Search Results for “FDA” – Page 149 – media

BioXcel’s Positive Alzheimer’s Agitation Data Overshadowed by Principal Investigator Fabrications

By David Adam Pictured: Person holding a cell phone in front of computer with stock data/iStock The release of positive topline results Thursday from the Phase III trial of BioXcel Therapeutics’ Alzheimer’s-related agitation treatment was overshadowed by disclosures to the SEC about fabricated email correspondences pertaining to the study’s safety data. In a Thursday SEC filing, BioXcel said that a trial site’s principal investigator—who enrolled 40% of the study participants at that site—was found to have fabricated email correspondences related to the timing of the filing for a serious adverse event (SAE) with the company’s vendor responsible for the monitoring of drug safety. The adverse event occurred in a subject in the placebo arm, the company said. In May 2023, it “came to the company’s attention that this same principal investigator in the TRANQUILITY II clinical trial may have fabricated email correspondence purporting to demonstrate that the investigator timely submitted ...
- Source: drugdu
- 108
- July 1, 2023
Teleflex recall of separating vascular catheters labeled Class I event

Dive Brief Teleflex’s recall of its Arrow Endurance Extended Dwell Peripheral Catheter System was categorized by the U.S. Food and Drug Administration as a Class I event, the most severe type of recall. The company began the recall in May after receiving 83 complaints, including 18 reports of injuries. If the catheter separates while in a blood vessel, fragments could spread to other parts of the body and cause adverse events including heart attack and death, the FDA said in a notice. Hospitals should check if they have any of the 262,016 devices recalled in the U.S. and stop using the affected products. Teleflex is asking clinical staff overseeing patients who are currently using an affected product to weigh the risks and benefits of removing and replacing the device. Dive Insight Teleflex acquired Arrow International in 2007 to gain control of a portfolio of vascular access devices. That portfolio now ...
- Source: drugdu
- 139
- June 30, 2023
Cellusion shares pipeline update for eye disease stem cell therapy

Cellusion plans to begin a Phase I/II trial for its bullous keratopathy candidate CSL-001 in 2024, says CEO Shin Hatou. After this, the company will begin a US Phase I/II study for the therapy in 2025, notes Hatou. The Tokyo, Japan-headquartered company aims to submit an investigational new drug (IND) application to the US Food and Drug Administration (FDA) in 2025. Hatou says the company may look to increase funding in the next few years either through further financing rounds or a possible initial public offering. Cellusion would be interested in continuing to work with its current investors and remains open to new investment opportunities to achieve this, he adds. Takuya Kaneko, Cellusion’s chief financial officer (CFO), says that the company aims to launch sales of CSL-001 in Japan by 2027. He says the company is looking for an alliance partner to support the product’s development in the US and ...
- Source: drugdu
- 97
- June 30, 2023
Biogen Shareholders Elect Susan Langer to Board of Directors Despite Controversy

By Tristan Manalac Pictured: A Biogen building/courtesy of PictureDesignSwiss/shutterstock After a June 12 shakeup of Biogen’s board of directors that included three directors foregoing their re-election, the company announced Monday that shareholders elected Susan Langer, who currently serves as president of Souffle Therapeutics, to the board. Langer will serve on the board for a one-year term, according to the press release. She was nominated by Alex Denner, a former member of the board who did not stand for re-election. According to reporting by Endpoints News and STAT News, Langer is Denner’s romantic partner and the mother of his child. BioPharma Dive reported that during Monday’s annual meeting of stockholders, Biogen management was asked why the company didn’t disclose this potential conflict of interest. Caroline Dorsa, the new chair, replied that Langer’s “personal matters obviously are much less relevant than what she brings to this board.” Langer has previously worked at ...
- Source: drugdu
- 136
- June 28, 2023
Biotech AltPep scores around $53m in Series B funding round

US-based amyloid diseases treatment solutions developer AltPep has raised $52.9m in its Series B investment round led by Senator Investment Group. Former investors such as Matrix Capital Management Company and Alexandria Venture Investments, who took part in the firm’s Series A round, joined the latest fundraise along with new backers. The new investors in Series B include Eli Lilly and Company, Partners Investment, and Section 32. As part of the deal, Senator Investment Group’s Rohit Vanjani will join the AltPep board. Besides, Lilly’s senior vice president and chief scientific officer for Neurobiologicals Ronald DeMattos will become a member of the Scientific Advisory Board at AltPep. Vanjani noted: “We believe AltPep is in an excellent position to optimise the value of its unique technology. “With scientific application for both therapeutics and diagnostics in a wide range of amyloid diseases, the potential for the company’s pipeline is vast and extremely promising.” The ...
- Source: drugdu
- 210
- June 27, 2023
AbbVie’s migraine medication Qulipta gets positive CHMP opinion

AbbVie announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for its migraine medication Qulipta (atogepant). Once the CHMP has issued a positive opinion, the EMA will send a recommendation to the European Commission (EC) to approve it. While not a guarantee, a positive CHMP opinion is generally a good indication that a drug is likely to be approved. In a June 2023 statement, AbbVie claims that full approval from the European Commission (EC) would position Qulipta as the only daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment for episodic and chronic migraines available in the EU. Qulipta is approved for use in the US. In 2021, it managed to secure FDA approval to treat episodic migraine, receiving further approval this year to also treat chronic migraine. The positive opinion is based on Phase III trial results submitted ...
- Source: drugdu
- 104
- June 25, 2023
Research reveals a potential gap in recommended care for people with obesity and overweight

By being undiagnosed or untreated, a significant fraction of people with obesity or overweight are not getting the recommended care, despite an increase in new treatment options, according to research being presented on June 17 at ENDO 2023, the Endocrine Society’s annual meeting in Chicago, Ill. “The number of people with obesity is high and rising in the adult U.S. population. Obesity is a complex and expensive disease that has been implicated in many chronic conditions including high blood pressure, diabetes, and cardiovascular diseases,” said Kyrian Ezendu, Ph.D., an Eli Lilly and Company advisor on benefit-risk research. “Medications to treat obesity are an integral part of long-term care for people with excess weight and are recommended for people with obesity or people with overweight and at least one obesity-related condition.” Ezendu and colleagues used data from linked electronic health records and insurance claims of people ages 18 to 80 years ...
- Source: drugdu
- 259
- June 20, 2023
Tessa Therapeutics Hodgkin’s Lymphoma CAR-T therapy shows promising Phase I data

Clinical-stage cell therapy company Tessa Therapeutics have announced positive safety and efficacy data from the trial (NCT04288726 of TT11X, its off-the-shelf CD30.CAR-modified EBVST (Epstein Barr Virus Specific T Cells) therapy in patients with relapsed or refractory (R/R) Hodgkin lymphoma. In tandem with Baylor College of Medicine, Tessa enrolled 18 patients with R/R Hodgkin’s Lymphoma in the trial, all of whom had been heavily pre-treated. Patients were administered with TT11X across four dosing levels, resulting in an overall response rate (ORR) of 78%. Higher doses produced improved clinical response, and no dose-limiting toxicities were observed. Treatment works by utilising highly specialised T-cells able to recognize and kill infected cells, whilst activating the body’s immune system to produce a coordinated response. The company claimed that early trials have demonstrated a strong safety profile and efficacy. TT11X is the lead allogenic cell therapy in Tessa’s planned pipeline of treatments built with its CD30.CAR ...
- Source: drugdu
- 171
- June 20, 2023
ANeuroTech shares plans for major depressive disorder pivotal programme

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD). This includes the company’s upcoming Phase IIIb trial, but also another Phase III study and a long-term safety trial, said ANeuroTech CEO Eric Buntinx in an interview with Pharmaceutical Technology. The company has already contacted funds based in Europe and in the US, said Buntinx. He added that ANeuroTech is speaking to more than ten different parties. The company plans to finish the round by September or October at the latest. ANeuroTech previously raised an undisclosed amount of capital as part of a Series A round, which featured investment from impact finance firm KOIS. ANT01 consists of a 15mg dose of pipamperone, which is a serotonin-2A and dopamine-4 blocker, per the company’s website. While ...
- Source: drugdu
- 120
- June 20, 2023
MSD’s Keytruda use in adenocarcinoma could be limited based on biomarker

Merck (MSD) has announced updated results with Keytruda (pembrolizumab) in the Phase III Keynote-811 trial, which opens up the possibility of changing the checkpoint inhibitor’s label in HER2-positive gastric or GEJ adenocarcinoma so it’s based on the tumour’s PD-L1 biomarker status. The Phase III Keynote-811 study (NCT03615326) met its progression-free survival (PFS) endpoint for treating human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in the intent-to-treat population. A pre-specified interim analysis of trial data found a “statistically significant” improvement in PFS compared to placebo in the ITT group. In 2021, as part of the same Keynote-811 trial, the US Food and Drug Administration (FDA) granted accelerated approval to Keytruda for treating locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, in combination with trastuzumab and chemotherapy containing fluoropyrimidin and platinum. Based on the latest Keynote-811 results, MSD now plans to work with the ...
- Source: drugdu
- 155
- June 20, 2023

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