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Manufacturing is the production of products across all industries, on a large-scale, using machinery.

TherapeuticsMD announces FDA approval of BIJUVA capsules to manage vasomotor symptoms of menopause

TherapeuticsMD, Inc., an innovative women's healthcare company, today announced that the United States Food and Drug Administration has approved BIJUVA (estradiol and progesterone) capsules, 1 mg/100 mg, the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.

29 Oct 2018

Biogen and Eisai present detailed results from phase 1b study of aducanumab at CTAD meeting

Biogen and Eisai Co., Ltd. announced that Biogen presented results at the Clinical Trials on Alzheimer's Disease meeting, in Barcelona, Spain, from the recent 36- and 48-month analyses of the ongoing long-term extension of the Phase 1b study of aducanumab, an investigational treatment for mild cognitive impairment due to Alzheimer's disease and mild AD.

29 Oct 2018

Novartis enters into clinical development agreement with Pfizer to improve treatment of NASH

Novartis announced today that it has entered into a clinical development agreement with Pfizer which will include a study combining tropifexor and one or more Pfizer compounds for the treatment of NASH, including an Acetyl CoA-Carboxylase (ACC) Inhibitor (PF-05221304, a Diacylglycerol O-Acyltransferase 2 (DGAT2) Inhibitor (PF-06865571, and a Ketohexokinase (KHK) Inhibitor (PF-06835919).

29 Oct 2018

Cutting-edge material can regulate its own temperature

A cutting-edge material, inspired by nature, that can regulate its own temperature and could equally be used to treat burns and help space capsules withstand atmospheric forces is under development at the University of Nottingham.

26 Oct 2018

The Lancet Infectious Diseases journal publishes clinical trial results for Shionogi’s cefiderocol

Shionogi & Co., Ltd. announced today that The Lancet Infectious Diseases journal has published clinical results from the pivotal randomized controlled trial evaluating cefiderocol for the treatment of complicated urinary tract infection in patients at risk of multidrug-resistant Gram-negative infections.

26 Oct 2018

Emergex completes toxicology testing on gold nanoparticle carrier system for vaccine platform

Emergex Vaccines Holding Limited, a biotechnology company pioneering a new approach to synthetic vaccine development in the field of infectious diseases, today announces the successful completion of preclinical toxicology testing on the gold nanoparticle carrier system that forms the fundamental basis for Emergex's entire infectious disease vaccine platform.

24 Oct 2018

Federal court orders Tennessee-based company to stop selling OTC drug products

A federal court ordered a Tennessee-based company to stop selling over-the-counter (OTC) drug products until the company complies with the Federal Food, Drug, and Cosmetic Act and other requirements listed in a consent decree.

24 Oct 2018

A major grant funds curiosity-driven research into plant communication

A major grant to fund curiosity-driven research into plant communication has been awarded to a John Innes Centre researcher and colleagues from two European institutes.

24 Oct 2018

Polyganics begins first-in-human clinical trial of LIQOSEAL for reducing CSF leakage

Polyganics today announced that it has initiated enrollment of patients into a first-in-human clinical trial of LIQOSEAL, its dura sealant patch.

23 Oct 2018

Novartis: Lancet publishes pioneering study of Aimovig’s efficacy in episodic migraine patients

Novartis announced today that the full data from the LIBERTY study of Aimovig (erenumab) in episodic migraine patients who had tried and failed two to four prior preventive treatments have been published in the Lancet.

23 Oct 2018

Stratasys to showcase potential of 3D printed models at MEDICA 2018

This year’s MEDICA World Forum for Medicine (Düsseldorf, 12-15 November) will see Stratasys (Hall 9, Stand D12) demonstrate how medical institutions and their suppliers throughout the world are using advanced 3D printing across the entire value chain.

22 Oct 2018

Merck presents MK-1454 Phase 1 data for treatment of advanced solid tumors or lymphomas

Merck, known as MSD outside the United States and Canada, today announced the first presentation of preliminary data from a Phase 1 clinical trial evaluating MK-1454, an investigational STING (stimulator of interferon genes) agonist, as monotherapy and in combination with KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, in patients with advanced solid tumors or lymphomas.

22 Oct 2018

Merck presents KEYNOTE-057 trial results for patients with high-risk non-muscle invasive bladder cancer

Merck, known as MSD outside the United States and Canada, today announced the first presentation of results from an interim analysis of KEYNOTE-057, a Phase 2 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, for previously treated patients with high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ or CIS plus papillary disease (Cohort A).

22 Oct 2018

Incyte announces Phase 2 FIGHT-202 trial data in patients with cholangiocarcinoma

Incyte Corporation announces updated data from its ongoing Phase 2 FIGHT-202 trial evaluating pemigatinib (INCB54828), its selective fibroblast growth factor receptor (FGFR) inhibitor, in patients with advanced/metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) who failed at least one previous treatment.

22 Oct 2018

Newly discovered compound shows potential for treating Parkinson's disease

A joint research group centered around Professor Hideyuki Okano and Associate Professor Jun Kohyama, Department of Physiology of the Keio University School of Medicine, together with a research group of Eisai Co., Ltd. has identified a compound that has the potential to be a treatment for Parkinson's disease by using dopaminergic neurons differentiated from induced pluripotent stem (iPS) cells from patients with familial Parkinson's disease.

19 Oct 2018

Middlemen suppliers can increase drug prices and hospital bills, say Johns Hopkins researchers

Hospitals should be cautious of group purchasing organizations, or entities that act as middlemen between health care providers and manufacturers, says Martin Makary, M.D., M.P.H., a professor of surgery at the Johns Hopkins University School of Medicine.

19 Oct 2018

Key insights into the application, production of bioactive materials

Anatomy, Modeling and Biomaterial Fabrication for Dental and Maxillofacial Applications provides readers with information about dental implants and biomaterial fabrication for maxillofacial procedures and dental bone / tissue repair.

19 Oct 2018

Metrohm software products make it easy to comply with ALOCA and ALCOA+ guidelines

Data integrity requires data to be complete, consistent, and accurate throughout their complete lifecycle, providing full transparency and traceability.

From Metrohm USA Inc. 17 Oct 2018

Purdue Pharma, Eisai announce positive topline results from Phase 3 study of lemborexant

Eisai Co., Ltd. and Purdue Pharma L.P. announced positive topline results from SUNRISE 2, a long-term Phase 3 efficacy and safety evaluation of lemborexant, an investigational agent for sleep-wake regulation currently being studied for the potential treatment of multiple sleep-wake disorders.

17 Oct 2018

Eisai enters into agreement with Eurofarma for development and sales of lorcaserin in 17 countries

Eisai Co., Ltd. has entered into an agreement to grant exclusive development and marketing rights for its anti-obesity agent lorcaserin hydrochloride (generic name, product name in the United States: BELVIQ, product name for once-daily formulation in the United States: BELVIQ XR, "lorcaserin") in 17 countries in Latin America and the Caribbean, excluding Brazil, to Eurofarma Laboratorios S.A. which has a business foundation in Latin America.

16 Oct 2018

Manufacturing News and Research

Further Reading

TherapeuticsMD announces FDA approval of BIJUVA capsules to manage vasomotor symptoms of menopause

Biogen and Eisai present detailed results from phase 1b study of aducanumab at CTAD meeting

Novartis enters into clinical development agreement with Pfizer to improve treatment of NASH

Cutting-edge material can regulate its own temperature

The Lancet Infectious Diseases journal publishes clinical trial results for Shionogi’s cefiderocol

Emergex completes toxicology testing on gold nanoparticle carrier system for vaccine platform

Federal court orders Tennessee-based company to stop selling OTC drug products

A major grant funds curiosity-driven research into plant communication

Polyganics begins first-in-human clinical trial of LIQOSEAL for reducing CSF leakage

Novartis: Lancet publishes pioneering study of Aimovig’s efficacy in episodic migraine patients

Stratasys to showcase potential of 3D printed models at MEDICA 2018

Merck presents MK-1454 Phase 1 data for treatment of advanced solid tumors or lymphomas

Merck presents KEYNOTE-057 trial results for patients with high-risk non-muscle invasive bladder cancer

Incyte announces Phase 2 FIGHT-202 trial data in patients with cholangiocarcinoma

Newly discovered compound shows potential for treating Parkinson's disease

Middlemen suppliers can increase drug prices and hospital bills, say Johns Hopkins researchers

Key insights into the application, production of bioactive materials

Metrohm software products make it easy to comply with ALOCA and ALCOA+ guidelines

Purdue Pharma, Eisai announce positive topline results from Phase 3 study of lemborexant

Eisai enters into agreement with Eurofarma for development and sales of lorcaserin in 17 countries

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

Exploring the G:Box and for high-quality imaging

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