Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 07 Jan 2021
Merus granted FDA fast track designation of zenocutuzumab for the treatment of patients with neuregulin 1 fusion cancers
7 January 2021 - NRG1 fusions are rare mutations in many types of solid tumours, including non-small cell lung cancer and ...
Posted by Michael Wonder on 07 Jan 2021
Drug prices increase and biopharma bashing returns
5 January 2021 - It’s an annual ritual. In the first week of January, drug companies announce their annual price increases. ...
Posted by Michael Wonder on 07 Jan 2021
Warning of shortages, researchers look to stretch vaccine supply
5 January 2021 - The N.I.H. and Moderna are examining whether doses of Moderna’s coronavirus vaccine can be halved to double ...
Posted by Michael Wonder on 07 Jan 2021
Most governments are not yet on track to hit their vaccine roll-out targets
6 January 2021 - Some countries aim to inoculate millions of people a day. So far, most are falling short. ...
Posted by Michael Wonder on 07 Jan 2021
Problems with paying people to be vaccinated against COVID-19
6 January 2021 - The US FDA has issued Emergency Use Authorisation for 2 vaccines for the prevention of coronavirus disease ...
Posted by Michael Wonder on 07 Jan 2021
Adalimumab biosimilars face product obsolescence before launch
6 January 2021 - Product differentiation by concentration is a threat to the multiple adalimumab biosimilars approved but not yet ...
Posted by Michael Wonder on 07 Jan 2021
RedHill Biopharma's RHB-204 granted FDA fast track designation for non-tuberculous mycobacteria disease
6 January 2021 - FDA Fast Track designation, together with previously granted QIDP designation, provides RHB-204 with eligibility for rolling NDA ...
Posted by Michael Wonder on 06 Jan 2021
EMA recommends Moderna COVID-19 vaccine for authorisation in the EU
6 January 2021 - EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent coronavirus disease ...
Posted by Michael Wonder on 06 Jan 2021
FDA accepts for priority review the new drug application for mirabegron for oral suspension and supplemental new drug application for Myrbetriq (mirabegron) tablets in paediatric patients
6 January 2021 - Astellas Pharma announced today that the U.S. FDA accepted priority review for its new drug application for ...
Posted by Michael Wonder on 06 Jan 2021
Farxiga granted priority review in the US for the treatment of patients with chronic kidney disease
6 January 2021 - Farxiga could become the first SGLT2 inhibitor approved to treat patients with chronic kidney disease, with ...
Posted by Michael Wonder on 06 Jan 2021
MorphoSys and Incyte announce the acceptance of the Swissmedic marketing authorisation application for tafasitamab
5 January 2021 - The Swissmedic marketing authorisation application seeks approval for tafasitamab in combination with lenalidomide for the treatment ...
Posted by Michael Wonder on 06 Jan 2021
KYE Pharmaceuticals announces approval of Corzyna in Canada (ranolazine extended release tablets)
5 January 2020 - KYE Pharmaceuticals today announced an important milestone, Corzyna (ranolazine extended release tablets) has now been approved by ...
Posted by Michael Wonder on 06 Jan 2021
Marius Pharmaceuticals submits new drug application to U.S. FDA for next generation oral testosterone replacement therapy in male patients with hypogonadism
5 January 2021 - Kyzatrex new drug application includes data demonstrating less than 2 mm Hg mean SBP increase as measured ...
Posted by Michael Wonder on 05 Jan 2021
Genentech’s novel anti-TIGIT tiragolumab granted FDA breakthrough therapy designation in combination with Tecentriq for PD-L1 high non-small cell lung cancer
4 January 2021 - Tiragolumab is the first anti-TIGIT therapy to be granted breakthrough therapy designation and marks the 37th ...
Posted by Michael Wonder on 05 Jan 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma
4 January 2021 - Bristol Myers Squibb today announced that the EMA validated its Type II Variation marketing authorisation application ...