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Pfizer's Beqvez taking on Hemgenix with FDA nod in hemophilia B

Pfizer Inc.’s Beqvez (fidanacogene elaparvovec) won FDA approval for use in adults with hemophilia B, making it the second adeno-associated viral (AAV) vector-based gene therapy available for patients in the U.S., following the late 2022 approval of CSL Behring’s Hemgenix (etranacogene dezaparvovec).

Behring-hemgenix , Pfizer-inc , Pfizer-inc- , Beqvez , Hemophilia-b , Adeno-associated-viral-vectors , Aav , Regulatory , Us- , Hematologic , Gene-therapy

Move over, Humira, there's a new mega-blockbuster in town

There was a time not that long ago when Merck & Co. Inc.’s Keytruda (pembrolizumab), with its multiple cancer indications, was seen as the heir apparent to Humira’s title of the biggest blockbuster drug. Not anymore. That title now belongs to Novo Nordisk A/S’ semaglutide, approved as Ozempic in 2017 to treat diabetes and as Wegovy in 2021 to help with weight loss.

Novo-nordisk , Merck-co , Novo-nordiska-s , Semaglutide , Ozempic , Wegovy , Humira , Adalimumab , Keytruda , Merck-amp-co-inc- , Pembrolizumab , Abbvie-inc-

With Bristol Myers' latest cuts, biopharma layoffs reach 7,800+

After investing $24 billion in three major acquisitions earlier this year, Bristol Myers Squibb Co. said April 25 it would cut 2,200 employees and discontinue 12 programs in an effort to save $1.5 billion and put the company on track for growth by the end of the decade. The number of jobs lost represent 28% of all biopharma jobs lost so far in 2024 – 7,834, as announced by 82 companies. There were 17,424 jobs lost at 185 companies in 2023 and 18,500 jobs lost at 123 companies in 2022, according to BioWorld data.

Bristol-myers-squibb-co , Bristol-myers-squibb , Bioworld , Bristol-myers-squibb-co- , Restructurings , Workforce-reductions , Layoffs , Analysis-and-data-insight , Cms ,

Immunitybio's bladder cancer therapy, Anktiva, gets FDA approval

After several delays, the interleukin-15 superagonist Anktiva (nogapendekin alfa inbakicept) from Immunitybio Inc. has been approved by the U.S. FDA for treating bladder cancer, specifically Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.

Immunitybio-inc , Bacillus-calmette-gu , Anktiva , Nogapendekin-alfa-inbakicept , Bladder-cancer , Bioworld , Cancer , Fda , Us- , Nantkwest-inc- , Immunitybio-inc-

China's investigator trials accelerate competitive CAR T development

China’s CAR T market is expected to grow from $72 million in 2022 to $342 million over the next decade. There are currently more than 400 CAR T therapies in the pipeline in China, and most of these are being developed by specialized Chinese biotechs. Research by Clarivate plc, BioWorld’s parent company, indicates that a notable proportion of CAR T-cell therapies in late-phase development in China are being developed through strategic partnerships and joint ventures between multinational corporations and domestic companies, including Johnson & Johnson and Nanjing Legend Biotech Corp., Juno Therapeutics Inc. and Wuxi Apptec Co. Ltd., and CASI Pharmaceuticals Inc. and Juventas Cell Therapy Ltd.

China , Nanjing , Jiangsu , Chinese , Wuxi-apptec-co , Juventas-cell-therapy-ltd , Pharmaceuticals-inc , Juno-therapeutics-inc , Legend-biotech-corp , Johnson , Nanjing-legend-biotech-corp

Turning the Corner: $54M series A propels lifelong immunity vaccines

Corner Therapeutics Inc. raised $54 million in a series A financing to create vaccines to protect against cancer and infectious diseases by helping the immune system engineer T cells. The company’s core interest is in advancements in immunotherapy through direct manipulation of T cells, which are the “keys to the kingdom for any cancer therapy,” Nick Seaver, Corner’s chief business officer, told BioWorld.

Nick-seaver , Corner-therapeutics-inc , Corner-therapeutics , Bioworld , Corner-therapeutics-inc- , Financings , Series-a , Infection , Vaccine , Newco-news , Dendritic-cells , Spark-therapeutics-inc-

Cerevel undersell? Bombshell Parkinson's phase III with tavapadon

Cerevel Therapeutics Inc.’s positive results from the long-shot pivotal phase III Tempo-3 trial with tavapadon – the first D1/D5 receptor partial agonist being studied as a once-daily treatment for Parkinson’s disease – added gravy to the $8.7 billion takeover by Abbvie Inc., disclosed late last year. The buyout’s centerpiece was the late-stage asset emraclidine, a positive allosteric modulator of the muscarinic M4 receptor, touted as a potential best-in-class, next-generation antipsychotic for schizophrenia, which strikes more than 5 million people in the G7 (U.S., France, Germany, Italy, Spain, U.K. and Japan).

Italy , France , Germany , Japan , Spain , Cerevel-therapeutics-inc , Abbvie-inc , Cerevel-therapeutics , Cerevel-therapeutics-inc- , Tavapadon , Parkinsons-disease

Vertex buying Alpine for $4.9B for phase III-ready IgAN asset

Vertex Pharmaceuticals Inc. is acquiring Alpine Immune Sciences Inc. for $4.9 billion in cash to gain Alpine’s lead product, phase III-ready povetacicept, which demonstrates best-in-class potential in patients with immunoglobulin A nephropathy (IgAN).

Reshma-kewalramani , Vertex-pharmaceuticals-inc , Alpine-immune-sciences-inc , Vertex-pharmaceuticals , Alpine-immune-sciences , Alpine-immune-sciences-inc- , Vertex-pharmaceuticals-inc- , Kidney-disease , Igan , Immunoglobulina-nephropathy , Immunoglobulin-a , Povetacicept

FDA adcom backs MRD as new endpoint in multiple myeloma trials

By a unanimous 12-0 vote, the U.S. FDA’s Oncologic Drugs Advisory Committee concluded that new evidence support the use of minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma (MM) clinical trials.

Oncologic-drugs-advisory-committee , Drugs-advisory-committee , Bioworld , Multiple-myeloma , Odac , Minimal-residual-disease , Regulatory , Cancer , Us- , Fda , Endpoint

Biosimilars coming into their own in China, despite concerns

The timing is ripe for a robust biosimilar market in China, given the rapid increase of novel biologics approved to treat cancer and inflammatory diseases in the country over the past decade and the looming patent cliffs for several established biologics. As of December, the NMPA had approved more than 20 biosimilars that were developed in China. Most of those referenced just two biologics – Roche AG’s cancer drug Avastin (bevacizumab) and Abbvie Inc.’s immunology drug Humira (adalimumab). In 2022, the oncology and immunology biosimilar market in China garnered sales of about $2 billion, according to Clarivate estimates. To reach their full potential in China though, biosimilars must win over prescribers and patients.

China , Abbvie-inc , Roche-ag , Avastin , Abbvie-inc- , Humira , Pfizer-inc- , Enbrel , Henlius-biotech-inc- , Hanlikang , Mabthera