-
AbbVie’s Vyalev Wins FDA Approval as First Subcutaneous Levodopa Therapy for Advanced Parkinson’s
•
AbbVie (NYSE: ABBV), a leading pharmaceutical company based in the US, has received approval from the US Food and Drug Administration (FDA) for its drug Vyalev (ABBV-951, foscarbidopa and foslevodopa). Vyalev is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). This approval positions Vyalev…
-
NMPA Clears AbbVie’s ABBV-706 for Clinical Trials Targeting SCLC and Neuroendocrine Tumors
•
The China National Medical Products Administration (NMPA) has granted clinical trial approval to ABBV-706, a novel antibody-drug conjugate (ADC) developed by AbbVie (NYSE: ABBV), for the treatment of relapsed/refractory small cell lung cancer (SCLC) and other neuroendocrine tumors . ABBV-706 is a targeted therapy that binds to SEZ6, a protein…
-
AbbVie Submits First BLA for c-Met Targeting ADC Telisotuzumab Vedotin to FDA
•
AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company in the U.S., has announced the filing of a first Biologics License Application (BLA) for telisotuzumab vedotin (Teliso-V), a first-in-class antibody-drug conjugate (ADC) targeting tumors that overexpress the c-Met protein. The U.S. Food and Drug Administration (FDA) has accepted the filing for…
-
Genmab’s Tepkinly/Epkinly Receives EC Nod for Relapsed Lymphoma Treatments
•
COPENHAGEN—Genmab A/S (NASDAQ: GMAB), a leading biotech company, has announced that the European Commission (EC) has granted market approval for its Tepkinly/Epkinly (epcoritamab), a CD3/CD20 bispecific T cell engager. The drug is indicated for third-line or later treatment of relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large…
-
AbbVie Completes Acquisition of Cerevel Therapeutics in $8.7 Billion Deal
•
US pharmaceutical giant AbbVie Inc. (NYSE: ABBV) has announced the successful completion of its acquisition of Cerevel Therapeutics (Nasdaq: CERE), a biotech company based in Cambridge, Massachusetts. AbbVie will pay $45.00 per share for Cerevel, totaling an approximate acquisition value of $8.7 billion. The transaction, initially announced in December 2023,…
-
AbbVie’s Allergan Aesthetics Wins NMPA Approval for Juvéderm Dermal Filler in China
•
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has secured marketing approval from China’s National Medical Products Administration (NMPA) for its Juvéderm product line, specifically the Juvéderm越致 dermal filler. This crosslinked sodium hyaluronate gel, which includes lidocaine for comfort during treatment, is designed for injection into the middle to deep…
-
AbbVie’s Q2 2024 Results Show Resilience Amid Humira Biosimilar Challenges
•
AbbVie Inc. (NYSE: ABBV) has reported its financial results for the second quarter of 2024, demonstrating a solid year-on-year (YOY) growth of 5.6% in constant currency terms, reaching $14.462 billion in revenue. The company’s long-standing blockbuster drug, Humira (adalimumab), continues to face biosimilar competition, resulting in a 28.9% YOY decline…
-
Sionna Therapeutics Secures Cystic Fibrosis Portfolio in Licensing Deal with AbbVie
•
US-based biotechnology company Sionna Therapeutics has announced a significant licensing agreement with fellow US firm AbbVie Inc. (NYSE: ABBV), through which Sionna has acquired rights to two Phase II molecules and one Phase I candidate. These pipeline candidates are all modulators designed to treat cystic fibrosis (CF). The deal includes…
-
Pfizer and AbbVie Announce Leadership Changes in Global R&D Divisions
•
In significant executive reshuffling, Pfizer Inc. (NYSE: PFE) and AbbVie (NYSE: ABBV) have both announced changes to their top leadership teams, particularly impacting their global research and development divisions. Pfizer’s Dr. Mikael Dolsten has stepped down from his role as Chief Scientific Officer (CSO) and President of Pfizer Research &…
-
Genmab and AbbVie’s Epcoritamab Earns FDA Accelerated Approval for Follicular Lymphoma
•
Genmab A/S (NASDAQ: GMAB), a Danish biotechnology company, and its co-development partner AbbVie (NYSE: ABBV), have announced that the U.S. Food and Drug Administration (FDA) has granted the first approval for Tepkinly/Epkinly (epcoritamab), an off-the-shelf T-cell engaging CD3xCD20-targeted bispecific antibody (BsAb). The molecule has received accelerated approval for the treatment…
-
AbbVie Bolsters Inflammatory Disease Portfolio with Celsius Therapeutics Acquisition
•
AbbVie (NYSE: ABBV), a major U.S. pharmaceutical company, has announced the acquisition of Celsius Therapeutics Inc., a biotechnology firm specialized in developing therapies for anti-inflammatory diseases. The transaction involves a cash payment of USD 250 million to acquire all equity interests in Celsius. Through this acquisition, AbbVie will obtain control…
-
AbbVie’s Skyrizi Secures FDA Approval for Ulcerative Colitis, Expands Treatment Portfolio
•
AbbVie (NYSE: ABBV) has announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Skyrizi (risankizumab), marking it for use in treating adults with moderate to severely active ulcerative colitis (UC). This approval positions Skyrizi as the first IL-23 specific inhibitor to be approved for…
-
AbbVie Warns Shareholders Against Tutanota’s Unsolicited Mini-Tender Offer
•
Private investment firm Tutanota has launched an unsolicited mini-tender offer to acquire up to 250,000 shares of AbbVie Inc. (NYSE: ABBV) at a price below market value, according to an announcement from the pharmaceutical company last week. AbbVie has made it clear that it does not endorse Tutanota’s offer and…
-
AbbVie Strikes Deal with FutureGen for Global Rights to Next-Gen TL1A Antibody FG-M701
•
AbbVie (NYSE: ABBV), a biopharmaceutical giant based in the US, has announced a licensing agreement with Beijing-based biotech FutureGen Biopharmaceutical Co., Ltd. The agreement centers around FutureGen’s preclinical asset, FG-M701, a next-generation TL1A antibody being developed for the treatment of irritable bowel disease (IBD). In this deal, AbbVie secures exclusive…
-
AbbVie-Calico Partnership Advances with FDA Approval for Fosigotifator Trial in Rare Brain Disorder
•
The US Food and Drug Administration (FDA) has welcomed an experimental therapy, fosigotifator, developed by AbbVie Inc. (NYSE: ABBV) and Calico Life Sciences, into its Rare Disease Therapy Pilot Program. The investigational eIF2B activator is currently undergoing a Phase Ib/II clinical trial for the treatment of vanishing white matter (VWM)…
-
AbbVie’s Telisotuzumab Vedotin Earns Breakthrough Therapy Designation in China for c-Met Positive NSCLC
•
AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company based in the U.S., has announced that its cutting-edge antibody-drug conjugate (ADC) telisotuzumab vedotin has been granted breakthrough therapy designation (BTD) in China. This designation is for the treatment of advanced or metastatic epidermal growth factor receptor (EGFR) wild-type (WT) non-squamous (NSq)…
-
Allergan Aesthetics’ Botox Secures New Indication for Masseter Muscle Protrusion in China
•
Allergan Aesthetics, a division of AbbVie (NYSE: ABBV), has announced that it has received approval for a new indication from the National Medical Products Administration (NMPA) for its Botox (botulinum toxin type A) product. The drug is now approved for the temporary improvement of significant or very significant masseter muscle…
-
AbbVie and Gilgamesh Pharmaceuticals Join Forces to Develop Psychiatric Disorder Therapies
•
AbbVie (NYSE: ABBV) has announced a partnership with US-based Gilgamesh Pharmaceuticals to develop a portfolio of next-generation therapies targeting psychiatric disorders. Under the agreement, Gilgamesh will receive an upfront payment of USD 65 million, with the potential for up to USD 1.95 billion in milestone payments and sales royalties. AbbVie…
-
AbbVie’s Rinvoq Outperforms Sanofi’s Dupixent in Moderate-to-Severe Atopic Dermatitis Trial
•
AbbVie (NYSE: ABBV) has announced positive results from a head-to-head Phase IIIb/IV clinical trial comparing its JAK inhibitor Rinvoq (upadacitinib) with Sanofi’s (NASDAQ: SNY) interleukin blocker Dupixent (dupilumab) in patients with moderate-to-severe atopic dermatitis. The trial demonstrated that Rinvoq was superior in improving eczema area and severity as well as…
-
European Commission Approves Pfizer’s Antibiotic Emblaveo for Multiple Indications
•
The European Commission (EC) has granted approval for Pfizer’s (NYSE: PFE) antibiotic Emblaveo (aztreonam + avibactam) for the treatment of complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), complicated urinary tract infections (cUTI), and infections caused by aerobic Gram-negative organisms in adults. The drug was reviewed under an accelerated assessment process…
