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AbbVie to Acquire ImmunoGen With its Platinum-Resistant Ovarian Cancer Drug Elahere

Pharmaceutical Executive Editorial Staff AbbVie acquiring all outstanding shares of ImmunoGen, Inc. for $31.26 per share, valuing the company at a total equity value of approximately $10.1 billion. AbbVie Inc. has announced the acquisition of ImmunoGen, Inc. along with its first-in-class antibody-drug conjugate (ADC) mirvetuximab soravtansine-gynx (Elahere), which has been FDA-approved to treat platinum-resistant ovarian cancer.1 With the transaction, AbbVie acquires in cash all outstanding shares of ImmunoGen for $31.26 per share, valuing ImmunoGen at a total equity value of approximately $10.1 billion. Boards of directors for both AbbVie and ImmunoGen approved the transaction, which they anticipate closing in mid-2024, subject to approval by ImmunoGen shareholders and regulatory agencies, as well as other customary closing conditions. The pending transaction is anticipated to be accretive to diluted earnings per share starting in 2027. In a press release, AbbVie said the acquisition accelerates its commercial and clinical presence in the solid tumor ...
- Source: drugdu
- 25
- December 4, 2023
Research Explores Adverse Outcomes From Energy Drink Intake Before, During Pregnancy

Don Tracy, Associate Editor JAMA study investigates whether consuming energy drinks was associated with adverse pregnancy outcomes and whether caffeine consumption affects fetal-growth restriction. Image Credit: Adobe Stock Images/Viktor Energy drinks, popular for increasing awareness and energy, have seen a 240% increase in sales since 1987, reaching $9.7 billion in US sales in 2015. Marketing for these products typically targets young adults; however, there are also safety concerns with their consumption, with associations found between energy drinks and health issues, including mental health symptoms and organ damage. There have been very few studies that have explored the link between energy drink intake before and during ...
- Source: drugdu
- 26
- December 4, 2023
FDA to investigate risk of T-cell malignancy from CAR-T cell immunotherapies

The US Food and Drug Administration (FDA) has announced its intention to investigate the safety of CAR-T therapies following reports that they could be linked to the development of T-cell cancers. Following reports from clinical trials and post-marketing adverse event data sources, the wide probe is directed at patients who received treatment with all currently approved BCMA- or CD19-directed autologous CAR-T cell immunotherapies. CAR-T-cell therapy is a type of immunotherapy that involves collecting and using patients’ own immune cells to treat conditions including lymphoma, leukaemia and multiple myeloma. T-cell malignancies have been seen in patients treated with several approved products in the class, including Bristol Myers Squibb’s (BMS) Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Johnson & Johnson and Legend Biotech’s Carvykti (ciltacabtagene autoleucel), Novartis’s Kymriah (tisagenlecleucel), and Gilead and Kite’s Yescarta’s Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel). Currently, the potential risk of developing secondary malignancies is labelled as ...
- Source: drugdu
- 28
- December 4, 2023
Boehringer Ingelheim and IBM announce AI antibody drug discovery partnership

Boehringer Ingelheim and IBM have announced a partnership aimed at advancing generative artificial intelligence (AI) and foundation models for therapeutic antibody development. The collaboration agreement will see Boehringer use an IBM-developed, pre-trained AI model that will be “further fine-tuned” on the German drugmaker’s specific proprietary data to help accelerate the pace at which it can create new antibody therapeutics. The companies noted that, despite “major” technological advances, the discovery and development of therapeutic antibodies against diverse targets remains a “highly complex and time-consuming process”. IBM’s foundation model technologies, which have already shown success in generating biologics and small molecules with relevant target affinities, are used to design antibody candidates for specific disease targets. These are then screened with AI-enhanced simulation to select and refine the best binders for the target. Boehringer Ingelheim outlined that it will produce small quantities of the candidates that can be tested experimentally. Andrew Nixon, global ...
- Source: drugdu
- 27
- December 4, 2023
Generation bio cuts 40% of staff in blow for non-viral gene therapy sector

US-based Generation Bio is cutting its workforce by 40%, becoming the latest company to announce lay-offs to save money this year. The restructuring includes the departure of key personnel, with medical chief Douglass Kerr and development leader Tracy Zimmerman among those leaving. The 29 November announcement adds to a series of setbacks in the field, with the cell therapy startup NexImmune reducing its workforce by over half this year, halting the development of its three adoptive T cell therapies. Generation anticipates that the downsizing and streamlining of its research and development focus will result in a cost-saving of $120m over the next three years, as outlined in a 27 November SEC filing. In April, Takeda announced that it was moving away from the adeno-associated virus (AAV) gene therapies sector amidst difficulties associated with gene therapy research development at the preclinical stage, highlighting that it is unlikely that many current AAV ...
- Source: drugdu
- 25
- December 4, 2023
EU’s IVD guidelines continue affecting early clinical work

The implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR) by the European Union (EU) continues to be a disadvantage for companies looking to start their clinical trials in the EU, said Malte Oppermann, senior director of clinical operations at Medigene. Oppermann spoke at a session of the Clinical Trials in Oncology (CTO) Europe 2023 conference in Munich, Germany, which took place 28 – 29 November. The session focused on the impact of IVD regulation changes on early-stage clinical trials and the challenges that come with clinical trials that incorporate IVDs. In a nutshell, IVDs are tests carried out on patient samples that can be used to prevent and treat diseases. In oncology, IVDs are used to detect biomarkers, which have become increasingly important in precision medicine. Examples of established biomarkers with approved therapies include the prognostic biomarkers HER2 and BRCA1. The IVDR came into effect on 26 May ...
- Source: drugdu
- 25
- December 4, 2023
Intas Pharmaceuticals Hit with Another FDA Warning Letter, Put on Import Alert

By Tristan Manalac Pictured: Sign outside the FDA’s office in Maryland The FDA has slapped Intas Pharmaceuticals with another warning letter over manufacturing violations, quality control lapses and compromised data integrity, this time at its plant in Gujarat, India. The regulator has also put the Indian facility on its import alert list, which allows the FDA’s field operatives to detain products from Intas without physical examination. In its Nov. 21 warning letter, the FDA pointed to four main issues found at the Gujarat plant over a 12-day site inspection in May 2023. According to the regulator, Intas failed to ensure that the drug products that it manufactures comply with ...
- Source: drugdu
- 34
- December 2, 2023
FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer

Acceptance based on results from the Phase 3 KEYNOTE-A39 trial, which showed a statistically significant and clinically meaningful improvement in overall survival and progression-free survival versus chemotherapy in these patients RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). This application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which aims to improve the efficiency of the review process of applications to ensure that treatments are available to patients as early as possible. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date ...
- Source: drugdu
- 38
- December 2, 2023
Vivos receives FDA 510(k) clearance for oral devices to treat severe sleep apnea

Dive Brief Vivos Therapeutics has received 510(k) clearance for the use of its oral devices in adults with severe obstructive sleep apnea (OSA). The Food and Drug Administration ruling, which comes 11 months after Vivos received clearance for an oral appliance in mild-to-moderate OSA, gives the green light to an application that was previously only possible off-label. The company’s trio of devices, called Complete Airway Repositioning and/or Expansion (CARE) oral appliances, include the DNA, mRNA and mmRNA products. Vivos’ share price increased nearly 834% to $41 when the market closed on Wednesday. The medtech company’s market capitalization was approximately $30.8 million even after the latest jump in its stock, according to Nasdaq. Dive Insight Vivos sells a set of airway repositioning and expansion devices for treating dentofacial abnormalities and OSA. The company has worked to add clearances to use more of the devices in the treatment of OSA, winning a ...
- Source: drugdu
- 27
- December 2, 2023
The Rumored Humana/Cigna Combination Makes Sense

Cigna and Humana are rumored to be in talks to combine through a stock-and-cash deal, which would create a company comparable in size to UnitedHealthcare and CVS/Aetna, according to a Wall Street Journal report published Wednesday. The rumors aren’t surprising and make a lot of sense for the two companies, one industry expert said. The deal would likely come in the form of an acquisition of Humana by Cigna, predicted Ari Gottlieb, principal of A2 Strategy Corp. David Cordani, CEO of Cigna, would likely be the CEO of the combined company, he added. Bruce Broussard, CEO of Humana, will be retiring next year, and current COO Jim Rechtin will succeed him. However, Gottlieb is unsure of what the buying price would be if a deal were to happen. The rumors come a few weeks after Reuters reported that Bloomfield, Connecticut-based Cigna is exploring selling its Medicare Advantage business. Louisville, Kentucky-based ...
- Source: drugdu
- 26
- December 2, 2023

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