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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
Point-Of-Care Tool Diagnoses Genetic Mutations within Hours

Blood disorders like sickle cell anemia arise from genetic mutations. Typically, newborns are screened for sickle cell disease at birth, with any irregularities reported within 96 hours. However, a follow-up blood test is necessary to confirm the diagnosis, and obtaining these results can take between two to four weeks. Often, seeking genetic analysis through specialized private laboratories can be both time-consuming and expensive. Now, a new tool can detect the presence of genetic mutations within hours instead of weeks. Researchers at the University of Calgary (Alberta, Canada) have created a system named One-pot DTECT. This innovation is designed for simplicity and ease of use, enabling any laboratory in the world to quickly set up its own kit for same-day genetic mutation analysis at a minimal cost per sample. One-pot DTECT comprises multiple enzymes and distinct DNA fragments that work together to identify and detect genetic signatures. The compact kit includes ...
- Source: drugdu
- 84
- February 8, 2024
Stalicla secures funds for late-stage assets amid CNS buzz

Stalicla announced the successful closing of a $17.4m Series B funding round as deal-making interest stirs in the central nervous system disorder space. “In the current environment, we see this [financing round] as a huge success, but we’re targeting a much larger round in Q3 2024 with the involvement of large venture capital funds,” says Stalicla CEO Lynn Durham in an exclusive interview with Pharmaceutical Technology. Stalicla aims to use the extra funds to launch a Phase III substance use disorder (SUD) study for its STP7 mGluR5 Negative Allosteric Modulator (mGluR5 NAM) platform in 2025. The US National Institute on Drug Abuse and the National Institutes of Health are supporting Stalicla’s development of STP7.Stalicla acquired the therapy through an in-licensing agreement with Novartis in January 2023. In this deal, the Swiss company acquired the worldwide rights for studies using the STP7 platform for SUD, neurodevelopmental disorders, and other indications in ...
- Source: drugdu
- 102
- February 8, 2024
Non-Endoscopic Capsule Sponge Device Helps Detect Esophageal Cancer

Barrett’s esophagus is a condition often resulting from reflux, characterized by stomach acid damaging the esophagus lining and causing cell changes. While these cells aren’t initially cancerous, there’s a risk they might transform into esophageal cancer, a type where cells in the esophagus proliferate uncontrollably, potentially spreading to other body parts. Esophageal cancer is among the deadliest cancers in adults, and early detection significantly improves survival rates compared to a diagnosis at an advanced stage. Since the symptoms of esophageal cancer can mimic heartburn and reflux, conducting early tests for cancer detection is crucial. Now, a non-endoscopic capsule sponge device has been designed to collect pan-esophageal samples which are then sent for laboratory testing to detect esophageal pre-cancer and other conditions. Cyted’s (Cambridge, UK) EndoSign cell collection device is designed to detect and monitor conditions such as chronic reflux and Barrett’s esophagus, ultimately aiming to prevent esophageal adenocarcinoma. The EndoSign ...
- Source: drugdu
- 86
- February 8, 2024

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