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Mira, a California-based women’s health technology company, has introduced its Menopause Transitions Kit, a new hormone monitoring kit designed for menopausal women. The at-home device enables women to track key hormone levels, offering real-time insights into the complex hormonal fluctuations associated with perimenopause and menopause.
For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.
Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Consequential FDA and EMA decisions.
Orion discovered and developed ODM-208 to treat hormone-dependent cancers, such as prostate cancer. Furthermore, Orion will oversee the manufacturing of ODM-208 for clinical and commercial supply. An oral, non-steroidal and selective CYP11A1 inhibitor, ODM-208 is currently being analysed in a Phase II trial in mCRPC patients.
The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. The regulator has issued a complete response letter. No concerns related to the clinical data package, safety or the medicine label.
Novo Nordisk overview Novo Nordisk, a subsidiary of Novo Holdings AS, is a healthcare company focused on discovering, developing, and manufacturing of innovative biological medicines. The company markets its products through subsidiaries in North America, Europe, Asia, Latin America, Africa, the Middle East and Australia.
Royalty Pharma, a company known for ponying up chunks of cash in exchange for long-term drug royalties, has hopped on board with Ascendis Pharma's long-acting growth hormone Skytrofa. Ascendis hopes to bring its second TransCon product to the market and overcome manufacturing issues.
To address growing demand, Gelteq is expanding production capacity with a Good Manufacturing Practice (GMP)-certified facility, aiming for scalable, reliable output by 2025. Across the industry, recent innovations in drug delivery signal a creative shift towards ease of administration and expanded treatment options.
NICE has rejected Johnson & Johnson’s oral prostate cancer drug Erleada (apalutamide) in patients with hormone-relapsed or hormone sensitive disease in first draft guidance. Hormone relapsed disease has stopped responding to hormone therapy and is usually treated with ADT alone or with Bayer’s Nubeqa (darolutamide) and ADT.
Amylin, a hormone co-secreted with insulin, plays a key role in regulating appetite by enhancing leptins effects the hormone that signals fullness after eating. Petrelintide, Zealand Pharmas long-acting amylin analog, is currently in Phase II clinical development and is designed for once-weekly subcutaneous injections.
Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity.
For Pluvicto that includes a pair of phase 3 trials in metastatic hormone-sensitive prostate cancer and metastatic castration-resistant prostate cancer, while for Lutathera it will affect studies for brain cancer glioblastoma, extensive-stage small cell lung cancer, and new NET indications.
The antitrust regulator in Spain has fined Merck approximately $39 million for preventing a competitor from marketing a generic version of a hormonal contraceptive, the latest effort by a European government to crack down on anti-competitive practices in the pharmaceutical industry. Continue to STAT+ to read the full story…
The health technology assessment (HTA) authority said that the PARP inhibitor “is not cost-effective at its current price” as a treatment for BRCA-positive prostate cancer that has spread to other parts of the body and relapsed after prior hormonal therapy.
The thyroid plays a critical role in the body by producing hormones that regulate metabolism, heart rate and body temperature among others. Types of Thyroid Conditions There are several different thyroid conditions, with each affecting thyroid hormone production or the gland’s structure, leading to a range of health issues.
Enzalutamide is under development for the treatment of non-metastatic castration-resistant prostate cancer, prostate cancer in patients with non-metastatic biochemical recurrence in the EU, China and Asia, and also for metastatic hormone-sensitive prostate cancer in the U.S,
Mellozzan contains the sleep hormone melatonin and is indicated for use in children with attention deficit hyperactivity disorder (ADHD) and sleep difficulties. EQL Pharma will serve as manufacturer and supplier of the therapy for all third-party deals signed by Adalvo.
They may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system. Biologics include a wide range of products , including: Vaccines. Allergenics.
Enzalutamide is under development for the treatment of non-metastatic castration-resistant prostate cancer, prostate cancer in patients with non-metastatic biochemical recurrence in the EU, China and Asia, and also for metastatic hormone-sensitive prostate cancer in the U.S,
Enzalutamide is under development for the treatment of non-metastatic castration-resistant prostate cancer, prostate cancer in patients with non-metastatic biochemical recurrence in the EU, China and Asia, and also for metastatic hormone-sensitive prostate cancer in the U.S,
Les Laboratoires Servier overview Les Laboratoires Servier (Servier) researches, develops, manufactures, and markets drugs for treating various diseases. The company also provides generic drugs and contract development and manufacturing services across its global network.
Douglas Pharmaceuticals overview Douglas Pharmaceuticals (Douglas) carries out the development and manufacture of nutraceutical and health products. The company also offers contract manufacturing and laboratory services. The company offers consumer, prescription and automation products.
Douglas Pharmaceuticals overview Douglas Pharmaceuticals (Douglas) carries out the development and manufacture of nutraceutical and health products. The company also offers contract manufacturing and laboratory services. The company offers consumer, prescription and automation products.
FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Orgovyx, which was granted Priority Review by the FDA, is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer. Indication.
Fooditive Group , a plant-based ingredient manufacturer, recently developed a vegan version of casein, one of the main animal proteins in milk. In developing the vegan casein, Fooditive aims to eradicate the downsides of factory farming, antibiotics, hormones and lactose.
Rezvilutamide is indicated for the treatment of metastatic hormone sensitive prostate cancer. Jiangsu Hengrui Medicine overview Jiangsu Hengrui Medicine (Jiangsu Hengrui) is a biopharmaceutical company that focuses on the research, development, manufacture, and distribution of novel pharmaceutical products.
Rezvilutamide is indicated for the treatment of metastatic hormone sensitive prostate cancer. Jiangsu Hengrui Medicine overview Jiangsu Hengrui Medicine (Jiangsu Hengrui) is a biopharmaceutical company that focuses on the research, development, manufacture, and distribution of novel pharmaceutical products.
Some of these chemicals are known endocrine (hormone) disruptors linked to developmental, cognitive and other health problems in babies and adults. In terms of the potential harms of food additives and packaging, synthetic chemicals that affect hormones have additive or synergistic effects.
Preservatives and additives serve as routine ingredients for manufacturers, extending the shelf-life of food products. That’s because American pork contains growth hormones. One notable growth hormone, ractopamine, often employed in pig farming, has been banned in numerous countries. It’s not just used to wash chicken, either.
Novartis announced it has broken ground on the construction of two new radioligand therapy manufacturing facilities in the US. The facilities are part of the company’s plans to expand its manufacturing and supply chain capabilities.
Large-scale manufacturing. The information contained within the download document is intended for pharmacists, pharmaceutical executives, sales managers, manufacturers, business development managers, pharmaceutical sales representatives, and any other individual involved in the pharmaceutical compounding sector. Packaging. •
Hormonal Status : A body’s hormones, such as levels of reproductive hormones and thyroid function, can impact tissue responses to radiation therapy. It also oversees Good Manufacturing Practices (GMP) for radiopharmaceutical production facilities to ensure consistent quality and safety standards.
Having headquarters in Ahmadabad, Gujarat, ‘ Fossil Remedies ’ is the top most Pharma franchises company in India with long years of experience.They manufacture and market more than 2800+ Pharma products and indulge in 8 Special divisions. 100+ Gynec & Hormones Products. They offer pharma franchise to interested parties.
Pediatric growth hormone deficiency (PGHD) is one such condition, affecting a child’s growth and development. This rare endocrine disorder, characterized by inadequate secretion of growth hormone from the pituitary gland, has profound impacts on physical and sometimes cognitive development.
After rejecting Eli Lilly’s Verzenio for breast cancer therapy earlier this year, NICE has relented, recommending the drug for routine NHS use alongside hormonal therapy fulvestrant. The February decision to reject the twice-daily drug was described as a “devastating blow” by patient advocacy group Breast Cancer Now.
The company filed heterocyclic composition patents in areas such as PAD4 inhibitors, factor Xa inhibitors, and nuclear hormone receptor modulators. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects.
Although the company is planning to double capacity through a new manufacturing expansion in North Carolina planned for the end of 2023, company executives are warning of supply challenges.
By investing into new technologies, automation, and digitalization, Bayer will implement a comprehensive program to substantially upscale its pharmaceutical manufacturing. Over the next three years Bayer will invest around 2 billion Euro into its manufacturing and supply chain capabilities.
Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.
Semaglutide acts as a glucagon-like peptide-1 (GLP-1) receptor agonist, mimicking the GLP-1 hormone released in the gastrointestinal tract after eating. Novo Nordisk, the pharmaceutical manufacturer of Ozempic and Wegovy, is actively addressing these supply challenges. There are safety concerns surrounding compounded semaglutide.
Advanz hiked the price of a pack of liothyronine tablets – used to treat thyroid hormone deficiency – from £20 in 2009 to £248 in 2017, taking advantage of a lack of competition for the drug even though it was out of patent. ” Advanz itself was directly fined £40.9 million and £51.9 million, respectively.
Biopharmaceuticals, also called biologics, are drug products that are manufactured using biological sources. Hormones (such as insulin, glucagon, and growth hormone, to name a few) are produced by recombinant DNA, as are blood factors, thrombolytic agents, interferons, monoclonal antibodies, therapeutic enzymes, and more.
Incidents such as the hormone replacement therapy drug shortage in early 2022 have shown the damaging impact supply chain issues can have on people who depend on these drugs. Neil Keegan is head of manufacturing at Automata, a London-based biotech company providing robotic automation solutions to the life sciences industry.
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