIOTIC
ADCOMM 5 SEP 2024
ADVANZ GAINS TEMPORARY BLOCK ON OCALIVA’S REMOVAL FROM EU MARKET 5 SEP 2024
ENGLISH HTA FINALLY GREENLIGHTS CONDITIONAL FUNDING FOR MSD’S WELIREG 5 SEP 2024
CLUSTER WARS: KOREA’S CHALLENGES IN SHAPING A BOSTON STYLE BIOPHARMA HUB 4 SEP
2024
IPSEN OUTPACES MARKET WITH LUCRATIVE PRIORITY REVIEW VOUCHER DEAL 4 SEP 2024
DIVERSITY ACTION PLANS: WHAT TO SUBMIT AND WHEN 4 SEP 2024
See All
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PINK SHEET PODCAST
Citeline · Drug Fix: Pediatric Rare Disease PRV Deadline Approaches, Potential
Makena Compounding Ban
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PERFORMANCE TRACKERS
Bookmark
* 31 May 2024
* DATA
US FDA’S JUNE APPROVALS FORECAST: NEARLY 30 GOAL DATES SUGGEST HOT START TO
SUMMER
By Bridget Silverman
June goal dates include RSV and pneumococcal vaccines, two COPD therapies,
Rocket and Sarepta gene therapies, and lots of oncology.
US FDA Performance Tracker Drug Review Drug Approval Standards
Bookmark
* 08 Aug 2024
* DATA
GLOBAL PHARMA GUIDANCE TRACKER – JULY 2024
By Vibha Sharma
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.
Guidance Documents Regulation International
US FDA PERFORMANCE TRACKER
BREAKTHROUGH DESIGNATIONS CBER APPROVALS
CDER APPROVALS PENDING BIOSIMILARS
QIDP DESIGNATIONS RMAT DESIGNATIONS
USER FEE GOAL DATES ADVISORY COMMITTEES
COMPLETE RESPONSE LETTERS
EUROPEAN PERFORMANCE TRACKER
NEW EU FILINGS
EU ACCELERATED ASSESSMENT TRACKER
NEW EU APPROVALS
EU CHMP OPINIONS AND MAA UPDATES
EU BIOSIMILAR FILINGS, OPINIONS AND APPROVALS
Multimedia
* 05 Sep 2024
* ANALYSIS
*
OBESITY DRUGS WILL GET BROAD COMMERCIAL COVERAGE IN 2025 DESPITE COST CONCERNS,
SURVEY SAYS
By Cathy Kelly
The Business Group on Health survey also highlights employers’ complicated
attitudes on prescription drug rebates in their health benefit programs.
Reimbursement Market Access
* 04 Sep 2024
* ANALYSIS
*
DIVERSITY ACTION PLANS: WHAT TO SUBMIT AND WHEN
By M. Nielsen Hobbs
With the deadline for comments on the US FDA’s draft guidance less than a month
away, the Pink Sheet offers an infographic outlining what the agency is
expecting in diversity action plans and when that might be implemented.
Clinical Trials Diversity & Inclusion
* 04 Sep 2024
* ANALYSIS
*
US FDA’S RARE PEDIATRIC VOUCHER PROGRAM FACES TIGHT DEADLINE FOR REAUTHORIZATION
By Sue Sutter
Under current law, drugs or biologics must receive rare pediatric disease
designation before 1 October to be eligible for a priority review voucher. The
sunset provisions caused a spike in designation requests and a push by pediatric
and rare disease advocates for an extension.
Rare Diseases Legislation
* 02 Sep 2024
* ANALYSIS
*
US FDA SEPTEMBER USER FEE CALENDAR SLIMS DOWN, STILL BOASTS MORE THAN FIVE NOVEL
AGENTS
By Bridget Silverman
New therapies in the wings include two candidates for Niemman-Pick disease type
C, a first-in-class antipsychotic, a targeted oncology therapy under Real-Time
Oncology Review, and a new drug for gastroparesis.
US FDA Performance Tracker Drug Review
Regional Comparisons
* 02 Sep 2024
* ANALYSIS
EU REVOKES INTERCEPT/ADVANZ’S OCALIVA APPROVAL AS MOMENT OF RECKONING NEARS IN
US
By Sue Sutter
The EU marketing authorization for the primary biliary cholangitis treatment has
now been revoked. Meanwhile the drug's approval is in jeopardy in the US, where
an advisory committee will opine on whether the accelerated approval drug has
confirmed clinical benefit.
Regional Comparisons Post Market Regulation & Studies
* 09 Aug 2024
* ANALYSIS
ENGLAND LAGS BEHIND EIGHT EUROPEAN COUNTRIES ON INNOVATIVE DRUG AVAILABILITY
By Eliza Slawther
In this third article of a series on new drug reimbursement recommendations by
the HTA body NICE, the Pink Sheet finds that fewer innovative medicines are
reimbursed in England than in eight other European nations.
BioPharmaceutical Europe
* 24 Jul 2024
* ANALYSIS
DECODING REGULATORY AGENCY DECISIONS: THE CASE OF AMYLYX’S RELYVRIO/ALBRIOZA IN
THE US AND EU
By Francesca Bruce
Relyvrio/Albrioza, Amylyx’s ill-fated treatment for amyotrophic lateral
sclerosis, was approved for marketing by the US Food and Drug Administration but
rejected by the European Medicines Agency. The Pink Sheet explores how the two
agencies applied the available regulatory flexibilities and the impact of other
factors, such as regulatory precedence and patient influence, on
decision-making.
Europe United States
* 19 Jul 2024
* ANALYSIS
*
PINK SHEET PODCAST SPECIAL: WHY THE US APPROVES MOST NEW DRUGS BEFORE THE EU
By Pink Sheet Team
Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals
analysis that found the US FDA still clears many novel products first, including
most new cell and gene therapies and cancer treatments.
Regional Comparisons Approvals
See All
Recent Stories
* 09 Sep 2024
* DATA
GLOBAL PHARMA GUIDANCE TRACKER – AUGUST 2024
By Vibha Sharma
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.
Guidance Documents Regulation
* 06 Sep 2024
* NEWS
RECENT AND UPCOMING FDA ADVISORY COMMITTEE MEETINGS
Recent and upcoming US FDA advisory committee meetings and a summary of the
topics covered.
Advisory Committees Drug Review
* 06 Sep 2024
* NEWS
GLENMARK SHELLS OUT ANOTHER $25M TO RESOLVE CIVIL PRICE-FIXING CHARGES
By David Wallace
Glenmark Pharmaceuticals agreed to pay $25m in the US to resolve its alleged
liability under the False Claims Act linked to price-fixing allegations.
Generic Drugs Legal Issues
* 06 Sep 2024
* ANALYSIS
*
PINK SHEET PODCAST: RARE PEDIATRIC DISEASE PRV DEADLINE, POTENTIAL MAKENA
COMPOUNDING BAN
By Pink Sheet Team
Pink Sheet reporter and editors discuss the potential fallout if the US FDA’s
rare pediatric disease priority review voucher program is allowed to sunset, as
well as an upcoming agency advisory committee meeting on potentially banning
compounding of the active ingredient in the now-withdrawn pre-term birth
prevention drug Makena.
Rare Diseases Advisory Committees
* 06 Sep 2024
* NEWS
*
NEW EU APPROVALS
By Neena Brizmohun
The Pink Sheet's list of EU centralized approvals of new active substances has
been updated to add seven new products, including Winrevair, MSD's treatment for
pulmonary arterial hypertension.
Europe Approvals
* 06 Sep 2024
* NEWS
DRC GETS FIRST MPOX VACCINE SHIPMENT & ISSUES EUA AHEAD OF WHO LISTING
By Neena Brizmohun
The Democratic Republic of Congo, the country worst hit by the mpox crisis, has
now received the first batch of vaccines for the disease. Meanwhile, the World
Health Organization is expected to complete its review for emergency use listing
of mpox vaccines soon.
Congo (Democratic Republic) Vaccines
* 06 Sep 2024
* NEWS
EU REGULATORS SHOULD USE AI ONLY WHEN ‘SAFE AND RESPONSIBLE,’ SAYS EMA
By Eliza Slawther
Medicines regulators in the EU have “much to gain” from using AI models in their
processes, but this technology must be used in a “safe and responsible” way,
says the European Medicines Agency.
Europe EU
* 05 Sep 2024
* ANALYSIS
US MEDICARE TO OFFER GUIDANCE ON REAL WORLD EVIDENCE TO SUPPORT COVERAGE
By Cole Werble
The US Medicare agency is encouraging use of observational trials to fulfill
Coverage With Evidence Development requirements, but details will await an
upcoming guidance on “fit for purpose” studies.
Medicare Post Market Regulation & Studies
* 05 Sep 2024
* ANALYSIS
*
OBESITY DRUGS WILL GET BROAD COMMERCIAL COVERAGE IN 2025 DESPITE COST CONCERNS,
SURVEY SAYS
By Cathy Kelly
The Business Group on Health survey also highlights employers’ complicated
attitudes on prescription drug rebates in their health benefit programs.
Reimbursement Market Access
* 05 Sep 2024
* ANALYSIS
FLAWED BUT APPROVABLE? CRAFTING INDICATION POSSIBLE FOCUS OF ITERUM’S ANTIBIOTIC
ADCOMM
By Sarah Karlin-Smith
A second pivotal study may be enough to push Iterum’s antibiotic through its
second FDA review, but data gaps raised concerns about inappropriate prescribing
contributing to antimicrobial resistance and could limit marketing
differentiation.
Advisory Committees Clinical Trials
* 05 Sep 2024
* NEWS
ADVANZ GAINS TEMPORARY BLOCK ON OCALIVA’S REMOVAL FROM EU MARKET
By Andrew McConaghie
Despite its legal stay of execution, lack of confirmatory data means the
European Commission’s decision for market removal is likely to stand.
Legal Issues Europe
* 05 Sep 2024
* NEWS
ENGLISH HTA FINALLY GREENLIGHTS CONDITIONAL FUNDING FOR MSD’S WELIREG
By Francesca Bruce
MSD welcomes the decision but says the drug should have gone through NICE’s
Highly Specialized Technologies route that allows more flexibility regarding
uncertainty around rare disease drugs.
United Kingdom Health Technology Assessment
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