Putting Patients First Blog

MAY 29, 2024

Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers. As of 2023, 30.8

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PharmaShots

APRIL 3, 2023

Shots: The first quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Date - Jan 04, 2023 Product – N/A The acquisition is completed from a shareholder group led by Nordic Capital, in an all-cash transaction valued at $2.8B per ADS up front & CVR of ~$2.50

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FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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ID Stewardship

JUNE 6, 2023

BCPS, BCIDP Article Posted 7 June 2023 With the exception of the questions in bold, this entire text was written by ChatGPT. Industry pharmacists can develop AI-driven solutions to monitor patient adherence, gather feedback, and remotely manage medication regimens, thereby promoting patient empowerment and improving therapy outcomes.

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pharmaphorum

APRIL 19, 2022

RudaCure hopes to launch phase 1 and 2 trials for RCI002 in 2023. I think the most important thing is making a good team and also good communication within that team is very important. Drug development is never a swift process, and RudaCure still has many steps to take to bring its drugs to global markets.

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Putting Patients First Blog

FEBRUARY 6, 2024

Nature Communications, 11(6265). The price of progress: funding and financing Alzheimer’s disease drug development. Translational Medicine Communications, 4(18). Comparison of research spending on new drug approvals by the National Institutes of Health vs the pharmaceutical industry, 2010-2019. Macpherson, K.,

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Express Pharma

MAY 14, 2024

Launched on March 14, 2023, ChatGPT-4 is its next avatar and is 40 per cent more effective than its predecessor at providing factual responses. New drug development: The field of new drug development is expanding its use of AI and big data in a synergistic way.

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Putting Patients First Blog

JULY 10, 2023

NHC Comments on PFDD: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making (PDF) July 5, 2023 Robert M. MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. Califf M.D.,

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Pharmaceutical Technology

FEBRUARY 1, 2023

Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind. Since the FDA approved AstraZeneca’s monoclonal antibody therapy Synagis (palivizumab) 25 years ago, drug development successes for RSV have been few and far between.

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FDA Law Blog: Biosimilars

JULY 9, 2024

The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. FDA strongly encourages sponsors to discuss plans for a waiver early in the planning stages of the study or development program. Some unanswered questions remain.

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Putting Patients First Blog

APRIL 14, 2023

10: External Data Submission Timing The NHC understands the tight timeline for the drug selection and price negotiation processes. Rutta Chief Executive Officer 1 “Externally-Led Patient-Focused Drug Development Meetings.” He is reachable via e- mail at egascho@nhcouncil.org. Sincerely, Randall L.

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Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The draft guidance, released on March 5, is open for comments until May 7, after which it will replace an earlier 2009 guidance for the industry.

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Pharmaceutical Technology

JUNE 6, 2023

Dr. Tobias Arkenau, Global Head of Drug Development & CMO at Ellipses, said the data gives Ellipses the backing to advance their pipeline. Another cohort of patients with RET-fusion positive NSCLC who had received treatment like chemo-immunotherapy, had an ORR of 69.7%. In both cases, DCR of over 96% were reported.

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Pharmaceutical Technology

JANUARY 22, 2023

“[In] the last 20 years, there have been a large number of companies that have jumped into the rare disease arena, and for some diseases like Rett syndrome, they have targeted resources to developing therapeutic agents,” he says. Along with these drugs comes the opportunity to raise awareness and funds for different rare diseases.

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Pharmaceutical Technology

JUNE 22, 2023

The European Commission’s (EC) plan to test a novel scheme to incentivise antimicrobial drug development companies remains beset by questions amidst the bloc’s drive to tackle the growing threat of antimicrobial resistance (AMR). Årdal previously wrote about the voucher scheme in a February 2023 article published in The Lancet.

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Pharmaceutical Technology

MARCH 15, 2023

The recent collapse on March 10, 2023, of the then-parent company Silicon Valley Bank, was the second largest bank failure in US history. This could open doors to greater collaboration between biopharmaceutical and startup companies and create further opportunities for drug development, driving innovation in the industry.

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Pharmaceutical Technology

MARCH 31, 2023

Now, in this hunt for new drugs, small to medium enterprises (SMEs) are also taking their chances in the quickly growing marketplace, with new methods of targeting obesity. This topic was at the forefront of a panel on obesity drug development. At the Bio-Europe Spring 2023 conference held on 20-23 March.

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Pharmaceutical Technology

MAY 23, 2023

In its Q1 report , Centessa stated plans to present more data from part five of the open-label expansion of the Phase IIa study, subject to completion, at an undisclosed scientific meeting in 2023. The FDA’s fast track designation is designed to speed up the regulatory process to allow faster drug development and review to fill unmet needs.

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Pharmaceutical Technology

JANUARY 26, 2023

Such is the pace at which treatments are being developed that the medical landscape within the next decade could look radically different to how it does presently. RoslinCT also works in conjunction with the Scottish Universities Life Science Alliance, with Skills Development Scotland playing an important role in furthering capabilities. “We

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Pharmaceutical Technology

FEBRUARY 28, 2023

First established in 2008, Rare Disease Day is observed every 28 February, with events set up across more than 100 countries in 2023 to unite the world in raising awareness. Orphan drug development is expanding Change is happening. With similar incentives offered by EU/EEA and UK law, orphan drug development has taken off.

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Pharmaceutical Technology

APRIL 24, 2023

Artificial intelligence (AI) is set to be the most disruptive emerging technology in drug development in 2023, unlocking advanced analytics, enabling automation, and increasing speed across the clinical trial value chain. Please check your email to download the Whitepaper.

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Pharmaceutical Technology

MARCH 23, 2023

Scientific research and a better understanding of the condition is driving new developments in medications. The condition’s symptoms are not homogeneous, and that makes drug development complicated,” Javier Szwarcberg, CEO of Spruce Biosciences, a rare disease company researching endocrine disorders, says.

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Pharmaceutical Technology

MARCH 22, 2023

Several drug development trends are driving injectables demand. This includes the rising number of biologic drugs on the market, which are mostly administered parenterally. The number of requirements in the revised Annex 1 has been significantly expanded from the original 2008 version and will come into force on 25 August 2023.

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Pharmaceutical Technology

APRIL 27, 2023

When combined with rapid advancement in delivery technologies, mRNA has the potential to lead to breakthroughs in the development of tailored treatment approaches in a wide range of indications from cancer to rare genetic disorders while enabling rapid responses to emerging threats. billion by 2028.

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