New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest...
Pink Sheet - April 23, 2024

BMS Has A Strong Pipeline, But Access Challenges Remain
Bristol Myers Squibb’s head of major markets, Monica Shaw, wants to improve patients’ access to lifesaving therapies. And the group...
Scrip - April 23, 2024

Novartis Hires Ex-BMS Chief As It Pursues US Growth Strategy
The Swiss pharma company is looking to tap into the experience of ex-BMS leader Giovanni Caforio to help further it...
Scrip - April 23, 2024

Maxwellia Delivers Two UK Menstrual Health Rx-To-OTC Switches
UK switch specialist Maxwellia delivers two “me too” reclassifications in the area of women's health: Evana Heavy Period Relief and Ultravana Period...
HBW Insight - April 23, 2024

WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies...
Pink Sheet - April 23, 2024

Irish Body Sets Out Five-Year Vision Strategy For Off-Patent Sector
With a focus on drug accessibility, supply chain resilience, and a balanced approach to sustainability, Medicines for Ireland “calls to...
Generics Bulletin - April 23, 2024

Post-Brexit UK Risks Being ‘Left Out In The Cold’ As EU Coordinates Action On Shortages
The UK is not alone in experiencing drug shortages, as data from across Europe show, but its departure from the...
Pink Sheet - April 23, 2024

Dr Reddy’s Knocked Back On Rituximab In US
Dr Reddy’s has received a complete response letter from the US FDA, knocking back its proposed rituximab biosimilar rival to...
Generics Bulletin - April 23, 2024

Sandoz And Samsung Celebrate Stelara Rival’s EU Approval
Sandoz and Samsung Bioepis have received final European Commission approval for their partnered Pyzchiva biosimilar rival to Stelara. But with...
Generics Bulletin - April 23, 2024

Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has...
Medtech Insight - April 23, 2024

Takeda, Astellas Found New JV To Support Japanese Bioventures
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and...
Scrip - April 23, 2024

Could Eledon’s Anti-CD40L Change Transplant Medicine?
Eledon Pharmaceuticals’ CD40 Ligand blocker has yielded impressive results for post-transplant immunosuppression and cutting-edge transplant doctors have also used it...
In Vivo - April 23, 2024

Turning That Frown Upside Down: Treating Depression With Facial Botox Injections
In this episode of the In Vivo podcast, Eric Finzi, CEO of Healis Therapeutics, discusses how his company is targeting major depression...
In Vivo - April 23, 2024