PharmaFocus Today – Page 239 – media

National Resilience lines up 440 new jobs at former AstraZeneca plant in Ohio

After multiple expansion forays overseas this year, biomanufacturing outfit National Resilience is returning to its American roots with plans to beef up production and add hundreds of new jobs at a recently purchased plant in Ohio. Resilience is expanding operations at the West Chester, Ohio, facility it bought from AstraZeneca in January, the technology-focused contract manufacturer said Monday. In turn, the company expects to create some 440 new jobs with an associated annual payroll of nearly $29 million over the next three years. The project represents a partnership between Resilience, JobsOhio and Cincinnati’s Regional Economic Development Initiative (REDI), the company noted. All told, the plan is set to nearly double Resilience’s current presence in West Chester, according to JobsOhio president and CEO J.P. Nauseef. In the company’s press release, Resilience’s CEO Rahul Singhvi pointed out that the West Chester site serves as the CDMO’s global center of excellence for commercial ...
- Source: drugdu
- 140
- December 14, 2023
After leak of neurotoxin, Sanofi plant in France is under scrutiny again

A Sanofi manufacturing facility in France, which was temporarily closed five years ago for emitting dangerous emissions, is under the microscope again after a recent leak caused the release of the same neurotoxin, bromopropane. The plant, which produces epilepsy drug Depakine (sodium valproate), released 75 times the allowable amount of bromopropane in mid-November, according to a report in the French news outlet Le Monde. The facility, located in Mourenx, stopped production “immediately” after noting “inconsistent measurements” of bromopropane emissions, according to a Sanofi spokesperson. “We quickly identified that this isolated and very brief event was linked to the degradation of the treatment unit’s activated carbons following the bad weather and heavy rains that had affected the region in the preceding days,” Sanofi said. “The coals were replaced and bromopropane emissions returned to normal, enabling production to resume after approval from the authorities.” Bromopropane—which is used in the production of Depakine—is ...
- Source: drugdu
- 111
- December 14, 2023
Genentech elevates interim CEO Ashley Magargee to full-time leadership position

Genentech’s brief leadership interregnum is coming to an end as the company’s interim chief executive, Ashley Magargee, prepares to take a permanent place on the throne. Magargee, who was tapped to temporarily steer the Roche subsidiary in November, will don the mantle of full-time CEO on Jan. 1, 2024, Genentech said Tuesday. Magargee, who most recently headed up Genentech’s commercial portfolio in addition to her interim CEO duties, is taking the place of Alexander Hardy. Hardy hit the exit back in November and now serves as CEO of BioMarin. Having served at Genentech since 2004, Magargee is no stranger to the South San Francisco-based drugmaker. In terms of her leadership pedigree, Magargee has operated in senior management positions at both Roche and Genentech across life cycle management, digital customer experience and market access, Genentech said in a release. Genentech and its Swiss parent Roche have been locked in a complicated ...
- Source: drugdu
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- December 14, 2023
Novartis puts ‘Sopranos’ actor in TV spot for MS drug Kesimpta

Novartis woke up one morning and hired itself a mom, putting Jamie-Lynn Sigler of The Sopranos fame at the center of a new TV spot focused on how Kesimpta empowers multiple sclerosis patients to use their time their way. Sigler, who played Tony Soprano’s daughter Meadow in the show, was diagnosed with MS aged 20 but only discussed her condition publicly almost 15 years later. At that time, the actor was taking Biogen’s Tecfidera, having previously “run the gamut” with MS drugs, but had suffered damage that prevented her from walking for long periods of time without resting and made stairs challenging. Today, Sigler is taking Kesimpta, a targeted B-cell therapy for patients with relapsing multiple sclerosis that received FDA approval shortly before Sigler first spoke about her MS diagnosis publicly. Novartis has made Sigler as the front of push to maintain the momentum of the Kesimpta launch. The ad ...
- Source: drugdu
- 114
- December 14, 2023
WHO calls on governments for urgent action to invest in Universal Health Coverage

The World Health Organization (WHO) has published the 2023 global health expenditure report, which sheds new light on the evolution of global health spending at the height of the COVID-19 pandemic. Released ahead of Universal Health Coverage (UHC) Day, the report reveals that in 2021 global spending on health reached a new high of US$ 9.8 trillion or 10.3% of global gross domestic product (GDP). Nevertheless, the distribution of spending remained grossly unequal. Public spending on health had increased across the world, except in low-income countries where government health spending decreased and external health aid played an essential supporting role. In 2021, about 11% of the world’s population lived in countries that spent less than US$ 50 per person per year, while the average per capita spending on health was around US$ 4 000 in high-income countries. Low-income countries accounted for only 0.24% of global health expenditure, despite having an ...
- Source: drugdu
- 113
- December 13, 2023
SystImmune and Bristol Myers Squibb Announce a Global Strategic Collaboration Agreement for the Development and Commercialization of BL-B01D1

December 11, 2023—SystImmune, a clinical-stage biopharmaceutical company, and Bristol Myers Squibb (NYSE: BMY) today announced an exclusive license and collaboration agreement for SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC). Under the terms of the agreement, the companies will jointly develop and commercialize BL-B01D1 in the United States. Through its affiliates, SystImmune will be solely responsible for development, commercialization, and manufacturing in Mainland China and will be responsible for manufacturing certain drug supplies for use outside of Mainland China. Bristol Myers Squibb will assume sole responsibility for development and commercialization in the rest of the world. BL-B01D1, a bispecific topoisomerase inhibitor-based ADC which targets both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3), is currently being evaluated in a global multi-center Phase 1 study (BL-B01D1-LUNG101) for safety and efficacy in individuals with metastatic or unresectable non-small cell lung cancer (NSCLC). Data from earlier clinical ...
- Source: drugdu
- 131
- December 13, 2023
Announcement of New Coronavirus Variant mRNA Vaccine (Omicron XBB.1.5) Approved for Emergency Use

Walvax Biotechnology Co., Ltd. (hereinafter referred to as the “Company”), in cooperation with Fudan University and Shanghai Blue Magpie Biopharmaceutical Co. (hereinafter referred to as the “RQ3033 Vaccine” or the “Vaccine”) developed by the Company in cooperation with Fudan University and Shanghai Blue Magpie Bio-pharmaceutical Company Limited (hereinafter referred to as the “Shanghai Blue Magpie”), which was approved by the relevant state departments for inclusion in the Emergency Use Program after receiving a letter from the Vaccine Research and Development Task Force of the State Council’s Research and Development Group of the Joint Prevention and Joint Control Mechanism on December 1, 2023 The “Vaccine” was approved for emergency use by the relevant state departments. The RQ3033 vaccine is an iterative vaccine developed on the basis of the mRNA technology platform jointly established by the Company, Fudan University and Shanghai Blue Magpie, and on the basis of the first-generation vaccine, i.e., ...
- Source: drugdu
- 121
- December 13, 2023
Announcement of Changchun BCHT Biotechnology Co. on Voluntary Disclosure of Approval of Clinical Trial Application for Freeze-dried Human Rabies Vaccine (Human Diploid Cells)

Important Notice: Changchun BCHT Biotechnology Co. (hereinafter referred to as the “Company”) has recently received the Notice of Approval of Drug Clinical Trial from the State Drug Administration. 2, the freeze-dried human rabies vaccine (human diploid cells) subsequent clinical trials are uncertain, and there is a certain degree of uncertainty whether the commercial purpose can ultimately be achieved. Investors are kindly advised to make decisions with caution and pay attention to the prevention of investment risks. The relevant information is announced as follows: I. Main information of the Notice of Approval of Drug Clinical Trial Acceptance No.: CXSL2300615 Notification No.: 2023LP02456 Drug Name: Lyophilized Human Rabies Vaccine (Human Diploid Cells) Conclusion: Agree to carry out clinical trials for the prevention of rabies. Approval date: December 6, 2023 The freeze-dried human rabies vaccine (human diploid cell) approved by the Company this time is freeze-dried human rabies vaccine (MRC-5 cell). II. Introduction ...
- Source: drugdu
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- December 13, 2023
As ICER places a spotlight on pharma’s price hikes, J&J, Roche and more hit back

After many years of tracking the pharmaceutical industry’s pricing tactics, the Institute for Clinical and Economic Review (ICER) is once again placing a spotlight on the price increases that end up costing the U.S. healthcare system the most. In an annual report (PDF) on “unsupported price increases” (UPIs), the independent nonprofit has placed scrutiny on hikes that it says aren’t supported by evidence of new clinical benefit, ranking the medicines by their contributions to excess healthcare spending. This year’s edition saw the return of AbbVie’s superstar Humira, which last year enjoyed a break from the annual list after being included in every other report since the series began in 2019. The fifth annual version, released Monday, evaluates the industry’s pricing moves in 2022. For Humira, 2022 was the last year of market exclusivity before the med’s dive off of the patent cliff. Humira captured ICER’s top spot on its UPI ...
- Source: drugdu
- 103
- December 13, 2023
Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy

Last month, Bristol Myers Squibb made the surprise announcement that the FDA will convene an advisory committee meeting to discuss the company’s bid to move the CAR-T therapy Abecma into earlier lines of treatment. Now, we know at least one reason why the FDA wants more opinions on the application. Abecma showed no advantage in extending patients’ lives compared with standard combination regimens when used in multiple myeloma patients after two to four prior lines of therapy, according to an updated interim analysis of the phase 3 KarMMa-3 trial presented at the 65th American Society of Hematology annual meeting. The statistical analysis revealed a negligible 1% increased risk of death for Abecma. But median overall survival looks better for Abecma, as patients lived a median of 41.4 months versus 37.9 months for control. The lack of an overall survival showing came in stark contrast to the 51% reduction in the ...
- Source: drugdu
- 120
- December 13, 2023

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