Drugs

Based in Spiez, Switzerland, the entity will serve as a center for the safe receipt, sequencing, storage and preparation of biological materials for distribution to other laboratories, in order to inform risk assessments, and sustain global preparedness against these pathogens, said the parties. “Close international collaboration to ensure the timely sharing of epidemiological and clinical

Nurtec ODT 75 mg is the first oral CGRP antagonist approved to prevent migraine Nurtec ODT 75 mg is now the only migraine medication approved to both treat acute migraine attacks and help prevent future migraine attacks In a pivotal Phase 3 clinical trial, Nurtec rapidly and effectively prevented migraine, reducing migraine days by 30%

PRINCETON, N.J.–(BUSINESS WIRE) May 27, 2021 — Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD).1 Zeposia, an oral medication taken once daily, is the first

FDA Approves Myfembree as the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids BASEL, Switzerland and NEW YORK, May 26, 2021 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Myfembree (relugolix 40 mg, estradiol 1 mg,

It is reportedly the largest Series A capital raising exercise for a Singapore biotech and was led by Polaris Partners. The funding round also included new investors, Invus. Existing investors – 6 Dimensions Capital, WuXi AppTec, DHVC, EDBI, Baidu Ventures, Vectr Ventures, Goodman Capital, WI Harper, and Nest.Bio – also participated in the exercise. Engine

FDA Approves Camcevi (leuprolide mesylate) for the Treatment of Advanced Prostate Cancer TAIPEI, May 26, 2021 /PRNewswire/ — Foresee Pharmaceuticals (6576.TWO), (“Foresee”) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Camcevi 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, as a treatment

Announced in December, the acquisition of Boston-based Biotech Alexion Pharmaceuticals, Inc., will support AstraZeneca’s ambitions to develop novel medicines in immunology. It is set to be AstraZeneca’s largest ever acquisition.​​ Today the CMA announced the launch of a merger inquiry, which is open for comments​​ until June 3, 2021. The CMA will decide on July

The trial will cover a cohort of 600 adults aged 65+, taken from last year’s COVID-19 Phase 3 vaccine trial. Having received their second dose of the COVID-19 vaccine at least six months ago, participants will be randomized into groups to receive either a COVID-19 booster with 20vPnC; a placebo COVID-19 shot with 20vPnC; or

May 12, 2021 Audience: Consumer May 12, 2021 — Hi-Tech Pharmaceuticals. Inc. of Norcross, GA is recalling Lot # 001211197, Exp. 12/25 of Lipodrene w/25mg Ephedra Extract Dietary Supplement due to the presence of 1,4-dimethylamylamine (DMAA). The FDA has warned that DMAA is dangerous because it can narrow blood vessels and arteries and cause a

Upon execution of the deal, technology transfer will commence immediately. Samsung Biologics’ Incheon facilities will use a state-of-the-art production line equipped for aseptic fill-finish, labeling, and packaging services. The agreement will support the production of hundreds of millions of doses of Moderna’s COVID-19 vaccine, destined to supply of markets outside of the US. John Rim,

News FDA Alerts Miracle8989 Issues Voluntary Nationwide Recall of PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000, Due to Presence of Undeclared Sildenafil and Tadalafil May 19, 2021 Audience: Consumer May 19, 2021 Irving, Texas, Miracle8989 is voluntarily recalling all lots PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000, capsules to

Recombinant AAV-based vectors are used to develop gene therapies, as well as holding the potential to treat certain neurological and neuromuscular diseases as well as other conditions across multiple therapeutic areas. However, manufacturing is currently time-consuming and expensive making it difficult to develop therapies for diseases requiring high doses or across larger patient populations. Neuroscience

May 21, 2021 Audience: Consumer May 21, 2021 — The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized more than 207,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including over 34,000 kilograms of bulk kratom. The dietary supplements are manufactured by Atofil,

Over 180 ADCs are currently in clinical trials and at least 50 biopharmaceutical companies are operating ADC development programs, with the market expected to grow from US$2-3bn in 2021 to US$13bn in 2026, according to a Kuick Research report.  Despite the projected growth of ADCs beyond oncology and into treatments for other diseases, their development

“BD’s new plant in Zaragoza will produce drug delivery devices, primarily for pharmaceutical companies that supply the European market with drugs in PFS such as vaccines and other biologics,”​ said Eric Borin, worldwide president of BD Pharmaceutical Systems. In December, the medical technology company and pioneer of the prefilled syringe (BFS), announced plans to invest

The US Food and Drug Administration (FDA) issued a complete response letter for the drug candidate, pegunigalsidase alfa, late last month. Later, Protalix said the rejection stemmed from the FDA’s pandemic-related inability to visit the manufacturing facility in Carmiel, Israel where it makes the enzyme replacement therapy using its plant cell-based protein expression system. An

The CAR-T therapy, PRG1801, is in development as a treatment for relapsed or refractory multiple myeloma. D. Reddy’s said the candidate has shown “strong signs of efficacy and an excellent safety profile​” in an investigator-initiated clinical trial in China.  Based on the early promise shown by PRG1801, Dr Reddy’s has agreed to an upfront payment

Originally developed for therapeutic delivery of RNA, Mirus’ LPNCs  have been adapted for a wide range of gene delivery applications. The deal expands Gamma Biosciences’ reach in gene therapy and next-generation vaccines, while supporting the launch of Mirus Bio’s flagship TransIT VirusGen platform for manufacturing of adeno-associated viruses (AAV) and lentivirus-based viral vectors for gene

FDA Approves Rybrevant (amivantamab-vmjw) as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations May 21, 2021 (HORSHAM, P.A.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has granted the accelerated approval of Rybrevant (amivantamab-vmjw) for the

Topline findings from interim Phase 2 trial results include: All subjects who received an adjuvanted vaccine candidate developed significant antibody and cellular immune responses after two doses Similar antibody responses were observed in adults and in the elderly There were no severe adverse events reported The reactogenicity events were generally mild to moderate and short

Under the agreement, Thermo Fisher will build and operate a 44,000-square-foot, cell therapy development, manufacturing and collaboration center in leased space on UCSF’s Mission Bay campus, which includes biomedical research facilities and hospitals. The site will offer clinical and commercial cGMP cell therapy manufacturing services, along with associated technology development support, to UCSF and other