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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
- 148
- 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
- 116
- 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
- 118
- December 2, 2023
Phase 3 Trial for GSK’s Blenrep Yields Positive Results in Relapsed or Refractory Multiple Myeloma

Don Tracy, Associate Editor Blenrep significantly extended the time to disease progression or death against existing care methods as a second-line treatment for relapsed or refractory multiple myeloma. GSK announced positive results from an interim analysis of its DREAMM-7 head-to-head Phase 3 trial evaluating belantamab mafodotin (Blenrep) as a second-line treatment for relapsed or refractory multiple myeloma. According to a company press release, the trial met its primary endpoint of progression-free survival (PFS) and showed that Blenrep when combined with bortezomib plus dexamethasone (BorDex) significantly extended the time to disease progression or death versus daratumumab plus BorDex, an existing standard of care for relapsed/refractory multiple myeloma.1 “Patients with multiple myeloma need treatment options after first relapse that are efficacious, readily accessible and have novel mechanisms of action,” said Hesham Abdullah, SVP, global head, oncology, R&D, GSK, in a press release.1 “We are particularly encouraged by the potential for belantamab mafodotin ...
- Source: drugdu
- 114
- December 2, 2023
Walgreens Unveils Tool To Help Patients Save on Prescriptions

The Walgreens Rx Savings Finder combines different third-party discount card options into one platform. It allows customers to search for a prescription, find a coupon for that prescription and text or email the coupon to themselves. They then show the coupon to a Walgreens pharmacist when they fill the prescription. By MARISSA PLESCIAWalgreens has launched a new solution that aims to make it easier for consumers to access discounts on prescription medications, the company announced Thursday. The Walgreens Rx Savings Finder combines different third-party discount card options into one platform. It allows customers to search for a prescription, find a coupon for that prescription and text or email the coupon to themselves. They then show the coupon to a Walgreens pharmacist when they fill the prescription. The solution is available at Walgreens.RxSense.com and works for any generic or brand-name drug. “Searching for prescription savings can be time-consuming and complicated – ...
- Source: drugdu
- 212
- December 2, 2023
Amgen and MSD-backed start-up wins $10m for drug and device development

Culmination Bio has secured $10m in investment from the Merck Global Health Innovation Fund (venture capital arm of MSD) and Amgen Ventures to develop an intelligence platform to facilitate diagnostic and therapeutic development. The US-based company has a library of multimodal and longitudinal data along with the accompanying biospecimens, Culmination Bio’s CEO Lincoln Nadauld told Pharmaceutical Technology. The data for Culmination’s library consists of de-identified HIPPA-compliant data from Intermountain Health. This allows the company to “identify specific patient cohorts and proactively or prospective rapidly recruit them”, which can accelerate drug discovery and clinical trial recruitment. Nadauld said that having biospecimens is instrumental in validating diagnostic devices, adding: “An example would be a liquid biopsy company validating their novel technology in the liquid biopsy space, for cancer. They often need fresh samples from patients with defined diseases, and we can deliver not only the biospecimens but the accompanying multimodal data that ...
- Source: drugdu
- 156
- December 2, 2023
Pharma’s engagement with healthcare providers has slipped in recent years

In recent years there has been a downward trend in health care provider (HCP) contact in the pharmaceutical industry with 65% of HCPs limiting access to three or fewer companies, said Aaron Bean, the vice president of commercial business consulting at Veeva Europe. At the Veeva Commercial Summit 2023, Bean discussed HCP engagement with the pharmaceutical sector at a media roundtable. He suggested that HCPs’ increased selectiveness could be a result of increased “time pressure” and changes in the way they consume information. Bean was presenting data from Veeva’s February 2023 Pulse Field Trends Report which showed geographic differences in HCP engagement. In data taken from April to September 2022 from European countries, the UK led the shift with 94% of HCPs only contacting three or fewer pharmaceutical companies, compared to 50% in Spain. The same dataset showed that differences also appeared when comparing therapy areas. In oncology, approximately 25% ...
- Source: drugdu
- 136
- December 2, 2023
Pepper wins $6.5m to develop ‘transomic’ drug discovery platform

Boston-based start-up Pepper Bio has raised $6.5m in oversubscribed seed funding to develop its Compass drug discovery platform. The financiers included venture capital companies such as NFX, Silverton Partners, Mana Ventures and others. Pepper’s CEO Jon Hu told Pharmaceutical Technology that the Compass platform provides biological maps for insight into different “-omics”- genomics, transcriptomics, proteomics and phosphoproteomics. The success rate of drug development from pre-clinical studies to regulatory approval is 3%-10%, says Hu. If one can improve this success rate, it can bring down the cost of drug approval, he adds. According to Hu, the high cost of development is driven by the cost of failed iterations of the therapy. Pepper sources its database consists of publicly and commercially available data in addition to its proprietary data, which was either generated in-house or acquired through partnerships. Hu added that public and commercial data undergoes a series of transformations including an ...
- Source: drugdu
- 106
- December 2, 2023
AbbVie diversifies oncology portfolio with $10.1 bn ImmunoGen acquisition

In a bid to expand its oncology pipeline AbbVie has announced it will acquire ImmunoGen under a definitive agreement. The proposed $10.1bn acquisition will see AbbVie purchase ImmunoGen’s outstanding shares at $31.26 per share. The acquisition is expected to be completed in mid-2024. On an investor call following the announcement this morning (30 November), AbbVie’s executive vice president and chief financial officer Scott Reents, said the funding of the transaction will be driven by a combination of cash and debt. The exact split of cash and debt has not been indicated, but Reents anticipates that AbbVie will spend at least $2bn in cash in the acquisition. Through the transaction, AbbVie will gain an asset in Elahere (mirvetuximab soravtansine-gynx), ImmunoGen’s lead antibody-drug candidate (ADC), which received an accelerated approval to treat folate receptor alpha (FRα)-positive, platinum resistant ovarian, fallopian tube, or primary peritoneal cancer, in November 2022. As per AbbVie’s executive ...
- Source: drugdu
- 109
- December 2, 2023
Boehringer Ingelheim Targets Stroma-Rich Cancers in Potential $509M AI Deal

By Kate Goodwin Pictured: Boehringer Ingelheim building/iStock, Sundry Photography Boehringer Ingelheim is striking a deal to leverage artificial intelligence for some of the hardest to treat cancers. Phenomic AI announced a collaboration agreement with the pharma giant Wednesday. The Toronto and Boston-based biopharma is getting a $9 million upfront payment with another potential $500 million on the line in milestones and royalties to discover targets for stroma-rich cancers. The stroma-rich cancer category is among the most difficult to treat. Including types like colorectal and pancreatic, the tumor stroma in these cancers provides a hard-to-penetrate barrier around the tumor that both protects the cancer and helps feed it. Phenomic’s platform is focused on targets that can break through the stroma to ...
- Source: drugdu
- 215
- December 1, 2023

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