Bolar Exemption India Files: Roche Blocks Alleged Infringer Of Evrysdi Patent
More legal action in India that has the Bolar exception provision at its crux with Roche warding off a local...
Scrip - April 29, 2024

Mismatch Between Growing Vaccine Pipeline and CDC’s ACIP Capacity
The Centers for Disease Control and Prevention’s ACIP is not able to take on all vaccine-like preventative medicines and still...
Pink Sheet - April 26, 2024

Keeping Track: Two Breakthrough Oncologics, Another Antibiotic Clear US FDA Along With Pfizer’s Hemophilia B Gene Therapy
The US FDA approved Day One’s pediatric brain cancer drug Ojemda, ImmunityBio’s bladder cancer immunotherapy Anktiva, an uncomplicated UTI claim...
Pink Sheet - April 26, 2024

Priority Review Vouchers: Tropical Disease Candidates Wait Years For FDA Action On Qualifying List
There are pending requests to add 13 candidates to the tropical diseases that qualify for a priority review voucher, according...
Pink Sheet - April 26, 2024

Pink Sheet Podcast: US FDA Biosimilar Strategy, Gene Therapy Accelerated Approvals, FDA v. Partisan Politics
Pink Sheet reporter and editors discuss the impact of FDA biosimilar promotion guidance on the future of the interchangeability designation...
Pink Sheet - April 26, 2024

Idorsia’s Novel Hypertension Pill Among Eight New Drugs To Win EMA Nod
The European Medicines Agency believes Idorsia’s Jeraygo should be approved for use in the EU at two different doses rather...
Pink Sheet - April 26, 2024

AI Used In Drug R&D Likely Exempt From Tough EU AI Rules, Says EFPIA
The European Commission’s landmark AI Act will introduce strict new rules for AI systems, with the exception of products used...
Pink Sheet - April 26, 2024

EU Parliament OKs New Rules On Use Of Patient Data In Research
The European Health Data Space is expected to give researchers, industry and public bodies access to large amounts of high-quality...
Pink Sheet - April 26, 2024

Danes Advise Pharma Firms To Test Their Anti-Tamper Devices
About 10% of marketed medicines chosen at random in Denmark had “non-functioning” anti-tamper devices, leaving them open to possible interference.
Pink Sheet - April 26, 2024

Joint Clinical Assessments: EU Guidance On Evidence May Be Flexible For ATMPs And Single Arm Trials
Real-world evidence and patient involvement can help developers shore up evidence from single arm trials for EU-wide joint clinical assessments.
Pink Sheet - April 26, 2024

News We're Watching: LDT Final Rule Near Publication, Zimmer ROSA Used In Shoulder Surgery, $60M For Menopause Clinic
This week, the US FDA's proposed final rule on lab-developed tests cleared another hurdle on the path to release; Zimmer...
Medtech Insight - April 26, 2024

Epitel Gets 510(k) Clearance On Remote EEG Technology
The REMI Remote EEG monitoring system and REMI Vigilenz AI could help patients with infrequent seizures get a quicker diagnosis.
Medtech Insight - April 26, 2024

Valuable Health Data Sources For Medtech Industry Come A Step Closer In The EU
The only step that remains now before the  European Health Data Space Regulation is approved is sign off by the...
Medtech Insight - April 26, 2024

Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous...
HBW Insight - April 28, 2024

The Aspirin Test For AI?
US FDA Commissioner Robert Califf tells Congress that regulators don’t have to know how artificial intelligence works in medicine, but...
HBW Insight - April 28, 2024

Biocon And Biomm Team Up In Brazil On Ozempic Rival – With Potential Near-Term Launch
India’s Biocon Limited has struck an exclusive deal for a generic version of semaglutide in Brazil with local player Biomm...
Generics Bulletin - April 26, 2024

Amneal Launches Ready-To-Use Pemetrexed And OTC Naloxone
Amneal launched two highly anticipated products, a ready-to-use pemetrexed injectable Pemrydi and over-the-counter naloxone spray, strengthening the firm’s focus on...
Generics Bulletin - April 26, 2024

…And Amgen Makes Three: Another Ustekinumab Biosimilar Gets Go-Ahead In EU
At the latest meeting of the EMA’s CHMP committee, the agency recommended that Amgen be granted a third European marketing...
Generics Bulletin - April 26, 2024

No Takers For Biogen’s Biosimilars Business?
It’s been a year since Biogen made it clear that it was ready to put its biosimilars business on the...
Generics Bulletin - April 26, 2024

Biogen Chases Fresenius After Revealing EU Tocilizumab Nod
Ahead of the EMA’s CHMP publishing its April meeting highlights, Biogen has revealed a positive opinion for its Tofidence biosimilar...
Generics Bulletin - April 26, 2024

Human Cell-Secreted Proteins Offer A Wellspring Of Potential Therapeutics
CEO Hanadie Yousef leads Juvena Therapeutics in utilizing an AI-based platform that analyzes cell-secreted proteins to identify potential therapeutics. One...
In Vivo - April 24, 2024

Fujifilm Demonstrates Health Specialism With European HealthTech Spinout
From X-ray film in 1936 to the world’s first digital X-ray system in 1983, Fujifilm has a long heritage in...
In Vivo - April 24, 2024

Financing Quarterly Statistics, Q1 2024
During Q1, biopharmas brought in an aggregate $30.1bn in financing and device company fundraising totaled $2.8bn; while in vitro diagnostic...
In Vivo - April 24, 2024

Helping Organizations Deliver On KPIs And Giving Staff A Voice
ImproveWell has won awards for its software technology that allows health care staff at the sharp end of patient care...
In Vivo - April 24, 2024