Search Results for “ Pfizer” – Page 28 – media

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
- 128
- September 19, 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 As per the most recent draft guidance, the drug has now been recommended for adults who do not respond to two previous migraine medicines, called triptans.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
- 110
- September 16, 2023
Alnylam Wins Adcomm’s Support for Heart Disease Drug Despite FDA Concerns

By Hayley Shasteen Pictured: FDA headquarters, iStock, GrandbrothersT he FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday voted 9-3 in favor of Alnylam Pharmaceuticals’ patisiran on whether its benefits outweigh its risks for the treatment of adults with cardiomyopathy induced by transthyretin amyloidosis. In the company’s announcement on Wednesday, Alnylam CMO Pushkal Garg said the “positive outcome” of the adcomm meeting is “supported by the efficacy and safety data observed in the APOLLO-B Phase III study and is another step toward bringing patients with the cardiomyopathy of ATTR amyloidosis a novel treatment option that addresses the underlying cause of disease and has the potential to meaningfully benefit patients’ functional capacity and quality of life.” The decision came after the panel’s day-long meeting in which adcomm members discussed whether the treatment effects demonstrated by data from Alnylam’s Phase III APPOLLO-B clinical trial were clinically meaningful for patients with cardiomyopathy induced ...
- Source: drugdu
- 114
- September 15, 2023
FDA Questions Efficacy of Alnylam’s Drug in ATTR-CM Ahead of Adcomm Meeting

By Connor Lynch Pictured: FDA Sign in front of building with blue sky background/Adobe Stock, Grandbrothers Alnylam Pharmaceuticals’ push for patisiran to be expanded to a much larger pool of patients for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis has hit a significant hurdle. In a briefing document released ahead of the Sept. 13 meeting of the FDA’s Cardiovascular and Renal Drugs Advisory Committee, the agency called into question the efficacy of the drug in treating that pool of patients. The company has been seeking approval for its drug patisiran, sold under the brand name Onpattro, to be used to treat patients with cardiomyopathy induced by transthyretin amyloidosis (ATTR-CM). The disease typically affects the hearts and tendons of elderly people, causing an accumulation of proteins which can lead to severe cardiomyopathy. The APOLLO-B study was looking at one key primary efficacy endpoint and one key secondary ...
- Source: drugdu
- 131
- September 14, 2023
AstraZeneca Signs AI-Powered Drug Discovery Pact with Verge

By Tristan Manalac AstraZeneca, through its rare disease division Alexion, has entered into a multi-target agreement with Verge Genomics to discover and develop drugs against novel targets in rare neurodegenerative and neuromuscular diseases, the companies announced Friday. Under the agreement, Alexion will make a $42 million payment in upfront fees, as well as equity and near-term investments. Counting milestones, the four-year collaboration can yield up to $840 million for Verge, plus potential royalties down the line. Alongside the drug discovery pact, AstraZeneca will also take an equity position in Verge. In return, Alexion will gain access to the California biotech’s proprietary full-stack CONVERGE platform, which applies machine learning to human tissue data in order to identify novel disease targets that have a high probability of yielding clinical success. Friday’s partnership will apply the AI-driven approach to several yet-undisclosed rare neurodegenerative and neuromuscular conditions. Alexion will have the option to select ...
- Source: drugdu
- 195
- September 12, 2023
GSK invests over $270m in vaccine manufacturing ahead of RSV vaccine launch

GSK has announced it is investing over £270m to build a new vaccine manufacturing facility at its Wavre campus in Belgium. The investment follows the launch of the company’s new respiratory syncytial virus (RSV) vaccine, Arexvy. Designed to increase the efficiency of manufacturing processes and reduce environmental impact, the new unit will handle freeze-dried vaccines, including Arexvy, as well as the company’s fast-growing shingles vaccine, Shingrix, and its malaria vaccine, Mosquirix. The plant will contain two wings: one for producing the UK company’s ‘non-live’ vaccines, and the other for making ‘live’ vaccines, which include Varilrix for chickenpox and Priorix for measles. A spokesperson from GSK said: “The ambition is to have tens of millions of doses lyophilized each year.” “The new centre will feature several cutting-edge technological innovations designed to increase the efficiency of manufacturing processes and reduce environmental impact,” the spokesperson added. In May, Arexvy became the first RSV ...
- Source: drugdu
- 203
- September 8, 2023
Astellas withdraws IRA lawsuit after avoiding CMS’ price negotiations list

Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act (IRA). But now that the Centers for Medicare & Medicaid Services (CMS) has released the first 10 drugs set for governmental bargaining, the company is ready to abandon its litigation. When CMS last week revealed its list of the first 10 drugs eligible for Medicare price negotiations, Astellas’ Xtandi did not make the cut. This surprised some pharma watchers, who had expected the Pfizer-partnered cancer blockbuster to be among the first drugs to face the controversial new process. Now, without Xtandi on the list, Astellas is pulling its lawsuit, Reuters reports. The 10 drugs on the CMS’ list are blockbusters marketed by Johnson & Johnson, Bristol Myers Squibb, Merck & Co., Novartis, Eli Lilly, AstraZeneca, Novo Nordisk and Amgen. Many of the companies whose drugs made the cut had already filed ...
- Source: drugdu
- 189
- September 8, 2023
Following in Tecentriq’s footsteps, Alecensa gives Roche another win in early-stage lung cancer

After a groundbreaking approval for Tecentriq, Roche has another positive early-stage lung cancer trial to celebrate. This time, the honor belongs to a targeted therapy in Alecensa. Alecensa, compared with chemotherapy, reduced the risk of tumor recurrence or death when used after surgery in certain non-small cell lung cancer patients, Roche said Friday. The patients had ALK-positive, stage 1b to 3a tumors that were completely resected before taking Alecensa. The positive readout, from the ALINA trial, makes Alecensa the first ALK inhibitor to show a benefit in early-stage NSCLC in a phase 3 trial, Roche noted. Data on patient survival remain immature. But the Swiss pharma said it’ll submit the results to the FDA and the European Medicines Agency for a potential label expansion. “If approved, Alecensa has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure,” Roche’s chief ...
- Source: drugdu
- 117
- September 6, 2023
BioNTech, DualityBio Move ADC into Phase III for HER2-Low Breast Cancer

By Kate Goodwin Pictured: 3D rendering of antibody-drug conjugate/iStock, Love Employee BioNTech’s licensed antibody-drug conjugate is moving on to Phase III testing in a potential effort to challenge AstraZeneca and Daiichi Sankyo’s blockbuster Enherto in a heavily treated breast cancer subpopulation. DualityBio, BioNTech’s partner and the ADC’s creator, posted the trial plans Wednesday. BioNTech added the ADC, DB-1303, to its portfolio in April 2023 when it paid China’s DualityBio $170 million upfront for rights to it plus a second preclinical asset. Another $1.5 billion is on the line in milestone payments, plus tiered royalties. DB-1303 will be pitted against chemotherapy in the open-label Phase III for patients with HER2-low, HR+ metastatic breast cancer patients whose disease has progressed despite endocrine therapy. ADC therapy is like a targeted missile for cancer, with an antibody targeted to deliver the cancer killing payload. DB-1303 is a topoisomerase-1 inhibitor. Phase I/II trial results showed ...
- Source: drugdu
- 110
- September 5, 2023
Bavarian Nordic Drops COVID Booster After Poor Phase III Results

By Connor Lynch Pictured: Syringe drawing up drug from vial/iStock, Kuzmik_A Bavarian Nordic is dropping its experimental, Phase III COVID-19 booster after clinical data showed limited effectiveness against new and emerging variants of concern. The Danish company announced that despite its COVID booster ABNCov2 demonstrating non-inferior levels of neutralizing antibodies as compared to Pfizer’s Comirnaty against the SARS-CoV-2 variant, the original COVID virus, the company would nevertheless not be pursuing commercialization of the vaccine. “In a follow-up analysis, when looking at this more distant variant, the levels of neutralizing antibodies induced by ABNCoV2 were lower than those stimulated by the non-adapted Wuhan-based Comirnaty, and fewer people had detectable antibodies following ABNCoV2 (64%) versus Comirnaty (85%),” the company said. The booster’s commercial viability was called into question because the new variants, such as XBB.1.5, are now the primary variants of concern. Bavarian Nordic said that the data “support the current position ...
- Source: drugdu
- 104
- September 5, 2023

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