Biogen’s Qalsody (tofersen) has been approved in the UK as the first therapy to treat a rare, genetic form of amyotrophic lateral sclerosis (ALS), also known as motor neurone disease (MND). The Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for tofersen through the International… Read More
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has brought in new regulations designed to make it easier for personalised cancer treatments and gene therapies to be made where patients are treated. The new legislation ‘The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations… Read More
Biogen has announced that it intends to invest an additional $2 billion in its existing manufacturing footprint in North Carolina’s Research Triangle Park (RTP). The announcement comes at the same time as AstraZeneca also revealed plans to invest in its US facilities. Since breaking ground in 1995,… Read More
The US Food and Drug Administration (FDA) has decided not to recommend Ultragenyx Pharmaceutical’s UX111 (ABO-102) AAV gene therapy as a treatment for patients with Sanfilippo syndrome type A (MPS IIIA). In its complete response letter (CRL), the FDA requested that the company provide additional information and… Read More
A group of medical professional societies have filed a lawsuit against Robert F Kennedy Jr in the US District Court for the District of Massachusetts to defend vaccine policy, and to put an end to what they call the Secretary’s “assault on science, public health and evidence-based medicine”. … Read More
A “battle” between the UK government and the pharmaceutical industry over drug prices has forced the government to delay publication of its plan for the life sciences, according to The Financial Times. The release of the life sciences review, initially scheduled for the start of… Read More
Datroway (datopotamab deruxtecan or Dato-DXd) has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). It is approved in patients who have received prior EGFR-directed therapy and platinum-based chemotherapy. The indication was… Read More
The UK National Institute for Health and Care Excellence (NICE) has reached its final decision on two Alzheimer’s treatments, denying their use on the NHS due to the therapies not providing “good value for money.” Eli Lilly’s donanemab and Eisai’s lecanemab were under final draft guidance by… Read More
The US Food and Drug Administration (FDA) has revealed plans to issue new Commissioner’s National Priority Vouchers (CNPVs) to companies “supporting US national interests”. The new voucher may be redeemed by drug developers to participate in a novel priority programme that shortens drug review time from approximately… Read More
Supernus Pharmaceuticals will acquire Sage Therapeutics through a tender offer totalling approximately $795 million. The transaction will provide Supernus with Zurzuvae (zuranolone) capsules CIV, the only US Food and Drug Administration (FDA)-approved oral medicine indicated for the treatment of adults with postpartum depression. Through a… Read More
A clinical trial for early-stage breast cancer patients with BRCA gene mutations has reported 100% survival after three years. In a Phase III trial, Cancer Research UK researchers stopped BRCA-linked breast cancers growing or coming back by giving patients olaparib tablets 48 hours after each chemotherapy dose. … Read More
Live-attenuated SARS-CoV-2 vaccine candidate, OTS-228, has demonstrated exceptional safety, efficacy, and genomic stability in preclinical animal models. The vaccine was developed under the scientific leadership of Professor Dr Volker Thiel, Chief Scientist of Rocketvax and Professor of Virology at the University of Bern. The latest… Read More
The UK could lose out on £11 ($14.8) billion in pharmaceuticals research and development (R&D) investment by 2033, according to WPI Economics. In the UK, the Voluntary Scheme or VPAG requires companies to pay the Department of Health and Social Care (DHSC) up to a quarter to… Read More
Results of a global study presented at the American Society of Clinical Oncology (ASCO) annual meeting have shown that camizestrant for advanced breast cancer can be used to treat emerging tumours. The study was funded by AstraZeneca and co-led by researchers at The Institute of Cancer Research,… Read More
Sanofi has entered into an agreement to acquire Vigil Neuroscience, a clinical-stage biotechnology company focused on developing novel therapies for neurodegenerative diseases, for $470 million. The company says this acquisition in neurology, one of Sanofi’s four strategic disease areas, enhances its early-stage pipeline and includes VG-3927, which… Read More
Trial results have revealed encouraging results for a new vaccine targeting group B meningococcus (MenB) and established that a gene-based vaccine platform can induce protective antibody responses against bacteria. The investigational vaccine, ChAdOx1 MenB.1, developed by researchers at the University of Oxford, was shown to be safe… Read More
