Category: Pharma

October 17, 2023

Zilbrysq (zilucoplan), billed as the first once-daily subcutaneously-administered complement C5 inhibitor, will launch onto the US market in competition with AstraZeneca’s Soliris (eculizumab) and follow-up Ultomiris (ravulizumab) – both given as intravenous infusions – which were approved for gMG in […]

September 13, 2023

Drug development is inherently costly and time-intensive, with potential attrition a persistent burden on companies’ finances (1). As companies gain a deeper understanding of cell and molecular biology and seek to develop more complex therapeutics for patient populations, they will […]

September 1, 2023

Clinical trials are essential for establishing the efficacy of new drugs, observing patients’ reactions to treatments, and representing populations of people that may not always be discussed in everyday conversation. Although there are many diseases and disorders that are waiting […]

August 17, 2023

The U.S. Food & Drug Administration has approved Akeega (niraparib and abiraterone acetate) for the treatment of BRCA-positive metastatic castration-resistant prostate cancer. The approval makes Akeega the first and only dual action tablet combining a poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor […]

August 1, 2023

The M7 (R2) guidance emphasizes the importance of safety and risk management in creating levels of mutagenic impurities that are anticipated to not pose significant carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that live in […]

July 25, 2023

Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech, a global biotech company specializing in the development and manufacture of biosimilars, expanded their existing strategic partnership agreement. Teva will also acquire subordinated convertible bonds to be […]

July 17, 2023

Novartis said it was drawn to DTx for multiple reasons, interested in both the biotech’s lead treatment for Charcot-Marie-Tooth as well as its capabilities with small, interfering RNA — a technology with which the pharma is already familiar. Small, interfering […]

July 10, 2023

Bayer and Peking University (PKU) will collaborate to foster the translation of basic pharmaceutical research into drug discovery and development, while accelerating scientific research on cutting-edge technologies across the pharmaceutical value chain. The collaboration will focus on selected key areas […]

June 28, 2023

This afternoon at 2 pm CET (8 am EDT), Bayer AG will host its Pharmaceuticals R&D Event 2023 for Investors. The company will present a deep dive on the innovation strategy in its four therapeutic core areas Oncology, Cardiovascular Diseases, […]

May 26, 2023

The designations for the investigational oral factor XIa inhibitor cover all three indication-seeking studies within the phase 3 Librexia development programme: ischaemic stroke, acute coronary syndrome and atrial fibrillation. According to the companies, the programme aims to evaluate whether milvexian […]

May 24, 2023

Acinetobacter baumannii are a common cause of pneumonia in hospitals, and infections can be life-threatening. Innoviva’s treatment consists of a drug, sulbactam, that’s similarly structured as the antibiotic penicillin, along with another compound, durlobactam, that helps protect it from degradation. […]

May 12, 2023

Outside advisors for the U.S. Food and Drug Administration voted Thursday to recommend approval of Neffy, the first epinephrine nasal spray for severe allergic reactions. Although most of the Pulmonary-Allergy Drugs Advisory Committee members supported the spray for adults (16:6) […]

May 4, 2023

Hovione and H&T Presspart have partnered to advance the development of Presspart’s Sunriser Capsule-based Dry Powder Inhaler platform. The companies plan to work together to develop the Sunriser Dry Powder Inhaler, which is flexible enough to address the challenges of […]

April 18, 2023

In 2018, FDA’s Center for Drug Evaluation and Research’s (CDER’s) Office of New Drugs (OND) developed a research program to centralize and enhance its regulatory science research activities. In more recent years, the OND Research Program (OND-RP) published its first […]

March 23, 2023

There are myriad factors influencing the drug delivery market, such as the rising prevalence of chronic conditions, an ageing population, and technological advancements in drug development, leading analysts to predict continued growth in the sector at a compound annual rate […]

January 4, 2023

The intention is to streamline the process for patients wishing to access their medical records via electronic health record systems (“EHR systems”) and to facilitate the ability for researchers, innovators, and policy makers to use the data in a trusted […]

January 3, 2023

What is decentralised storage? Corporate data can be stored in one of three ways: on premises (the company’s in-house computer network), in the cloud (with service providers such as Amazon AWS, Google Cloud, or Microsoft Azure), or in decentralised storage […]

December 29, 2022

COVID-19 erupted, mutated, and was supplemented by the challenges of monkeypox and the need to catch up with major treatment and immunisation backlogs accumulated during the pandemic. At the same time, the industry must address the long-term difficulty of providing […]

December 28, 2022

In pharma, multi-billion-dollar deals dominate M&A headlines, but most deals are far shorter of this range and generally lie between $10-$500 million. Since the first wave of consolidation started in 1988, there has been a significant concentration of the pharma […]

November 29, 2022

‘Supporting the era of green pharmaceuticals in the UK’ highlights that, while Britain can play a leading role in the sustainability agenda for pharmaceuticals, action must also be taken on a global scale to ensure impact. The pharmaceutical industry’s share […]