The availability of Ocrevus has been branded a “landmark moment” by the MS Society.
News
Waylivra granted conditional marketing authorisation in Europe
The authorisation follows the positive opinion recommending approval provided by the Committee for Medicinal Products for Human Use (CHMP).
AMR could cause 10 million deaths per year by 2050
The disease that causes one-third of all AMR related deaths – drug-resistant tuberculosis (DR-TB) – is rarely talked about.
Pfizer’s Vyndaqel, Vyndamax win US nod for rare disease
The approval is based on a clinical trial which showed that after an average of 30 months, the survival rate was higher in the Vyndaqel group.
EU approval for Palynziq in adult phenylketonuria
It’s the first substitution therapy approved in Europe to target the underlying cause of PKU by helping the body to break down Phe.
AZ’ Calquence trial to stop early after hitting endpoints
The drug was found to significantly increase the time patients live without disease progression.
Final week to book tickets for the International Clinical Researcher of the Year awards ceremony!
We are now approaching the final week to book tickets for the 2019 PharmaTimes international Clinical Researcher of the Year gala dinner & awards ceremony.
FDA approves Ruzurgi for children with Lambert-Eaton myasthenic syndrome
The FDA has also granted the application Priority Review and Fast Track designations.
Prostate cancer mutation found to triple risk of death
The research also identified clues for how some patients with prostate cancer could be treated more effectively using immunotherapy and a breast cancer treatment.
Vectura wins patent litigation battle against GSK, awarded $89.7M
The companies had entered into an agreement in 2010 under which GSK had taken a license to formulation technology covered by a Vectura patent family.
Roche launches HER2 biomarker test for breast and gastric cancer
The test “advances Roche’s commitment to personalised healthcare”.
FDA hits Acacia with another rejection, cites manufacturer issues
The same issue was raised initially in October 2018.
NHS improvements to give patients faster access to pioneering treatments
New improvements to the Accelerated Access Collaborative (AAC) will put the most promising medicines through the clinical development and regulatory approval process faster.
Haseeb Ahmad named new ABPI president
The Association of the British Pharmaceutical Industry (ABPI) has named Novartis’ Haseeb Ahmad as its new president.
Bayer joins Sensyne Health consortium for accelerating new medicine discovery
Bayer is to become Sensyne Health’s preferred pharmaceutical partner to work together on the development of a national linked patient data capability.
