Search Results for “EC” – Page 85 – media

FDA Rejects ARS Pharmaceuticals’ Needle-Free EpiPen Alternative

Agency cites a need for more research to be completed. ARS Pharmaceuticals revealed in a company press release that the FDA issued a complete response letter (CRL) regarding its new drug application (NDA) for neffy, a potential nasal spray alternative to the EpiPen. According to the response, the agency stated that it needed more research before agreeing to approval. The denial comes amid an initial advisory committee vote to approve the treatment back in May. “We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive Advisory Committee vote. In fact, multiple Committee members highlighted the favorable profile of neffy in our completed single-dose nasal allergy challenge study and that any decline in exposure 20 minutes after dosing, after the expected response ...
- Source: drugdu
- 200
- September 22, 2023
CDMOs SK pharmteco, Oxford Biomedica make cell and gene therapy manufacturing M&A plays

It’s a boom time in the cell and gene therapy market, with manufacturers making moves to secure a larger piece of the pie. Wednesday, two CDMOs revealed acquisitions that will bolster their production capabilities and increase their global presence. Korean manufacturer SK pharmteco has taken a controlling stake in the Philadelphia-based Center for Breakthrough Medicines (CBM) for an undisclosed sum. Meanwhile, England’s Oxford Biomedica said it is in talks with Institut Mérieux to buy out its subsidiary, ABL Europe, for 15 million euros ($16 million). SK’s move comes after it invested $350 million in CBM in January of last year. As part of the agreement, SK had an option to increase its stake, which it exercised, becoming its largest stockholder. CBM was established in 2019 at a former GSK site. The prior funding allowed CBM to begin building end-to-end manufacturing capabilities. SK boasted that the site will be the world’s ...
- Source: drugdu
- 100
- September 22, 2023
FDA Rejects ARS’ Epinephrine Nasal Spray Despite Adcomm Support

By Tristan Manalac Pictured: FDA signage outside its office in Maryland/iStock, hapabapa The FDA on Tuesday turned down ARS Pharmaceuticals’ application for its epinephrine nasal spray neffy for the treatment of type I allergic reactions in adults and children weighing at least 30 kg. In its Complete Response Letter (CRL), the regulator asked ARS to conduct an additional pharmacokinetic and pharmacodynamic study that evaluates repeated neffy doses compared with repeat administrations of an epinephrine injection in participants with allergen-induced allergic rhinitis. According to the company’s announcement on Tuesday, the FDA is making this request despite aligning with ARS in August 2023 regarding the need to conduct this study as a post-marketing requirement. The regulator and the company have also already settled on the final physician’s labeling for the product. In May 2023, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16-6 that neffy’s risk-benefit profile was favorable in adults. The ...
- Source: drugdu
- 116
- September 22, 2023
Anthos Stops Mid-Stage Atrial Fibrillation Trial Due to ‘Unprecedented’ Efficacy

By Tristan Manalac Pictured: Illustration of a blood clot in a blood vessel/iStock, libre de droit Anthos Therapeutics is ending the Phase II AZALEA-TIMI 71 study ahead of schedule after its investigational monoclonal antibody abelacimab demonstrated an “overwhelming reduction” in bleeding compared to Bayer and Johnson & Johnson’s Xarelto (rivaroxaban), the company announced Monday. Patients treated with abelacimab saw a sharp reduction in the composite endpoint of major and clinically relevant non-major bleeding events compared with counterparts given rivaroxaban, the current standard-of-care oral anticoagulant. The Massachusetts-based biopharma did not provide specific data in Monday’s announcement but said that the Data Monitoring Committee stopped the study early following these data. Anthos will share the full results and analysis of the trial in an upcoming medical meeting. Due to the “overwhelming reduction in bleeding” reported in AZALEA-TIMI 71, abelacimab may represent a “paradigm shift” in atrial fibrillation care particularly in the prevention ...
- Source: drugdu
- 95
- September 20, 2023
FDA approves Pfizer/BioNTech and Moderna’s adapted COVID-19 vaccines

The updated vaccines more closely target current circulating variants The US Food and Drug Administration (FDA) has granted approval for Pfizer/BioNTech and Moderna’s updated COVID-19 vaccines, to tackle currently circulating variants. As previously recommended by the FDA, both vaccines have been adapted to closely target the XBB.1.5. Omicron variant by including a monovalent component. Both companies’ mRNA vaccines are approved for use in individuals aged 12 years and older and authorised for emergency use in those aged six months to 11 years. The FDA has said that it is “confident in the safety and effectiveness” of the two updated vaccines and that its risk assessment demonstrated that the benefits of both vaccines for individuals aged six months and older outweighed the risks. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Peter Marks, director of the ...
- Source: drugdu
- 145
- September 20, 2023
Pfizer’s Vydura recommended by NICE for acute migraines

The treatment is the first oral GPCR receptor antagonist class recommended for NHS use The National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Vydura (rimegepant) as a cost-effective option for the treatment of acute migraines in adults. The recommendation marks Vydura as the first drug in the oral GPCR receptor antagonist class to be recommended for routine NHS use as treatment for the condition. Published in NICE’s draft guidance, Vydura is recommended for adults who have previously tried at least two triptant-based therapies that were ineffective, not tolerated, or contraindicated. It is also recommended after prior use of nonsteroidal anti-inflammatory drugs, such as ibruprofen and aspirin, and paracetamol didn’t work well enough. Triptants are a group of medicines used to treat a migraine or headache. The recommendation was based on clinical trial evidence, which showed that Vydura is more likely to reduce pain in patients within 2 ...
- Source: drugdu
- 128
- September 20, 2023
Anavex’s Blarcamesine Slows Cognitive Decline in Alzheimer’s Patients

By Tristan Manalac Pictured: Illustration of amyloid oligomers/iStock, selvanegra A follow-on analysis of a landmark Phase IIb/III study showed that Anavex Life Sciences’ investigational drug blarcamesine significantly slowed down cognitive decline in patients with Alzheimer’s disease, the company announced Thursday. At 48 weeks, the change in the Alzheimer’s Disease Assessment Scale-Cognitive Subscale version 13 (ADAS-Cog13) scores in blarcamesine-treated patients was significantly better than placebo comparators. Blarcamesine was likewise significantly better than placebo when cognition was evaluated using the Clinical Dementia Rating scale Sum of Boxes (CDR-SB) scale, according to Anavex’s news release. The company bolstered these clinical findings with biomarker data, which showed that blarcamesine treatment resulted in a significant drop in pathological amyloid beta levels and a corresponding improvement in Aβ42/40 ratio, pointing to the molecule’s strong anti-amyloid potential. Anavex’s drug candidate also resulted in lower brain volume loss versus placebo. When it came to safety, the most common ...
- Source: drugdu
- 105
- September 19, 2023
New Biotech Targets Rare Respiratory Disorders with Inhaled Gene Therapies

By Kate Goodwin Pictured: Human lung anatomy concept/iStock, magicmine Oxford-based biotech AlveoGene launched Thursday with plans to leverage a proprietary platform from the U.K.’s Gene Therapy Consortium to develop inhaled gene therapies for rare respiratory disorders. With seed funding from Oxford Science Enterprises, alongside other academia venture capital funds, AlveoGene has exclusively licensed the Gene Therapy Consortium’s next-gen lentiviral delivery platform—called InGenuiTy—for the treatment of respiratory diseases with high unmet need. However, use of the CTFR gene is excluded from the deal as Boehringer Ingelheim exercised its option in 2021 to develop the inhaled formulation, which is in the works for cystic fibrosis. AlveoGene’s first target will be treating Alpha-1 Antitrypsin Deficiency (AATD), one of the most common rare disorders. AATD is inherited and leads to reduced levels of a plasma protein that protects the lungs, leading to increased risk for lung and other diseases. It’s a major genetic risk ...
- Source: drugdu
- 104
- September 18, 2023
EMA CHMP recommends approval for Moderna’s updated Covid-19 vaccine

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorisation for Moderna’s Spikevax, an updated Covid-19 vaccine targeting the SARS-CoV-2’s XBB.1.5 sublineage. The vaccine is intended for active immunisation for the prevention of Covid-19 in those aged six months and above. The latest development comes after the company filed a regulatory application seeking approval for the updated vaccine in July 2023. Based on the positive opinion from the committee, the European Commission will adopt a decision on the vaccine approval for autumn/winter 2023. Moderna has obtained clinical results for the monovalent XBB.1.5 vaccine candidate which offered an immune response against sublineages of XBB, XBB.1.5, XBB.1.16, and XBB.2.3.2, apart from BA.2.86, EG.5 and FL.1.5.1 variants. Injection site pain was reported to be the most frequently solicited local adverse event for the updated vaccine. Fatigue, myalgia, headache, chills and arthralgia were the ...
- Source: drugdu
- 145
- September 18, 2023
NICE recommends use of Vydura for acute migraines on the NHS

Adults in England and Wales with acute migraines will now have access to a new treatment after the National Institute for Health and Care Excellence (Nice) recommended Pfizer’s Vydura for use on the NHS. In May, NICE recommended the drug – with the generic name rimegepant – for the prevention of migraines. At the time, NICE said up to 145,000 people would benefit from the treatment, though the drug was only permitted for use as a fourth-line treatment option. As per the most recent draft guidance, the drug has now been recommended for adults who do not respond to two previous migraine medicines, called triptans. Although this means Vydura is still not recommended for primary use, the move will help an additional 13,000 people access the treatment, NICE said. Patients who do not benefit from taking nonsteroidal anti-inflammatory drugs or paracetamol have also been endorsed to take the treatment in ...
- Source: drugdu
- 108
- September 16, 2023

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