Search Results for “ Pfizer” – Page 27 – media

CHMP recommends European authorisation for seven new drugs

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended seven new drugs for authorisation. The drugs include Pfizer’s Elrexfio for the treatment of multiple myeloma and Astellas Pharma’s Veozah for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Elrexfio (elranatamab) is a subcutaneously administered bispecific B-cell maturation antigen-directed CD3 T-cell engager. The US Food and Drug Administration (FDA) granted accelerated approval for Elrexfio in August for patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. According to GlobalData, sales for Elrexfio are expected to reach $536m by 2029. One of its competitors in the market is Talvey (talquetamab-tgvs), marketed by Janssen, which was approved as a fifth-line treatment for relapsed/refractory multiple myeloma in August. Talvey is forecasted to generate $1.9bn in sales by 2029. Astellas Pharma’s Veozah ...
- Source: drugdu
- 111
- October 19, 2023
Biogen Lays Off 113 Reata Employees Weeks After Completing $7B Acquisition

By Tristan Manalac Pictured: Biogen sign/The Boston Globe via Getty, John Tlumacki Biogen is laying off 113 employees from Reata Pharmaceuticals’ Plano, Texas site, according to a Worker Adjustment and Retraining Notification notice. The layoffs, set to take effect in late November, come just months after Reata was acquired by Biogen for $7.3 billion in July 2023. At the time, Biogen had just launched a sweeping cost-reduction program which involved terminating around 1,000 employees in an effort to save $1 billion in operating expenses by 2025. Late last month, Biogen completed the acquisition of Reata. In an emailed statement to Endpoints News, a Biogen spokesperson confirmed the job cuts which will mostly affect “roles where there are existing synergies at Biogen.” The positions include general and administrative services, as well as some development-focused jobs. “We are retaining those colleagues who have been essential to the launch of Skyclarys to ensure ...
- Source: drugdu
- 226
- October 14, 2023
FDA Rejection Is a Delay, Not a Detour for Alnylam’s Aim to Treat Heart Disorder

Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024. By FRANK VINLUAN An Alnylam Pharmaceuticals drug developed to treat a rare disease’s potentially fatal effects on the heart has fallen short in its bid for FDA approval, costing the company a chance to immediately challenge a Pfizer product that has become a blockbuster seller in the indication. But the biotech still has another chance with a different drug in late-stage development that could offer patients a better alternative. Alnylam was seeking approval of its drug, Onpattro, as a treatment for cardiomyopathy caused by hereditary transthyretin amyloidosis (hATTR). According to the Cambridge, Massachusetts-based company, the FDA’s complete response letter said ...
- Source: drugdu
- 217
- October 11, 2023
Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond. By FRANK VINLUAN Accelerated approval offers a way to more quickly bring patients drugs for diseases that have few treatment options. But that speedy path to the market comes with the understanding that the FDA can take its regulatory blessing away—unless the company takes its drug away first. That is what Takeda Pharmaceutical has decided to do with its cancer drug, Exkivity. Following discussions with the FDA, the Japanese pharmaceutical giant is voluntarily withdrawing Exkivity from the market. Exkivity treats non-small cell lung cancer by targeting epidermal growth factor (EGFR). That cancer protein must have exon 20 mutations—the same genetic signature addressed by Johnson & Johnson’s Rybrevant. ...
- Source: drugdu
- 197
- October 10, 2023
Already Partnered With Nvidia and Eli Lilly, Iambic Adds $100M for AI Drug Discovery

Iambic Therapeutics brings together software engineers and drug-hunting scientists, all sharing the goal of using artificial intelligence to optimize properties of small molecule drugs. The startup will apply its Series B financing to a cancer drug pipeline that includes two candidates on track for the clinic in 2024. By FRANK VINLUAN Drug discovery isn’t only about finding new targets. There’s still plenty of opportunity to find better ways to hit targets that are already drugged, according to Tom Miller, CEO of startup Iambic Therapeutics. Understanding how a molecule interacts with a known disease target enables drug hunters to design molecules that could be superior alternatives for patients. Miller notes that a molecule’s ability to bind to a target protein while leaving related proteins unaffected improves its safety. It’s also important to understand how the distribution of a molecule across tissues in the body affect efficacy. Iambic’s drug discovery research employs ...
- Source: drugdu
- 227
- October 6, 2023
FDA Authorizes Novavax’s Covid-19 Vax, Set to Join Fall Rollout of Updated Shots

A Novavax Covid-19 vaccine developed for the fall vaccination season now has the FDA green light, bringing an alternative to the messenger RNA shots that are already rolling out to pharmacies, doctor’s offices, and other locations throughout the country. The FDA decision announced Tuesday afternoon is not an approval. Last year’s emergency authorization for the Novavax vaccine is now amended to include an updated formula, which reflects currently circulating variants. The initial Novavax vaccine was authorized for those 18 and older. For the updated shot, the FDA expanded the age range to 12 and older. The regulatory decision for the latest version of the Novavax vaccine means the company’s initial vaccine, developed for the original SARS-CoV-2 strain, is no longer authorized for use in the U.S. Gaithersburg, Maryland-based Novavax makes its protein-based vaccines with nanoparticle technology that engineers proteins that mimic antigens found on natural pathogens. For its Covid-19 vaccine, ...
- Source: drugdu
- 128
- October 4, 2023
Seagen and Astellas’ Padcev, in Keytruda combo, delivers ‘practice-changing’ bladder cancer win

As Seagen prepares for its takeover by Pfizer, the company’s Astellas-partnered cancer drug Padcev has chalked up a key trial win—in combination with Merck’s Keytruda—in previously untreated metastatic bladder cancer. In the study, Seagen and Astellas’ antibody-drug conjugate Padcev and Merck’s PD-1 superstar Keytruda scored on both overall survival and progression-free survival compared with chemotherapy. An independent data monitoring committee found that the combo’s life extension benefit surpassed the pre-specified efficacy boundary at an interim analysis, the companies said in a Friday release. The results could open the combo up to patients who are eligible for platinum-based chemotherapies cisplatin or carboplatin, regardless of their PD-L1 status. “This study has the potential to be practice changing and offer a new standard of care for first-line metastatic bladder cancer,” Seagen’s R&D head Roger Dansey, M.D., said in the release. “We look forward to presenting the results at an upcoming medical conference and ...
- Source: drugdu
- 108
- October 4, 2023
Evaxion partners with Afrigen Biologics to develop mRNA gonorrhea vaccine

The Danish artificial intelligence (AI) biotech Evaxion has announced plans to develop an mRNA vaccine against gonorrhea in partnership with Afrigen Biologics. Gonorrhea antigens identified through Evaxion’s EDEN platform have shown strong protective effects in preclinical trials, as per the company. The partnership will investigate the function of these antigens when presented in the mRNA form. After the validation phase, the partners will discuss an agreement for clinical development and commercialisation, with the opportunity to involve additional collaborators. Cape Town, South Africa-based Afrigen Biologics is set up as a specialised centre to support mRNA vaccine development and technology transfer, will take charge of developing the mRNA vaccine in low and middle-income countries and African territories. Gonorrhea is a sexually transmitted infection, caused by the bacteria Neisseria gonorrhoeae. It heightens the vulnerability to HIV, a prevalent health concern in many low and middle-income countries (LMICs). Birgitte Rønø, Evaxion’s Chief Scientific Officer ...
- Source: drugdu
- 103
- September 30, 2023
AbbVie Ends I-Mab Deal for CD47 Antibody Compounds, Products

By Tristan Manalac Pictured: AbbVie headquarters in California/iStock, Michael Vi AbbVie has terminated its license and collaboration agreement with I-Mab, the Maryland- and Shanghai-based biotech announced in an SEC filing posted Friday. As a result, I-Mab will regain the global rights to develop and commercialize all CD47 compounds covered by the deal, including the monoclonal antibody lemzoparlimab. The termination will take effect on Nov. 20, 2023 and will not affect the $200 million in upfront and milestone payments that I-Mab had already received from AbbVie. According to I-Mab’s SEC document, AbbVie is pulling away from the partnership as a “strategic decision,” though a prior program discontinuation also factored into its decision. AbbVie and I-Mab first entered into their global agreement in September 2020. For an upfront payment of $180 million and the promise of up to $1.74 billion in success-based milestones, AbbVie earned exclusive rights—outside of the greater China area—to ...
- Source: drugdu
- 179
- September 27, 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
- 99
- September 20, 2023

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