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Category: Pharma


Industry, Pharma

Brain drug developer Alto Neuroscience prices $129M IPO

February 2, 2024

Via: Biopharma Dive

Another biotechnology company has hit Wall Street via an initial public offering, the third to do so this year in an uptick of IPO activity that suggests rebounding investor interest in life sciences stocks. Alto Neuroscience raised about $129 million […]


Industry, Pharma

At FDA meeting, experts wrestle with hurdles to developing preterm birth drugs

January 25, 2024

Via: Biopharma Dive

The Food and Drug Administration this week convened a group of experts to discuss ways to develop new drugs for preventing spontaneous early births, a major health concern for which there are no good treatments. At the two-day workshop led […]


Industry, Pharma

FDA turns down Satsuma’s nasal migraine treatment

January 19, 2024

Via: Pharmaphorum

The drug – a new dry powder intranasal formulation of the well-established migraine therapy dihydroergotamine mesylate (DHE) – was submitted for approval in the US last March as an easy-to-use, portable treatment option for acute migraine attacks, with or without […]


Industry, Pharma

CDER Approved 55 Novel Drugs in 2023

January 18, 2024

Via: Biopharm International

FDA’s Center for Drug Evaluation and Research (CDER) published its New Drug Therapy Approvals 2023 report on Jan. 16, 2024 highlighting new drugs approved in 2023. CDER approved 55 novel drugs during the year and expanded indications or patient populations […]


Industry, Pharma

AI could revolutionise pharma compound synthesis

January 16, 2024

Via: Pharmaphorum

Their novel approach to high-throughput experimentation (HTE) could do away with the current need to run trial-and-error experiments to see how chemicals used to make medicines react with one another, predicting their behaviour virtually, and has been described in a […]


Industry, Pharma

5 questions facing pharma in 2024

January 10, 2024

Via: Biopharma Dive

The arrival of powerful new drugs for obesity has reshaped the pharmaceutical industry, transforming Eli Lilly and Novo Nordisk into the sector’s most valuable companies and sending others scrambling to catch up. Analysts predict that so-called GLP-1 drugs like Lilly’s […]


Industry, Pharma

Structure shares sink as obesity pill misses expectations in small study

December 18, 2023

Via: Biopharma Dive

An experimental obesity pill being developed by Structure Therapeutics helped lower the blood sugar levels of people with Type 2 diabetes in a clinical trial, but didn’t match the degree of weight loss observed in testing of a rival medicine. […]


Industry, Pharma

ASH23: Pharma branding, Editas’ high bar and clinical trial diversity

December 11, 2023

Via: Biopharma Dive

At the American Society of Hematology’s annual meeting, pharmaceutical branding is inescapable. Johnson & Johnson’s and GSK’s new logos are splashed across the side of phone charging stations. Sanofi, among others, let attendees know via hand sanitizer stands that it […]


Industry, Pharma

UCB bags FDA approval for second myasthenia gravis drug

October 17, 2023

Via: Pharmaphorum

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 […]


Industry, Pharma

Handling New Therapies Moving Through Drug Development at a Rapid Pace

September 13, 2023

Via: Biopharm International

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 […]


Clinical Trials, Industry, Pharma, Research and Development

Clinical Trials and their Impact on the Pharma Industry

September 1, 2023

Via: Biopharm International

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 […]


Industry, Pharma

FDA Approves Akeega for BRCA-Positive Metastatic Prostate Cancer

August 17, 2023

Via: Drugs.com

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 […]


Industry, Pharma

FDA Guidance on Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals

August 1, 2023

Via: Biopharm International

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 […]


Industry, News, Pharma

Teva Pharmaceuticals, Alvotech Expand Strategic Biosimilars Pact

July 25, 2023

Via: Contract Pharma

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 […]


Industry, Pharma

Novartis buys a preclinical biotech and its RNA drug technology

July 17, 2023

Via: Biopharma Dive

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 […]


Industry, Pharma

Bayer extends partnership with Peking University to foster pharmaceutical innovation in China

July 10, 2023

Via: World Pharma News

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 […]


Biotech, Industry, Pharma

Bayer’s new pharmaceutical R&D strategy to accelerate breakthrough innovations

June 28, 2023

Via: World Pharma News

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, […]


Industry, Pharma

BMS and Janssen’s antithrombotic granted FDA fast track designation

May 26, 2023

Via: PMLiVE

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 […]


Industry, Pharma

FDA approves new antibiotic for hospital-acquired pneumonia

May 24, 2023

Via: Biopharma Dive

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. […]


Industry, Pharma

FDA Panel Recommends Approval of First Nasal Spray, Neffy, to Combat Severe Allergy Attacks

May 12, 2023

Via: Drugs.com

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) […]