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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
- 148
- 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 Published in NICE’s draft guidance, Vydura is recommended for adults who have previously tried at least two triptant-based therapies that were ineffective, not tolerated, or contraindicated.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
- 132
- September 20, 2023
As Lonza CEO departs, Catalent scoops up rival CDMO’s bioscience business head to lead biologics

Mere hours after it surfaced that Lonza’s CEO, Pierre-Alain Ruffieux, will step down, the Swiss CDMO has lost another major executive. And this time, the exec is jumping ship to U.S. contract manufacturing rival Catalent. Monday, Catalent named Lonza’s David McErlane group president of its biologics segment. McErlane, who most recently served as Lonza’s senior vice president and head of the bioscience business, will take up his post at Catalent on Sept. 25, a source familiar with the matter told Fierce Pharma. McErlane’s hiring represents one of the first major strategic grabs since Catalent caved in to activist investor Elliott Management last August. The New Jersey CDMO is now working to rejuvenate its business after a difficult stretch of manufacturing snares, executive turnover and dwindling revenues. Before joining Catalent, McErlane led a Lonza department that provides specialty raw materials and technology solutions for cell and gene therapies, injectable drugs, vaccines ...
- Source: drugdu
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- September 20, 2023
FDA Approves GSK Myelofibrosis Med That Has Edge Over Others in Drug Class

Myelofibrosis can already be treated with several drugs from a class of medicines that address a pathway driving this type of blood cancer. A drug from GSK is now the latest entrant into the class, but with an additional component that specifically treats the anemia complication affecting myelofibrosis patients. FDA approval of GSK’s momelotinib covers the treatment of adult myelofibrosis patients regardless of whether or not they have been previously treated with another drug for the cancer. The regulatory decision announced late Friday marks the payoff for the pharmaceutical giant’s bet on a molecule it acquired in a $1.9 billion deal. The GSK drug, known in development as momelotinib, will be marketed under the brand name Ojjaara. In myelofibrosis, inflammation and scar tissue (fibrosis) impair the bone marrow’s ability to normally produce red blood cells. The disease leads to anemia, which must be treated with regular blood transfusions. Other complications ...
- Source: drugdu
- 181
- September 19, 2023
CMS Is Getting More Serious About Penalizing Hospitals For Price Transparency Noncompliance

The Centers for Medicare & Medicaid Services (CMS) has fined two hospitals in September for alleged violations of its price transparency rule. This marks the third month in a row that the agency has issued fines against hospitals for price transparency noncompliance, following a yearslong period of light enforcement. The two fines issued on September 5 were the thirteenth and fourteenth penalties CMS has imposed on hospitals for price transparency violations. Saint Elizabeths Hospital in Washington, D.C. was fined $677,440, and Holy Cross Hospital in Silver Spring, Maryland was fined $325,710. CMS’ rule aims to make hospitals’ pricing data more accessible to patients so they can compare costs and make more informed decisions about the healthcare services they choose. The law requires all hospitals to post their gross charges, payer-specific negotiated charges, de-identified minimum negotiated charges, de-identified maximum negotiated charges and cash prices on their websites in a machine-readable file. ...
- Source: drugdu
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- September 19, 2023
Novartis Shareholders Approve Sandoz Spin-Off as Product Plans Increase

By Connor Lynch Pictured: Novartis office in Germany/iStock, TBE Sandoz is finally nearing the end of its path towards independence. Over a year after Novartis finalized its plans to spin off its generics and biosimilars division, the Swiss pharma’s shareholders on Friday approved the move, which is expected to take effect on or around Oct. 4. The Novartis board of directors also approved the move back in July, paving the way for it to go ahead once the shareholders had signed off. The deal will see Novartis shareholders receive one Sandoz share for every five Novartis shares they hold, and the same ratio of American Depository Receipts (ADRs). Board of Directors Chair Joerg Reinhardt said in a statement that with “this step, both Sandoz and Novartis will be able to optimize management focus, allocate capital on business priorities, and be in a better position to create sustainable shareholder value in ...
- Source: drugdu
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- September 19, 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
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- September 19, 2023
Gilead-backed Lyndra Therapeutics cuts nearly a quarter of staff as ph. 3 data nears

Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophrenia drug nears an interim readout. The cuts come after the company’s recent decisions to outsource commercial manufacturing and partner on both the development and commercialization of “all future products,” a spokesperson said Friday. The company is also leaving its headquarters in Watertown, Massachusetts, and is consolidating at a nearby location in Lexington. “With our topline data readout from our pivotal trial of oral weekly risperidone expected in the next few weeks, we feel these changes will set us up to successfully navigate the regulatory pathway ahead and ultimately bring oral weekly medications to patients,” the spokesperson said. The company plans to partner up on lead asset LYN-005, though a collaborator has not been disclosed or named, the spokesperson ...
- Source: drugdu
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- September 19, 2023
Iovance’s PDUFA date for lifileucel pushed due to FDA backlog

The US Food and Drug Administration (FDA) is feeling the strain on its resources and has had to delay the priority review of Iovance Biotherapeutics’s lifileucel to 2024. The Prescription Drug User Fee Act (PDUFA) action date for the priority review of the Biologics License Application (BLA) for lifileucel has been postponed from 25 November 2023 to 24 February 2024. However, Iovance was quick to add that the reason for pushing the date was the FDA’s “insufficient resources” and that it was working with the agency to expedite the review for a potentially earlier approval date. The company also added that the FDA reported no major review issues, no concerns regarding the status of the confirmatory trial, and had no plans to hold an advisory committee meeting. The markets viewed the news favourably, as Iovance’s stock rose by more than 15% in pre-market trading. The company’s market cap stands at ...
- Source: drugdu
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- September 19, 2023
Bristol Myers Squibb reveals plans to double number of drugs in registrational trials

Bristol Myers Squibb (BMS) has revealed plans to double the number of drugs in registrational trials over the next 18 months. The drugmaker currently has six candidates in clinical trials, including an anti-IL-13 monoclonal antibody under development to treat eosinophilic oesophagitis and an LPA1 antagonist being evaluated in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. The pipeline update includes a CD19-directed cell therapy expanding into clinical trials for immunologic diseases, a GPRC5D-targeting cell therapy starting a registrational trial in relapsed/refractory multiple myeloma (RRMM), and a BCMA x CD3 T-cell engager advancing into a phase 3 trial, also for RRMM. The company will also be progressing a protein degrader to a late-stage trial in first-line large B-cell lymphoma, moving an androgen receptor degrader into pivotal studies in metastatic castration-resistant prostate cancer, and is expecting proof-of-concept data for a BET inhibitor in myelofibrosis. In addition to its growing registrational portfolio, the company ...
- Source: drugdu
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- September 19, 2023

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