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Tailor-made solutions

Use the expertise and experience of Pharma Intelligence to produce custom solutions that are actionable, flexible, and tailored to help you successfully navigate biopharma portfolio management, commercial optimization, and R&D strategy. Benefit from:

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Discover new business opportunities, reduce risks, and make better, faster decisions with tailor-made pharmaceutical solutions from Pharma Intelligence.

Pink Sheet

US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion

CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.

View article
Generics Bulletin

Overseas API Manufacturing Identified As Key Vulnerability In US Supply Chain

After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.

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Medtech Insight

Netherland’s DEKRA Is Latest Notified Body Designated Under EU IVDR

With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.

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Scrip

Biogen/Sage’s Zuranolone Data May Not Be Enough For Tough Commercial Landscape

The drug may have enough efficacy for approval, but data fell short of the benchmark seen as necessary for commercial adoption.

View article
Medtech Insight

StrataGraft Topical Burn Treatment Gets US FDA Approval

The topical treatment is made from human skin cells and can be applied to speed the healing of deep thermal burns.

View article
Citeline Study Feasibility

Minimizing Luck in Study Feasibility

This informative whitepaper introduces you to best practices in study feasibility, which laid the groundwork for our new predictive analytic that is launching soon, Citeline Study Feasibility. Our industry-leading technology will deliver advanced insight to improve your clinical trial decisions, fast-track enrollment and optimize cycle times – all with less effort.

Topic Clinical Trials

View white paper
Scrip

Novavax’s Latecomer COVID-19 Vaccine Impresses With 90% Efficacy Result

Arriving two to three months later than planned, Novavax’s nanoparticle-based vaccine is still a welcome addition to the field, for both rich and poor countries.

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Scrip

Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: a ground-breaking approval for Alzheimer’s in the US; LAG-3 inhibitors and new Keytruda data generate excitement at ASCO; and clinical progress for another COVID-19 vaccine.

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HBW Insight

Bayer Leads Push For Self-Care In India As Local Business Launches

Bayer has launched a dedicated Consumer Health business in India to market products in key OTC categories. The company is also working to bring different stakeholders together through the creation of a new organization dedicated to promoting self-care in the South Asian country.

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HBW Insight

New York’s Age Restrictions On Weight Loss, Sports Supplement Sales Fail To Fly

New York legislation to restrict sales of weight loss and sports nutrition supplements to minors failed without reaching a vote before the end of the session. But the proposal will continue to be a challenge for industry in New York as well as around the country.

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Biomedtracker, Datamonitor Healthcare

Plan for 2021 ASCO with Pharma Intelligence

The Pharma Intelligence analyst team will be covering the 2021 ASCO virtual meeting from June 4-8, 2021.

Single report
Medtech Insight

Commission’s eIFU Draft Unleashes Diametrically Opposed Views Among Device Users

Industry wants to see the number of products for which electronic IFU are permitted to be expanded. But there is a strong lobby pushing for paper IFU to still be made available.

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Generics Bulletin

Celltrion Opens Up Canadian Market For Remsima SC

Celltrion has pushed into another new market with its Remsima SC subcutaneous version of infliximab, launching the innovative biosimilar in Canada.

View article
Pink Sheet

Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial

Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.

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Medtech Insight

Pre-MDR Predictions and What You Can Expect

Updates to the EU Medical Devices Regulation are just weeks away from becoming a reality for manufacturers and suppliers. Medtech Insight delivers expert insights into the latest developments and what they could mean for your business.

Topic Medtech

Single report

Latest headlines

Scrip

18 Jun 2021

Biogen Gives Up On Gosuranemab After No Benefit Seen In Alzheimer's Study

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Medtech Insight

18 Jun 2021

QUOTED. 18 June 2021. Harith Rajagopalan.

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Medtech Insight

17 Jun 2021

UK ABHI Perspectives On Enabling Regulation – Part 1: Regulatory Certainty Vital For Medtechs

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Pink Sheet

17 Jun 2021

US FDA Plans To Get Tougher On Oncology Dose Optimization

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Pink Sheet

17 Jun 2021

Will COVID Finally Help US FDA And Sponsors Overcome Their ‘Angst’ On Innovative Trial Designs?

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Pink Sheet

17 Jun 2021

Domestic In-Person Inspection Work Could Be Back To Normal This Summer, Woodcock Says

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Pink Sheet

17 Jun 2021

340B Contract Pharmacy Feud: Court Undercuts HHS Position Against Drug Firms In Ruling

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Generics Bulletin

17 Jun 2021

EU Industry Sets Out Priorities In Structured Dialog

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Scrip

17 Jun 2021

Executives On The Move: New Chief Scientific Officers At Sigilon, Sensorion And IMV

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HBW Insight

17 Jun 2021

Colgate Slams Industry Self-Regulation Review But Agrees To Pull Optic White Stain Removal Claim

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HBW Insight

17 Jun 2021

OTC Allergy Switch Approved For Bayer In US

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Pink Sheet

17 Jun 2021

BIO 2021 Notebook: Biogen CEO On Corporate Responsibility

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Medtech Insight

17 Jun 2021

Digital Health Roundup, May 2021: Immersive Technologies In Surgery Suite, ‘Smart’ Toilets And Pills, New SaMD Cybersecurity Standards

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Scrip

17 Jun 2021

Apollo’s Next Steps: Apply Learnings From Prior Hub-And-Spoke Entities

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Medtech Insight

17 Jun 2021

Medtech Backs US Supreme Court Decision Upholding Affordable Care Act

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Tailor-made Pharma Solutions

Tailor-made solutions

Pharma Intelligence latest insights

US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion

Overseas API Manufacturing Identified As Key Vulnerability In US Supply Chain

Netherland’s DEKRA Is Latest Notified Body Designated Under EU IVDR

Biogen/Sage’s Zuranolone Data May Not Be Enough For Tough Commercial Landscape

StrataGraft Topical Burn Treatment Gets US FDA Approval

Minimizing Luck in Study Feasibility

Novavax’s Latecomer COVID-19 Vaccine Impresses With 90% Efficacy Result

Quick Listen: Scrip’s Five Must-Know Things

Bayer Leads Push For Self-Care In India As Local Business Launches

New York’s Age Restrictions On Weight Loss, Sports Supplement Sales Fail To Fly

Plan for 2021 ASCO with Pharma Intelligence

Commission’s eIFU Draft Unleashes Diametrically Opposed Views Among Device Users

Celltrion Opens Up Canadian Market For Remsima SC

Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial

Pre-MDR Predictions and What You Can Expect

Latest headlines

Biogen Gives Up On Gosuranemab After No Benefit Seen In Alzheimer's Study

QUOTED. 18 June 2021. Harith Rajagopalan.

UK ABHI Perspectives On Enabling Regulation – Part 1: Regulatory Certainty Vital For Medtechs

US FDA Plans To Get Tougher On Oncology Dose Optimization

Will COVID Finally Help US FDA And Sponsors Overcome Their ‘Angst’ On Innovative Trial Designs?

Domestic In-Person Inspection Work Could Be Back To Normal This Summer, Woodcock Says

340B Contract Pharmacy Feud: Court Undercuts HHS Position Against Drug Firms In Ruling

EU Industry Sets Out Priorities In Structured Dialog

Executives On The Move: New Chief Scientific Officers At Sigilon, Sensorion And IMV

Colgate Slams Industry Self-Regulation Review But Agrees To Pull Optic White Stain Removal Claim

OTC Allergy Switch Approved For Bayer In US

BIO 2021 Notebook: Biogen CEO On Corporate Responsibility

Digital Health Roundup, May 2021: Immersive Technologies In Surgery Suite, ‘Smart’ Toilets And Pills, New SaMD Cybersecurity Standards

Apollo’s Next Steps: Apply Learnings From Prior Hub-And-Spoke Entities

Medtech Backs US Supreme Court Decision Upholding Affordable Care Act

Next steps

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