media – Page 316 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

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
- 140
- 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
- 140
- 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
- 169
- 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
- 180
- 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
- 149
- 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
- 160
- 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
- 147
- 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
- 241
- 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
- 193
- 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
- 167
- December 2, 2023

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