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FDA approves first oral GLP-1 treatment for type 2 diabetes

Fri, 09/20/2019 - 12:00
The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise. Rybelsus is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States that does not need to be injected.

Dengue virus becoming resistant to vaccines and therapeutics due to mutations in specific protein

Fri, 09/20/2019 - 10:00
Researchers from Duke-NUS Medical School (DukeNUS), in collaboration with the Agency for Science, Technology and Research (A*STAR)'s Bioinformatics Institute (BII), and the University of Texas Medical Branch (UTMB), USA, have discovered that the dengue virus changes its shape through mutations in Envelope (E) protein to evade vaccines and therapeutics.

AstraZeneca amends collaboration with Ironwood for Linzess in China

Thu, 09/19/2019 - 10:00
AstraZeneca has amended its collaboration agreement with Ironwood Pharmaceuticals, Inc. (Ironwood) in China mainland, China Hong Kong and China Macau for Linzess (linaclotide), a first-in-class new treatment for patients with irritable bowel syndrome with constipation (IBS-C).

Educational campaign helps teens and their caregivers tackle the everyday challenges of living with moderate-to-severe atopic dermatitis

Wed, 09/18/2019 - 12:00
Teenagers face many challenges, and growing up with a chronic skin disease called atopic dermatitis (AD) can impact the ups and downs and transitions to young adulthood. Sanofi and Regeneron, in partnership with the National Eczema Association (NEA), today launched the next phase of Understand AD, a disease awareness initiative focused on educating people about moderate-to-severe AD.

Study points to new drug target in fight against cancer

Wed, 09/18/2019 - 10:00
Researchers have identified a potential new drug target in the fight against cancer. In a study this week in the Proceedings of the National Academy of Sciences, an international team of researchers describe how a cancer-linked version of the protein mitoNEET can close the primary gateways in the outer surface of mitochondria, the "power plants" that supply cells with chemical energy.

FDA takes first action under new international collaboration with Australia and Canada

Tue, 09/17/2019 - 12:00
The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the Australian Therapeutic Goods Administration (TGA) and Health Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.

FDA grants Fast Track designation for Farxiga in heart failure

Tue, 09/17/2019 - 10:00
AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death, or the worsening of heart failure, in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).

SMi's 9th Annual Orphan Drugs & Rare Diseases Conference

Mon, 09/16/2019 - 12:00
15 - 16 October 2019, London, UK.
The orphan drug market is continuously growing and is expected to reach $176 billion by 2020, with a CGR of 10.5% just for orphan drugs - this is twice the growth rate of the overall prescription drug market (5.3% CGR from 2014-2020). By 2020, orphan drugs are set to account for 19% of global prescription sales.

Gene-targeted cancer drugs, slow release overcome resistance

Mon, 09/16/2019 - 10:00
Biomedical engineers at Duke University have developed a method to address failures in a promising anti-cancer drug, bringing together tools from genome engineering, protein engineering and biomaterials science to improve the efficacy, accuracy and longevity of certain cancer therapies.

Roche presents new 6-year OCREVUS (ocrelizumab) data which showed that earlier initiation and continuation of treatment reduced disability progression in multiple sclerosis

Fri, 09/13/2019 - 10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced longer-term data from the Phase III open-label extension studies of OPERA I, OPERA II and ORATORIO showed that patients who were treated with OCREVUS® (ocrelizumab) continuously for six years or more had reduced risk of disability progression in relapsing MS (RMS) and primary progressive MS (PPMS).

A promising treatment for an incurable, deadly kidney disease

Thu, 09/12/2019 - 10:00
A potential treatment for polycystic kidney disease - a genetic disorder that causes the kidneys to swell with multiple cysts and can eventually lead to organ failure - has shown promising results in animal testing. A study describing the drug's development and testing appears today in Nature Communications. The study shows an approximately 50 percent reduction in kidney size in afflicted mice following treatment.

Abbott announces new data that shows artificial intelligence technology can help doctors better determine which patients are having a heart attack

Wed, 09/11/2019 - 12:00
Abbott (NYSE: ABT) announced that new research, published in the journal Circulation, found its algorithm could help doctors in hospital emergency rooms more accurately determine if someone is having a heart attack or not, so that they can receive faster treatments or be safely discharged.

SMi's Inaugural Pharmaceutical Manufacturing & Cleanroom Technology Conference

Wed, 09/11/2019 - 10:00
9 - 10 October 2019, London, UK.
SMi Group are pleased to announce the Inaugural Pharmaceutical Manufacturing & Cleanroom Technology Conference, taking place on the 9th and 10th October 2019 in London, UK. As the first event in Europe that focuses on cleanroom technology and aseptic manufacturing in the pharmaceutical industry, the conference will serve to bridge that gap between the two areas while simultaneously providing a unique selling point.

Existing drug could treat aggressive brain cancer

Tue, 09/10/2019 - 12:00
A research team from the University of Georgia's Regenerative Bioscience Center has found that a compound molecule used for drug delivery of insulin could be used to treat glioblastoma, an aggressive, usually fatal form of brain cancer. Glioblastoma, also known as GBM, is a fast-growing, web-like tumor that arises from supportive tissue around the brain and resists surgical treatment.

Roche presents new OCREVUS (ocrelizumab) biomarker data that increase understanding of disease progression in multiple sclerosis at ECTRIMS

Tue, 09/10/2019 - 10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data from OCREVUS® (ocrelizumab) trials in relapsing and primary progressive multiple sclerosis (MS). The analyses provide new insights into the biology of MS that advance the understanding of disease progression, with the goal of identifying and slowing disease progression as early as possible to preserve patient function over the long term.

New drug may protect against memory loss in Alzheimer's disease

Mon, 09/09/2019 - 12:00
A new drug discovered through a research collaboration between the University at Buffalo and Tetra Therapeutics may protect against memory loss, nerve damage and other symptoms of Alzheimer's disease. Preclinical research found that the drug - called BPN14770 - deters the effects of amyloid beta, a hallmark protein of Alzheimer's that is toxic to nerve cells.

FDA approves first treatment for patients with rare type of lung disease

Mon, 09/09/2019 - 10:00
The U.S. Food and Drug Administration has approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition.

Disruptive Technologies in Pharma 2019

Fri, 09/06/2019 - 10:00
20 - 21 January 2020, London, UK.
The conference aims to bring together experts of emerging technologies to discover the opportunities with regards to Artificial intelligence, Machine Learning, Internet of Things, Digital therapeutics, eHealth and blockchain. The effect of these technologies on the industry will be discussed with the aim to highlight challenges related to the implementation of these new technologies and to discuss how to overcome them.

Boehringer Ingelheim eExpands KRAS cancer program with Lupin's clinical stage MEK inhibitor compound

Thu, 09/05/2019 - 12:00
Boehringer Ingelheim and Lupin Limited (Lupin) announced a licensing, development and commercialization agreement for Lupin's MEK inhibitor compound (LNP3794) as a potential targeted therapy for patients with difficult-to-treat cancers. The partnership aims to develop Lupin’s lead MEK inhibitor compound in combination with one of Boehringer Ingelheim’s innovative KRAS inhibitors for patients with gastrointestinal and lung cancers harboring a broad range of oncogenic KRAS mutations.

Sandoz announces global deal to commercialize proposed biosimilar natalizumab, a key multiple sclerosis medicine

Thu, 09/05/2019 - 10:00
Sandoz, a Novartis division and a global leader in biosimilars, announced that it has entered into a global commercialization agreement for a proposed natalizumab biosimilar. The medicine is in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS).