Blog
RSS FeedPosted by Michael Wonder on 11 Feb 2021
CSL confident it can make vaccine to cover variants, if needed
11 February 2021 - CSL is confident it can make an updated version of AstraZeneca’s COVID-19 vaccine to cover any ...
Posted by Michael Wonder on 11 Feb 2021
BrainCool receives FDA breakthrough device designation for Cooral System for prevention of oral mucositis
11 February 2021 - Recent Medicare reimbursement ruling provides an additional boost in paving the way for elimination of one of ...
Posted by Michael Wonder on 11 Feb 2021
BrainQ gets FDA breakthrough status for its device for reducing disability following stroke
11 February 2021 - The breakthrough device designation, which comes after new trial data, is expected to expedite the device's path ...
Posted by Michael Wonder on 11 Feb 2021
Seagen and Genmab submit tisotumab vedotin biologics license application to the U.S. FDA for patients with recurrent or metastatic cervical cancer
11 February 2021 - Submission based on positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology ...
Posted by Michael Wonder on 11 Feb 2021
Cerus Endovascular receives FDA breakthrough device designation for its Contour Neurovascular System
11 February 2021 - Cerus Endovascular today announced that it has received breakthrough device designation from the U.S. FDA for ...
Posted by Michael Wonder on 11 Feb 2021
FDA approves first in class Evkeeza (evinacumab-dgnb) for patients with ultra rare inherited form of high cholesterol
11 February 2021 - In pivotal Phase 3 HoFH trial, adding Evkeeza to standard lipid-lowering therapies reduced ow-density lipoprotein cholesterol by nearly ...
Posted by Michael Wonder on 11 Feb 2021
FDA’s generic drug program in 2020 helped ensure availability of high quality, affordable drugs amid COVID-19
11 February 2021 - Generic drugs play a vital role in facilitating access to lifesaving medicines for Americans and remain a ...
Posted by Michael Wonder on 10 Feb 2021
European Union admits errors in coronavirus vaccine rollout, 'deeply regrets' decision on export curbs
10 February 2021 - European Commission President Ursula von der Leyen has acknowledged failings in the EU's approval and rollout ...
Posted by Michael Wonder on 10 Feb 2021
It will be six years before the world is vaccinated against COVID-19: experts
10 February 2021 - It will take six years to vaccinate enough of the world’s population to reduce the threat ...
Posted by Michael Wonder on 10 Feb 2021
Drug maker will slash prices on cancer medicines to end price gouging probe in Europe
10 February 2021 - After months of deliberation, the European Commission has accepted an offer from Aspen Pharma to reduce ...
Posted by Michael Wonder on 10 Feb 2021
EMA expected to approve Johnson & Johnson vaccine by March
10 February 2021 - The European Medicines Agency is expected to give its approval to the COVID-19 vaccine developed by ...
Posted by Michael Wonder on 10 Feb 2021
Botox (onabotulinumtoxinA) receives FDA approval for paediatric detrusor overactivity associated with a neurologic condition
10 February 2021 - Milestone marks 12th U.S. therapeutic indication for Botox. ...
Posted by Michael Wonder on 10 Feb 2021
Clarification on Sputnik V vaccine in the EU approval process
10 February 2021 - The EMA has to date not received an application for a rolling review or a marketing ...
Posted by Michael Wonder on 10 Feb 2021
EMA preparing guidance to tackle COVID-19 variants
10 February 2021 - EMA is developing guidance for manufacturers planning changes to the existing COVID-19 vaccines to tackle the new ...
Posted by Michael Wonder on 10 Feb 2021
FDA authorises monoclonal antibodies for treatment of COVID-19
9 February 2021 - Today, the U.S. FDA issued an emergency use authorisation for bamlanivimab and etesevimab administered together for the ...