PharmaFocus Today – Page 167 – media

Hemogenyx gets reprieve as FDA lifts clinical hold on AML CAR-T therapy

Hemogenyx has received the all-clear from the US Food and Drug Administration (FDA) to begin a Phase I clinical trial of its acute myeloid leukaemia (AML) chimeric antigen receptor (CAR) T-therapy in the US. In June 2023, the US FDA placed a clinical hold on the trial for HEMO-CAR-T, requesting additional information from Hemogenyx after a splicing deficiency during manufacture of the lentivirus used to produce CAR-T cells. Hemogenyx produced a plan, supported by laboratory tests to address FDA’s concerns in August 2023, which was accepted the following month. In January, the London, UK-based biopharma issued a complete response to the agency to lift the hold. Hemogenyx’s stock price has increased by 62% following the announcement of the lifting of the hold today (9 February) since the market close yesterday.CAR-T therapies have been hitting the headlines recently after the FDA launched an investigation into the incidence of potentially associated secondary ...
- Source: drugdu
- 139
- February 10, 2024
Multiplexed PCR Test for Pathogen Detection and Antibiotic Resistance Helps Deliver Rapid UTI Treatment

Individuals suffering from urinary tract infections (UTIs) face the risk of continued pain and discomfort, chronic infections, kidney infections, and in severe cases, sepsis. This makes timely and accurate diagnosis of UTIs crucial. Now, a novel multiplexed PCR test capable of detecting 26 pathogens and 12 antibiotic resistance gene markers can assist clinicians in administering rapid UTI treatment. PathogenDx (Scottsdale, AZ, US) has launched D3 Array-UTI which is based on the company’s patented Dynamic Dimensional Detection (D3 Array) technology. This cutting-edge multiplexed molecular diagnostics technology offers triple-redundant testing for quality assurance and provides both qualitative as well as quantitative results in a single reaction. Additionally, it offers automated, cloud-based data analysis, reporting, and management. PathogenDx’s advanced microarray testing platform is designed for human diagnostics (for research use only), as well as for the food and agricultural industries. It can rapidly detect and identify up to 50 pathogens simultaneously in a ...
- Source: drugdu
- 67
- February 10, 2024
AbbVie’s full year 2023 sees 6.4% net revenue drop

AbbVie has reported a decrease in net revenues to $54.32bn for the year ended 31 December 2023, marking a 6.4% decline from the previous year’s $58.05bn.The company’s diluted earnings per share (EPS) on a generally accepted accounting principles basis also fell sharply by 59% to $2.72, compared to $6.63 in 2022.Adjusted diluted EPS saw a 19.3% decrease from $13.77 to $11.11. The company’s global immunology portfolio, which faced stiff competition from Humira biosimilars, saw revenues decrease by 9.6% to $26.14bn.Humira’s global net revenues stood at $14.40bn while Skyrizi and Rinvoq contributed $7.76bn and $3.97bn respectively. In the oncology sector, AbbVie’s global net revenues experienced a 10.1% decrease, amounting to $5.92bn.Its neuroscience portfolio showed resilience with an 18.2% increase in global net revenues, reaching $7.72bn. The aesthetics portfolio, however, recorded a slight decrease of 0.8%, with revenues of $5.29bn.AbbVie has provided an adjusted diluted EPS guidance range for 2024 between $11.05 ...
- Source: drugdu
- 98
- February 10, 2024
Novo Holdings acquires Catalent for $16.5bn

Novo Holdings, the Novo Nordisk Foundation’s holding and investment company, declared plans for a $16.5bn acquisition of Catalent as the company expands its manufacturing capabilities. In the merger, Novo Holdings will receive all outstanding shares of Catalent for $63.50 per share in cash. This price reflects a premium of 39.1% to the closing price of Catalent’s common stock on 28 August 2023. This date was the contract development and manufacturing organisation’s (CDMO) last trading day before announcing Catalent’s new strategic and operational review committee, which assessed the company’s business strategy and operations. The Catalent board unanimously advised Catalent stockholders to complete the merger. In a 5 February press release, Novo expressed plans to complete the deal towards the end of this year, dependent on closing conditions, which include gaining approval from Catalent’s stockholders and securing necessary regulatory approvals. Novo is flush with cash these days as is evident in Novo ...
- Source: drugdu
- 94
- February 10, 2024
RegenxBio advances two candidates to make waves in the CNS space

US-based biotech RegenxBio is seeing a pivotal Phase III study on the horizon as its Phase I/II AFFINITY study of RGX-202 for Duchenne muscular dystrophy (DMD) completes patient enrolment for the second dose level. In a 7 February press release, the company announced that of the three patients treated with dose level 1 of RGX-202 in the AFFINITY trial (NCT05693142), the third patient demonstrated by far the largest increase (83.4%) in microdystrophin expression compared to control at three months. In DMD, a mutation in the dystrophin gene normally responsible for protecting muscle fibres from progressively breaking down contributes to the condition. Microdystrophin is an abbreviated yet functional version of dystrophin, and its expression is often used as a surrogate measure to evaluate therapies. The patient also showed a decrease (93%) in serum creatinine kinase (CK) levels from baseline at ten weeks. The company expects to initiate a pivotal study for ...
- Source: drugdu
- 125
- February 9, 2024
Reuters

After Novartis reportedly backed out of late-stage talks to acquire Cytokinetics earlier this year, the company appears to still be on the M&A prowl.Novartis is in advanced talks to acquire German cancer drug maker MorphoSys, Reuters reports, citing two people familiar with the matter. The anonymous sources stayed mum on details about the bid and a potential acquisition price, according to the news service. Also involved in the MorphoSys M&A talks is Incyte, according to Reuters.As a “matter of policy,” Novartis does not comment on “market rumors/speculations,” a company spokesperson said over email. Incyte and MorphoSys did not immediately respond to Fierce Pharma’s requests for comment. Both known bidders have preexisting ties to the company, with Novartis taking over a MorphoSys preclinical cancer program in 2022 and Incyte partnering on MorphoSys’ sole commercial product, the lymphoma med Monjuvi.Monjuvi garnered $92 million in U.S. sales last year, and MorphoSys expects 2024 sales of between $80 million and $95 million. The Novartis ...
- Source: drugdu
- 104
- February 9, 2024
Novartis CEO’s 2023 pay rises 21% as Roche’s helmsman nets $11M in his first year

After leading Novartis and Roche through pivotal years in 2023, the CEOs of the Swiss drug giants each netted multimillion-dollar compensation packages. Novartis handed its CEO Vas Narasimhan 13.3 million Swiss francs ($15.3 million) in total compensation for 2023, according to the company’s annual report (PDF). At grant value, the pay is 21% more than what he earned the year before.By comparison, Roche paid (PDF) its helmsman, Thomas Schinecker, a total of 9.6 million Swiss francs ($11 million). The former Roche Diagnostics chief took over from current Chairman Severin Schwan to become the group’s CEO last year. At Roche, the CEO transition—and the loss of its pharma division leader Bill Anderson to Bayer—marked the dawn of a new era. As for Novartis, the company recently became a pure-play innovative medicines company after spinning off the generic maker Sandoz in October.In his sixth year as Novartis’ CEO, Narasimhan saw his base salary climb 2% year over year to 1.82 million Swiss francs. The largest ...
- Source: drugdu
- 105
- February 9, 2024
FDA and EMA team up to expedite complex generic drug development

In a move to enhance patient access to complex generic drugs, the FDA’s Office of Generic Drugs (OGD) and the EMA have joined forces in a new pilot programme. This initiative, an extension of the original parallel scientific advice (PSA) programme, homes in on complex generics, also known as ‘hybrid medicines’ as per EMA terminology.Launched in 2005, the original programme offers a means for sponsors of new medicines to seek guidance from regulatory agencies in both the US and EU, regarding scientific matters related to product development. The new voluntary programme aims to facilitate concurrent discussions between generic drug manufacturers and regulatory bodies, with the ultimate goal of improving patient access to harder-to-develop generic drugs. To participate in the PSA programme, applicants must submit requests to the EMA and FDA. Examples of suitable candidates for this programme include proposals for single bioequivalence studies, approaches with common comparators, and the use ...
- Source: drugdu
- 116
- February 8, 2024
Pfizer Teams With American Cancer Society to Reduce Cancer Care Disparities

Pfizer announced a partnership with the American Cancer Society aimed at reducing disparities in cancer treatment. As part of the initiative, Pfizer is providing $15 million in funding. This money will go towards improving the health outcomes of cancer patients from underrepresented communities in the United States. This will include working to improve access to cancer screenings, clinical trial opportunities, and patient care. In a press release, Pfizer’s chief oncology officer and executive vice president Chris Boshoff said, “Cancer doesn’t discriminate–and neither should cancer care. Everyone should have the same opportunity to access the latest advances in care, regardless of their background or where they live. We’re proud to partner with the American Cancer Society on a broad, community-focused initiative to reach people living with cancer where they are, with urgency, and connect them to resources to receive the care they deserve.” The partnership will work under the banner of ...
- Source: drugdu
- 76
- February 8, 2024
Telix to acquire QSAM Biosciences for $123.1m

Australia-based global biopharmaceutical company Telix Pharmaceuticals has agreed to acquire US-based QSAM Biosciences for $123.1m.The deal comes after the companies signed a conditional non-binding term sheet for the prospective acquisition.Telix will also acquire QSAM’s lead investigational drug, Samarium-153-DOTMP (153Sm-DOTMP), a new kit-based bone-seeking targeted radiopharmaceutical candidate. The acquisition terms include an upfront payment of $33.1m (A$50.8m), payable as 4,369,914 ordinary shares of Telix.The deal also comprises contingent value rights that could see additional payments of $90m on meeting clinical and commercial milestones. These payments may be made in cash and/or shares.QSAM focuses on the development of therapeutic radiopharmaceuticals for primary and metastatic bone cancer. Its 153Sm-DOTMP for bone cancer has applications in pain management and therapy for bone metastases and osteosarcoma, including for paediatric patients.It complements Telix’s focus on oncology therapies and has shown promising safety, efficacy and commercial potential in early trials. The drug also has an improved safety ...
- Source: drugdu
- 98
- February 8, 2024

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