Blog
RSS FeedPosted by Michael Wonder on 29 Nov 2022
NICE’s new methods: putting innovation first, but at what cost?
28 November 2022 - Traditionally the gatekeeper to the NHS, NICE has increasingly reoriented its role towards facilitating access to innovative ...
Posted by Michael Wonder on 21 Nov 2022
New Quality Innovation Expert Group supports medicine innovation
21 November 2022 - The EMA has established a Quality Innovation Expert Group to support innovative approaches for the development, ...
Posted by Michael Wonder on 10 Nov 2022
Aleta Biotherapeutics receives Innovation Passport Designation for biologic CAR T-cell therapy engager ALETA-001
7 November 2022 - ALETA-001 was developed to address the urgent unmet need of patient relapse after CD19 targeted CAR ...
Posted by Michael Wonder on 08 Nov 2022
Blue Earth Therapeutics awarded UK MHRA innovation passport for investigational 177Lu-rhPSMA-10.1 for treatment of metastatic castrate-resistant prostate cancer
8 November 2022 - Lutetium LU 177 labeled radiohybrid prostate specific membrane antigen (Lu 177-rhPSMA-10.1) is an optimised therapeutic radiopharmaceutical. ...
Posted by Michael Wonder on 07 Sep 2022
FDA accepts Integral Molecular's letter of intent on membrane proteome array antibody specificity test into ISTAND drug development tools pilot program
7 September 2022 - Integral Molecular has been accepted into the US FDA's ISTAND pilot program. ...
Posted by Michael Wonder on 23 Aug 2022
The EU HTA regulation: a new frontier for access to innovative technologies
23 August 2022 - A new health technology regulation is due to be applied to help EU countries determine the effectiveness ...
Posted by Michael Wonder on 23 Aug 2022
AstraZeneca's Soriot warns new US drug price law will hurt innovation
23 August 2022 - AstraZeneca's Chief Executive Pascal Soriot warned on Tuesday new US legislation capping drug prices would reduce ...
Posted by Michael Wonder on 22 Aug 2022
Drug pricing reforms can hurt innovation. Here are 3 ways to prevent that.
22 August 2022 - Giving billions of dollars in government prize money to drug companies might sound like an idea from ...
Posted by Michael Wonder on 20 Aug 2022
Regulatory considerations to keep pace with innovation in digital health products
19 August 2022 - Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital ...
Posted by Michael Wonder on 08 Aug 2022
Lurbinectedin receives the Innovative Medicine designation by the UK’s MHRA
5 August 2022 - PharmaMar has announced today that Zepzelca (lurbinectedin) has received the Innovation Passport (Innovative Medicine designation) by the ...
Posted by Michael Wonder on 02 Aug 2022
Critics decry drug pricing provisions in Inflation Reduction Act, say they will stifle innovation
2 August 2022 - The push back against the prescription drug pricing provisions in the Inflation Reduction Act is relentless and ...
Posted by Michael Wonder on 17 Jul 2022
'Government excessively controls drug prices, not recognising novel drugs' value'
15 July 2022 - The Government is wielding excessive power to lower drug prices without recognising the values of innovative ...
Posted by Michael Wonder on 14 Jul 2022
Revolo Biotherapeutics awarded Innovation Passport for ‘1805 in the United Kingdom for the treatment of moderate to severe rheumatoid arthritis
14 July 2022 - Revolo Biotherapeutics today announced that it was awarded an Innovative Medicines Designation, or Innovation Passport, from the ...
Posted by Michael Wonder on 28 Jun 2022
The Innovative Medicines Fund - good news for patients but has an opportunity been missed to be more ambitious?
27 June 2022 - NHS England and Improvement has announced the launch of the Innovative Medicines Fund. The ABPI’s Director ...
Posted by Michael Wonder on 16 Jun 2022
Savara awarded innovation passport in United Kingdom for molgramostim nebuliser solution, a novel investigational inhaled biologic
16 June 2022 - Innovation passport awarded to molgramostim for the treatment of auto-immune pulmonary alveolar proteinosis, a rare lung disease. ...